Research Compliance Resume Sample
Lavonne Ullrich
87405 Runolfsdottir Stream,
Boston,
MA
+1 (555) 562 3506
Work Experience
Director of Research Compliance & Global Support
01/2016
-
PRESENT
Phoenix, AZ
- Achieve regional and global objectives
- Develop and to implement regional and global policies and procedures
- Participate and contribute towards discussions held by the Compliance Global Business Team for Research
- Certified IRB Professional (CIP) or Certified IRB Coordinator (CIC) or Certified Clinical Research Professional (CCRP)
- Assists with identifying research operational/compliance areas to be audited, preparing audit notifications and making arrangements for conducting on-site audits
- Identifies and quantifies research compliance deficiencies. Recommends changes to operational systems/practices in order to secure compliance
- Evaluates audit results with appropriate consideration of relevance and accuracy. Formulates conclusions against accumulated audit evidence
- Prepares timely, thorough, clear and concise written reports of research compliance audits
- Arranges audit findings discussion conferences with departments/teams to present audit findings and make recommendations for corrective action plans. Communicates effectively with researchers, administrative staff and other research workforce members to ensure a successful audit
Research Compliance Analyst
10/2012
-
07/2015
New York, NY
- Assesses audit responses provided by operational areas to determine appropriateness of such responses. Makes recommendations for additional follow-up audits, if required
- Maintains appropriate and complete audit files. Secures, indexes and archives all documents for storage
- Independently conducts focused investigations or special reviews into suspected/alleged research non-compliance
- Works collaboratively with other departments to obtain required documents and actively researches background information as required for the special review or investigation
- Conducts interviews in a confidential and professional manner to obtain the information required for the special review or investigation
- Responds to special reviews or investigations with confidentiality, and ensuring that documentation meets standard fraud investigative techniques
- Appraises, or assists in appraising, the adequacy of corrective and preventive action(s) taken to effectively address non-compliant conditions
- Prepares timely, thorough, clear and concise written reports of research compliance special reviews or investigations
- Makes presentations as requested during and/or at the conclusion of the special review or investigations discussing deficiencies and recommending corrective and preventive action(s) to improve compliance
Research Compliance Spec Inter
02/2009
-
08/2012
San Francisco, CA
- Maintains appropriate and complete special review or investigation files. Secures, indexes and archives all documents for storage
- Evaluate and implement the compliance program (i.e., policies, procedures, training, systems and controls, reviews, etc.) for CS' Equity and Fixed Income Research Departments, which includes formulating and implementing requirements applicable to changing regulatory requirements and the supervision of those businesses
- Keeping abreast of regulatory developments and supporting the department’s participation in the consultation and impact assessment processes
- A strong understanding of core responsibilities within the research department
- Experience the compliance aspects of working within the research department
- The provision of specific compliance advice and training to business staff on regulatory developments, policy initiatives, projects, new business initiatives and process improvements
- Responsibility for interpreting and enforcing applicable rules and regulations, with emphasis on research related regulations
- Act as the compliance liaison for matters regarding Internal Audit, regulatory inquiries and inspections and Employee Conduct matters (e.g. licensing, personal account dealing, outside business activities and monitoring) relating to Research
Education
Portland State University
2003 - 2008
Bachelor's Degree in Related Area
Professional Skills
- Proven management skills including priority setting and work assignment and tracking
- Strong communication and excellent interpersonal skills – required
- Excellent verbal and written communication skills and the ability to respond effectively to confidential inquiries or complaints
- Excellent organizational skills and ability to prioritize tasks and multi-task
- Effective human resource management skills; demonstrated success supervising staff and identifying and engaging resources in a complex environment
- Excellent skills in establishing and implementing customer service standards
- Demonstrated supervisory experience or experience in mentoring and developing staff
How to write Research Compliance Resume
Research Compliance role is responsible for research, organizational, interpersonal, training, customer, microsoft, organization, excel, insurance, planning.
To write great resume for research compliance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Research Compliance Resume
The section contact information is important in your research compliance resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Research Compliance Resume
The section work experience is an essential part of your research compliance resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous research compliance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular research compliance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Research Compliance resume experience can include:
- Detail oriented and accurate with strong analytical, research, evaluation, and writing skills
- Excellent time management skills with ability to independently organize and efficiently deal with multiple ongoing activities
- Strong time management skills and ability to work in a deadline-driven environment
- Very detail oriented and good communication skills
- Proficiency in Microsoft applications, Adobe Pro, and Windows systems, including basic skills with Microsoft Word, Excel and Access
- Experience in dealing with federal/state regulations; and experience in the design of compliance monitoring
Education on a Research Compliance Resume
Make sure to make education a priority on your research compliance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your research compliance experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Research Compliance Resume
When listing skills on your research compliance resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical research compliance skills:
- Good written communication skills including the ability to communicate effectively by email
- Skills in problem solving, multi-tasking, working with frequent interruptions, and is an effective listener
- Active listening, critical thinking, good interpersonal skills and ability to multi-task
- Excellent organizational skills, the ability to multitask, meet deadlines, and problem solving abilities – required
- Demonstrated proficiency with the most current version of applications in the Microsoft Office Suite, including advanced skills in Word and Excel
- Problem solving skills; multi-task, work with frequent interruptions, effective listener
List of Typical Experience For a Research Compliance Resume
1
Experience For Research Compliance Analyst Resume
- Excellent knowledge of regulatory information regarding the protection of humans in biomedical research
- Experience supporting a web-based application for data, preferably clinical trials data
- The role requires regular collaboration with our global compliance teams, global bank experience preferable
- Developing and conducting Compliance training as appropriate
- Develop, draft and implement effective policies, procedures and processes for the establishment and continued improvement of effective compliance programs consistent with OIG’s seven elements
2
Experience For Director of Research Compliance & Global Support Resume
- Conducts follow-up of action required items identified in compliance reviews, ensuring the Principal Investigator (PI), and/or research team completes the required actions within the identified timeframe as outlined in the compliance review report until resolution of all required actions is achieved
- Assists in the review, analysis, and completion of results of compliance reviews and activities, and assists in the preparation of reports detailing the findings including aggregate information for enterprise and metrics reports
- Assists in the development and revision of ORI P&Ps as well as Standard Operating Procedures (SOPs) by offering input on content. Conduct yearly review of existing P&Ps and SOPs and facilitate revisions as needed. Manage and/or assist with special projects, as assigned
- Serve as the University resource regarding the compliance efforts related to the full breadth and scope of the University’s research enterprise, including
- Tracking and submitting IND / IDE submissions including initial applications, amendments, and annual reports to the FDA
- Advanced proficiency in public speaking, and writing
- The University’s existing research practices and policies and procedures
- Responsible for institutional review of all research involving human subjects and/or rDNA
3
Experience For MGH Research Compliance Associate Resume
- Monitors the status of submissions, reviews, reviewer communications, and follows up using a specified database
- Disseminates information regarding current requirements and/or changes related to assigned area(s)
- Serves as liaison between faculty/staff and the Office of Research Compliance and Integrity regarding Compliance Committee submission requirements
- Develops and delivers educational training programs on research compliance for the campus community
- Schedule meetings and/or investigations of alleged non-compliance reports by investigating in a sensitive, fair, and confidential manner
- Maintain knowledge of current information and issues regarding laboratory animal science and engage in professional development activities
- Articulate both orally and in writing
- Advanced understanding and application of theoretical knowledge of research compliance as it relates to human subject research and IRB functions
4
Experience For Research Compliance Specialist Resume
- Interact with faculty, verbally and in writing, with professionalism and decorum
- On the job training in regulatory affairs such as the protection of human subjects
- The University’s structure and operations, and the administrative and academic offices responsible for various aspects of research compliance; and
- Aides the department in ensuring the effective operation of the CSHL Institutional Review Board for the protection of human subjects (IRB), the Institutional Biosafety Committee (IBC), and the Institutional Animal Care and Use Committee (IACUC)
- Reads and reviews IRB and IBC submissions
- Assists the scientific staff in submissions to the IRB and the IBC
- Keeps abreast of federal regulations
- Collects, organizes, reviews, and analyzes documentation related to research records and activities in the assigned research compliance area(s) to determine whether proper university, state, and federal requirements are followed
- Serves as specialist in the assigned area(s) and provides guidance to faculty, staff, and students
5
Experience For Research Compliance Services Administrator Resume
- Assists in the development and implementation of policies and processes to ensure compliance with applicable protocols, laws, and regulations
- Ensures accurate management of records for regulatory review; processes corrections, as needed
- Coordinates and participates in the conduction of audits
- Assists with the development, implementation, and maintenance of databases to monitor compliance; provides statistical information for reports, documents, and publications, as needed
- Manages specific Research Compliance area web pages by providing updated information to the web master and ensuring all links are properly functioning
6
Experience For Senior Manager, Clinical Research Compliance Resume
- Efficient management of one of the four IRB committees responsible for reviewing and approving research involving the participation of human subjects
- Attends training and conferences, as needed, and reviews publications/websites on relevant research compliance program information
- Maintains confidentiality regarding subjects, records, and review of issues
- Work with the Director, Sponsored Research and Programs Compliance, to process research agreements, and streamline and automate research agreements processing
- Conduct pre-review of submissions requiring IRB review to ensure completeness and compliance with applicable regulations and policies
- Provide guidance to researchers and IRB members about regulations and CUNY policy concerning protection of human subjects
- Prepares statistical and administrative reports
7
Experience For Research Compliance Spec Inter Resume
- Review protocols that meet the regulatory criteria for exemption from IRB review and make exemption determinations, as appropriate
- Serve as communications liaison between the IRB and the researchers
- Assist in the implementation of new or modified research compliance policies and procedures; research compliance education and training initiatives; and research compliance quality improvement initiatives
- Screening and editing all new full committee studies submitted to the IRB, and providing extensive feedback and guidance to research team members and IRB members
- Participating in deliberations during IRB meetings as an ex officio, nonscientist voting member, providing IRB chairs, vice chairs and members with regulatory, ethical and policy guidance as well as specific information about individual research studies
8
Experience For Director of Research Compliance Resume
- Composing a large volume of in-depth analytical correspondence based on the IRB deliberations, records meeting minutes, and issuing approval notices based on conditions imposed by the IRB
- Advising faculty and staff on how their projects, programs and applications can best comply with ethical, regulatory and procedural requirements for the conduct of human research
- Training research staff in the preparation of applications, consent forms and recruitment materials, and being available for ongoing consultation and in-person presentations
- Reviewing, analyzing and implementing UCSF policies and guidance for the protection of the safety and welfare of human research participants and preparing and implementing procedures as needed
- Primary responsibility to register O-CTSU investigator initiated trials,. upload required documentation, maintain current status and report research results. Works closely with faculty investigators, study team (including the statistician), and multisite management
- Assist with the development and implementation of policies and procedures designed to promote compliant practices and mitigate risk when using animals for biomedical research, education, or product safety assessment
- Prioritize work, work independently, and manage a variety of projects simultaneously
- Provide guidance and training to investigators to assure compliance with research regulations and standards
- Participate in semi-annual IACUC inspections, program reviews, and preparation of federal, state and institutional reports
9
Experience For Director of Research, Compliance, & Ethics Resume
- Develop and maintain an IACUC compliance database, and help monitor corrective actions mandated by the IACUC or external regulators
- Generate reports, charts, and presentations
- Provides direction and advice to researchers involving human subject research protocols including submission, completeness/accuracy, informed consent documentation, amendments, continuing review protocols and adverse events submission; reviews submitted protocols for exempt or expedited review and approval
- Guides and advises departmental investigators, research teams, hospital administrators and staff regarding regulations and compliance activities as they pertain to clinical research of human subjects; supports Adverse Event Committee and IRB Committee meetings, as needed
- Works with the IRB staff to facilitate throughput of studies through the review process; conveys department study priorities to the IRB Committees
- Assists with compliance with all federal regulations, institutional policies and procedures, guidelines and state law in IRB files and protocols; assists in the development of departmental procedures
- Conducts and supports educational sessions with researchers and study coordinators
- Serve as the sponsor respresentative for Network trials to interact with performance sites, the trial Project Manager, National Data Management Center (NDMC) and cIRB staff to facilitate review of documents for protocol compliance for cIRB submission and other protocol related regulatory issues
- Use independent judgment to, interpret, analyze and perform the sponsor’s review in collaboration with the NCC Project Manager, the (NDMC) staff and the trial investigator sponsor
10
Experience For Associate Vice Provost for Research Compliance Resume
- Assist in the resolution of non-routine protocol related issues in coordination with the project manager, trial and site investigators, the NDMC and a site’s research staff
- Responsible for attending or participating in various NCC and NINDS meetings, webinars and teleconferences
- Act as an advisor to the Vice President for Research and Operations Manager on all issues concerning responsible and compliant conduct of research
- Serve as Institutional Official for the human research protection program, Deputy Institutional Official for the animal welfare program and Research Integrity Officer for research misconduct allegations and cases
- Ensure necessary and appropriate communication between the University and Federal and State entities to maintain University research operations in compliance with government regulations, to report mandated reportable compliance events, and to confirm correct interpretation/implementation of numerous regulations
- Provide advice to and counsel Audit Management on complex compliance risk management and control issues
- Maintain a liaison with SUNY Counsel on regulatory matters or issues of interpretation, legal/compliance issues and research misconduct proceedings
List of Typical Skills For a Research Compliance Resume
1
Skills For Research Compliance Analyst Resume
- Demonstrated experience developing and delivering interactive, multi-media training programs
- Advanced skills in strategy development, systems planning and change management
- Demonstrated leadership conceptualizing, initiating, and implementing compliance programs that support research while ensuring accountability
- Experience in developing and conducting education and training programs in compliance and integrity
- Demonstrated ability working with a diverse population within a compliance setting
- Two years’ experience in auditing or specialized training/certification e.g. CIA, SQA
2
Skills For Director of Research Compliance & Global Support Resume
- Able to provide good judgment, decision-making, and problem solving
- Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities
- Strong proficiency in public speaking, and writing
- Extensive experience leading business-process improvement, organizational-change initiatives and familiarity with information-systems implementation
- Experience in engaging in academic research
3
Skills For MGH Research Compliance Associate Resume
- Experience using internet based electronic document management systems, in particular IRB Manager
- Experience supporting administrative functions of a large college or university faculty committee
- Experience and ability for hands-on work with common laboratory animals including mice, rats and larger animals
- Advanced knowledge of quantitative and qualitative research design; scientific research concepts and terminology, and experience reviewing study protocols
- Experience working in a research intensive institution of higher education
- Experience in a team based professional setting
- A broad interest in current biomedical research and experience in the communication of science – required
4
Skills For Research Compliance Specialist Resume
- Experience in university research compliance environment required
- Related experience
- Accepting applications from inside and outside the University of Florida
- Understanding of organizational rules and regulations. Five or more years at UCSF
- Working knowledge of scientific and medical concepts and terminology
- Acting in accordance with HDFCCC policies and practices
- Understanding of the legal, financial, and social aspects of technology transfer, intellectual property protection, management and licensing
- Understanding of the process of research and the needs of researchers
5
Skills For Research Compliance Services Administrator Resume
- Identify obstacles in workflows relating to data entry and reporting and work out solutions with study teams and those responsible for the data
- Knowledge of the federal regulations for research using human subjects and recombinant DNA (rDNA) technology, bioethics, animal use, and HIPAA – desirable
- Knowledge of Federal and State regulations regarding human subjects’ research and recombinant DNA research – desirable
- Pace of work is sometimes hectic and always challenging
- Overall understanding of the role of the research enterprise in a major research university
- Emotional intelligence and professionalism in building customer/client relationships
6
Skills For Senior Manager, Clinical Research Compliance Resume
- Present information in a clear concise manner both in writing and verbally
- Human subjects, and animal care and use: academic training in the biological or social sciences, humanities or bioethics
- Familiarity with internet searching
- Solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective
- In-depth understanding of the operational requirement related to the management and implementation of the IRB review process
- Knowledge of Federal and Institutional confidentiality policies applicable to electronic databases containing protected health information
- Proficiency in working in web-based database systems and electronic data entry
- Problem solve issues; listen, interpret and confirm understanding of others' communications; and to be objective
7
Skills For Research Compliance Spec Inter Resume
- Solve problems, issues; listen, interpret and confirm understanding of others' communications; use sound judgement; and be objective
- Willingness and ability to take initiative, and to work both independently and collaboratively as part of a team – required
- Traditional office space located within a busy hospital
- Frequent employee and professional contacts
- Proficiency in Microsoft Office, Excel, PowerPoint, website content construction, communication and basic statistical operations
- Create, compose, and edit basic, routine and complex written materials
8
Skills For Director of Research Compliance Resume
- Certified Clinical Research Professionals (CCRP)
- Demonstrated management and supervisory skills, including an ability to teach and mentor professional staff and to achieve both timely completion of goals and client satisfaction
- Knowledge of policy, practice, and organization of federal funding agencies; understanding of University issues in a broader context
- Thorough knowledge and understanding of the requirements for regulatory compliance related to human subjects, laboratory animals, biohazardous agents and recombinant DNA, research integrity, conflict of interest and federally funded research
- Substantial experience promoting research compliance programs in a doctoral-extensive research University setting with exposure to many different areas of University administration
- Lead and manage people, mediate disputes and communicate effectively with faculty, administration and staff
9
Skills For Director of Research, Compliance, & Ethics Resume
- Experience in applying for and managing grants and contracts
- Exercise good judgment, to negotiate successfully, to solve problems, to plan strategically and to make decisions in a fast paced environment where the consequences of decisions can have a large impact
- Excellent interpersonal, organizational skills and administrative experience, including the ability to interact effectively in a culturally and ethnically diverse community
- Excellent ability to establish metrics to measure effectiveness and efficiency of service team and drive strategic operational decisions
- Proven advanced knowledge of good clinical practice guidelines, FDA regulations, and university policy and procedures in Human Experimentation
- Excellent leadership abilities to oversee multiple functions or departments
- Demonstrated expertise in working with diverse individuals and teams
- Good Clinical Practice GCP
- Proven ability to understand oncology, the specific organ cancers, and the standard of care treatments, as well as new experimental drug and biologics
10
Skills For Associate Vice Provost for Research Compliance Resume
- Working knowledge of pancreas/islet clinical trials
- Work across different functional areas and groups with all levels of management and staff
- Experience in human subjects research compliance including in-depth understanding of applicable federal, state and local regulations and requirements
- Familiar with Federal regulations and guidance pertaining to human subject and animal subject protections in research
- Current Certified IRB Professional (CIP) or ability to obtain certification within one year
List of Typical Responsibilities For a Research Compliance Resume
1
Responsibilities For Research Compliance Analyst Resume
- Serve as Research Foundation contact for HIPAA compliance in human subject research activities. Function as coordinator for compliance with SBU’s Misconduct in Science policy when involved. Communicate with RF counsel regarding continuing legal/compliance issues
- Proven ability to prioritize in a fast-paced work environment
- Prior AAVLD standard and implementation experience
- Demonstrated ability and desire to learn; curiosity around the research activities in which they are involved
- Demonstrated knowledge of ethical principles related to the ethical conduct of human subjects research
- Five years of experience in clinical research
- Demonstrated ability to identify problems, recommend, and implement solutions
- Scientific laboratory technician experience
2
Responsibilities For Director of Research Compliance & Global Support Resume
- Recruit members for all boards, including actively recruiting federally mandated community members
- Communicate with other universities in collaborative research endeavors to ensure facilitation of the activity
- Negotiate with sponsors (NIH, pharmaceutical companies, etc.) to streamline consent document language and to clarify difficult areas of requests
- Conduct reviews of IRB & IACUC protocols and evaluate protocols involving compliance activities to ensure they are in line with relevant regulations and policies
- Develop training, educational materials, web-based tools, and outreach programs for the University community and work directly as necessary with faculty, staff and students to ensure compliant and responsible conduct of research
- Monitor developments and changes in statutes, court rulings, rules and regulations that impact research compliance requirements, and promptly respond to periodic changes in Federal regulations and other guidelines
- Ongoing monitoring of compliance and AQ/QI Initiatives for active human research
3
Responsibilities For MGH Research Compliance Associate Resume
- Disseminate up-to-date news on regulations to appropriate parties in a timely fashion
- Directly supervise 2 Assistant Directors who manage 6 staff members to include assigning and directing work, appraising work performance, managing employee corrective action, addressing complaints and resolving problems
- Implement changes in office operations as needed to be responsive to faculty
- Drive teamwork within and between departments and organizations
- Serve as Research Foundation contact for HIPAA compliance in human subject research activities. Function as coordinator for compliance with SBU's Misconduct in Science policy when involved. Communicate with RF counsel regarding continuing legal/compliance issues
4
Responsibilities For Research Compliance Specialist Resume
- Managing and coordinating the development of new investigator-initiated trials and all subsequent amendments with the PI, study team, review committees, and regulatory organizations ensuring Federal, State, University, sponsor, and HDFCCC standards and policies are met
- Work with team members to develop and maintain best practices for the office and improve timelines and quality
- Register new trials, amend and update registrations twice yearly, report accrual quarterly, for UCSF investigator initiated clinical trial activities to CTRP and to clinicaltrials.gov
- Partner with Protocol Editors, PPMs, and biostatisticians to ensure that they are educated about the potential consequences of their practices on mandatory results reporting to the National Cancer Institute (NCI)
- Vet accrual data for NCI reporting, and cross-check data stored in various online portals and reconcile all inaccuracies or missing data to ensure accuracy, matching and completeness
- Stay current on NCI CTRP and clinicaltrials.gov requirements, and UCSF Helen Diller Comprehensive Cancer Center (HDFCCC) and UCSF policies and procedures
- Monitor NCI policies for relevant changes to processes or requirements, and work with HDFCCC leadership
- Understand and educate HDFCCC staff in partnership with staff educators on the purpose and importance of these compliance registrations and processes
- Research administration certification (e.g. CIP, CPIA)
5
Responsibilities For Research Compliance Services Administrator Resume
- General knowledge in data collection and analysis techniques; statistics or social science research techniques; knowledge of common organization-specific computer application programs namely, APeX, Iris, OnCore, MyExpense and BearBuy
- Proven ability to synthesis medical information and determine if the medical information within the medical records has been abstracted and recorded currently in the study database
- Proven ability to problem solves on the spot and determine if a medical event or non- compliance is significant and reportable to the DSMC Manager or the Chair of the DSMC
- Thorough knowledge and ability to apply all relevant Federal and state, regulations, policies, and federal guidance documents
- Proficiency in written communications
- Proficient in use of common computer programs (Word; Excel)
- Proficiency with office equipment and knowledge of standard office software
- Read and comprehend complex materials
6
Responsibilities For Senior Manager, Clinical Research Compliance Resume
- Relevant compliance certification - Certified IRB Professional or Certification obtained within six months of hire date
- Sufficient professional experience, adequate education, and sound judgment to comprehend, interpret, and analyze publications and reports concerning applicable policies, procedures, and regulations on human subject research issues
- Working knowledge of a significant body of scientific and/or medical concepts as well as terminology in order to be able to converse knowledgeably with researchers as well as to analyze and create documents and correspondence
- Demonstrated excellent oral (public speaking) and written communication, problem solving and analytical skills. Ability to independently initiate and compose highly technical, comprehensive and concise correspondence to investigators
- Quickly identify and synthesize salient features from a fast-paced discussion of highly technical broad-ranging information into a cohesive and well-written stipulations based on this discussion; ability to include individual analysis and research into this process
- Excellent organization and interpersonal skills; ability to work with a wide-variety of customers, including faculty members, research staff, students, IRB members and chair persons as well as other office, including Director and Assistant Directors in a consistently professional and service-oriented manner
7
Responsibilities For Research Compliance Spec Inter Resume
- Manage and correctly prioritize a large task list; ability to perform against deadlines with frequent interruptions and competing priorities
- Knowledge of human subject protection regulations
- Intermediate to advanced proficiency using Microsoft Office products, as well as proficiency using administrative, financial or academic programs, systems or databases
- Proactive, flexible, and customer focused with strong interpersonal communication skills to work effectively with diverse members of the university community and external constituents
- Proven ability to problem solve on the spot and determine if a medical event or non- compliance is significant and reportable to the supervisor or the Chair of the DSMC
- Two years of experience in administrative analysis or operations research, or an equivalent combination of education and experience
- Basic knowledge of relevant federal, state, organizational and system policies
8
Responsibilities For Director of Research Compliance Resume
- Knowledge of standard office software
- Proficiency with office equipment
- Travel to Oakland and other UCSF campus locations
- Excellent interpersonal and communication skills both verbally and in writing. Ability to exercise tact, mature judgment, diplomacy, and flexibility to promote positive working relationships
- Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology
- Knowledge of clinical research trials and study teams processes
9
Responsibilities For Director of Research, Compliance, & Ethics Resume
- Willingness to obtain certification as an IRB professional if not already certified
- Strong working knowledge of laws, regulations, policies, and nationally accepted standards regarding the care and use of animals in research, testing, and instruction
- Strong knowledge of the IACUC protocol review and approval process
- Good oral communication skills, including the ability to conduct training presentations in front of small groups. Has the ability to overcome language barriers of others
- Previous experience as a post-approval compliance monitor
- Can work productively with minimal supervision and as part of a team
- Experience with animal research techniques including anesthesia, aseptic technique, and drug administration as well as recognition of normal animal behavior and appropriate handling of laboratory animals
- Certification as a Laboratory Animal Technologist (LATG), Certified Manager of Animal Resources (CMAR), or Certified Professional IACUC Administrator (CPIA)
- Understanding of clinical research methods and operations, IRB, FDA, IND and IDE submission processes, NIH RAC submission process, and submitted to other research review committees and regulatory bodies
10
Responsibilities For Associate Vice Provost for Research Compliance Resume
- IRB or clinical research experience
- Up to one year of work experience in the human subjects protection program area or in a combination of relevant work experience in other research protection program, social and behavioral research, clinical research, or in management of human research
- Five to seven years of experience in staff management, or an equivalent combination of education and experience
- Basic knowledge of relevant federal, state, and system policies
- Certified IRB Professional (CIP) or willingness to complete within six months
- Expert knowledge and ability to apply all of the Federal, state, system and university regulations, policies and federal guidance documents
- Expert knowledge of quantitative and qualitative research design, scientific research concepts, and terminology
- Resolve conflicts in a timely basis
- Work experience in clinical trials as a clinical research coordinator, administrator, regulatory staff member, or relevant experience working with a research study team
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