Clinical Research Resume Sample
Mervin Fahey
77095 Gleichner Groves,
Houston,
TX
+1 (555) 878 0026
Work Experience
Manager, Clinical Research
04/2018
-
PRESENT
San Francisco, CA
- Acts as the primary site contact for the sponsor’s CRA for assigned industry trials
- Independently prepares for and participates in NCI, FDA, pharmaceutical and other audits for assigned trials, as well as any other trials assigned to the CISO CRA’s Team
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home
- Proficient in speaking and writing the country language and English. Good written and oral communication skills
- A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
- Prepare and assisting in initiating implementation of clinical studies including preparation of Ethics Committee/Institutional Review Board materials and communicating approval
- Provide site personnel training including preparation/maintenance of study documents, completion of forms, and understanding of examinations/assessments required
Clinical Research Monitor
02/2014
-
12/2017
Phoenix, AZ
- Maintain site and internal documentation in accordance with established Standard Operate Procedures (SOP´s) for agency/internal auditing
- Provide documentation, monitoring and distribution of contract obligations including financial obligations
- Ensure that trial contract obligations are met in a timely manner
- Serve as key contact to assigned clinical sites throughout the study process until site closeout
- Facilitate and support audit activities both in-house and at sites
- Prepare site visit reports
- Remain trained on EW SOPs and applicable clinical regulations
- Be available for monthly Clinical Team meetings in EW EMEA office, Nyon, Switzerland
- OTHER: Assume responsibility for additional assignments as directed by the CTO Director of Operations
Medical Assistant, Clinical Research Center
08/2007
-
08/2013
Phoenix, AZ
- Maintain contact with key institutional departments as necessary
- Monitor and reporting site enrollment progress including device accountability in registration studies
- Identify & documenting enrollment deviations (inclusion/exclusion criteria, eligible not enrolled patients)
- Collect completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation (paper CRF)
- Review, confirming and auditing documentation of the eCRF
- Monitor identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
- Deliver monitored CRF´s to Clinical Affairs or European Data Management if applicable
- Resolve identified CRF/eCRF queries and follow-up with the specific study sites to resolve them
Education
Vincennes University - Jasper Campus
2002 - 2007
Bachelor's Degree in Nursing
Professional Skills
- Take initiative and demonstrate the ability to work effectively pro-active on cross-functional teams with strong leadership skills
- Possess excellent strategic planning skills, good judgment and strong decision making capabilities
- Excellent organizational, interpersonal, verbal, and written communication skills, (including experience in making presentations)
- Demonstrated excellent communication skills in speaking and writing
- Strong interpersonal skills, customer focused, and ability to work independently, managing multiple priorities across a highly matrixed global organization
- Strong leadership skills with proven success in people management
- Position requires composition ability, data analysis skills, scientific writing and presentation skills
How to write Clinical Research Resume
Clinical Research role is responsible for research, clinical, organizational, interpersonal, training, advanced, computer, clear, technical, software.
To write great resume for clinical research job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Research Resume
The section contact information is important in your clinical research 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 Clinical Research Resume
The section work experience is an essential part of your clinical research 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 clinical research responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical research position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Research resume experience can include:
- Experience with solid understanding of current Good Manufacturing Practices, Good Tissue Practices, and Quality Programs
- Strong organizational skills, good at multi-tasking
- Have excellent interpersonal skills, including but not limited to: communication, problem-solving, teamwork development, leadership, mentorship
- Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
- Strong communication skills (written, verbal, listening) with all levels of the organization
- Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change
Education on a Clinical Research Resume
Make sure to make education a priority on your clinical research resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical research 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 Clinical Research Resume
When listing skills on your clinical research 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 clinical research skills:
- Knowledge and skills with Microsoft Office, Microsoft Word and Excel along with strong organization skills and attention to detail are essential
- Excellent interpersonal skills in establishing and maintaining effective working relationships
- Demonstrates effective written and oral communication skills to a varied audience including, but not limited to; medical staff, hospital staff, and patients
- Excellent follow up skills required, including excellent follow through with colleagues and families
- Demonstrated experience in writing skills and understanding of research grant application process
- Excellent attention to details in data collections, strong written and oral communication skills
List of Typical Experience For a Clinical Research Resume
1
Experience For Manager, Clinical Research Resume
- Effective verbal and written communication skills enhancing BCBST business processes, and provider credential satisfaction.10%
- Demonstrated analytical, negotiation, meeting management, cross-functional team and leadership skills at a management level are required
- Demonstrated planning skills; ability to create and track detailed project plans
- Excellent problem-‐solving skills
- Excellent Finnish, English & Swedish communication skills
- Strong experience in using and developing EDC and CTMS systems
- Computer skills vital including Word, Excel, PowerPoint
- Some experience with database software/strong interest in learning more
- Validate data using FITBIR Validation Tool
2
Experience For Clinical Research Monitor Resume
- Communicate effectively with sponsors and clinical sites
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Needs experience developing and managing EDC, CTMS or QMS systems
- Good understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
- Desired experience with software packages for neuroimaging processing and statistics, such as FreeSurfer, SPM, FSL and R
- Experience with programming in Matlab and/or other related computing languages
- Previous Oncology onsite monitoring experience
- Experience in Immunology GI monitoring
- Clinical trial experience (CRO, healthcare setting and industry acceptable)
3
Experience For Clinical Research Coordinator Associate Resume
- Maintain a good working knowledge of interventional clinical practices, new devices and outcome measures as related to assigned work
- Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)
- Experience/knowledge of neuroimaging
- Experience creating clinical evaluation reports and templates
- Provide assistance to research center staff in their daily work related to prioritizing projects and tasks
- To guide researchers through the process of forming a good data request
4
Experience For Clinical Research Supervisor Resume
- Experience using Medidata RAVE system
- Strong understanding of cardiovascular anatomy, pathology and physiology required
- Related experience in subject recruitment, assessment, and analysis related to neuroimaging research
- Previous experience with human subject (behavioral/neuroimaging) research
- Proven track record in personnel/team management and team building
- At least seven (7) years experience in clinical research and in handling subjects and patients in a clinical research setting
- Independent monitoring experience – at least 2 years
- Knowing, implementing, monitoring and assuring the Program’s compliance with University of Florida institutional regulations regarding research
5
Experience For Clinical Research RN Resume
- Authoring or assisting in the creation of Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets
- Coordinating with Investigational Drug Services (Pharmacy) for study visits requiring study drugs and arranging for orders and dispensing
- Working with the monitor from the sponsoring company during site initiation
- Ensuring Monitoring Plan requirements are being met and escalates risks
- Participating in the strategic planning for clinical trials team and assisting with development and implementation of the overall divisional plan
- Assisting with the preparation, organization and follow-up of investigator, site communications and clinical monitoring tracking
- Assisting in the creation of corrective and preventive action plans and trending reports
- Overseeing action item tracking and resolution status
- Performing co-monitoring visits as needed
6
Experience For Manager Clinical Research Resume
- Conducting investigations and audits of potential research compliance violations and implementing corrective action
- Reporting & writing data reports
- Interacting with sponsors on developing analysis plans
- Screening potential patients for protocol eligibility and presenting trial concepts and details to patients
- Participating in the informed consent process and enrolling patients on protocol
- Understanding of financial implications of the department and ability to analyze financial data, reports, project budgets, staffing, and expenditures
7
Experience For In-house Clinical Research Associate Resume
- Using existing FITBIR form structures, as applicable, for the ORION study
- Preparing and managing research protocols
- Working knowledge of US Federal government regulations regarding the conduct of human clinical research
- Working knowledge of information systems, including PC and Microsoft Office (Word, Access, PowerPoint, and Excel) and statistical software
- Providing input on study protocol, CRFs and other study documents
- Managing site assignments in collaboration with manager
- Facilitating communication and information flow between assigned project teams and assigned monitors on project
- Ensuring monitors are trained, current with project requirements and understand study milestones
- Reviewing data and source documentation from investigational sites for accuracy and completeness
8
Experience For Clinical Research Analyst Resume
- Attending Core/Study team meetings
- Explaining the ideal outcome of analysis plans to sponsors
- Coordinating patient care in compliance with protocol requirements
- Assisting with the maintenance of the Trial Master File to ensure completeness
- Working knowledge of dashboard software such as Tableau
- Recruiting and entering eligible candidates into research studies by obtaining informed consent and maintaining a clinical database
- Acting as liaison with members of internal and external units and reporting on progress
9
Experience For Clinical Research Coordinator Healthcare Resume
- Preparing reports to the Institutional Review Board in a timely manner
- Maintaining timely, accurate and thorough records of the program’s research activities
- Conducts hiring, training, directing, developing, and evaluating of staff
- Arranges meeting logistics. Drafts meeting agendas and assists in preparing meeting minutes
- Liaises with protocol principal investigators to establish pharmacy’s role in the trial for study drug compounding, packaging, and dispensing
- Help prepare manuscripts and reports, including preparing tables and formatting references
10
Experience For Field Clinical Research Associate Resume
- Work with the department to organize and improve health care services, including the tracking and reporting metrics for performance, program outcomes
- Manages action items resulting from meetings through resolution, including developing action plans
- Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP
- Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines
- Conduct certain human resource functions such as evaluation of staffing need, interviewing, performance evaluations, timekeeping and conflict resolution
- Thorough and first-hand knowledge of all clinical research processes including IRB submission, recruiting, collecting patient data and specimens
List of Typical Skills For a Clinical Research Resume
1
Skills For Manager, Clinical Research Resume
- Strong attention to detail, and competence to manage multiple priorities and respond effectively with limited guidance
- Solid working knowledge, skills, and understanding of project and program management techniques and technologies
- Excellent organizational skills and knowledge of federal legislation regarding human subject research and the provision of health care
- Effective leadership, people management, interpersonal, communication, and problem solving skills
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
- Plans, manages time and prioritises effectively
- Excellent verbal, written, interpersonal and written communication skills
- Well-organized, detail-oriented and excellent follow-up skills
2
Skills For Clinical Research Monitor Resume
- Demonstrated organizational skills and ability to manage complex IT projects
- Excellent interpersonal, communication, and presentation skills are required
- Strong communication, organizational skills, and self-motivated
- Work independently and proactively, with good organizational skills
- Strong interpersonal skills and flexibility for work in diverse settings
- Excellent analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of data efficiently and accurately
- + Experience working in a team/matrix environmentrequiring strong working relationships
3
Skills For Clinical Research Coordinator Associate Resume
- Strong working knowledge of statistics and experience using statistical packages for analyzing datasets (SAS, Excel, SPSS, etc.)
- Demonstrates strong leadership, team building and problem solving ability
- Prior research experience, including interaction with human subjects, ideally in a mental health setting
- Successfully manage multiple competing priorities and adapt quickly to changing priorities
- Adequate word processing skills with advanced MS Word and MS Excel are required
- Proven experience working with computers
- Skilled at providing excellent customer service
- Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines
- Technical writing skills (protocols, CRF development, study tools)
4
Skills For Clinical Research Supervisor Resume
- Proven experience in strategic planning, risk and change management
- Prior clinical trial experience, including source document and regulatory document maintenance
- Related quality assurance experience, including supervisory experience
- Competencies and essential skills in the following: cross functional Last
- Basic computer skills and working knowledge of Windows, Word, Excel
5
Skills For Clinical Research RN Resume
- Technical skills and familiarity with imaging software packages such as SPM, FSL and/or FreeSurfer
- In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively address complex or new problems
- Interpersonal skills, detailed -oriented and meticulous
- Current medical device industry experience, people management, project management and budget management experience required
- Communicate effectively with the public, staff, faculty and students with proper English usage
- Organizational skills and management of large number of electronic forms and data points
- Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively
- Proven experience in resource and expectations management in a matrix organization
6
Skills For Manager Clinical Research Resume
- Effective experience required
- Demonstrated experience
- Prior Experience in clinical study management or research collaborations is required
- Strong knowledge of Therapeutic Area(s), subject matter expertise and international experience are desirable
- Clinical experience with psychiatric populations and familiarity with DSM-IV diagnoses are very important. Experience with SCID helpful
7
Skills For In-house Clinical Research Associate Resume
- Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate
- Effectively work in a fast paced environment with multiple projects and timelines
- Beginning to Intermediate level Metlab experience
- Experience with direct line management of staff including hiring, training, oversight and mentoring
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Russia
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in South Africa
- Experience designing and overseeing a clinical development program, with emphasis on studies in humans
- Clinical research experience and/or basic science research including involvement with clinical protocols and participating in clinical trials
- Previous experience working with MRI scanning and data analysis
8
Skills For Clinical Research Analyst Resume
- Clinical research experience including involvement with clinical protocols and participating in clinical trials
- Two years’ experience in working within and/or conducting pragmatic, observational, and community-based health care projects
- Related hands-on experience in acquiring and/or processing fMRI data
- Extensive experience in conducting and managing Clinical Research Projects
- Over 5 years and up to and including 7 years of experience in clinical research preferably in a managed care setting
- Oversee supervisors and/or subordinate managers, including establishing priorities
9
Skills For Clinical Research Coordinator Healthcare Resume
- Substantial clinical development and execution experience, handling multiple parallel programs
- Experience working with documentation systems
- Able to prioritize work with an appreciation and understanding of organizational drivers, mission, critical objectives and budgetary expectations
- Cost-effectiveness analysis, financial accounting, or microeconomics
- Expertise in and excellent working knowledge of core trial management systems and tools
- Experience with clinical trial management systems/tracking databases
- One (1) year of experience working as a Registered Nurse (RN)
- Experience in Women’s Health monitoring
- Oncology monitoring experience required
10
Skills For Field Clinical Research Associate Resume
- Ideally 2 years’ monitoring experience in clinical development phase II-IV
- Valid Driver’s License and acceptable driving record at the time of hire
- Experience as a field clinical research monitor (Traveling CRA)
- Research experience in a healthcare setting required
- Experience in managing staff
List of Typical Responsibilities For a Clinical Research Resume
1
Responsibilities For Manager, Clinical Research Resume
- Effective verbal and written communication skills enhancing BCBST business processes, and provider credential satisfaction
- Demonstrated experience working in clinical research as an In-house Clinical Research Associate, Clinical Research Coordinator, or Regulatory Affairs Associate
- Prior experience in a healthcare environment of clinical research setting
- Experience teaching, orienting and mentoring new employees to clinical research
- Experience using Enterprise Reporting for reconciling grant finances
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Bulgaria
- Nursing experience, preferably in a hospital setting
- Experience in acquiring and/or processing fMRI data
- Experience with programming software including Matlab and Python
2
Responsibilities For Clinical Research Monitor Resume
- Experience managing grants using PeopleSoft tools
- Demonstrate expertise in leading-edge theories, techniques and/or technologies currently used in clinical trial design and conduct
- Work collaboratively with investigative sites to develop strong, long-term, working relationships
- Previous experience working on issues related to nutrition and/or obesity prevention
- Experience assessing clinical research protocols
- Independent field monitoring experience for clinical trials
3
Responsibilities For Clinical Research Coordinator Associate Resume
- Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials
- Professional attitude. Ability to respond well to changing priorities
- Demonstrated technical expertise in data models, database design development, data mining, and data segmentation
- Adept at queries, report writing, and presentation of findings with a strong drive for process optimization and data integrity
- Experience/knowledge of quantitative sensory testing
- Ensures patient questions and concerns are answered prior to obtaining consent. Explains in detail protocol requirements to the patient
- Experience assisting in the development of policy, procedure or patient education materials related to clinical research
4
Responsibilities For Clinical Research Supervisor Resume
- Substantial experience with standard software packages including Word, Excel, and PowerPoint
- Clinical Research Coordinator experience in an academic setting
- Experience working with IRB and research compliance regulations
- Clinical Monitoring experience
- Troubleshooting, contact, account, document and site management, monitoring visit report process and troubleshooting
5
Responsibilities For Clinical Research RN Resume
- Implementing digital and site facing clinical trial innovation to improve clinical trial efficiencies, reduced timelines and costs
- Understanding of statistics and familiarity with STATA or similar data analysis software
- Ensuring significant participation by all centers across the portfolio to positively impact recruitment performance and reduce study timelines and cost
- Ongoing portfolio surveillance and cross departmental collaboration with the CSUs to ensure network membership adequately supports program needs
- Providing seamless communication related to feasibility outcomes, study timelines to the CSU Network Site Liaisons
6
Responsibilities For Manager Clinical Research Resume
- Ensuring the reliable recruitment commitment of the Network sites against targets
- Understanding of mental health prevention and treatment
- Assists the Development Manager with disseminating funding opportunities and updating PI’s with status of funding and award notices
- Data collection and recording of everything surrounding the trial (doctor and patient information)
- Assist the investigators in evaluating, documenting, and reporting adverse events and other safety related data
- Oversee the collection and processing for specimens to meet study requirements, including saliva specimens and intravenous blood samples
- Understands and keeps a current understanding of FDA and Medicare guidelines for clinical trial billing
- Involvement in the activities required for the preparation, setting up, conducting and completion of clinical studies
- Acts as a resource and assists in the development of and provides training related to audit, monitoring, and QA/QI findings
7
Responsibilities For In-house Clinical Research Associate Resume
- Assist in obtaining outside documents and study specimen procurement and handling
- Prepare for monitoring/auditing visits, work with monitors when on site, and address all inquiries and follow-up as required by policies
- Proficiency in using computers, software, and web-based applications in a previous administrative setting
- Completion of an accredited Medical Assistant training program and/or an accredited Phlebotomy training program required
- Available to support site staff for studies not currently involved in performing on-site monitoring
- Audit monitor performance for studies not currently performing on-site monitoring, as requested
8
Responsibilities For Clinical Research Analyst Resume
- Advises Principal Investigator on funding source instructions regarding the grant budget, application, and allowable costs
- Conduct telephone screening calls for patients inquiring about their participation in clinical trials
- Interact and educate patients and families to help them gain an understanding and alleviate any apprehension regarding the studies
- Obtain written informed consent from patient allowing for free expression of fears, questions, etc., to ensure patient understanding
- Serve as a resource to others for all aspects of conducting a complex and multi-site clinical study, and lead a robust and expansive team
9
Responsibilities For Clinical Research Coordinator Healthcare Resume
- Writes informed consents following IRB requirements
- Submits application and applicable documents (protocol, informed consent, etc.) to overseeing Institutional Review Board (IRB)
- Conduct audit of selected participant’s source documentation including review of the electronic medical record, research files, labs etc
- Primary point of contact to support planning and execution of Celgene-sponsored clinical trials (phase’s I-IV)
- High level of exposure to cutting edge clinical trials
- Coordinates preparation of responses to regulatory agencies’ questions regarding the clinical study
- Represent clinical development function for other teams’ need including business development and legal related projects
- Serves as CRA back up providing verbal and written communication with study personnel
- Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable
10
Responsibilities For Field Clinical Research Associate Resume
- Assist with start-up activities, including essential document review and collection as requested
- Perform Interim Monitoring Visits for assigned studies
- Review research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required
- Assist study team as necessary in resolving lab queries and other issues
- Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements
- Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance
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