Senior Clinical Research Resume Sample
Trever Klein
52286 Kris Parkways,
Detroit,
MI
+1 (555) 976 6918
Work Experience
Senior Clinical Research Spec
01/2016
-
PRESENT
San Francisco, CA
- With limited supervision, plan, evaluate, coordinate and/or manage elements of multiple or complex research projects for a designated department, program, or central unit. Mentor level 1 or 2 employees
- Work a variable schedule that could include day, evening and night shifts, weekends and holidays
- Identifying eligible patients and approaching them for informed consent
- Enrolling subjects as outlined in IRB approved protocols and performing study procedures
- Provide HIV risk reduction counseling and testing to Emergency Department patients
- Processing blood and body fluid specimens and preparing them for shipping
- Working in conjunction with hospital clinical staff and communication with the treating teams
- Provide administrative assistance to lead coordinators and principal investigators with documentation needs and research data maintenance and reporting
Senior Clinical Research Professional
02/2012
-
10/2015
Los Angeles, CA
- Handle Social Work issues related to all studies
- Oversee regulatory needs of all studies
- Plan, evaluate, coordinate and/or manage elements of multiple or complex research projects for a designated department, program, or central unit. Mentor level 1 or 2 employees
- Oversee the other Clinical Research professionals and student workers
- Oversee progress on each grant
- Possess understanding of regulatory requirements
- . Ensure study progress is in accordance with baseline project timeline
- Assist in planning and implementing the clinical study’s goals and objectives; organize patient enrollment planning; conduct quality assurance activities; compile and analyze data
Senior Clinical Research Coordinator Licensed
10/2006
-
09/2011
San Francisco, CA
- Provide Project leadership and portfolio analysis to Clinical Department
- Responsible for identifying and delivering process improvement opportunities
- Create emphasis on programs and cross-program information
- Key focus on program management development- process; metrics and tools etc
- Clinical Study governance
- Develop, Manage and execute to Operations team objectives
- Experience leading and managing various projects (on time) that involve resources and tasks across multiple teams using Project Management tools
Education
Liberty University
2000 - 2005
Bachelor's Degree in Related Discipline
Professional Skills
- Knowledge of, and ability to apply, IRB and federal regulations (FDA, OHRP, HIPAA) as they pertain to human subject research and the ability to interpret and apply laws, regulations and guidelines (ICH-GCP) to ensure the overall protection of human subjects
- Demonstrated ability to communicate sensitive matters diplomatically and tactfully with all levels of researchers, faculty, staff and external regulatory entities and industry sponsors
- Strong interpersonal skills, including the ability to build relationships and work collaboratively with all levels of researchers and staff to effectively educate, explain and provide advice relating to research compliance and best practices
- Strong administrative skills, including the ability to work independently, prioritize multiple projects, adhere to deadlines, maintain confidentiality and stay organized
- In-depth knowledge of investigational drug/device regulations, clinical research best practices (ICH-GCP) and the federal regulations governing clinical research practices
- Exceptional communication skills including excellent presentation and writing skills
- Demonstrated practical skills with successful project management initiatives
How to write Senior Clinical Research Resume
Senior Clinical Research role is responsible for software, training, database, recruiting, auditing, reporting, design, research, travel, events.
To write great resume for senior clinical research job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Clinical Research Resume
The section contact information is important in your senior 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 Senior Clinical Research Resume
The section work experience is an essential part of your senior 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 senior 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 senior clinical research position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Clinical Research resume experience can include:
- Experience working in a Clinical department
- Demonstrated ability to work in a matrix and remote management structure
- Demonstrated problem analysis and solution recommendation capabilities
- Outstanding verbal communications in both formal and informal settings
- Multi-site contracting and onboarding of new participating sites
- Completes continuing education and training programs as assigned on continual basis, in addition to continuing education required for licensure renewal
Education on a Senior Clinical Research Resume
Make sure to make education a priority on your senior 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 senior 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 Senior Clinical Research Resume
When listing skills on your senior 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 senior clinical research skills:
- Knowledge of adult teaching and learning principles and skills in program development, coordination, presentation in a variety of modalities, and evaluation and assessment
- Analyze information, general programming skills, software development and design, software debugging, Software Documentation, software testing
- Demonstrated ability to form strong functional relationships
- Meticulous source documentation skills
- Draws required study labs following Good Clinical Practice and documenting appropriately
- Project Management experience in a clinical setting
List of Typical Experience For a Senior Clinical Research Resume
1
Experience For Senior Clinical Research Spec Resume
- Ensure quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions
- Coordinate obtaining continuing education credits for continuing education offerings whenever possible
- Serve as a positive change agent to initiate and support progress toward and the achievement of organizational strategic research related goals (NCI designation)
- Develop relationships with the local academic and healthcare community and serve as consultant, advisor, facilitator and/or instructor to external groups (clinicians, infusion nurses, investigators, researchers in other departments, etc...)
- Coordinate clinical site audit activities including pre-inspection training at clinical sites and within the department
- Lead the drafting and reviewing of study reports
- Support the development and completion of regulatory reporting requirements, internal reporting requirements, and clinical publications and presentations
2
Experience For Senior Clinical Research Professional Resume
- Maintain CTMS and other project tracking tools
- Review clinical monitoring reports
- Evaluates clinical and adverse event data for completeness during the conduct of the study and for completion of clinical study reports
- Coordinate physician meetings such as Investigator Meetings, Clinical Events Committees, and Data Safety Monitoring Boards
- Participates in one or more clinical studies from preparation, activation, enrollment, submission, maintenance, and study closure phases
- Contribute in the development and review of Clinical Investigational Plans with statistical justifications, patient informed consent, case report forms, clinical study material, and clinical databases in collaboration with cross functional teams
- Ensure the overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies; e.g., monitoring reports, device tracking, and CAPA tracking systems
3
Experience For Senior Clinical Research Spec-erp Resume
- Interact with sites, vendors, and cross functional team member
- Assist in the development and review of Clinical Investigational Plans with patient informed consent, case report forms, clinical study material, and clinical databases in consultation with the cross-functional project team
- Assist with investigation and site selection process
- Maintain and update study records on clinicaltrials.gov
- Perform the initiation and implementation of clinical investigations
- Mentors junior team members on the execution of the project
- 6) Conduct all assigned activities in compliance with national, local, & institutional guidelines, according to all HIPAA, GCP, and other applicable requirements. Activities include coordinating: new study activation requirements, screening/enrolling participants, regulatory and compliance requirements, maintaining appropriate study documentation/records, and managing study data
List of Typical Skills For a Senior Clinical Research Resume
1
Skills For Senior Clinical Research Spec Resume
- Valid driver’s license; ability to rent automobile
- Experience inproject/program management in a clinical researchenvironment
- Coordinates with investigators the External Research Program (ERP) submission, tracking, and local administration all in alignment with existing SOP’s
- Complete training and follow standard operating procedures
- Ensures timely reporting of research data, following study specific guidelines
2
Skills For Senior Clinical Research Professional Resume
- Submission of continuing reviews, SAE/AE, protocol deviations, and amendments as needed
- Financial tracking of study budget and expenses related to site invoices, study equipment/lab purchases, committee member payments, etc
- Data flow management of completed CRFs and tracking EDC data entry
- Plans, implements and coordinates all aspects of assigned studies, including creation of study specific source documentation
- Conducts study participant assessments for patients including Informed Consent and study eligibility, and collection of all necessary documentation
- Local customers, authorities and KOLs about local Clinical Affairs
- MEIC R&D: to develop and execute research feasibility and pre-market studies to full fill the product development and regulatory requirements
- Clinical BU: for in-depth knowledge about the local clinical environment and for mandatory consultation on site nomination
- Working knowledge and experience with clinical trial regulatory documents such as study protocols, informed consent documents and contractual documents such as Clinical Trial Agreements
3
Skills For Senior Clinical Research Spec-erp Resume
- Experience with clinical trial financial planning or general budget development
- Evidence of proficiency with Microsoft Word, Excel and Outlook
- Excellent time and task management skills including adhering to project work plans, tight deadlines, unscheduled client requests, internal project budgets, and general process completion timelines
- In case needed, takes care of study management for local studies at the request of the BU clinical team and Performs Country Clinical Project and Research activities as required
- Forwards approved local studies to the clinical BU, PAN, MCO and / or RCC for execution and facilitates the access to other departments (such as Regulatory, Quality, Reimbursement), Authorities and Ethics Committees
- Strong IRB regulatory & compliance knowledge is required
- Exceptional organizational skills with attention to detail and accuracy, and excellent oral and written communication skills required. Significant computer proficiency
4
Skills For Senior Clinical Research Coordinator Licensed Resume
- With Bachelors (Clinical or Scientific) or 2-5 Years with Masters or 0-3 with Doctorate
- Directly relevant experience, preferably in an academic or clinical setting. For nursing-focused role, three years nursing experience, and two years of experience in the area of clinical specialization
- Manage multiple tasks & priorities
- Development of protocols, consent, and case report forms
- Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, cardiac rhythm and heart failure therapies and technologies
5
Skills For Senior Clinical Research Data Specialist Resume
- Work experience, with at least 2 years in a clinical setting
- Experience in Pulmonary Critical Care
- Obtain written consent for study participation
- Screen patients for inclusion in study based on pre-determined criteria
- Ensure that the patient treatment provided and data collected adhere to the study protocol
- Perform routine physical/clinical procedures
- In conjunction with the investigator, document and evaluate adverse events and response to treatment
- Implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources
- Report data to sponsor and respond to queries
6
Skills For Senior Clinical Research Mgr SH Resume
- Obtain, process and ship patient blood samples for laboratory analysis
- Maintain interface with nursing and other professional personnel to interpret protocol application for a given patient and to answer questions about the study in progress
- Prepare presentations and reports that show progress, trends, recommendations and/or conclusions
- Work with study sponsors through communications and visits to ensure compliance
- Interfaces with Infectious Diseases Center Clinic Physicians and Staff to support practice issues specific to recruitment and follow-up of participants for duration of study
- Follows large caseload of study participants from study screening through end-of-study evaluations, including all necessary source documentation and data collection/entry
- Assist in establishing standard operating procedures for continuous review and development of quality improvement plans for our unit
- Identifies, collects and analyzes data that serve as a basis for outcome measurement of assigned clinical research studies
- Advances research objectives through participation in professional committees and presentations
7
Skills For Senior Clinical Research Analyst Resume
- Participate fully as a vital member of the IDC Research Team to ensure the continued success and growth of our unit
- Develops or provides input into the required clinical documents (such as the Clinical Study Management Plan, the Clinical Investigational Plan, study objectives, study budget and project schedule, study training materials, and study reports) in collaboration with investigators and the cross-functional study team to meet business needs
- Responsible for identification of data collection and data reporting requirements to assure clinical study objectives are achievable
- Drives collaboration of a study leadership team to assure high quality and successful project delivery
- Interfaces with key functional areas in order to align the clinical study with needs for other business areas (Marketing, research, regulatory, development, patient management, reimbursement.)
- Strong project management skills and proficient use of project management tools (e.g. MS Project, Visio)
- Cultivates strong relationship with clinical investigators and site staff
- Facilitates meetings with health care professionals, consultants and internal scientific or tactical committees
8
Skills For Senior Clinical Research Operations Manager Resume
- Collaborates with clinical field organization to drive study execution and data quality initiatives
- Oversee evidence dissemination and strategic planning for clinical projects / programs. Convenes investigator conferences to review study findings and advise on direction
- Critically evaluates study progress and metrics, collaborating with cross functional teams to identify risks and mitigation plans, if applicable
- Participates in or drives process improvement initiatives
- Problem Solving: Provides solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practical, and consistent with organization objectives
- Impact: Exerts some influence on the overall objectives and long range goals of the organization. Contributes to the completion of work group objectives. Failure to obtain results or erroneous decisions or recommendations would typically result in moderate impact on customers and/or results and considerable expenditure of resources
- Liaison: Internal interactions extend beyond the immediate work group and include frequent interaction with management. External interactions are primarily to solve problems or improve processes
- 1) Design, develop and analyze multiple data resources to provide client, provider with data trends and manage care trends
9
Skills For Senior Clinical Research Budgeting Specialist Resume
- 2) Work with the department to organize and improve health care services, including the medical home program, for patients with sickle cell disease to assist team with tracking and reporting metrics for performance, program outcomes and evaluations of claim costs and utilization trends
- Work on multiple projects in a fast paced environment with strong work ethic and integrity
- Problem solving, teamwork, and ability to work well in a diverse environment
- 5) Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols
- Conducts routine and directed internal audits to ensure compliance with federal regulations (FDA, HIPAA), ICH-GCP, NCI requirements, the IRB approved protocol, institutional policies, UCCI internal SOPs; and, to ensure data quality and accuracy
- Prepares and distributes timely reports of audit findings to the research team and regulatory staff, reviews corrective action plans/audit responses for adequacy and assures corrective actions are taken by study teams through follow-up reviews and associated activities
- Assists with the development and maintenance of systems for tracking and reporting of compliance & QA metrics, assists with the preparation of reports to stakeholders as needed
- Identifies trends in audit findings and compliance metrics, and develops and implements educational programs, or corrective actions, for research groups to reduce instances of identified noncompliance
- Analyzes Investigator Initiated Trials (IIT) protocols to customize audit plans for protocol specific benchmarks in addition to assisting with the creation of case report forms, study specific SOPs/tools, and database form design (OnCore, RedCAP)
10
Skills For Senior Clinical Research Coordinator Pain Management Resume
- Serves as a trainer/mentor to UCCI research personnel, designing training & educational materials as needed and presenting such materials to groups of researchers & staff
- Assist the DSMB/PRMC Coordinator, Sub-site Monitor, and other UCCI research staff with auditing or QA activities as needed, including but not limited to: preparation for cooperative group audits, monitoring visits, and DSMB meetings
- Design a research orientation program to train UCCI Clinical Trials Office personnel in clinical research best practices by promoting the use of clinical simulations, team-based multidisciplinary practices and utilizing multiple teaching strategies based upon learning styles or setting
- Onboard, mentor and assist new employees to assimilate successfully into the UCCI
- Design, coordinate, implement and evaluate a variety of formal continuing education programs for research personnel based on identified learning needs, emerging trends in research, new processes and practices, etc
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