Reports To: Clinical Trial Manager (CTM)
FLSA Status: Exempt
Department: Clinical Operations
Candidates for Senior Clinical Research Associate (Sr CRA), independently or in consultation with the Clinical Trial Manager should be able to perform the following tasks:
- Demonstrate a solid understanding of therapeutic indications and the study protocol(s) assigned.
- Assist in project planning; timeline preparation, preparation and review of study plans, including the Clinical Monitoring Plan and review of eCRF guidelines/specifications.
- Provide vendor management that may include EDC, IRT, Central Lab and specialty vendors.
- Develop clinical documents including ICFs, protocol support documents, Pharmacy Manuals, Lab Manuals, site support documents, and source documents.
- Select clinical Investigators appropriate to the therapeutic area and phase of the study.
- Assess potential study sites to ensure the facility, staff and patient population are adequate for study conduct.
- Facilitate budget planning and support site budget review, tracking and reconciling site related invoices of planned vs. actual spend.
- Independently manage study tracking, enrollment, site performance in collaboration with CTM
- Assess/review/ensure CRO monitoring quality, perform monitoring visits (PSV through closeout) as needed, review Monitoring Visit Reports (MVRs) and MVR metrics, attend SIVs and assist with site training, etc.
- Review essential documents for IP release, provide label review, and preparation and coordination of IP supply
- Perform TMF reviews for assigned study(ies) and support Clinical Trial Assistant with the set up and management of the filing.
- Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits independently or in conjunction with the CRO.
- Perform co-monitoring visits to evaluate CRO’s CRAs, site performance and review source documents at the site to ensure compliance with the protocol.
- Ensure the timely, accurate and complete collection and submission of study data.
- Identify, address, and resolve issues and problems as they might occur.
- Ensure collection of all data and remaining study supplies for return to the InCarda/CRO as appropriate.
- Ensure that appropriate study documents are complete and properly filed.
- Help prepare the site for possible inspections by Health Authorities.
- Assist the InCarda/CRO in problem solving and provide consultation on monitoring and study related activities.
- Demonstrate strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Work independently in a fast-paced environment.
This position may require up to 20% travel.
Knowledge, Skill and Competency Requirements:
- Excellent oral and written communication skills, interpersonal relationship skills, negotiating skills, knowledge of scientific method, GCPs and regulations relating to clinical research.
- Must have a working knowledge of computer technology and its application to the clinical environment.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
- Ability to provide clear direction and guidance to others.
- Demonstrated ability to lead by example and mentor others.
Must have a minimum of a bachelor’s degree, preferably in a relevant biological or health science discipline, and an MS or relevant experience is preferred. This position requires a minimum of six years of clinical research experience, five as a working CRA or equivalent in a pharmaceutical or biotech environment. Experience should include direct study oversight responsibility as well as field monitoring. Experience as a Study Coordinator or Research Nurse in cardiovascular disease will be considered a strong plus.
This position has no current supervisory responsibilities.
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure.
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.