The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to:
- Assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation
- Coordinate or assist in distribution of trial-related materials to study sites
- May assist in preparing the Site Initiation Visit presentation or review of clinical monitoring plans
- Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file held by TRI or Sponsor/Client
- Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs
- Track essential regulatory documents in a centralized web-based system and/or other database
- Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems
NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.
- Bachelor's Degree in life sciences or another health-related field
- Clinical trials /human subjects research experience with at least some knowledge of FDA/ICH GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO environment (e.g., In-house CRA, Study Coordinator, IRB Coordinator, Regulatory Coordinator/Associate): 1-3 years (preferred)
- Understanding of medical and clinical trials terminology
- Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution
- Able to work independently or with minimal supervision as well as within a team
- Excellent attention to detail with organizational and prioritization skills for efficient productivity
- Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum)
- Excellent professional writing and verbal communication skills (position requires clear phone and email communication)
- Able to multi-task during the review/processing and preparation of essential regulatory documentation
- Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right
- Must have excellent time management skills, able to adhere to strict timelines and expectations
- Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus
- Experience with using a Trial Master File, a plus
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