In-House Clinical Research Associate

Location: Bethesda, MD 20817 (hybrid – 2 days in-office, 3 days remote)

About the role

The In-House Clinical Research Associate supports clinical study teams—primarily field CRAs and the Project/Task Manager—on clinical-trial administrative duties.

Responsibilities

• Retrieve, file, and maintain essential regulatory documents from clinical-trial sites for the Trial Master File (TMF) or another central documents platform or system 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.
• Coordinate or assist in distribution of trial-related materials to study sites.
• May assist in monitoring-visit preparation and/or follow-up such as teleconference arrangements, regulatory-file review, and agenda preparation.
• Note: Specialized experience in eTMF (e.g., Veeva Vault) processing and system-administration skills may be required for some staff. This role may also serve as a transition or training role for the position of field CRA.

Requirements

• 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 (MS Word, Excel, Outlook at a minimum).
• Excellent professional writing and verbal communication skills (clear phone and email communication required).
• Able to multi-task during the review/processing and preparation of essential regulatory documentation.
• Self-motivated, with a positive attitude, and willing to ask questions to ensure the job is done right.
• Excellent time-management skills; able to adhere to strict timelines and expectations.

Qualifications

• Bachelor’s degree.
• Experience with regulatory-document review/collection and IRB submissions (including OHRP regulations) is a plus.
• Experience with using a Trial Master File is a plus.

Pay

$50,000–$80,000