In-House CRA

Hybrid In-House CRA Posted: 18 May 2026 Location: Rockville, MD Reference: 1004701 Candidates must work 2 days on site in Rockville/Bethesda, MD 20817 Job Description Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by 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-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. Job 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 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. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status. #J-18808-Ljbffr Dexian DISYS