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In House CRA
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.
* Please note this position will work on-site (Bethesda, MD).
* Bachelor's Degree in life sciences or another health-related field.
* Bilingual in Spanish is an added plus.
* Previous experience with clinical trials /human subjects research.
* 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): One to three (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.
* Excellent MS Word, Excel and Outlook skills required.
* 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.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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