In House CRA - Beacon Hill Staffing Group, LLC

Compensation

: $58,070.00 - $91,730.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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Job Summary

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).



REQUIREMENTS
* 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.



Associated topics: antibody, diet, dietician, food scientist, histologist, kinesiology, microbiology, nutritionist, protein, therapeutic * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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