In-House Clinical Research Associate

Industry

Health and Safety

Advert ID

USA_450129

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD50000-70000 per year

No. of Openings

1

Branch Information

Bethesda, MD - (USA) 4800 Hampden Lane Suite 200 MD Bethesda , MD - 20814 Phone : 301-215-6346

ContactNumber

301-215-6346

Job Description

IN-HOUSE CLINICAL RESEARCH ASSOCIATE ( up to 5 positions)

Salary range - $50K - $70K - depending on experience



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 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) when not on travel.



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.