CRO In-House Clinical Research Associate (Bilingual in Spanish a plus)

Technical Resources International Inc. - Bethesda, MD

Full-time
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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.
  • This position will work on-site (Bethesda, MD) when not on travel.

EDUCATION/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.

Job Type: Full-time

Experience:

  • Clinical Research: 1 year (Required)

Education:

  • Bachelor's (Required)

Work authorization:

  • United States (Required)

Required travel:

  • 25% (Required)