In-House Clinical Research Associate job in Bethesda at Technical Resources International
Technical Resources International

Bethesda, Maryland

This job has expired.

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
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.

  • Bachelor's Degree in life sciences or another health-related field
  • Clinical trials /human subjects research experience with at least some 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): 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
  • 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

Get job alerts by email. Sign up now!

This job has expired.

LGBTQ Inclusion Jobs

Gain Access

Add Your Resume

Add your resume to our resume database that can be searched by employers looking to hire!

Job Alerts

Stay up to date with job alerts! Customize your alerts based on a specific area, category and receive weekly updates!

Sign up now to gain access!

More Science and Research jobs

ModernaTX, Inc.
Norwood, Massachusetts
Posted about 5 hours ago
ModernaTX, Inc.
Norwood, Massachusetts
Posted about 5 hours ago
ModernaTX, Inc.
Cambridge, Massachusetts
Posted about 5 hours ago
View Science and Research jobs ยป