In-House CRA

Technical Resources International, Inc. is seeking an In-House Clinical Research Associate to support clinical study teams, field CRAs, and Project/Task Managers. The role focuses on collecting, reviewing, tracking, and maintaining essential regulatory documents, coordinating trial materials, and assisting with monitoring visit preparation and follow-up.

Responsibilities

• Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system 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
• Coordinate or assist in distribution of trial-related materials to study sites
• May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation

Preferred

• Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus
• Experience with using a Trial Master File, a plus
• Regulatory document review
• IRB submissions
• OHRP regulations
• Trial Master File

Benefits

• Hybrid position with 2 days in TRI's Bethesda, Maryland office and 3 days working remotely

Company

• Full-service contract research organization for drug and medical device development
• Bethesda, Maryland, USA
• http://tech-res.com/
• Founded in 1979
• 201-500 employees

Qualifications

• 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
• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely
• Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus
• Experience with using a Trial Master File, a plus

Required skills

• Clinical Trials, IRB Submissions, Microsoft Excel, Microsoft Outlook, Microsoft Word, OHRP Regulations, Regulatory Document Review and Collection, Trial Master File (TMF), Veeva Vault, eTMF Processing

Preferred skills

• Experience with using a Trial Master File, a plus

Experience

• Entry level