In-House Clinical Research Associate

Technical Resources International, Inc.; Bethesda (MD); On-site; USD 50,000 - 80,000; Full time

Job summary

Technical Resources International, Inc. in Bethesda, MD is seeking an In-House Clinical Research Associate to support clinical study teams with regulatory document management and compliance tasks. The ideal candidate holds a Bachelor's Degree and possesses excellent negotiation, communication, and organizational skills. The role demands proficiency in Microsoft Office and may involve regulatory document review experience. The salary range is $50,000-$80,000 annually, with no travel required.

Qualifications

• Must have understanding of medical and clinical trials terminology.
• Must be able to negotiate effectively with site staff.
• Must work independently or collaboratively within a team.
• Attention to detail and organizational skills are essential.
• Experience with regulatory document review/collection is advantageous.

Responsibilities

• Maintain essential regulatory documents for clinical trials.
• Review site documents for accuracy and compliance.
• Track documents in a centralized system.
• Coordinate distribution of trial-related materials.
• Assist in monitoring visit preparations.

Skills

Understanding of medical and clinical trials terminology

Ability to negotiate

Excellent attention to detail

Proficiency with Microsoft Office

Excellent professional writing and verbal communication skills

Time management skills

Education

Bachelor's Degree

Tools

Microsoft Office

Trial Master File

Job description

In-House Clinical Research Associate - (IHCRA001_COMPANY_1.1)

Job Title: In-House Clinical Research Associate

Location: Bethesda, MD 20817 US (Primary)

Category: Clinical Operations

Job Type: Full-Time

Salary Range: 50,000-80,000

Education: Bachelor's Degree

Travel: None

Job Description

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:

• 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.

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.

Job Requirements

• 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.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.