In-House CRA

Candidates must work 2 days on site in Rockville/Bethesda, MD 20817

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 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.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.