Junior Clinical Research Associate

Location
20817, Bethesda
Posted
Nov 30, 2021
Ref
CR
Required Education
Bachelors Degree
Position Type
Full time

Piper Companies is currently seeking a Junior Clinical Research Associate for an opportunity in Bethesda, MD. The In-House Research Associate will be a part of a passionate team of Clinical Research Associate professionals who support trial that involve medical breakthroughs. This opportunity is remote until January 2022 then will transition into 3 days remote!

 

 Responsibilities of the Junior Clinical Research Associate:

·       Maintain visit preparation or follow up arrangements, regulatory file review and agenda preparation.

·       Assist in preparation of the Site Initiation Visit presentation or review of Clinical Monitoring plans.

·       File, maintain and retrieve essential regulatory documents from clinical trial sites for the Trial Master File (TMF).

·       Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP or SOPs.

·       Troubleshoot essential regulatory documents.

 

Qualifications of the Junior Research Associate:

·       Bachelor’s degree in life science or related field.

·       1-3 years of experience with Clinical Trial/Human Subject Research

·       Must be able to multi-task during review, processing, and preparation of essential documentation.

·       Experience with TMF is desired but not required.

 

Compensation for the Junior Clinical Research Associate:

  • Salary Range: $50,000- $65,000 Based upon experience
  • Comprehensive Benefits: Medical, Dental, Vision, and 401K

 

Keywords: TMF, eTMF, Electronic Trial Master File, Trial Master File, CRO, Contract Research Organization, FDA, Regulation, Regulatory, CRA, Clinical Research Associate, ICH GCP, SOP, Standard Operating Procedure, regulatory file review, agenda preparation, Microsoft Office, MS Word, Excel, Outlook, IRB, Internal Review Board, IRB Submission, Regulatory Coordinator, Pharmaceutical, OHRP regulations, clinical trial, human subjects, Veeva Vault, Site Initiation Visit, database