Clinical Research Associate
Medix
This is a Full-time position in Washington, DC posted February 27, 2022.
We are searching for In-House CRAs interested in working with a full-service Contract Research Organization Plus.
This CRO+ is located in the Washington DC area and provides a unique range of support services to private industry, government agencies, and associations in areas of communications, clinical research, and information technology.
The role is full-time and includes a competitive wage and benefits.
The In-House Clinical Research Associates are an integral part of the clinical study teams who are primarily responsible for supporting the field CRAs and Project Managers on clinical trial administrative duties.
Job responsibilities 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.
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
Qualifications:
Bachelors 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: 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
Excellent professional writing and verbal communication skills
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) is a plus
Experience with using a Trial Master File is a plus
