Regulatory Document Control Coordinator - Warrendale, PA
Branch ID: 2278
We are working with a client in Warrendale that is looking for someone with clinical trial experience to work on a project as Regulatory Document Control Coordinator. The Document Control Coordinator reports to the Manager of Regulatory Affairs, and this position is specific to the management of the trial master files (TMF) for clinical studies. The TMF is a critical component of the clinical trial process and is maintained by the Regulatory Affairs team. This is a TEMPORARY project slated to last 3-4 months. Applicants MUST be able to commit to a 3-4 month project role and experience with clinical trials is required.
Maintain Trial Master File
- Ensure all regulatory documents are procured and maintained in accordance with regulations
- Work closely with clinical operation leads to ensure all necessary documents are submitted to the TMF in a timely manner
Participate in team meetings and anticipate TMF activities
- Review regulatory documents for accuracy and completeness
- Update and maintain TMF content list
- Have a general understanding of study details in relationship to vendors, labs, IRBs, etc.
New Investigator regulatory submissions the FDA
Other duties as assigned
In return, we offer competitive hourly pay, direct deposit and temporary benefits!
Detail oriented (both oral and written) Self-motivated 1-2 years of relevant experience in clinical trial / clinical research role Associates degree / Bachelor degree Experience in Microsoft Word Experience in Microsoft Excel Excellent communication skills Effective time and prioritization management
The Company supports affirmative action and equal employment opportunity. The Company will provide equal employment in employment practices to all applicants for employment. Employment decisions shall be made without regard to any protected characteristic such as, but not limited to, race, color, religion, gender, age, disability, national origin, ancestry, citizen status, gender identity, sexual orientation, marital status, status in regard to public assistance, disabled veterans, recently separated veterans, Armed Forces service medal veterans and other protected veterans, genetic information and other legally protected classes. Furthermore, the Company is an E-Verify employer. Information provided on this application will not be used for any discriminatory purposes. The Company complies with all applicable federal, state and local non-discrimination laws and regulations. The Company will provide reasonable accommodations in the application or interviewing process. If you need a reasonable accommodation in the application or interviewing process, please contact us.
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Regulatory Document Control Coordinator
City, State or Zip Code: Warrendale, PA
Position Type: Temporary Position
Date Posted: 4/16/2019