Site Regulatory Specialist - Remote US
About The Position
This position will work closely with the Regulatory Affairs department, site leadership and/or principal investigators to ensure compliance as well as preparing for auditing activities while meeting strict deadlines. This is a remote position based in the US; relocation assistance and visa sponsorship are not available. Duties include and are not limited to: Provides site level regulatory support to the TN Oncology site and internal department managers in relation to the status of start-up and ongoing regulatory maintenance Establishes and maintains a document management system for regulatory paper and electronic files for each study at the site Maintains updated physician credentials for TN Oncology site and other critical documentation ensuring compliance Meet with monitors and auditors to review regulatory binder Tracks documents pending site regulatory signatures Posts and permissions protocol documents Other duties as assigned
Requirements
- Associate's Degree, with Bachelor's Degree preferred.
- 1 - 3 years' work experience in a clinical research, health care, hospital, or pharmaceutical environment.
- Experience with medical and clinical research terminology.
- Work experience with all MS Office Suite of products including Excel, Microsoft Word, PowerPoint, SharePoint, and Outlook.
- Experience working in an environment requiring good organizational skills and solid deadlines.
Responsibilities
- Managing and tracking regulatory documents and protocol training to maintain site compliance for industry sponsors and GCP/FDA requirements.
- Provides site level regulatory support to the TN Oncology site and internal department managers in relation to the status of start-up and ongoing regulatory maintenance.
- Establishes and maintains a document management system for regulatory paper and electronic files for each study at the site.
- Maintains updated physician credentials for TN Oncology site and other critical documentation ensuring compliance.
- Meet with monitors and auditors to review regulatory binder.
- Tracks documents pending site regulatory signatures.
- Posts and permissions protocol documents.
- Other duties as assigned.
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being.
- Competitive compensation package.
- Annual bonus or long-term incentive opportunities may be offered.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
