6 Regulatory Affairs Assistant (START Midwest) Jobs in Grand Rapids, MI
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Cancer & Hematology Centers of Western Michigan is Hiring a Regulatory Affairs Assistant (START Midwest) Near Grand Rapids, MI
- Stamp and distribute all incoming departmental mail
- Prepare file folders for all new studies
- Maintain regulatory files (paper and electronic), including IRB submissions and correspondence
- Review, process and/or submit IND Safety reports, SUSAR reports, and other interim safety reports to the IRB
- Process and/or submit SAE reports to the IRB
- Grant and maintain monitor access to SharePoint
- Oversee monitor visits (ensure files are up to date, print quality assurance comment cards for each study, be available to answer questions from monitors, etc)
- Review, obtain signatures (if needed), and file incoming monitor letters
- Obtain signatures on Delegation of Authority logs (or similar logs) from appropriate personnel
- Maintain and request updated laboratory documents (CLIAs, CAPs, Director CVs/MLs, normal ranges) for core laboratories
- Review incoming lab reports for outside laboratories and request laboratory documents
- Share responsibility with other Regulatory Affairs staff to note changes in FileMaker database (personnel, study monitors, etc)
- Perform other duties as assigned
Job Summary
Full Time
Ambulatory Healthcare Services
$62k-80k (estimate)
06/01/2023
05/14/2024
chcwm.com
GRAND RAPIDS, MI
100 - 200
1979
Private
$10M - $50M
Ambulatory Healthcare Services
Related Companies
The following is the career advancement route for Regulatory Affairs Assistant (START Midwest) positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Assistant (START Midwest), it can be promoted into senior positions as a Regulatory Auditing Senior Analyst that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Assistant (START Midwest). You can explore the career advancement for a Regulatory Affairs Assistant (START Midwest) below and select your interested title to get hiring information.
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