What are the responsibilities and job description for the Regulatory Document Specialist position at Semmes Murphey Clinic?
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Job Type
Full-time
Description
The Semmes Murphey Foundation improves patient care and community health by advancing neuroscience through research and education. The foundation supports the Semmes Murphey Clinic, a leading brain and spine care center.
The Regulatory Document Specialist will support document control, staff training, and data entry for clinical research studies. Additionally, they will coordinate and maintain all Institutional Review Board (IRB) submissions and contracts.
Our employees are our best asset, and that is why we offer an excellent benefit package for full-time employees. We want you to have the resources you need to take care of your family, grow your career, and invest in your future. We offer Medical, Dental and Vision options through BCBS of TN, a Health Savings Plan (HSA) with a dollar-for-dollar company match, company paid life and disability insurance, and a 401K with a 3% match and 10% profit sharing contribution. Not to mention Paid Time Off (PTO) accrues based on hours worked per week and holidays are paid in addition to PTO.
We Are Looking For Someone Who Can
Minimum Requirements:
#SMF
Job Type
Full-time
Description
The Semmes Murphey Foundation improves patient care and community health by advancing neuroscience through research and education. The foundation supports the Semmes Murphey Clinic, a leading brain and spine care center.
The Regulatory Document Specialist will support document control, staff training, and data entry for clinical research studies. Additionally, they will coordinate and maintain all Institutional Review Board (IRB) submissions and contracts.
Our employees are our best asset, and that is why we offer an excellent benefit package for full-time employees. We want you to have the resources you need to take care of your family, grow your career, and invest in your future. We offer Medical, Dental and Vision options through BCBS of TN, a Health Savings Plan (HSA) with a dollar-for-dollar company match, company paid life and disability insurance, and a 401K with a 3% match and 10% profit sharing contribution. Not to mention Paid Time Off (PTO) accrues based on hours worked per week and holidays are paid in addition to PTO.
We Are Looking For Someone Who Can
- Coordinate Document Control to facilitate the timely opening and maintenance of new and ongoing trials at the site: communicate and collaborate with clinical research team to identify and resolve any regulatory issues. Additionally, facilitate collection of site training documents from study initiation visits as well as coordinate and collect ongoing amendment training documents.
- Assist in communication with the IRB, sponsors, the FDA and research subjects
- Coordinate training of study staff, physicians, fellows, and associated staff regarding ICH, GCP, CFR’s and SOPs related to research practices and clinical studies. Serve as information specialist and resource for regulatory, ethical, and methodological questions and issues from staff, coordinators, and researchers
- Ensure the study staff are in compliance and up to date on all Federal, State, and local laws and regulations
- Manage the entire contract lifecycle from drafting to execution and monitoring
Minimum Requirements:
- Bachelor's degree in related healthcare or science field
- Regulatory or data entry in related businessor healthcare field
- Regulatory Affairs Compliance (RAC) certification
- SOCRA certification
#SMF
