Regulatory Affairs Specialist Lead
7 days ago
We are seeking a highly skilled Regulatory Affairs Specialist I to join our team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson. This is an excellent opportunity for a motivated and detail-oriented professional to contribute to the advancement of oncology treatments and improve outcomes for cancer patients globally.
The successful candidate will have a strong understanding of regulatory affairs compliance, including FDA and GCP guidelines, and experience in managing document management systems for regulatory paper and electronic files. Additionally, they will be responsible for maintaining updated physician credentials, informed consent forms, and protocol modifications in compliance with IRB policy and HIPAA.
Key Responsibilities- Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks.
- Maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors, and/or other networks.
- Establish and maintain a document management system for regulatory paper and electronic files.
- Update and manage protocol and consent form modifications or amendments in compliance with Institutional Review Board (IRB) policy and HIPAA.
- Organize and coordinate IRB documentation for trials.
Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations, conducting community-based clinical trials. With over 30 years of experience, SCRI has contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today.
As part of Total Rewards, we offer a competitive compensation package, including an estimated salary range of $65,000 - $85,000 per year, based on performance, experience, and skills. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities, may be offered.
What We Offer- A dynamic and supportive work environment.
- Ongoing training and development opportunities.
- A comprehensive benefits package, including medical, dental, and vision insurance.
- A 401(k) retirement savings plan with employer match.
- Tuition reimbursement and education assistance programs.
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Regulatory Affairs Professional
7 days ago
The Woodlands, United States Lifelancer Full timeWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Sarah Cannon Research Institute (SCRI), a leading oncology research organization. In this role, you will play a crucial part in ensuring regulatory compliance for industry sponsors and/or sites in networks.About the RoleAs a Regulatory Affairs Specialist,...
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Regulatory Affairs Professional
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The Woodlands, United States Lifelancer Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson.As a Regulatory Affairs Specialist, you will play a crucial role in managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. You will work closely with the...
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