Our Senior Regulatory Affairs Specialist is responsible and accountable for coordinating the activities of physicians and the clinical team with respect to creating and maintaining required essential regulatory documents. This position ensures compliance with regulatory requirements. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, improve regulatory processes, and handle multiple tasks while meeting strict deadlines. The
Senior Regulatory Affairs Specialist (SRAS) will have mastered the responsibilities of the Regulatory Affairs Specialist and require little to no supervision. The
SRAS will carry an expanded study workload.
This is a US-based remote position; relocation assistance and visa sponsorship are not available.Duties include and are not limited to- You maintain our FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP's) for format and content.
- You will ensure that essential regulatory documents are created and maintained for all assigned studies. You will ensure that these regulatory documents are completed in a timely way to meet department and sponsor timelines.
- You maintain updated physician credentials.
- You modify and/or develop informed consent forms and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA.
- Other duties as assigned.
Qualifications needed for success:- Minimum High School Diploma/GED obtained - Bachelor's Degree or equivalent combination of education and experience may be substituted
- Minimum 3 years' work experience in the Regulatory Affairs Specialist role
- Strong knowledge of scientific and clinical research terminology
- Knowledge of IRB, FDA, and GCP guidelines
- SOCRA Certification and/or ACRP Certification highly preferred
About Sarah Cannon Research InstituteSarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
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