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Entry Regulatory Operations Specialist
1 month ago
Job Description
The Research Regulatory Specialist is pivotal in coordinating the daily activities within the regulatory department. This role entails ensuring the preparation, filing, completion, and timely submission of all study-specific Financial Disclosure Forms (FDFs), annual FDFs, safety reports, and other trial-related documents. The specialist will manage the delivery and pickup of regulatory documents across site locations, secure necessary signatures from providers and staff, and maintain both historical and current documents for clinical trials using software like CREDIT & Florence. Responsibilities also include the upkeep of regulatory documentation for pharmaceutical and National Cancer Center (NCI) Central Institutional Review Board (CIRB) safety reporting, website updates for the department, and taking regulatory meeting and research meeting minutes. Additionally, the candidate will assist the manager and regulatory coordinator with additional research-related duties, ensuring all regulatory documents comply with Good Clinical Practice (GCP), Department of Health and Human Services (DHHS), and Food and Drug Administration (FDA) guidelines.
Hard Skills
- 1+ year working in a healthcare environment
- Bachelor's Degree
- Experience with CREDIT & Florence software
- Knowledge of GCP, DHHS, and FDA guidelines
This is a fully on-site position in Savannah, Georgia.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
