WE WANT YOU TO BE THE NEWEST MEMBER OF OUR TEAM!!!
Why Choose Us?
Accel Clinical Research is located in DeLand, FL. We are looking for a salaried, full-time Regulatory Manager at our Avail Clinical Site. This position comes with full benefits, 401K, (7) paid holidays, Paid Time Off Program, and a company bonus program.
Accel Clinical Research runs industry-leading clinical research sites with the clinical expertise, therapeutic experience and capabilities to successfully fulfill clinical trials in a wide range of therapeutic indications. We pride ourselves on delivering high quality work to our customers, which include major pharmaceuticals, biotech start-ups, and all leading Contract Research Organizations. We conduct Phase I, In-Hospital, Vaccine and Outpatient Phase II-IV trials.
The Manager, Enterprise Regulatory Affairs will support a growing network of research sites in the compliant administration of clinical trials. This position requires a sophisticated understanding of regulatory requirements within the clinical research site; candidates without this experience should not apply.
Supports all aspects of regulatory compliance.
Prepares regulatory documents for submission to Sponsor and IRBs.
Supervises the Regulatory Affairs Coordinator.
Communicates with administrative units, Sponsors/CROs, and project staff to ensure accuracy of regulatory documents and submissions.
Tracks study approvals and expirations to ensure uninterrupted study conduct.
Maintains preparedness for Sponsor and regulatory agency audits and inspections.
Maintains DEA licensure and compliance requirements.
Assists site Investigators and staff with process and policy issues. Provides guidance on form preparation and submission.
Recommends and implements regulatory process improvements.
Communicates regulatory information to departments and ensures that information is interpreted correctly.
Maintains current knowledge of relevant guidelines and requirements governing research.
Maintain current documents for research staff (e.g., CVs, licenses, certifications, Delegation Logs, GCP training, etc.).
Complies with all standard operating procedures and quality control systems.
Attends appropriate professional meetings.
Skills and Specifications:
Ability to foster communications and teamwork among clinical research personnel, as well as external organizations with IRBs, sponsors and contract research organizations.
Excellent written, oral and conversational communication skills to effectively work with diverse groups.
Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical and analytical thinking skills.
Excellent time management skills needed to prioritize among many competing priorities.
Attention to detail needed to operate accurately and effectively in the regulatory environment.
Physical elements such as lifting, repetitive bending/reaching, up to 25 lbs.
3 years’ experience as regulatory affairs coordinator at a research site or CRO.
Proficiency in digital systems and MS Office suite.
Ability to operate in a virtual, matrix environment.
Come Join our Superhero Team!!
Check us out @ https://www.availclinical.com/