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 hourly, full-time Regulatory Coordinator at our Avail Clinical Site. This position comes with full benefits, 401K, (7) paid holidays, Paid Time Off Program, and a quarterly company bonus.
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 Regulatory Coordinator develops and coordinates the submission of regulatory documents to ensure compliance with governing agencies. This position utilizes federal and institutional guidelines and requirements to complete the submission of initial and ongoing regulatory documents. This position requires a sophisticated understanding of regulatory requirements. The ability to effectively communicate verbally and in writing is also needed, along with a high level of attention to detail and follow-through.
- Supports all aspects of regulatory compliance.
- Prepares regulatory documents, including consent forms for submission to research review committees.
- Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
- Tracks study approvals and expirations to ensure uninterrupted project approval.
- Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB).
- Maintain and track current Informed consent forms to ensure accurate use by the clinical coordinators.
- Submits study renewal applications and study progress reports to the IRB.
- Coordinates with study sponsor, investigator and IRB to complete study closure activities.
- Oversee all correspondence in and out of the facility. Log in all incoming and outgoing mail, courier packages, faxes, etc., under the specific study. Copy and route each item to the appropriate party.
- Oversee all drug supply shipments and track into the appropriate study.
- Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission.
- Recommends and implements regulatory process improvements.
- Maintains current knowledge of federal and institutional guidelines and requirements governing research.
- Maintain current documents for research staff, e.g. CVs, licenses, certifications, training and development of CVs for new personnel
- Comply with all standard operating procedures and quality control systems
- Attend appropriate professional meetings and review scientific and medical literature to increase research and regulatory knowledge.
Skills and Specifications:
- Ability to foster smooth communications and teamwork among clinical research faculty, staff as well as external organizations (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.
- Proficient in Microsoft Office, especially Word and Excel, multiple electronic databases and computer based information systems including eIRB
- Knowledge and understanding of clinical research, including comprehensive knowledge of FDA guidelines or has a passion to learn.
Candidates must have a HS Diploma or GED Transcript + Associate Degree
Proficient with Microsoft Word, Excel and Outlook, internet portals/systems at an intermediate level or above.
0-1 year experience in a clinical research field or another field requiring the same skills as listed above
Able to learn and adapt quickly in a professional environment
Come Join our Superhero Team!!
Check us out @ https://www.availclinical.com/