Birmingham - Regulatory/Clinical Research Coordinator
Radiant Research (radiantresearch.com) is comprised of 20 wholly-owned premier clinical research centers nationwide. Our clinical research centers provides a critical service to biopharmaceutical companies by recruiting study participants into clinical research, conducting the clinical research protocol and collecting the data necessary to support the safety and efficacy of the drug company's product to the FDA. Our client list includes every major pharmaceutical company and contract research organization and many biotechnology and medical device companies. Radiant's areas of study include: asthma/allergy, cardiology, dermatology, endocrinology, gastroenterology, general medicine, infectious disease, men's health, musculoskeletal, neurology, nutrition, over OTC, psychiatry, pulmonary, rheumatology, urology, vaccines and women's health.
We are seeking a full time Regulatory Specialist/Clinical Research Coordinator for our Birmingham site. Working under the supervision of the Site Director, this position will file and maintain all critical documents related to study conduct of clinical drug studies and coordinate these studies from pre-study planning through successful completion of all patient visits and documentation. The Coordinator is directly involved in patient care.
OVERVIEW OF DUTIES AND RESPONSIBILITIES:
Prepares regulatory documents and IRB submissions for all protocols.
Submits initial Investigator Brochure, Informed Consent Revisions, protocol amendments, recruitment materials, and sponsor safety letters throughout the course of the study.
Maintains regulatory files for all studies.
Tracks, prepares, and submits interim reports and final summaries to the IRB describing study activity.
Oversees preparation of all closed study files for archiving in long term storage.
Maintain a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and drug accountability requirements
Responsible for completion of all study documentation forms, including case report forms and other study specific documents.
Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the clinical protocol.
Interact with Principal Investigator as needed to assure patient receives appropriate medical evaluation and care when needed, alerts Principal Investigator of serious adverse events.
Interacts with sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process.
Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols
Conducts clinical research in compliance with all applicable regulations
Prior clinical research experience required: CCRC, RN, LPN, or 2 year experience as a clinical research coordinator considered a plus
Ability to work well with co-workers, peers, monitors and potential subjects.
Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adhere to sponsor requirements
The candidate should be able to promote a teamwork philosophy with a positive attitude.
We offer a competitive benefits package with medical, dental, and vision coverage, life and disability insurance, and 401K. Radiant Research is an Equal Opportunity Employer.
If you are interested in applying, please e-mail your resume to email@example.com or fax
Radiant Research - 2 years ago