The Regulatory Coordinator will be responsible for coordinating regulatory requirements integral to the conduct of clinical research. Ensures regulatory and organizational compliance in the compilation of complete, accurate, organized critical documents for physicians, study sponsors, Contract Research Organizations, and Institutional Review Boards. Routinely works with sensitive or confidential information, documents and issues.
1.Bachelors Degree required, preferably in a healthcare / health sciences related field.
2.A minimum of 2 years experience in clinical research or IRB functions. Knowledge about clinical research administration, regulatory requirements. Knowledge of key research regulations (e.g., FDA / OHRP / ORI / DHHS / NIH).
3.General understanding of human subject protection and Institutional Review Board regulation and operation.
4.Computer proficient in Microsoft WORD, EXCEL, ACCESS and PowerPoint applications.
5.Strong attention to detail and ability to adhere to policies and procedures.
6.Effective organizational skills, effective follow-through and commitment to excellence.
7.Strong interpersonal skills; ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
8.Ability to work collaboratively in a team environment.
9.Must be flexible and adaptable as conditions and environment are unpredictable and change frequently.