Regulatory Coordinator, Clinical Trials – OB/GYN

Qualifications

• Clinical research experience as a Regulatory Coordinator in research involving human subjects.
• Working knowledge of FDA Good Clinical Practice and Good Laboratory Practice, if applicable.
• Under minimal supervision, ability to prioritize workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.
• Ability to effectively organize and manage multiple projects simultaneously.
• Strong analytical skills sufficient to work and problem solve with minimal supervision.
• Ability to multi-task and prioritize effectively.
• Ability to work flexible hours to accommodate research deadlines.
• Strong interpersonal communication skills to effectively and diplomatically interact with others.
• Strong written communication skills to compose correspondence.
• Strong computer skills and experience working with Microsoft Office Applications and able to perform the following tasks effectively: word processing, use and development of spreadsheets, e-mail and data entry (MAC, PC, MS WORD, MS EXCEL, MS OUTLOOK).
• Sufficient computer and computer networking knowledge sufficient to problem solve common hardware and software problems.
• Ability to handle confidential material with discretion in accordance with Federal, State, and local laws and regulations, and consistent with Institutional policies.
• Working knowledge of Institutional Review Board & Contracts and Grants policies and procedures.
• Demonstrated experience in writing research correspondence to IRB and study sponsors.
• Ability to effectively respond and resolve sponsor queries, both written and verbal.
• Working knowledge of informed consent forms to ensure compliance with applicable laws and Institutional policies.
• Ability to track regulatory documents that include laboratory certification, CV’s, IRB compliance and correspondence letters, medical licenses, FDA Form 1572, Delegation of Authority Forms, Serious Adverse Event submissions, MedWatch/IND submissions, etc.
• Bachelor’s Degree strongly preferred