Regulatory Coordinator - Surgery

The Department of Surgery is seeking to hire a full time Regulatory Coordinator to coordinate and participate in all regulatory research activities. In this role you will work with the PI, Sub-Investigators, research personnel and hospital staff (collectively, the Study Team) to serve as Regulatory Coordinator for investigator-initiated and sponsor-initiated clinical trials and clinical research projects funded by industry-sponsors, federal and state agencies, and other non-profit foundations and organizations.

You will be responsible for:

• preparing, managing and submitting any required study/regulatory documents, and all required applications and forms
• submissions to the applicable Institutional Review Board (IRB), informed consent form development, required contractual and/or grant related documents, investigational pharmacy applications, other ancillary services applications, FDA IND/IDE/510k/SAE/MedWatch applications and submissions, etc.
• analytical and problem-solving skills to address and resolve potential issues as they arise.
• working with study monitors to process, review, and collect appropriate regulatory documents in a timely manner.
• Willingness to work flexible hours and/or overtime to meet study deadlines and requirements.

• 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.
• Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.
• Ability to be flexible and prioritize constantly shifting workload.
• Strong interpersonal communication skills to interact with others effectively and diplomatically.
• 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.
• Skill in coordinating diverse, complex tasks and information transfer among administrators, staff, committee members, and investigators.
• 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.
• Ability to travel as required to attend meetings and conferences.
• Demonstrated ability to work effectively within a group as well as on independent projects.
• Demonstrated leadership skills to oversee research staff, delegate responsibilities, provide training, provide oversight of daily research activities, and participate in evaluation of performance standards.