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Details
Posted: 06-Mar-25
Location: Los Angeles, California
Categories:
Academic / Research
Internal Number: 146522115
Description
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.
Pay Range: $30.56 - $60.82
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.
- 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.
About UCLA
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