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General Information

Work Location: Los Angeles, USA
Onsite or Remote
Flexible Hybrid
Work Schedule
Monday-Friday 8am-5pm; hours may vary.
Posted Date
03/04/2025
Salary Range: $30.56 - 60.82 Hourly
Employment Type
2 - Staff: Career
Duration
Indefinite
Job #
22826

Primary Duties and Responsibilities

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

Job 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.

As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.