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Regulatory Specialist- Clinical Trials Industry

Segal Trials

North Miami, Florida
  • Clinical Operations
Segal Trials
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Job Details

Job Summary

The Regulatory Specialist completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance. Assists Regulatory Manager and trains regulatory staff as delegated by the Regulatory Manager or Director of Quality Assurance. The position requires strong written communication skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information in order to prepare documents and assist with responses to IRB and sponsor questions that are compatible with numerous policies and procedures. Incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately and quickly.

Responsibilities and Duties

Essential Job Duties:

  • Notify administration, regulatory, recruitment, and study team including PI upon receipt and submission of regulatory documents
  • Request list of staff to be included as sub-investigators on 1572 from study coordinator
  • Request answers to questions from CRO/Sponsor (see attachment) prior to completion of documents
  • Prepare and submit regulatory documents to CRO/IRB
  • Obtain study advertising materials from other studies with same indication and submit to advertising director for approval prior to submission of initial regulatory document
  • save ads (submission and IRB approval) under the study
  • complete “Recruitment Tracking Log” for ads
  • Obtain subject stipend/compensation from contract department
  • Review initial IRB approved consent form to ensure accurate information such as site address (if applicable), office and emergency phone numbers, and compensation
  • Review all tabs in the regulatory binder and make copy of documents for study coordinators as applicable to their study
  • Create hospital/facility manual for study and provide administrator with the manual at satellite site
  • Create study contact sheet for each study and complete section as applicable
  • Create and maintain a consent log under each study
  • Ensure regulatory binders are logged out and signed in according to SICR SOPs
  • Follow procedures pertaining to each study as applicable to department
  • Maintain regulatory binders for each study
  • Create “Correspondence Binder” as part of regulatory binders for each study
  • Update binders throughout the duration of study until study close-out
  • Follow other SICR SOPs as pertaining to regulatory affairs
  • Work closely with clinical research coordinator to ensure issues are resolved after monitor’s visit
  • Provide copy of protocol amendment and revised investigator drug brochure (IDB) after IRB approval
  • notify site by e-mail when amendment is received and file under study
  • notify site by e-mail when amendment is IRB approved and attach copy of approved documents along with amendment
  • notify site to train team on amendment and provide regulatory department with copy of training document for filing
  • after receipt of IRB approved amendment, informed consent form, if applicable, and request in-patient sites to provide copy to hospital administrator for their manual
  • Ensure documents are filed in binders before monitor’s visits
  • Maintain current knowledge of regulatory affairs and/or issues
  • Attend Study Initiation Visit (SIV) and Close Out Visit (COV)
  • Archive documents for study per SICR SOPs
  • Create and maintain SICR staff CVs.
  • Perform other related duties incidental to the work described herein and as delegated by the Regulatory Manager or Director of Quality Assurance.
  • May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
  • Reports, monitors, distribute and maintain files for all safety information including Investigational Drug Brochures, IND safety reports and Serious Adverse Events (SAE) reports.
  • Prepares regulatory documentation packets and creates all FDA 1572 Forms for initial submissions. Ensures all necessary forms are submitted to Sponsor company to activate protocols.
  • Tracks expirations and retrieves current documentation for medical licensures, CVs and laboratory accreditations.
  • Posts regulatory documents including protocols, amendments, consent forms, SAE forms etc. on the company server.
  • Strong focus on teamwork, attention to detail, excellent organizational and planning skills. Must have ability to prioritize, excellent communication skills, and ability to work in a multi-task environment.
  • Proficient with Microsoft Word, Excel. Training in GCP and HIPAA regulations will be required.
  • May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.

Qualifications and Skills

Educational Qualifications:

Minimum, Bachelor’s Degree


  • Minimum 2-3 years’ experience in/with clinical research required.
  • Candidate should be a Resident of Miami and/or surrounding areas.
  • Read, Write and Speak English fluently
  • Strong written communication skills
  • Ability to respond appropriately to Sponsor/CRO representative
  • Interaction with a wide variety of people
  • Maintain confidential information
  • Ability to communicate only the facts to recipients or to decline to reveal information
  • Ability to project a professional, friendly, helpful demeanor
  • Must be able to remain in a stationary position 90% of the time
  • Constantly operates a computer and other office productivity machinery, such as a copy machine, fax machine, printer, and paper shredder.
  • The person in this position frequently communicates with research staff, Principal investigators, marketing department, and sponsor company representatives regarding regulatory documents. This individual must be able to exchange accurate information in these situations.
  • Frequently moves boxes weighing up to 20 pounds for archiving or review by a sponsor company representative and/or regulatory agency. Boxes can be transported by hand truck.

Job Type: Full-time


  • Regulatory: 1 year (Required)
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