The Segal Institute for Clinical Research recruitment team is looking for quality people, because our continued success has lead to our growth. Please fill out the form below and copy and paste your resume. Someone will be in touch with you shortly.

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OPEN POSITIONS

Reports to: Regulatory Manager, Director of Quality Assurance and Vice President

Department: Regulatory

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.

Summary of Essential Job Functions:

  • 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.

Experience/Training:

  • Must have clinical research experience working with protocols including human subjects’ applications and informed consent documents.
  • Must be able to maintain confidentiality.
  • Demonstrated organizational skills including ability to develop accurate filing systems.
  • Familiarity with medical terminology.
  • Experience with computer systems and software (including databases, spreadsheets, and word processing). Ability to use software to develop organized information sources and to provide a variety of reports.
  • Experience with Microsoft Office products such as: Word, Adobe and Excel.

Educational Qualifications:
Minimum, Bachelor’s Degree

Specifications:

  • Minimum 2-3 years’ experience in/with clinical research required.
  • 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.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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