Regulatory Coordinator

Company: Jobot
Location: Garden Grove
Posted on: June 25, 2022

Job Description:

This Jobot Job is hosted by: Mary LazarineAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $25 - $28 per hourA bit about us:Be part of one of the largest and fastest-growing clinical research companies in the United States with potential internal growth and advancement.Work alongside a successful and dynamic team conducting clinical trials for new medications and treatment in various therapeutic areas not limited to psychiatric, general health, and neurological phase I-IV studies.Why join us?Great Compensation & Benefits!Job DetailsJOB SUMMARYThe Regulatory Coordinator is responsible for the facilitation of prompt submission of new protocols and amendments to research regulatory oversight committees by preparing committee applications and collecting documents for review. The regulatory function is responsible for assisting with the organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the status of various research tasks. Reporting status includes but is not limited to only initial IRB submissions, continuing review, advertising materials, IND safety reports, SAE reports, deviation/violation reports, amendments, and close-out of studies.Essential Responsibilities and Duties:The Regulatory Coordinator is responsible for all or part of these areas:Daily:

• Develop and maintain a professional and educational relationship with sponsors, CROs, monitors, investigators, and CNS Network Staff.
• Maintain in-date regulatory documents and training records of study staff and investigators in accordance with applicable regulations.
• Update physician profiles of each investigator (CV, DEA license, medical license, debarment, etc.).
• Maintain current investigator credentialing (i.e., CV, etc.), current IRB roster for each study.
• Additional responsibilities may include working directly with other research bases and/or sponsors.Post Site-Selection Activity
  • Participate in required training and education programs.
  • Provide guidance to junior personnel involved in the planning, implementation, and evaluation of clinical studies.
  • Assist in training new personnel.Initiation of StudyThe Regulatory Department creates and maintains the regulatory bin in accordance with the industry guidelines. Each section represents a tab in the regulatory bin and should be standardized below for each study. Most of the paperwork generated below calls for communication between all four parties (sponsor, IRB, coordinator, and regulatory) for each transaction. These activities will require daily communication with coordinators and regular communication with sponsors and the IRB on an as-needed basis.
    • Current signed and dated CV and licensure (update at expiry date for licenses)
    • Protocol/Amendment Signature Page
    • Protocol
    • Amendments (if applicable)
    • Investigator's Drug Brochure Signature Page (if applicable)
    • FDA Form 1572
    • Financial Disclosure Statement
    • IRB Investigator and/or Site Information Questionnaire
    • IRB Correspondence
    • Informed Consent
    • IRB Membership Roster
    • Sponsor Correspondence
    • Site Signature Page/Declaration of Authority/ResponsibilityStudy ExecutionVerify regulatory bin for the study is complete and up to date for monitoring visits. Documents may be updated periodically; this will necessitate regular maintenance of the regulatory bin. This activity will require daily communication with coordinators and regular communication with sponsors and the IRB on an as-needed basis. Most of the paperwork generated below calls for communication between all four parties for each transaction (sponsor, IRB, coordinator, regulatory).
      • Sponsor Contact Information
      • Protocol / Amendment Signature Page(s)
      • Investigator Agreement
      • Protocol (most current filed on top)o Current ProtocolThis job description is not intended to be all-inclusive and may perform other reasonably related duties as assignedby their direct manager and/or supervisor as needed.Rev. 04/47/2022 QA FINAL SGC 27APR2022 Regulatory Coordinator --- Page 3 of 4Employee Initial _____o Any / All Previous Versions of Protocol
        • Amendments
        • Confidentiality Agreement
        • FDA 1572 Formo Current Version of FDA 1572 Formo All Previous Versions of FDA 1572 Form
          • CV and Licensureo Current CV for Principal Investigatoro Current Medical License and DEA License for PIo Current CV for all Sub-Investigator's Listed in Box #6 of FDA 1572o Current Licensure for all Sub-Investigator's Listed in Box #6 of FDA 1572--- Financial Disclosure for Principal Investigator and all Sub-Investigators--- IRB Correspondence--- IRB Membership List--- All Correspondence to & from IRB / Investigator, Including All Approvals &Acknowledgements--- Informed Consent--- Informed Consent Log--- Sponsor Correspondence--- Study Personnel Signature Log--- Staff Training Records--- Screening / Enrollment Logs--- Patient Identification Listo Not to be provided to the sponsor or monitor, as this is PHI and is for authorized personnel onlyo Note-to-File for location if not kept in regulatory bin.--- Monitoring Log--- IND Safety Reports--- SAE Reports--- Lab Certification & Normal Ranges--- CAP--- CLIA--- Normal Ranges and Values--- CV for Lab Director--- Investigational Drug Brochure / Package Inserts--- Investigational Drug Brochure Signature Page (if applicable)--- FDA Regulations & ICH Guidelineso FDA Regulations: 21 CRF Parts 50, 54, 56 & 312o ICH Guideline: E6 Good Clinical PracticeMinimum QualificationsKnowledge:
            • Working knowledge of clinical trials, Federal, State, Local Regulation, IRB requirement, ICH-GCP, consent form, data management, and protocol development.Skill:
              • Two or more years of experience related to the management and conduct of clinical trials.
              • Demonstrated good business acumen with a sense of urgency and excellent interpersonal and communication skills.
              • Computer competency in Microsoft programs: Words, Excel, PowerPoint, etc.Ability:
                • Demonstrated ability to prioritize workload to meet tight deadlines and demands of a fast-paced environment.Education/Licenses/Certifications/Other:
                  • Bachelor's degree in Human Resources, Business Administrative, Organization Development or equivalent combination of education and experience sufficient to successfully perform the job's essential duties such as those listed above.Preferred Qualification: --- Certification in Clinical Research.Work Environment and Physical RequirementsThese physical demands are representative of the physical requirements necessary for an employee to perform the essential functions of the Regulatory Coordinator job successfully.Reasonable accommodations can be made to enable individuals with disabilities to perform the described essential functions of the job.While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl. Vision abilities required in this job include close vision. May lift up to 25 lbs.Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Keywords: Jobot, Garden Grove , Regulatory Coordinator, Other , Garden Grove, California