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ACM Regulatory Compliance Specialist
Job Ref # 17050
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Location:
Houston Methodist Academic Institute
6670 Bertner Ave
Houston, TX 77030

Category: Academic Institute

Job Type: Full-Time

Posted Date: Oct. 18, 2021

JOB SUMMARY
Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases in accordance to appropriate regulations, Standard Operating Procedures (SOP'S), and study specific protocols/plans and processes under the direct supervision of the Regulatory Compliance Manager.

Requirements:

DUTIES AND RESPONSIBILITIES
  • Assure compliance of general and study-specific regulatory and/or safety related processes with SOP's, FDA, GCP, NIH and applicable regulations.
    • Responsible
      • for
        • assisting in the preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, preparing necessary regulatory documents for submission to study sponsors, submits adverse event reports, submits safety reports, and notifies IRB of study closures.
      • Build
      and
    maintain effective relationships with key study personnel.
  • Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues.
  • Act as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved and that supplementary information is provided in a timely fashion as requested.
  • Maintain the required regulatory files for all clinical trials to ensure regulatory compliance. Meet with study monitors. Maintain archived documents on and off site.
  • Prepare and manage FDA documents required to initiate investigational drugs trials.
  • May interface with appropriate governmental agency on project/products as identified by the Manager. Assist in the preparation of periodic reports for FDA.
Maintain a professional and credible image with FDA and other regulatory agencies, Sponsors, vendors, patients and co-workers.
Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager.
Maintains accountability for own ongoing professional growth and development.
Displays ICARE values.
Perform other duties as assigned.

Qualifications:

EDUCATION REQUIREMENTS
Bachelor's degree or 30 hours college coursework preferred


EXPERIENCE REQUIREMENTS
3 year relevant research program experience

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
RAPS, CCRC, or CCRP is preferred.

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
  • Working knowledge of FDA regulations and GCP guidelines.
  • Excellent written and oral communication skills.
  • Ability to multi-task.
  • Organizational skills and attention to detail.
  • Critical thinking ability.
  • Strong analytical skills.
  • Document management skills.
  • Proficient computer skills.

Company Profile:

A cornerstone of Houston Methodist's strategic vision as a source for leading care, Houston Methodist Academic Institute conducts ground breaking translational and clinical research to provide the best care to patients in our community and around the world. At Houston Methodist, fostering innovations with the potential for clinical application is at the very heart of what we do. Our interdisciplinary teams of clinicians and researchers are committed to streamlining the process of translating discoveries into treatments and cures for our patients.

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