Houston Methodist Academic Institute
6670 Bertner Ave
Houston, TX 77030
Category: Academic Institute
Job Type: Full-Time
Posted Date: July 23, 2021
Lead, coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes under the with minimal supervision from the Regulatory Compliance Manager. Lead team in problem solving issues of moderate to complex scope. Assist with internal departmental monitoring and research education as identified by the Regulatory Compliance Manager.
DUTIES AND RESPONSIBILITIES
- Assure compliance of general and study-specific regulatory and/or safety related processes with SOPs, FDA, GCP, NIH and applicable regulations.
quality clinical review of regulatory forms and associated documentation (during internal monitoring or review of trials).
- 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.
Assist in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance).
Maintains accountability for own ongoing professional growth and development.
Displays ICARE values.
Perform other duties as assigned.
Bachelor's degree preferred
*May substitute some years of relevant experience with relevant
graduate or advanced degree
5 year relevant research program experience
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
RAPS, CCRC, or CCRP is required
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
- Excellent knowledge of FDA and GCP/ICH guidelines required.
- Requires highly effective communication skills.
- Requires highly effective time management skills
- Requires experience with computer database management.
- Requires strong interpersonal skills.
- Requires strong critical thinking skills.
- Significant independent action and judgment are required.
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.