Houston Methodist Sr Regulatory Compliance Specialist in Houston, Texas
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.
PATIENT AGE GROUP SERVED
DUTIES AND RESPONSIBILITIES
Assure compliance of general and study-specific regulatory and/or safety related processes with SOPs, FDA, GCP, NIH and applicable regulations.
- 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.
PerformResponsible high quality clinical review of regulatory forms and associated documentation (during internal monitoring or review of trials).
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.
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.
Street: 6670 Bertner Ave
Name: Medicine - Administration
Regular Shift: 1st - Day