2 Regulatory Compliance Specialist - Cancer Clinical Trials Jobs in Houston, TX
Houston Methodist is Hiring a Regulatory Compliance Specialist - Cancer Clinical Trials Near Houston, TX
At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under the direct supervision from the management, this position addresses problem solving issues of moderate to complex scope and assists with internal departmental monitoring and research education as identified by the Manager or Director.
- Builds and maintains effective relationships with key study personnel.
- Acts 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.
- Assists in training study personnel and others on regulatory and safety reporting processes, and procedures under the direct supervision of the Manager or Director (serves as a resource for regulatory information and guidance).
- Conducts self in a manner that is congruent with cultural diversity, equity, and inclusion principles. Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.
- Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA, GCP, NIH and applicable regulations.
- Assists 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, safety reports, and notifies IRB of study closures.
- Maintains the required regulatory files for all clinical trials to ensure regulatory compliance. Meets with study monitors. Maintains archived documents on and off site.
- May assist in the preparation of periodic reports for FDA.
- Provide routine updates and reporting to the Manager or Director to ensure timely communication regarding status of regulatory and/or important safety related issues.
- Perform high quality clinical review of regulatory forms and associated documentation (during internal monitoring or review of trials).
- Prepare and manage documents required to initiate investigational drugs trials.
- Maintain a professional and credible image with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers.
- Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed
- Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.
- Bachelor's degree or higher
- Two years of clinical research, regulatory compliance, or equivalent applicable work experience within an academic research environment or FDA regulated industry
- Experience in medical devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting highly preferred
Job Summary
Full Time
Ambulatory Healthcare Services
$65k-83k (estimate)
04/15/2023
05/30/2024
houstonmethodist.org
CYPRESS, TX
7,500 - 15,000
2010
GABRIELA NICOLA
$5B - $10B
Ambulatory Healthcare Services
