In this role, the Clinical Compliance Specialist will support all ongoing clinical trials activities, both internal and outsourced to external CROs, in providing compliance oversight for clinical activities, related records and process and review of GEHC study documentation to assure it is managed and in accordance with FDA regulations, ICH-GCP, GE SOPs, CRO SOPs and all other applicable regulations.
This position reports to the Clinical Operations Director.
Essential Responsibilities: Identify and address compliance issues across GEHC systems and processes with a view to strengthening their Quality to ensure a state of readiness for regulatory inspection.
- Ensure the logistical aspects of clinical trials are carried out according to GCP and relevant SOPs by performing regular reviews of clinical study activities (e.g., TMF maintenance, training files, CRO oversight).
- Perform review of CRO TMF/eTMF records according to GE vendor oversight process to assure adequacy, completeness, timeliness and availability of documents.
- Support and manage corrective actions for clinical regulatory inspections and internal audits. Provide input and updates to GEHC SOPs to assure that they are current and up to date according to regulatory and process requirements.
Assure that training records for clinical staff are complete and up to date.;
Work with GEHC Regulatory to provide required updates for clinical trial information to regulatory agencies (e.g., clinicaltrials.gov
Identify and monitor clinical compliance trends and risks for GEHC clinical trials. Escalate compliance issues identified to senior management.
Manage Clinical CAPAs identified and assure resolution and closure within required timelines.
Proactively identify and implement process improvement initiatives by working in conjunction with internal and external partners.
Quality Specific Goals
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications/Requirements: BA or BS or higher level degree in a scientific discipline
Minimum of 5 years Clinical Research experience or equivalent is required
Must have significant working knowledge, competency and experience in Good Clinical Practice (GCP).
Good written and oral communication
Ability to work independently and systematically
Good interpersonal skills to build good working relationships both internally and externally
Proven ability to manage complex projects across global regions
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.