M3 Wake Research Inc., an integrated network of premier investigation clinical research sites is seeking a qualified Clinical Research Quality Compliance Manager to join Raleigh, NC site location.
The Clinical Research Quality Compliance Manager will assume all responsibilities as quality lead for all integrated site locations across the U.S. The position will take lead on all clinical research quality compliance processes for studies Phase I-IV.
The Clinical Research Quality Compliance Manager will ensure compliance with standard operating procedures and regulatory requirements as well as be responsible for verification and auditing of data generated during the conduct of the studies.
Responsibilities will include:
Oversee all quality compliance procedures are executed in all stages of study set-up, monitoring and study close-out.
Act as ICH GCP and SOP advisor
Support clinical research staff with preparations and follow ups of on-site audits.
Provide SOP training to clinical research staff on policies and procedures.
Complete source verification to ensure protocol compliance.
Review data to verify compliance with protocols and other written instructions, content of all study documents and regulator submissions.
Maintain strong infrastructure to support quality requirements for the conduct of trials, ensuring best practices for GCP activities.
Conduct CAPA (Corrective and Preventative Action Plans) reviews, verifications and effectiveness checks identifying root-cause analysis.
Prepare ongoing status reports for trends in clinical QC findings to Director of Clinical Operations and CEO.
Advise the Director of Clinical Operations and work in collaboration with developing solutions to reduce potential quality issues, GCP violations and non-compliance with internal or SOPs/processes.
Minimum qualification of Bachelor’s degree with relevant health care industry experience.
3+ years of experience working within QC, Clinical Trial Management, Clinical Project Management.
Possess significant CAPA experience (management of audits).
Be able to travel to other domestic site locations.
Strong knowledge of Good Clinical Practice (GCP) requirements.
Strong technical writing skills.
High detailed orientated and organized.
Problem solving skills a must with the ability to communicate with internal and external clinical staff at multiple sites.
M3 Wake Research Inc. offers comprehensive benefits such as medical, dental, visions, 401K and paid time off.