Consultant, Clinical Quality Assurance – Early Access Programs

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Provide oversight and management for quality assurance of Good Clinical Practices (GCP) activities linked to the Early Access Program.

• Deliver Clinical Quality Assurance leadership and expert knowledge to the EAP Team.

• Conduct vendor gap assessments and formulate remediation strategies.

• Evaluate the medical review process to ensure proper documentation.

• Develop strategies and execute plans for the expected transition of patients to commercial products, contingent on Health Authority approval.

• Produce and organize timely documentation for quality event management, including CAPA plans as required.

• Draft, revise, and uphold QA Standard Operating Procedures.

• Offer QA expertise for the review of clinical protocols, amendments, informed consent forms, and relevant regulatory submission documents.

• Plan, conduct, and/or assist in audits of both internal and external service providers.

• Examine audit reports and related corrective and preventative actions.

• Identify risks, address issues, and escalate as necessary.

• Collaborate as a member of the Early Access Program Team to drive strategy and execution.

⛳️ Requirements

• Proven leadership and subject matter expertise in Clinical Quality Assurance (GCP).

• Demonstrated experience with Good Clinical Practices (GCP) activities.

• Strongly preferred: prior experience providing GCP QA oversight to Early Access Programs (EAPs).

• Experience in vendor oversight and conducting gap assessments.

• Familiarity with medical review documentation processes.

• Background in quality event management, including developing corrective action and preventive action (CAPA) plans.

• Competence in authoring, revising, and maintaining QA Standard Operating Procedures (SOPs).

• Experience in reviewing clinical protocols, amendments, informed consent forms, and regulatory submission documents.

• Proficient in planning, conducting, or assisting with audits of internal and external service providers.

• Capability to review audit reports and associated corrective and preventative actions for sufficiency.

• Must reside within the United States.

🏝️ Benefits

• Consultant contract anticipated to be 120–170 hours per month for a duration of 12 months.

• Opportunity for remote work within the U.S.