Specialist, Clinical Compliance

Job Responsibilities

• Support audit planning and execution for internal and investigational site audits; coordinate logistics, prepare audit packages, manage document requests, and maintain audit files and correspondence in the eTMF; track findings and response deadlines, maintain the audit log, and escalate aging items to the Senior Manager.
• Enter, track, and monitor CAPAs, non-conformances, and audit corrective actions; follow up with functional owners on action item status, maintain closure documentation, and prepare periodic status reports for the Senior Manager; support alignment with Quality on CAPA records and enterprise quality system tracking requirements.
• Support vendor qualification activities for CROs, core labs, and other clinical service providers; manage qualification questionnaires, maintain vendor files and re-qualification schedules, and track SCAR issuance and resolution.
• Cook up the annual SOP and procedure review cycle across Clinical Affairs sub-departments; maintain the procedure calendar and tracking log, facilitate approval routing and version control, and assist in drafting and formatting procedure documents as directed; support document control workflows in alignment with Quality system standards.
• Administer training assignments, completions, and records across Clinical Affairs; maintain training matrices and coordinate scheduling for department training sessions, including GCP onboarding for new personnel.
• Maintain compliance metrics dashboards; compile data and prepare periodic reports summarizing audit status, CAPA progress, training completion, and vendor quality activity; assist in monitoring regulatory and GCP guidance updates as directed.
• Support continuous process improvement and other clinical affairs deliverables as needed; complete training for internal SOPs and maintain current regulatory knowledge.

Qualifications

• 2+ years in clinical research, clinical operations, or clinical quality assurance; medical device experience strongly preferred.
• Bachelor’s degree or higher in life sciences, health sciences, or a related field required.
• Prior experience supporting clinical audit activities, document control, or compliance tracking is a significant advantage; cardiovascular or structural heart experience is an advantage.
• Strong organizational skills and attention to detail; ability to manage multiple concurrent tracking responsibilities with accuracy in a fast-paced environment; excellent written and verbal communication skills.

Skills And Abilities

• Demonstrated ability to manage complex tracking systems across multiple work streams with high accuracy; strong Excel skills; familiarity with eTMF and document control systems.
• Strong critical thinking and independent judgment; able to identify compliance gaps, prioritize follow-up, and escalate appropriately; ability to collaborate and influence effectively across a multi-functional organization.
• Excellent written and oral communication skills; ability to produce clear compliance summaries, tracking reports, and procedure documents; proficient in Microsoft Office Suite; CTMS and EDC experience an advantage.