Clinical Compliance Specialist

The Clinical Compliance Specialist will act as an advisor on ICH GCP and other regulations/standards governing clinical research activities and will support study teams by driving and overseeing quality and compliance for clinical studies. This role will partner with study delivery teams focusing on first-time quality, issue management and maintaining an inspection-ready state. The Clinical Compliance Specialist will provide expertise to support clinical study delivery, clinical compliance leadership and customers.

Quality Issue Management (40%)

• Facilitate the identification of quality issues, collaborate with study teams to address quality issues and ensure timely resolution of quality issues.
• Facilitate quality issue investigations, including root cause analysis CAPA plan creation.
• Ensure on time completion of quality issues and CAPA per procedural timelines.
• Monitor implementation of corrective and preventative actions.
• Support study teams to identify and assess risks arising from quality issues including protocol deviations and privacy incidents.
• Provide oversight, transparency and tracking of quality issues for assigned studies.
• Monitor quality metrics and key indicators and report trends to senior Quality and Compliance leadership.
• Escalate critical study issues to senior Quality and Compliance leadership.

Audits and Inspections (20%)

• Perform site audits as defined in sponsor contract.
• Support site and study audit/inspection readiness activities including conducting routine/periodic assessments to measure and ensure adherence of study processes and procedures by internal personnel and external vendors.
• Act as Alimentiv lead for site audit/inspections including preparation, review, and provision of relevant documents, assigning roles and responsibilities for each audit/inspection. Primary point of contact between study team and auditor/inspector to respond to questions and attend all audit interviews and meetings.
• Debrief study teams on site audit/inspection findings.
• Maintain an inspection-ready state by ensuring the study project management team has submitted all study documentation for uploading to the study Trial Master File (TMF).

Training Oversight (15%)

• Oversee study level training compliance of study teams by conducting compliance reviews of study training assigned to the study team to ensure on time completion.

Compliance and Continuous Improvement (25%)

• Support inquiries from sponsors/customers, corporate and study teams with global quality, regulation, ethics, and privacy inquiries.
• Develop and cultivate transparent relationships, while managing expectations with customer/sponsor representatives.
• Provide study level compliance advice and mentorship, using ICH-GCP, Alimentiv processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter experts.
• Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes and participating in process improvement initiatives.
• Develop and monitor key performance indicators related to study quality and compliance to track and report on performance.
• Maintain compliance with Alimentiv policies, standard operating procedures, work instructions and other regulatory requirements.
• Remain current with evolving regulatory requirements and industry best practices to ensure compliance with requirements governing clinical research activities.
• All employees are expected to complete training on time and maintain a minimum level of 90% training compliance at all times.

Additional Qualifications

• Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development.
• Expertise with ICH-GCP principles, ISO 20916 and ISO 14155.
• Strong interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Superior analytical skills focusing on identifying potential compliance issues, investigating root causes, brainstorming and identifying alternatives and assessing the effectiveness of actions.
• Strong skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues.
• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.
• Ability to plan, organize, prioritize and manage workload independently, keeping the patient and customer at the focus.
• Superior critical thinking skills.
• Knowledge of Quality by Design principles.
• 7+ years of related experience.
• Bachelors Degree.