Clinical Compliance Specialist

Clinical Compliance Specialist

Requirements

• 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

Responsibilities

• 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
• 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)
• 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
• 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

Preferred Qualifications

No preferred qualifications provided.