Major Responsibilities:
· Responsible for monitoring, inspecting and proposing measures to ensure compliance with established quality standards.
· Perform vendor qualification audits, ensuring adherence to established validation process.
· Author, review and update company SOPs and policies; ensure compliance by those identified as responsible to them.
· Manage company-side of IND’s Learning Management System (LMS), ensuring individuals receive required trainings.
· Ensure Data Security for participating subjects, including General Data Protection Regulation (GDPR) and 21 Code of Federal Regulations (CFR) 21 as pertain to data/records maintained for study participants.
· Ensure Good Clinical Practice (GCP) Training is provided for those in applicable positions; maintains Accreditation files.
Qualifications/Requirements:
· Bachelors’ degree with 8+ years experience in compliance and quality assurance in a clinical research environment, or Masters’ with 6+ years experience.
· Experience working within clinical research field and within a matrix environment, performing quality assurance activities for complex initiatives involving human subject research and related federal regulations.
· Demonstrated problem-solving and critical thinking skills, as well as ability to develop processes where there is no existing roadmap.
· Excellent communication skills, both verbal and written; experience with PowerPoint and making presentations.
· Strong interpersonal skills and experience managing people and processes; cultivates strong relationships with people at all levels.
· Managed projects and project team effectively; interacts effectively with individuals at all levels.
· Strong remote work competencies: Self-starter; independent worker; manages time and priorities effectively; strong communication skills (verbal/written); technologically savvy.
Unique Requirements:
· Periodic travel < 10% required
