The Clinical Research Quality & Compliance Specialist plays an integral role in the data integrity and regulatory compliance of pharmacy services related clinical research. The specialist cultivates an in-depth understanding of federal regulations as well as an understanding of day-to-day clinical drug study processes.

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• Maintains current knowledge and provides guidance on federal research regulations through review of current publications and attendance at conferences.
• Interfaces with study sponsors, investigators, and study teams for routine monitoring visits, audits, and ensures completion of required follow-up. Serves as liaison between study sponsors and the research team. Identifies protocol content which may conflict and communicates deviations, SOPs, GCP and regulations to investigators and pharmacy leadership.
• Performs pre-study, initiation, routine, and close-out visits for multi-site central services pharmacy studies to ensure subject safety and data integrity. Verifies source and other pharmacy trial records are accurate, complete, and maintained.
• Works closely with the Senior Research Training and Compliance Coordinator-Pharmacy to analyze internal audits, refines processes to ensure the quality of data integrity, and maintains regulatory compliance.

Education: BA/BS degree in healthcare or medical/science field, required.

Certifications: CCRC or CCRP (or obtain within 1 year of hire), required.

Skills:

• Thorough understanding of federal regulations including U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCPs), and Institutional Review Board (IRB) policy.
• Working knowledge of IRB and regulatory processes, required.
• Ability to teach according to different learning styles. Ability to deliver crucial feedback in a candid, compassionate manner.
• Strong critical thinking and well-developed organizational skills with a demonstrated attention to detail. Strong written and verbal communication and presentation skills.
• Documented people skills with “hands on” management style.
• Self-directed, results driven with the ability to manage workload. Experience in following long-term plans and adhering to schedules.
• Working knowledge of PCs and word processing and data management software including Microsoft Office Suite, SharePoint, SmartSheet, Electronic Data Capture (EDC) and Electronic Medical Records (EMR).
• Knowledge of medical terminology, disease states, pharmaceutical terminology, pharmacy regulations
• Leadership experience, strong interpersonal skills and understanding of group dynamics.

Experience:

• 3 years of Clinical Research, or equivalent experience, required.
• Pharmaceutical experience desirable.

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

EOE M/F/Disability/Vet