Compliance Coordinator

Role Overview

• Conduct and document assigned periodic monitoring according to the monitoring plan which includes verification of subject safety and adherence to Institutional, WVUCI CRU, federal and state regulations and specific protocol requirements including:
• Verification of subject study research data including informed consent process, eligibility, treatment, follow-up, and safety reporting documentation to ensure compliance with study protocols.
• Review of study-related regulatory documentation such as correspondence, delegation logs, institutional review board communication, deviations, and progress reports for each assigned study.
• Verifies validity of research results by ensuring timely, accurate, and complete source data and Case Report Form documentation.
• Quality Assurance and Quality Control:
• Lead collaborations with clinical research teams in non-compliance issue identification, finding solutions and implementing corrective and preventive action plans and processes to remediate issues.
• Follows monitoring procedures and tools for investigator-initiated IND or IDE-enabling clinical trials (or other trials as needed where there is no external sponsor/monitor).
• Support the clinical research team by ensuring they have adequate training and processes for the responsible conduct of research.
• Generate monitoring reports and ensures any non-compliances are adequately resolved in a timely manner.
• Participate in the preparation and follow-up activities for regulatory agency and Sponsor audits as needed to ensure successful outcomes
• Present findings and recommendations for areas of improvement to management in areas that affect clinical research programs at the institution.
• Assist in identifying training needs and in developing and/or executing training programs for study staff and supporting departments.
• Data Safety and Toxicity:
• Coordinating internal Data Safety and Toxicity Committee meetings and subsequent review sessions as needed. Meetings to include review of internal unanticipated events and response assessments, external safety reports, investigator initiated trials monitoring reports per DSMP and external audit findings.
• Perform secondary review of eligibility for interventional clinical trials.
• Other duties as assigned. May include monitoring of external institutions participating in Investigator Initiated Trials sponsored by WVUCI

Requirements

• Bachelor’s degree in appropriate area of specialization.
• A minimum of three (3) years of experience in the following: Research coordination and/or project management in clinical research.
• Any equivalent combination of related education and/or experience will be considered.
• Knowledge, Skills and Abilities:
• Working knowledge of regulatory aspects of pharmaceutical and medical devices industries and government sponsored clinical research studies including institutional review board (IRB) regulations, US FDA Code of Federal Regulations (US FDA CFR) & Guidances, National Institute of Health (NIH), International Conference on Harmonization (ICH) GCP,Medicines and Healthcare Products Regulatory Agency (MHRA), Therapeutic Products Directorate (TPD) or HealthCanada, etc.
• Project management and/or study coordinator or other research experience in an academic clinical research facility or industry research facility and/or medical/clinical training.
• Experience in clinical research including proficiency with databases and/or patient data.
• Strong desire to learn, seek out, and apply new knowledge, methods, and information.
• Experience in National Cancer Institute NCTN Cooperative group trials.
• Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, WVUCI staff, and others.
• Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills.
• Proven sense of professional ethics and conduct, understanding and effectively using and applying Emotional Intelligence strategies and skills.
• Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capability.
• Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Demonstrated ability to establish and maintain effective working relationships with stakeholders and critical staff, both internally and externally, through a variety of communication mediums and venues.
• Project manager mindset and basic skills including: delegation, scheduling, communication, critical thinking, task and quality management, risk management, and flexibility.
• Proficiency with Microsoft Office suite, particularly Excel, Word.
• Research Certification with SOCRA or ACRP preferred or able to obtain within 6 months of hire

Tech Stack

• Google Cloud Platform

Benefits

• 37.5-hour work week
• 13 paid holidays ( staff holiday calendar )
• 24 annual leave (vacation) days per year ( employee leave )
• 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks.
• Wellness programs