Hartford HealthCare Corp.
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DescriptionJob Schedule: Full Time
Work where every moment matters.
Every day, almost 30,000 Hartford HealthCare colleagues come to work with one thing in common: Pride in what we do, knowing every moment matters here. We invite you to become part of Connecticut’s most comprehensive healthcare network.
The Hartford HealthCare Cancer Institute (HHC CI) is a pioneering member of the Memorial Sloan Kettering (MSK) Cancer Alliance. Through the bi-directional collaboration facilitated by this partnership, community providers are better positioned to provide state-of-the-art, evidence-based cancer care to improve the lives of cancer patients. Together, the Hartford Healthcare Cancer Institute and Memorial Sloan Kettering are staying ahead of cancer.
The Hartford HealthCare Cancer Institute focuses on offering our cancer patients an unparalleled network of coordinated services– all under one roof. Our system of care includes a truly integrated team with the most talented, experienced, and compassionate caregivers and physicians, backed by the latest cutting-edge technology.
The Regulatory Analyst (RA) is responsible for maintaining overall regulatory compliance through timely and accurate submissions to oversight bodies, management of essential documents, maintenance of site records and policy enforcement. The regulatory analyst serves as a resource to investigators and research staff by maintaining a customer service relationship with assigned faculty and staff; collaborating with other cross-functional team members to ensure the highest quality of clinical research activities; and develops and maintains professional relationships with external research and funding agencies.
While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the RA supports, facilitates and coordinates the regulatory related clinical trial activities and plays a critical role in the conduct of the study.
• Responsible for moderate complexity protocols, regulatory compliance and ensuring accurate and timely reporting of all essential regulatory affairs.
• Responsible for the maintenance of the regulatory site files and working closely with the nurse/coordinator, research staff and investigators to assure that all regulatory documents for the research studies are up-to-date and include all pertinent communications.
• Maintain high quality research by using Good Clinical Practice (GCP) guidelines.
• Supports site operations by attending pertinent meetings, and presenting research information, including metrics, at regular investigator meetings, research staff meetings, or equivalent.
• Maintains knowledge of active portfolio across all Hartford Healthcare sites (study status, accrual, gaps, etc.) and serves as a resource to investigators and peers.
• Responsible for objectively reviewing regulatory file and independently performing root cause analysis and proposing reliable and reasonable corrective/preventative action plans.
• Reporting any unanticipated problems involving risks to research participants or others, non-compliance/serious, non-compliance and/or misconduct to the IRB and the sponsor in compliance with Federal and institutional policies and procedures.
• Bachelor’s Degree in Science or Healthcare related field, required.
• Master’s Degree in Science or Healthcare related field, preferred.
Licensures or Certificates
• Good Clinical Practices Training Certificate, preferred.
• ACRP, SOCRA certification, preferred.
• Two (2) years of direct clinical research experience
• Two (2) years of oncology experience, preferred
• Two (2) years of regulatory specific responsibility, preferred
• Working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.)
• General understanding of medical terminology, specifically in the Hematology/Oncology space
• Intermediate proficiency in Microsoft Office
We take great care of careers.
With locations around the state, Hartford HealthCare offers exciting opportunities for career development and growth. Here, you are part of an organization on the cutting edge – helping to bring new technologies, breakthrough treatments and community education to countless men, women and children. We know that a thriving organization starts with thriving employees- we provide a competitive benefits program designed to ensure work/life balance. Every moment matters. And this is your moment.