Research Regulatory Analyst
at Hartford HealthCare

Date Posted: 6/16/2019

Job Description

Work where every moment matters.

Every day, almost 20,000 Hartford HealthCare employees 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 certified 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.


Job Summary
The Regulatory Analyst is a part of the Cancer Clinical Research Office. The Regulatory Analyst position requires knowledge of the IRB policies and procedures and federal regulations for clinical trials. Responsibilities include but, are not limited to the following:

• Providing regulatory continuity during the pre-study and post-approval process
• Coordinate and facilitate the appropriate filing of regulatory paperwork for the clinical research trials in oncology which are supported by Memorial-Sloan Kettering (MSK) Alliance, National Cancer Institute (NCI), industry, cooperative groups, and investigator-initiated etc.
• Serve as a resource for investigators in communicating and trouble –shooting issues with the Office of Research Administration, IRB, and other committees involved in the clinical research pre-study and post-approval process
• Collaborate with other clinical trial staff to ensure highest quality clinical research activities
• Travel will be required to other sites within the Health Care system as needed

Job Requirements

Education
• Bachelor’s Degree in a related field

Experience
• Three to five years previous experience in regulatory compliance in clinical trials
• ACRP, CCRP, or CIP or research related certification a plus
• Strong knowledge of research regulatory requirements (including FDA and other federal and state regulations); GCP/ICH guidelines.
• Experience in submitting applications to Local and Central IRB’s such as continuing reviews, amendments, reports, etc.

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.

Job Snapshot

About Us

We are always looking for dedicated, talented, and caring health professionals to join our team.

You are sure to find a position to match your skills, as we have availabilities in a wide variety of departments and entities.

Hartford HealthCare partners offer competitive salaries and benefits, as well as a stimulating work environment that inspires excellence.

Hartford HealthCare offers a comprehensive benefits program to full-time and part-time employees.

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