Job Schedule: Full Time Standard Hours: 40 Job Shift: Shift 1 Shift Details:
Work where every moment matters.
Every day, over 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 Institute of Living, one of the first mental health centers in the U.S., remains one of America’s leading not-for-profit centers for patient care, research and education in the fields of behavioral, psychiatric and addiction disorder. Through our dedicated, experienced and skilled clinicians, we provide patients and their families with the highest quality of personalized care. Programs are offered for children, adolescents and adults struggling with mental illness as well as offering services specializing in Anxiety, Eating Disorders, and Geriatric Services.
Responsible for 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.
The goal of this position is to facilitate the processing of necessary regulatory submissions in a proactive way.
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
Handling confidential information appropriately
Bachelor's Degree is the minimum requirement. Healthcare background is strongly preferred
At least 3 years of relevant work experience in regulatory compliance in clinical trials is required
ACRP, CCRP, or CIP or research related certification a plus
Proficient in verbal and written English required
Ability to manager and meet timelines
Flexible, adaptable and agile in the changing environment
Strong knowledge of research regulatory requirements (including FDA and other federal and state regulations); GCP/ICH guidelines
Experience in submitting applications to IRB such as continuing reviews, amendments, reports, etc.
Computer, quality assurance and time management skills required
Working knowledge of software applications like Microsoft Word, Excel, PowerPoint, MS Outlook, and iRIS
Ability to learn new software and technology quickly and efficiently
Strong interpersonal and organizational skills
Detail oriented with exceptional communication skills
We take great care of careers.
As a Hartford Healthcare entity, The Hartford Hospital Institute of Living provides eligible employees with an extensive benefits package and all the benefits of working in a thriving centrally located urban community:
Medical and dental benefits
401(k) plan with employer match
Generous paid time off with accrual starting on the date of hire
Additional voluntary benefits as well as employee discount programs
Located on the Institute of Living’s historic park-like grounds designed by Frederick Law Ohlmsted
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.