Hartford HealthCare Medical Group Specialists
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DescriptionJob Schedule: Part Time
Work where every moment matters.
Every day, almost 30,000 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.
Hartford HealthCare Medical Group is one of the largest medical practices in New England with multiple locations throughout Connecticut and Rhode Island. We consist of a team of professionals ranging from Medical Assistants to Physician Assistants and everything in between. Our physician led medical group enjoys an excellent reputation with patients and the medical community, offering primary care, urgent care and more than 30 different specialties.
The Clinical Research Coordinator of the HHC Neurogastroenterology and Motility Center is an integral member of the research team. The CRC works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research assistants. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Supports program building and emerging programs or recovery models. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Responsibilities of the Clinical Research Assistant include, but are not limited to, the following:
Ensures proper research conduct in accordance with Federal, State and local policies and Good Clinical Practice and protocol adherence
Responsible for highly complexity protocols (i.e. Bayesian model), novel or adaptive trial designs, first-in human/class drugs, advanced disease types and/or moderate-to-high patient acuity
Responsible for high patient/study case load (i.e. 10-12 active studies, 15-20 accrual/yr) and/or rapid enrollment (i.e. just in time model)
Responsible for complex clinical trial logistics (i.e. new site, emerging program, in-patient studies, CART)
Critically evaluates research protocols for feasibility, resourcing and logistical implementation. Identifies challenges and independently remove barriers and mitigates risks.
Provides direction and guidance to the Principal investigator regarding protocol requirements, institutional guidelines and good clinical practice.
Independently coordinates research activities in accordance with the protocol including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Provides training & education and key clinical information to the clinical team (i.e. lab, infusion, nursing, etc.) to ensure all research required elements are performed and conducted in accordance with the study guidelines (i.e. safety pause).
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Reviews documentation to ensure the accuracy, completeness, legibility and timely completion of data
Ensures reliability and validity of clinical research trial data
Maintains effective and ongoing communication with sponsor, key partners, research participants, PI and regulatory bodies (i.e. IRB) during the course of the study.
Bachelor’s degree in Science or Healthcare related field required
Master’s degree Science or Healthcare related field preferred
Four (4) years of direct clinical research experience
Three (3) years of patient facing responsibilities
Advance knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to independently navigate ambiguous areas
Demonstrated ability to exercise sound judgment
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.