Clinical Research Associate - Clinical Research Center

Hartford HealthCare•Hartford, CT

About The Position

Work where every moment matters. Every day, more than 40,000 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 Hospital is one of the largest and most respected teaching hospitals New England. We are a Level 1 Trauma Center that provides cutting edge treatment to its patients. This is made possible by being home to the largest robotic surgery center in the Northeast and the Center for Education, Simulation and Innovation (CESI), one of the most-advanced medical simulation training centers in the world. When hospitals cannot provide the advanced care, expertise and new treatment options their patients require, they turn to us. Job Summary: As a specialized research professional the Clinical Research Associate (CRA) collaborates with the Principal Investigator (PI) in leading all activity associated with research study protocols. This includes but is not limited to; research conduct, budget negotiation & management, initiating collaborations with other investigators and areas pertinent to the performance of the study, monitoring research progress and making necessary changes towards process improvement, leading efforts to initiate new studies, attending IRB meetings to expedite the start-up process. The CRA supervises all study activity and may delegate responsibilities to Research Assistants and/or Research Associates as appropriate. In addition, the CRA supervises HHC approved Research Volunteers. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRA leads, facilitates and coordinates all clinical trial activities playing a critical role in the supervision and conduct of the study. By performing these duties, the CRA works with the PI, department, sponsor, IRB and institution to support and provide guidance on the administration of the compliance, financial, personnel and all aspects of the clinical study.

Requirements

Bachelor degree in an appropriate science discipline such as biology, psychology, etc.
On a case by case basis, Associate degree may be considered with significant years of research experience. Master’s Degree preferred
Five years of clinical research experience.
Or, seven years of practical clinical research experience is required with an Associate degree.

Responsibilities

Compiles and extracts data by performing and reviewing patient information to ensure integrity of patient data for analysis and development of protocols.
Enrolls patients in studies by screening for eligibility criteria, consulting with physicians and obtaining patient informed consent to ensure patient safety preserved and regulatory standards are met.
Instructs hospital staff and physicians on current study by familiarizing them with protocol requirements to assure proper execution.
Works effectively as a team member both within and across clinical settings to promote an integrated delivery of health care services through communication, cooperation and collaboration.
Train, mentor and supervise lower level research staff, students, interns, and volunteers
Assign tasks to Clinical Research Assistants and Clinical Research Associates as appropriate in collaboration with the CRC manager
Support other staff in all aspects of study conduct including, oversight associated with meeting the goals outlined in the protocol and clinical trial agreement
Motivate others, monitor study performance and lead study meetings
Manage complex multisite, interventional high risk drug/device research protocols
Presents at conferences (abstracts, poster presentations) and assists in preparation of manuscripts
Must have in depth knowledge of at least one clinical area
Serve as CRC leader internal/external, advising other staff regarding complex protocols and projects in one or more clinical area
Provide a leadership role in developing, implementing, and evaluating the conduct of clinical research
Takes a lead role and/or coordinates or presents at internal external clinical research education event/conferences
Lead activities designed to improve organizational performance metrics
Reviews and develops a familiarity with the clinical trial agreement and/or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPP) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions
Coordinates appropriate and timely payments to participants (if applicable) in accordance with policies and procedures
Contributes directly regarding continued and yearly performance appraisal of Clinical Research Center team members
Promotes and monitors lower level personnel regarding the ethical conduct of research by assuring that good faith suspicions of misconduct in research as defined within Research Administrations Policy and other misconduct as described in HHC Code of Conduct are reported appropriately.
Registers (if required) studies on ClinicalTrials.gov and maintains current and accurate information
Coordinates all aspects of study activity as required of a Clinical Research Associate