The MGH Crohn’s and Colitis Center is a multidisciplinary center providing state-of-the-art care. It is also at the forefront of clinical trials in Inflammatory Bowel Disease. Receiving general direction from the Clinical Research Program Manager, the Sr. Clinical Research Coordinator is responsible for recruitment, regulatory documentation, and management of clinical research activities within the Crohn’s and Colitis Center, including all activities necessary to effectively start, conduct, and end specified projects.
· Day-to-day implementation and oversight of clinical research studies
· Trial initiation – including budget development, protocol submission for approval from Partners Human Research Committee, and facilitation of review and execution of Clinical Trials Agreements through Partners Clinical Research Office
· Working in close concert with Principal Investigator and participating physicians to screen, consent and enroll eligible study patients
· Liaison with human subjects research committee members, core laboratories, site investigators, and study staff for maintaining continuous high quality and efficiency of standard operating procedures.
· Generate study-related reports for various committees, funding organizations, and regulatory agencies.
· Work with PI to implement and oversee study monitoring and data management and prepare reports for data safety monitoring committees
· Working in close collaboration with the grants managers to monitor expenditures and ensure projects proceed quickly and within budget and payments due are collected from sponsor
· Working in close collaboration with Patient Billing Manager, Research Compliance, and Research Finance to ensure study-related procedures are billed appropriately and corrections are made promptly, if necessary
· Support initiation of new clinical trials
· Assist with development of protocols and consent forms
· Create operations manuals and case report forms, as needed
· Coordinate use of Research Pharmacy and Clinical Research Centers, as needed
· Assist with training of CRC I’s, as needed
· Order study-related equipment and supplies
· Process subject remunerations
· Lead orientation and close out meetings
· Arrange the agendas and logistics of the annual training/review meetings of the investigators and coordinators, and for the meetings of the Steering and Safety Monitoring Committees, in concert with other meetings of the study investigators
· Field site questions and, in consultation with the PI, provide protocol clarifications on a daily basis via telephone, fax, e-mail and surface mail
· Monitor enrollment site performance for subject accession and data acquisition in accordance with the protocol sand convey this information to the PI on a weekly basis
· Monitor and report adverse events and other major concerns related to the studies and disseminate the information to the PI, Medical Monitor, FDA and Steering Committee
· May be asked to oversee IND applications and FDA communication for studies with investigator held INDs
· Managing the operation of study visits and serves as liaison to study participants on scheduling and study-related questions
BA/BS required, MA/MS/MPH preferred.
A minimum of 3-5 years of directly related experience required.
Must be able to work independently and display initiative to introduce innovations to research study.
Must have the ability to prepare and monitor budgets, to identify problems and develop solutions, prioritize tasks and set deadlines.
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
: MA-Boston-MGH Main Campus
MGH Main Campus
55 Fruit Street
: Massachusetts General Hospital(MGH)
Standard Hours : 40
: Day Job
Recruiting Department : MGH Gastrointestinal Unit
: Oct 22, 2018