Website Massachusetts General Hospital
Functions independently as Project Manager and is responsible for the planning and implementation of all phases of several currently funded clinical trials, as well as the initial stages for future trials. The team is focused on cardiovascular disease and improving cardiovascular outcomes. Currently funded multicenter trials include NIH (STOP-CA, REPRIEVE-MR) and Industry-funded clinical studies. A major focus of the program is the use of imaging for patients at risk of cardiovascular disease and reducing cardiovascular events among patients with cancer.
- Ensures ongoing data integrity by being responsible for quality control of data. Develops and amends standard manual of operating procedures and study protocol documents.
- Contributes to the content and development of numerous data forms and documents for multiple trials and research studies.
- Liaison to sponsors (industry and NIH), internal and external laboratories, on-site research collaborators, and relevant hospital departments to coordinate specific trial activities.
- Directs supplier of study drug/placebo, prepares IND application to FDA if needed, develops timeline for manufacture and distribution of drug supply to subjects.
- Responsible for preparation of reports and resource for the PI, Co-Investigators, Partners HealthCare, NIH, industry sponsors, CRO, local and central IRBs, and FDA.
- Supervises the preparation of all documentation for securing IRB approval, and then ensuring on-going IRB approval for the study and study sites.
- Designs and writes recruitment materials, publicity and newsletters to meet patient enrollment goals in compliance with IRB regulations.
- Assisting sites with IRB approval and documentation as well as compliance with good clinical practice and clinical study.
- Responsible for all aspects of project direction and study coordination for numerous NIH and industry funded studies.
- Develops and implements operational procedures for studies to logically and effectively sequence and structure the protocol-required study procedures as part of responsibility for all aspects of study direction and administration.
- Knowledge of federal and local regulatory guidelines with respect to the conduct and fulfillment of clinical trial documentation
- Strong interpersonal, leadership and team-building skills and the ability to smoothly integrate the demands of sponsor, hospital and other groups necessary to perform all aspects of multiple clinical trials being run concurrently
- Excellent judgment and ability to understand, interpret and implement protocol requirements
- Excellent organizational skills to formulate long term complex procedure requirements in compliance with vigorous and competing timetables
- Excellent written and communication skills
- Knowledge of cardiovascular imaging and management of cardiovascular imaging related datasets
- Ability to work with a diverse set of constituencies from countries world-wide.
- Must be able to make independent, effective and appropriate decisions in numerous situations
Qualification & Experience:
- Bachelor’s Degree
- Preferred: Prior experience with all aspects of NIH-sponsored clinical trials. Prior experience with design and management of clinical trials required. Excellent communication skills.
- Required: Minimum of 2 years progressively more responsible experience in clinical research and medical imaging. Knowledge of federal regulatory requirements for good clinical practice of trials.
- Master’s Degree
Company: Massachusetts General Hospital
Vacancy Type: Full Time
Job Location: Boston, MA, US
Application Deadline: N/A