Clinical Research Project Manager

Site: The General Hospital Corporation

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

 

Job Summary

We seek an energetic, organized, and detail-oriented Project Manager with experience in the conduct of clinical research studies. The Project Manager will be responsible for coordination of a large NIH-funded multicenter lung transplant trial. The trial will recruit patients at Massachusetts General Hospital (MGH), as well as across 15 other sites. MGH will serve as the Administrative Core for the study and the Project Manager will be responsible for coordinating IRB and regulatory approval for all sites through the Mass General Brigham IRB, as well as enrolling patients in the trial at MGH. The Project will work under the general direction of the Principal Investigator and the Sr. Clinical Research Program Manager.

 

Qualifications

• The primary responsibility for the Project Manager will be to coordinate IRB approval and regulatory documentation for all participating sites, as well as implement the study at MGH. The Project Manager will plan and implement study protocols, create standard operating procedures, collect, and manage study data, assist in study activities, perform systematic literature reviews, and synthesize relevant data. The candidate will also prepare study progress reports and presentations, and may provide support analysis and help with the preparation of manuscripts. Initial focus will be launching the study, IRB application, and ensuring each staff member is fully trained. The Project Manager will recruit and enroll patient in the clinical trial. They will be responsible for data entry and management. In addition, the Project Manager will manage invoicing for all active research studies; assist with coordination and development of budgets and contracts; develop appropriate databases for tracking scientific, financial, and administrative information; develop best practices; create SOP’s; train new research staff members; as well as assist professional staff in the dissemination of research and operational efforts through presentations and written material. The position requires strong leadership and project development skills. While this is not a clinical position, it requires a good knowledge of basic clinical concepts and an understanding of how and when to communicate with clinicians. The Project Manager position requires the ability to be highly self-directing, resourceful, professional, and organized. The Project Manager will help ensure smooth communication and follow-up among all staff working with study subjects.

  The candidate must demonstrate superior organizational, time management, and communication skills, as well as intellectual independence and initiative. He/she will protect confidential and sensitive research data with integrity. The ability to work both independently and as part of a team is essential to this job. Other job duties and responsibilities are listed in detail below. This is a full-time (40 hours/week) position; evening and occasional weekend hours will be required.

• Additional Job Description

  The incumbent will act as the critical liaison between the MGH Admin Core and the other 15 participating sites.

  The Project Manager oversees the implementation of the protocol at the site and is responsible for oversight of all protocol functions and activities.

  • Oversee regulatory affairs of the study
  • Oversees regulatory affairs of the study, collates and files forms, documents, and other paperwork to set up and maintain research data (paper and electronic), patient files, and regulatory binders per FDA, IRB, and NIH standards
  • Works with physicians and nurses to screen subjects for research study by reviewing patient data for eligibility; ensures patients referred meet study criteria
  • Establish recruitment strategies and assure implementation and goal attainment on trials
  • Oversee collection and integrity of study data
  • Serve as a project administrator, working on systems improvement, project development and establishment of project SOPs
  • Assist with expediting funding and study start-up at MGH and other participating centers
  • May operate equipment to process blood samples; evaluates sample results to ensure correct processing; labels and ships specimens in compliance with regulatory and sponsor standards
  • Resear