Clinical Research Coordinator I, Orthopaedic Oncology Service MGH

The General Hospital Corporation; Boston (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

The General Hospital Corporation in Boston seeks a research professional to design study protocols with principal investigators, coordinate multi-site trials, and prepare IRB submissions in compliance with clinical and regulatory standards.

You will manage data for reports, ensure quality control, assist with manuscripts, train staff, and support research financing across study sites.

Responsibilities

• Study designs: design protocols with PIs and ensure feasibility and regulatory alignment.
• Coordinate multi-center trials with NIH, FDA, industry and foundations.
• Write IRB applications and liaise with IRB and Human Research Committee.
• Enroll patients via informed consent and follow up at time points.
• Data management: maintain databases, extract information for reports.
• Quality: develop manuals and ensure regulatory document compliance.
• Manuscripts: assist PI with writing and editing publications.
• Training/Supervision: supervise staff and conduct training.
• Research finance: track invoices to sponsors.

Job description

Site: The General Hospital Corporation

Job Summary

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.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Study Design/Completion: The incumbent designs research protocols in conjunction with the PIs, providing critical input as to feasibility of study design and available resources. The incumbent ensures study designs that are compatible with clinical practices and may coordinate multi-center trials with NIH, FDA, industry, and private foundations. When required, the incumbent coordinates and implements research design process at multiple sites. The incumbent develops detailed protocol documents that meet federal/institutional standards. The incumbent serves as a resource for patients and study sponsor personnel.

The incumbent works directly with the MGB Human Research Committee and Institutional Review Board (IRB). In this role, the incumbent is responsible for writing IRB applications and serves as the day-to-day liaison to the IRB and Human Research Committee. This person must be able to work collaboratively with staff physicians to process studies and protocols as required.

The incumbent demonstrates understanding and knowledge of designated study protocols and methods of implementation.

The incumbent identifies and enrolls patients into research studies via the informed consent process and follows up with them at necessary time points, when applicable.

Data Management: The incumbent organizes, establishes, and maintains research databases and uses these databases to extract information for reports, papers, and general feedback to the study team. The incumbent collects, compiles, tabulates and analyzes research data. The incumbent ensures that data is entered in timely fashion into the database accurately, and reviews and analyzes significant data and statistics in the computer file. The incumbent works to ensure that appropriate quality control systems are in place to monitor the progress of data acquisition and to define new approaches to data management while ensuring quality and completeness of database and patients' files. The incumbent maintains all required records and serves as a resource to staff and patients in providing statistical information from the database. The incumbent is also responsible for submitting and maintaining Data/Material Use Agreements with external sites.

Quality: In this role, the incumbent is responsible for quality control, and works with both internal and external colleagues to ensure rigorous adherence to internal and external quality standards. The incumbent develops, writes, and promulgates the Division's operations manuals. The incumbent ensures consistency of all regulatory documents, both internal to MGB and those from external sources - i.e., FDA, NIH, industry sponsors.

Manuscripts: The incumbent will assist the PI with writing manuscripts. Through this process, the incumbent will be highly involved with the editing of these manuscripts. The incumbent assists in writing and editing research publications, as well as performs independent literature searches and selects references for final publication. The incumbent prepares data and graphics and assists in presenting study findings to interested groups both within and outside of the hospital. The incumbent may be expected to attend scientific conferences to present study findings.

Training/Supervision: The incumbent is responsible for supervising the service's research staff, including undergraduate student interns and medical students. In this role, the incumbent reviews work of trainees and serves as a resource for staff. The incumbent conducts on and off-site training sessions to appropriate audiences - including PI's, Co-investigators, interns, and all relevant staff.

Research Finance: When studies involve funding from Sponsors, the incumbent is responsible for tracking and submitting study invoices to the sponsor, especially those that involve patient-related costs.

Following established policies, procedures, and study protocols, provides assistance on clinical research studies, in