Clinical Research Coordinator I, Orthopaedic Oncology Service MGH

Mass General Brigham•Boston, MA

4d•Hybrid

About The Position

The Clinical Research Coordinator I works with physicians, clinical nurses, and staff in the Orthopaedic Oncology Service to identify and recruit eligible patients for clinical studies and obtain local and federal regulatory approval for research. The coordinator serves as the primary contact for the service’s research administration and supports studies from design and regulatory review through recruitment, data management, quality control, publication, training, and financial tracking. The role collaborates with principal investigators on protocol design and feasibility, prepares protocol and IRB documents, liaises with the MGB Human Research Committee and IRB, and supports single- and multi-site studies. The coordinator identifies, enrolls, and follows up with participants; maintains research databases and records; collects and analyzes study data; and supports quality standards and data agreements. The position also assists with manuscripts, literature searches, graphics, presentations, and conferences; supervises and trains research staff and trainees; and tracks sponsor invoices. Study support may include scheduling visits, performing clinical tests such as phlebotomy and EKGs, and maintaining study data. This is a 40-hour-per-week regular position with a hybrid work arrangement at 32 Fruit Street and a day shift. Patient care is not required. The role requires comfort working in clinical settings and the operating room. Candidates completing a bachelor’s degree may have six months from hire to provide degree equivalency verification, or up to one year if starting per diem.

Requirements

Bachelor’s degree in a related field, or qualifying experience in lieu of a degree; experience-in-lieu is accepted.
Some relevant research project work; 0–1 year preferred.
Comfort and ability to work in clinical settings and the operating room.
Careful attention to detail and good organizational skills.
Ability to follow directions.
Good interpersonal and communication skills.
Computer literacy.
Working knowledge of clinical research protocols.
Ability to demonstrate respect and professionalism for subjects’ rights and individual needs.

Nice To Haves

Some relevant research project work (0–1 year preferred).

Responsibilities

Collaborate with principal investigators to design research protocols, assess feasibility and resources, and ensure designs are compatible with clinical practice.
Coordinate multi-center trials and, when required, implement research design processes across multiple sites.
Develop protocol documents that meet federal and institutional standards.
Write IRB applications and serve as the day-to-day liaison to the IRB and MGB Human Research Committee.
Identify, recruit, interview, consent, enroll, and follow up with eligible study participants.
Support clinical research studies by evaluating and consenting patients, collecting and organizing patient data, scheduling study visits, performing clinical tests such as phlebotomy and EKGs, and maintaining study data.
Establish and maintain research databases; collect, compile, tabulate, analyze, and accurately enter data in a timely manner.
Monitor data acquisition and quality, maintain complete databases and patient files, and maintain required records.
Submit and maintain Data/Material Use Agreements with external sites.
Provide quality control and help ensure adherence to internal and external quality standards.
Develop, write, and distribute the Division’s operations manuals, and ensure consistency of regulatory documents.
Assist principal investigators with manuscript writing and editing; conduct literature searches, select references, prepare data and graphics, and help present study findings.
Attend scientific conferences to present study findings when expected.
Supervise service research staff, including undergraduate interns and medical students; review trainee work and serve as a staff resource.
Conduct on- and off-site training for principal investigators, co-investigators, interns, and relevant staff.
Review proposals for compliance with sponsor and organizational guidelines and verify sponsor requirements are met.
Verify study form accuracy and update forms according to protocol; prepare data for analysis and data entry; document patient visits and procedures.
Assist with regulatory binders, QA/QC procedures, and study regulatory submissions.
Track and submit sponsor study invoices, particularly invoices involving patient-related costs.