Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The incumbent works under the general direction of Dr. Santiago Lozano-Calderon and is required to work with physicians, clinical nurses, and staff to identify and recruit eligible patients for clinical studies. This incumbent will be the primary compliance officer for the Orthopaedic Oncology Service, responsible for obtaining regulatory approval at both the local and federal level for the service's research endeavors. Additionally, the incumbent will act as primary contact for all of service's research-related administration.

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.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Must be capable of taking initiative to complete all job responsibilities independently and effectively with minimal supervision. The incumbent must demonstrate analytical skills to problem solve and display initiative to introduce innovations to research study. The ability to adhere to all regulatory and procedural policies related to the laboratory functions is required. The ability to communicate effectively, be highly organized, and be detail-oriented is necessary to perform the above job functions. The incumbent must have the ability to identify problems and develop solutions for situations that are either analytical or technical in nature. The incumbent requires the ability to prioritize tasks and set deadlines.
• The incumbent must be able to and comfortable with working in clinical settings and the operating room.
• Requires excellent computer skills.
• Knowledge of database management, statistical analysis techniques, and research methodologies is preferred.

EDUCATION:

• Bachelor's degree required.

EXPERIENCE:

• 1-2 years of research experience highly preferred.

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.