Clinical Research Coordinator I
GENERAL SUMMARY/ OVERVIEW STATEMENT:
At MGH Orthopaedic Trauma, our doctors specialize in emergency orthopaedic care and post-traumatic reconstructive surgery for patients injured in motor vehicle collisions, industrial accidents and falls. MGH Ortho Trauma is a member of the Harvard Orthopedic Trauma Initiative is one of the most successful fully-integrated cross-campus clinical programs. The Initiative has a very robust clinical research patient-reported outcomes programs that have grown substantially during the last several years.
The Clinical Research Coordinator I position offers exposure to the clinical, operative, and academic aspects of Orthopedic Trauma Surgery. This position offers terrific opportunities to both work with expert Orthopedic Trauma surgeons and contribute to cutting-edge innovations.
Working independently and under general supervision from the Principal Investigators, the Clinical Research Coordinator I will provide support to clinical research studies and outcomes data collection. He/She may be responsible for the following activities: gathering data from the clinical record; recruiting and enrolling subjects into clinical protocols; developing and implementing patient recruitment strategies; and recommending changes to protocols.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Coordinates the implementation - both internally and externally - of sponsored clinical research studies, including robotic joint replacement research.
- Works directly with the Mass General Brigham Institutional Review Board (IRB), and is responsible for writing IRB applications and serves as the day-to-day liaison to the IRB. This person must be able to work collaboratively with staff physicians to process studies and protocols as required.
- Initiates and maintains contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgment as to the suitability of their participation.
- Reviews and collects appropriate data from the patient clinical record. Gathering patient images, X-rays, as well as operative and clinical notes
- Develops, organizes, and/or maintains the study database. Responsible for data validation and quality control.
- Administers, scores, and evaluates responses to study questionnaires.
- Maintains regulatory documentation.
- Supporting physicians with ongoing studies, projects, videos, papers and presentations.
- All other duties as assigned.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
- Ability to work independently.
- Excellent interpersonal skills are required for working with the study participants.
- Excellent oral and written communication skills.
- Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
- Knowledge of clinical research protocols.
- Excellent organizational skills and ability to prioritize a variety of tasks.
- Impeccable attention to detail.
- Ability to demonstrate professionalism and respect for subjects rights and individual needs.
- Knowledge of data management programs.
- Experience with coding and statistical analysis is preferred, but not required.
Qualifications - External
EDUCATION:
- BA/BS required. Coursework in biology or other pre-medical or related fields is not required but may be helpful.
EXPERIENCE:
- Previous research experience including interface with research subjects, collection of clinical data, and/or familiarity with IRB requirements and regulatory documentation of research is preferred, but not required.