The TCRC Clinical Research Coordinator II is part of a team of providers and support staff that support investigators in the implementation and execution of their studies. Responsibilities include IRB submission and amendments, application for service, creation of order sets and flow sheets to mirror the protocol, participant recruitment, scheduling of appointments and other activities as delegated (as per study specific delegation log). Commensurate with experience and motivation, opportunity exists to participate in scientific manuscript preparation and writing. Creative thinking, a willingness to learn new skills, and the ability to handle multiple projects are expected. Knowledge of epic and research scheduling platform. Prior research or work experience is preferred.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.
Collects & organizes patient data
Maintains records and databases
Uses software programs to generate graphs and reports
Assists with recruiting patients for clinical trials
Obtains patient study data from medical records, physicians, etc.
Conducts library searches
Verifies accuracy of study forms
Updates study forms per protocol
Documents patient visits and procedures
Assists with regulatory binders and QA/QC procedures
Assists with interviewing study subjects
Administers and scores questionnaires
Provides basic explanation of study and in some cases obtains informed consent from subjects
Performs study procedures, which may include phlebotomy.
Assists with study regulatory submissions
Writes consent forms
Verifies subject inclusion/exclusion criteria
Performs administrative support duties as required
A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:
Maintain research data, patient fields, regulatory binders and study databases
Perform data analysis and QA/QC data checks
Organize and interpret data
Develop and implement recruitment strategies
Act as a study resource for patient and family
Monitor and evaluation lab and procedure data
Evaluate study questionnaires
Contribute to protocol recommendations
Assist with preparation of annual review
May assist PI to prepare complete study reports
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
Careful attention to details
Good organizational skills
Ability to follow directions
Good communication skills
Computer literacy
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects' rights and individual needs
The Clinical Research Coordinator II should also possess:
Ability to work independently and as a team player
Analytical skills and ability to resolve technical problems
Ability to interpret acceptability of data results
Working knowledge of data management program
Qualifications
EDUCATION:
Bachelor's degree required.
EXPERIENCE:
New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.
SUPERVISORY RESPONSIBILITY (if applicable):
A Clinical Research Coordinator I does not have any supervisory responsibility.
A Clinical Research Coordinator II may assist with the training and orientation of new staff members.
EEO Statement
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.