Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The mission of the MGH Clinical Translational Research Unit Core is to support investigators in the discovery, development, and implementation of promising therapeutics and associated diagnostics for individuals with complex brain disorders affecting cognition, behavior, emotion, sensory and motor functioning, and other diseases as related to the brain. Under the general supervision of the CTRU Core Program Director, the Clinical Research Coordinator is responsible for all aspects of project coordination for clinical and translational trials and/or studies and/ or projects for a large group of investigators representing the MGH Martinos Center for Biomedical Imaging and the MGH Departments of Neurology, Psychiatry and Radiology.

They will liaise with study sponsors, CROs, funding agencies, central vendors, as well as all levels of study staff of the CTRU to ensure the smooth operation of assigned MGH and multi-site clinical trials and translational research projects. The incumbent should display a high degree of initiative and independent judgment to continually assess and direct a wide range of projects and clinical trial activities. The Clinical Research Coordinator will be responsible for all trial activities from initiation and implementation to close-out of assigned multi-center research activities.

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

SUPERVISORY RESPONSIBILITY (if applicable):

A Clinical Research Coordinator II may assist with the training and orientation of new staff members.

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

EDUCATION:

Bachelor's degree required.

EXPERIENCE:

Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.