Clinical Research Coordinator
Massachusetts General Hospital(MGH)

GENERAL SUMMARY/ OVERVIEW STATEMENT:
Under the supervision of the Principal Investigator and the Program Manager for the MGH Paralysis Center, the Clinical Research Coordinator I will work closely with the team to provide research and organizational support for designated research studies within the Center.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

A Clinical Research Coordinator I performs the below duties:

• Prepare, organize, and update research protocols and regulatory documents.
• Perform data collection and database entry related to particular studies.
• Coordinate research-related visits and communications with patients, as well as arrange meetings/conferences with the research team.
• May assist in preparing research data for analysis and manuscript preparation.
• Works in collaboration with the PI, Clinical Trial Office, and departmental research administrator and to assist in the coordination and management of new and existing research studies.
• Assists with preparation of research protocols (IRB and/or IACUC); prepares, organizes, updates, and maintains regulatory documents in accordance with FDA and institutional guidelines. Informs research team of deadlines associated with the submission of regulatory documents.
• Assisting program manager in completing deliverables pertaining to study.
• Supports Research Nurse during data collection.
• Collects and abstracts patient data from medical records and accurately enters it into the research database (including RedCap). As needed, runs established reports for use by the investigator.
• Maintains REDCap databases for ongoing studies.
• Verifies accuracy of study forms
• Updates study forms per protocol
• Assists with formal audits of data
• Assists with interviewing patients
• Provides a basic explanation of studies and in some cases obtains consent forms from patients
• Assists with study regulatory submissions
• Collates, mails, or emails patient surveys and questionnaires; receives completed forms and enters information into the research database. Serves as point person for patients needing help or information with these materials.
• Schedules and organizes patient research visits, answer patient questions, and facilitates communications with patients regarding research-related activities
• Organizes research phone conferences and meetings; responsibilities include: sending and tracking invitations, scheduling and organizing conference calls, and distributing meeting agendas and materials.
• Attends scheduled and ad hoc research meetings with the research team to keep current on the study status and priorities of the various research projects.
• Provides office support including answering the phone, maintaining updated research files and folders, making photocopies, faxing and emailing documents.
• May assist with supply orders
• Perform literature searches when requested.
• Performs other duties as assigned.
• Assists with preparation of research protocols (IRB and/or IACUC); prepares, organizes, updates, and maintains regulatory documents in accordance with FDA and institutional guidelines. Informs research team of deadlines associated with the submission of regulatory documents.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Ability to work independently and as a team member
• Good communication skills
• Computer literacy
• Working knowledge of clinical research protocols
• Ability to perform multiple tasks independently
• Good organizational skills
• Good attention to detail
• Ability to follow directions
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs

The Clinical Research Coordinator I 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.

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