Clinical Research Coordinator 1

As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women's Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care, and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.

We're focused on a people-first culture for our system's patients and our professional family. That's why we provide our employees with more ways to achieve their potential. Mass General Brigham is committed to aligning our employees' personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development-and we recognize success at every step.

Our employees use the Mass General Brigham values to govern decisions, actions, and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.

This position works under the general supervision of the Program Manager within the Center for Clinical Research Operations (CCRO). The Study Coordinator is responsible for the patient facing aspects of clinical research studies. He/she will coordinate across the PI and Study Team to carry out the day to day duties involved in enrolling, tracking, and following up on patients involved in clinical trial studies. The Clinical Research Study Coordinator is responsible for maintaining a close effectual working relationship with Project Managers, Program Managers, Principal Investigators and patients.

The Clinical Research Study Coordinator will proactively address the demands of clinical research, working both independently and as part of a dynamic group to provide exceptional customer service to the Massachusetts Eye and Ear distinguished research community and collaborators in their pioneering efforts in science and medicine.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Coordinates the implementation, both internally and externally, of clinical research studies.

• Initiates and maintains recruitment contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgment as to the suitability of their participation. May be required to perform clinical assessments such as blood pressure, weight, ECGs, etc.

• Working in concert with Principal Investigator and/or Project Manager to develop and implement patient recruitment strategies.

• Interacts with patients/subjects with regard to the study, including but not limited to consenting, education, procedural instruction, and follow-up. Serves as a liaison between patient and physician, as well as a resource for participants and their families.

• Responsible for data collection and maintaining study patient information databases. Develops, organizes, and/or maintains the study forms. Responsible for data validation and quality control, data entry into eCRFs. May be required to input data, and/or perform minimal analysis and run various reports.

• Responsible for mailing various study information or packets to study participants.

• Answers phone calls and questions regarding the study protocol. Refers participants when appropriate to principal and co-investigators.

• In conjunction with Project Manager, completes regulatory paperwork for institutional review board submissions/approval (IRB).

• Keeps study PI informed of study progress at all times.

• Above duties plus:

o Verifies accuracy of study forms

o Updates study forms per protocol

o Prepares data for analysis and data entry

o Assists with formal audits of data

o Documents patient visits and procedures

o Assists with regulatory binders and QA/QC procedures

o Assists with interviewing study subjects

o Administers and scores questionnaires

o Provides basic explanation of study and in some cases obtains informed consent from subjects if IRB allows

o Verifies subject inclusion/exclusion criteria

QUALIFICATIONS

• BS/BA degree required

• Previous laboratory, research, or clinical work preferred. Some knowledge of medical terminology, GCP, IRB and/or research studies highly desired.

• Sound independent judgment and willingness to learn competence in research methodologies a must.

SKILLS/ABILITIES/COMPETENCIES

• Must possess the ability to thrive in a busy, high-volume, and deadline driven team environment that requires coordination of multiple activities and the judgment and flexibility to reprioritize tasks as needed.

• Ability to follow directions.

• High degree of computer literacy.

• Computer literacy and proficiency in Microsoft Office Suite.

• Excellent verbal and written communication skills.

• Excellent interpersonal skills are required for working with study participants.

• Requires strong organization and communication skills with a focus in customer service.

• Analytical skills and the ability to resolve technical or research problems

• Prioritize a variety of tasks.

• Careful attention to detail.

• Ability to demonstrate professionalism and respect for human subject rights and individual needs.

• Knowledge of clinical research protocols

• Knowledge of data management programs

• Ability to work independently.

WORKING CONDITIONS

• Category I: Exposure to blood. Universal Precautions mandatory training required.

• Laptop provided

• Lifting of 10 to 20 lbs.