Senior Clinical Research Coordinator

Site: The Brigham and Women's Hospital, Inc.

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

 

Job Summary

coverletter required to be considered for this position

Under the guidance of the Principal Investigator and Senior Project Manager, the Senior Research Clinical Study Coordinator functions independently and proficiently with minimal oversight. They are responsible for the complete coordination of assigned clinical research activities within all phases and complexities of the clinical trial, including investigator-inititiated or other high-profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and assists with the management of less experienced staff.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Oversees, prepares, submits and maintains all regulatory submissions (new studies, annual reviews, amendments) in a timely manner. Has a strong understanding of clinical trial endpoints and the ability to sufficiently evaluate and process data

Oversee and/or responsible for the Institutional Review Board (IRB) submissions and other regulatory forms and adhering to the timelines of the study start-up process.

Develop informed consent documents, source documents, and other documents as applicable.

Responsible for educating new staff and research participants on protocol expectations and proper conduct of clinical trials.

Interact with potential study participants and study participants to implement protocol with fidelity. Provide participant education, procedural instruction, and follow-up. Serve as a liaison between study participant and research team.

Responsible for collecting data and maintaining participant information database for study. May be required to input data, do minimum analysis and run various reports.

Support the safety of clinical research participants.

Understand and proficiently communicate all components of research documents, such as protocol, informed consent, investigator brochure and research instructions.

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

Answer any phone calls and inquiries regarding study protocol. Refer participants to principal investigator or co-investigators as clinically indicated.

Responsible for training and orienting all new staff.

Interact with study monitors, scheduling monitoring visits as indicated, and providing timely responses to study queries.

Maintain study inventory and order study supplies when necessary.

Ensures the appropriate delegation of study related tasks (i.e.: Delegation of Authority) on all protocols.

Communicate with participant’s clinical care providers as needed and document research visits within electronic health record system, in compliance with institutional policies.

Contribute to research team environment, serving as back-up coordinator to support other studies in department, cross-training/peer-mentoring other team members, and contributing to research meetings.

All other duties, as assigned.

 

Qualifications

Education
Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials

Experience
Related post-bachelor's degree research experience 3-5 years required

Knowledge, Skills and Abilities
- Ability to work more independently and as a team member.
- High degree of computer literacy and analytical skills.
- Ability to identify both technical and non-technical problems and develop solutions.
- Ability to interpret acceptability of data results.
- Highly proficient data management skills and working knowledge of data management systems.
- Able to display initiative to introduce innovations to research study.
- Excellent time management, organizational, interpersonal, written, and verbal communication skills.

 

Additional Job Details (if applicable)

 

Remote Type

Onsite

 

Work Location

221 Longwood Avenue

 

Scheduled Weekly Hours

40

 

Employee Type

Regular

 

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