Senior Clinical Research Coordinator, CCI

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
The mission of the Mass General Brigham's (MGB) Office of Clinical Research (OCR)/ Brigham and Women's Hospital's Center for Clinical Investigation (CCI) is to strengthen the culture for clinical research at the Brigham and Women’s Hospital, by building services helpful to clinical investigators and facilitating the success of individual investigators.

This position is working very independently and under very general supervision from a manager or Principal Investigator, provides support to clinical research studies.

Job Summary

The MGB OCR/BWH CCI is seeking a full-time Senior Clinical Research Coordinator (CRC-Senior) to join our multidisciplinary team. This position offers the opportunity to take on a leadership role in advancing innovative supportive care research.

The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities.

Qualifications

Key Responsibilities

Leadership & Training

- Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices.

- Assist CCI leadership with allocating workload and providing ongoing feedback.

Study Coordination

- Support participant eligibility reviews, recruitment, informed consent, and coordination of study visits.

- Support data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs.

- 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.

- Working in concert with Principal Investigator and/or Research Manager, develops and implements patient recruitment strategies.

- Interacts with patients/subjects with regard to the study, including patient education, procedural instruction, and follow-up. Serves as a liaison between patient and physician, and as a resource for participants and their families.

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

- In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval.

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

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

- Communicates regularly with the PI(s) and sponsors about all aspects of the research trial.

- Ensure that knowledge about regulatory requirements are current by reading and attending local seminars related to policy and regulatory issues (FDA, NIH, IRB, etc.)

- Meet regularly with Manager, and CCI Administration.

- Participate in ongoing training and educational activities with CCI. Responsible for providing support for CCI program development.

- Monitors, maintains, sets up any study equipment.

- Maintains inventory and orders supplies when necessary.

- All other duties, as assigned.

Regulatory & Compliance

- Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports.

- Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies.

Program Development

- Assist in developing standard operating procedures and quality assurance systems.

- Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions.

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

Work Location
221 Longwood Avenue

Scheduled Weekly Hours
40

Employee Type
Regular

Work Shift
Day (United States of America)

Pay Range
$55,712.04 - $82,014.40/Annual

Grade
6
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:
2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.