Senior Clinical Research Coordinator

Site: The General Hospital Corporation

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

• Summary
• Working independently and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Additionally, provide input into determining study subject suitability, input into recruitment strategy, methodology design, statistical analyses, protocol design, and manuscript writing.

• Does this position require Patient Care?
• No

• Essential Functions
• -Independently determines the suitability of study subjects.

-Develops and implements recruitment strategies.

-Participates in the design of research methodology.

-Plans, performs, and designs statistical analyses.

-Recommends protocol changes, writes protocols, and contributes to manuscripts.

-Independently performs specialized projects.

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)

The Massachusetts General Hospital Center for Optimal Aging and Serious Illness (CASI) Research is seeking a Senior Clinical Research Coordinator (Sr CRC) to support innovative, high-impact clinical research focused on improving the lives of older adults, individuals living with serious illness, and their care partners. Our work spans observational studies, intervention design, clinical trials, and implementation research aimed at enhancing quality of life, pain and symptom management, communication and decision-making, and care delivery in the context of aging and serious illness.

Senior CRCs play a vital role in the successful implementation of research studies and center-wide initiatives. Responsibilities include supporting study start-up and regulatory activities; recruiting, enrolling, and retaining study participants; conducting study assessments and follow-up activities; managing research data; assisting with manuscript preparation and dissemination of study findings through scientific presentations and publications; and facilitating community and stakeholder engagement. Sr. CRCs work closely with inter-professional investigators, research staff, program managers, interventionists, trainees, and data analysts in a highly collaborative and mission-driven environment.

Ideal candidates will be self-motivated, attentive to detail, have the capacity to tend to multiple priorities and deadlines, and demonstrate strong interpersonal and organizational skills. They should be friendly, proactive, comfortable communicating by phone and videoconference with people from all backgrounds, and strong problem solvers. Candidates with prior clinical research experience are required. Candidates with prior experience with serious illness, supporting older adults and other vulnerable and minoritized populations, family caregivers and diverse groups are strongly encouraged to apply.

Principal Duties and Responsibilities:

Study Start-Up and Regulatory Activities

• •Support and coordinate start-up activities, including protocol development, preparation of study materials, IRB submissions, site activation, and coordination with Human Research Affairs and other regulatory stakeholders.
• •Develop, edit, and maintain study documents, including protocols, consent forms, participant communications, regulatory submissions, and study reports.

Study Conduct and Participant Engagement

• •Support and coordinate participant recruitment, screening, enrollment, informed consent, retention, and follow-up activities across one or more research studies.
• •Conduct study visits, assessments, and data collection activities while ensuring participant safety, confidentiality, and adherence to study protocols.

Data Management and Regulatory Compliance

• •Maintain and oversee study data and documentation, including source documents, case report forms, regulatory binders, data entry, study tracking, and resolution of data queries.
• •Ensure compliance with institutional, sponsor, and federal requirements through preparation of regulatory submissions, annual reviews, progress reports, protocol modifications, adverse event reporting, and maintenance of study records.

Quality Assurance and Study Oversight

• •Support study quality and data integrity efforts through ongoing review of study records, preparation for audits and monitoring visits, and implementation of corrective actions as needed.
• •Support coordination of multi-site studies and collaborate with investigators, sponsors, monitors, and partnering institutions to ensure successful study execution.

Administrative and Operational Support

• •Coordinate study meetings, trainings, communications, and operational activities with internal and external collaborators to support efficient study implementation.
• •Provide administrative support for study operations and center-wide initiatives as needed.

Scientific Support

Contribute to scholarly activities, including literature reviews, abstracts, scientific presentations, manuscripts, and other dissemination products.

Grant Support

Contribute to grant-related activities, including preparation of reports for sponsors and stakeholders, budget development, presentations for sponsors and stakeholders, and other dissemination products.

Leadership and Mentorship

Train and mentor research staff, coordinators, interns, volunteers, and trainees, while fostering a collaborative and mission-driven research environment.

The candidate should:

• •be well-organized, self-motivated, and attentive to detail;
• •have excellent time management and organizational skills, with the ability to effectively manage multiple priorities and problem solve in a fast-paced research environment, with minimal supervision;
• •have excellent written and verbal communication skills, with the ability to communicate effectively with diverse audiences, including research team members, interdisciplinary clinicians and investigators, patients and community stakeholders, and scientific audiences through manuscripts and presentations.
• •have the ability to work independently, take initiative, and interact with clients and colleagues of multiple disciplines;
• •demonstrate respect and professionalism for subjects’ rights and individual needs;
• •cultural sensitivity and humility in working with older adults and stakeholders in community settings;
• •be proficient in using administrative software (Excel, Word, PowerPoint), electronic healthcare records, webpage development, and electronic data capture systems (e.g. REDCap, Q