At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission—from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.
At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.
Job Summary
Works independently under minimal supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. Will have experience with institutional and federal regulations governing clinical research. In addition, +may assist management in the areas of Quality Control and Training & Development, and may provide input into the assessment of departmental procedures. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact.Does this position require Patient Care? Yes
Essential Functions
-Identify changes associated with Standard Operating Procedures and develop procedure to ensure compliance.
-Manage studies of a particular specialized program.
-Pre-activation activities including pre-site qualification visits, SIVs, and facility tours.
-Organize and prepare for internal/external audits.
-Assist clinical team in screening potential patients for study participation.
-Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition.
-Obtain protocol clarifications from the study sponsor and communicate information to the research team.
-Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
-Schedule and prepare for monitoring visits with sponsors.
Qualifications
The Department of Psychiatry is seeking a Research Coordinator to work with a research group in the Geriatric Psychiatry Program on NIH funded grants focused on mental health and preclinical cognitive disorders. She/he will coordinate activities for community-based intervention studies and activities for other grant-related projects. The studies focus on increasing access to mental health and cognitive care for underserved, multicultural and low-income older adults and involve quantitative and qualitative data collection. Activities include but are not limited to: recruitment and enrollment; IRB applications, coordination of study activities, assisting participants with study logistics; implementing and maintaining quality assurance procedures; assisting with data management and reports; assisting with literature review, conference abstracts and manuscripts; support grant reporting; conducting presentations and recruitment outreach in community settings and managing communication with community partners. The position is full-time at 40 hours/week and will report to the Principal Investigator.
Major duties
Coordinate research activities and assist with regulatory activities
Assist with recruiting participants for research projects
Collect & organize participant data
Maintain records and databases
Use software programs to generate graphs and reports
Conduct literature searches
Verify accuracy of study forms
Update study forms per protocol
Document participant visits and procedures
Assist with interviewing study participants
Administer surveys and conduct qualitative interviews
Assist with development of consent forms
Verify subject inclusion/exclusion criteria
Perform administrative support duties as required
Lead regulatory materials such as IRB applications and QA/QC procedures
Assist with other grant-related activities as needed
Train other staff members in data collection, fidelity assessments, neuropsychological testing
Conduct recruitment presentations in the community
Assist with grant and manuscript developing and writing
In collaboration with the PI, lead preparation of study results, including drafting of written reports of results, tables, figures, abstracts and/or manuscripts for submission to meetings, conferences and/or journals.
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
No
Licenses and Credentials
Experience
Clinical Research or Compliance experience 2-3 years required
Knowledge, Skills and Abilities
- High level time management and organization skills.
- Excellent written and verbal communication skills.
- Knowledge of current and developing clinical research trends.
- Strong interpersonal skills.
- Ability to work independently and display initiative.
- Ability to identify problems and develop solutions.
Additional Job Details (if applicable)
Careful attention to detailsGood organizational skillsMust demonstrate respect and professionalism Ability to work independently and as part of a team Ability to follow directions, prioritize tasks and meet deadlinesWorking knowledge of clinical research protocols Computer literacy, including use of spreadsheet and data management software such as RedcapBe comfortable working and travelling to community settings Must have own transportation
Remote Type
Hybrid
Work Location
15 New Chardon Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement:
The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.
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.