Senior Clinical Research Coordinator

Mass General Brigham•Boston, MA

1d•Hybrid

About The Position

Dr. Archana Basu’s Pediatric Population Health in Action program in the division of Child and Adolescent Psychiatry, is focused on trauma-informed population mental health interventions for children and families, and associated research projects. The Senior Clinical Research Coordinator will assist our team in performing a range of administrative responsibilities for a portfolio of clinical and research projects. This would include developing and maintaining IRB protocols for human subjects research and related regulatory approvals, including clinical trials and observation studies, grants (e.g., grant budgets, overall grant submission), and support the administrative oversight of the team (communicating with the finance team). Example clinical programs include the (1) The Integrated Primary Care (IPC) program for children and youth (infants - age 21), which integrates psychology and social work clinicians in primary care clinics to screen, triage, and provide brief interventions for a range of mental health needs for patients, and (2) trauma-informed psychotherapy interventions that aim to address children’s emerging emotional and behavioral difficulties. The program’s research includes studies of biobehavioral mechanisms underlying childhood adversity outcomes and examining family-centered psychotherapy interventions to address adversity-associated developmental, mental, and physical health problems for children and youth. Under Dr. Basu’s guidance and in accordance with hospital policies and procedures, the Senior Clinical Research Coordinator will perform a range of administrative activities necessary to conduct human subjects clinical trials and observational research, as described below. This is a hybrid position (in-person days required) that entails working with a multidisciplinary team of psychology, social work, psychiatry, and primary care teams. Must have strong interpersonal, organizational, and team-oriented skills, who is able to work in a respectful and professional manner with team members, collaborators, and study participants from a range of backgrounds. Must have prior experience in working well within a team and demonstrate excellent communication and writing skills. Have a strong interest in supporting mental health care for children and families and relevant experience in managing grant budgets and human subjects IRB protocols, particularly in a hospital-based setting.

Requirements

Bachelor's Degree Related Field of Study required and/or Graduate Diploma Related Field of Study preferred
CITI/ MGB Human Subjects training required
Experience with developing and managing IRB protocols for human research subjects and clinical trials, grant budgets, and data management.
3+ years of directly related clinical research work experience. At least one-year prior clinical research experience interacting with the medical system particularly with children or adolescent patients.
Excellent interpersonal skills are critical to working within the hospital setting, our multidisciplinary team of clinicians and researchers, and supporting human subjects’ research
Excellent written and verbal communication skills
Highly organized and detail-oriented
Excellent team management skills
Facility to interact professionally with all levels of staff
Ability to organize time and prioritize effectively. This includes the ability to ask for direction when appropriate and the flexibility to handle multiple tasks and deadline pressures.
Knowledge and experience with human subjects’ research and IRB requirements
Experience with common software, including Microsoft Office and Teams (e.g., Word, PowerPoint, Excel, Outlook), Dropbox, and R software among others
Skilled in using reference management software such as EndNote
Ability to conduct reference and literature searches using PubMed and other search engines, and advanced internet searches
Ability to design, prepare, deliver, and evaluate standard operating procedures
Ability to compile and manage data, analyze information, and produce reports
Administrative skills to meet the regulatory compliance required by IRB reporting
Ability and willingness to learn new research and administrative skills
Ability to compile and manage data, analyze information, and produce reports
Knowledge of current and developing trends in areas of professional expertise (e.g., new statistical analytic tools, literature review, AI research tools)
Comfortable learning new computer applications, including relevant AI tools
Experience in managing multiple projects within a portfolio, including the use of project management tools

Responsibilities

Assist PI in developing and maintaining all IRB protocols and approvals, and regulatory submissions (e.g., writes consent and assent forms)
Track and renew approved IRB or other regulatory and data use agreement approvals on time
Identify and report IRB protocol deviations
Update study forms per protocol
Assist with writing IRB protocols and recommend protocol changes
Maintains research data, patient files, regulatory binders and study databases
File adverse events report with the IRB
Responsible for QA/QC procedures and checks
May develop systems for QA/QC
Assists in maintaining records and databases
Assists with formal audits of data
Tracks status of CITI training certificates of all staff, regulatory binders
Conduct literature reviews
Participate in design and execution of research projects
Participate in the recruitment and screening of study subjects
Perform study procedures
Contribute to the authorship of papers and publications
Assists PI in developing and submitting new grant submissions (e.g., develops study budgets, reviews various grant components)
Post-funding, tracks grant budgets and administrative components of the study (e.g., annual reports)
Manages payment of corporate card expenses
Uses software programs (e.g., Excel, R) to generate graphs and reports
Organize (develop agenda, manage logistics of in-person/ virtual meetings), participate/ co-lead meetings
Coordinate hiring and onboarding (e.g., research coordinators, clinical team members)
Perform team administrative data (e.g., tracks team members leave procedures, funding timelines etc.)
Write standard operating procedures for team processes and projects
Develop project-related websites
Manage PI biosketch, SciENcv, and CVs
Plan and initiate new activities, meetings, and support the PI’s program operations
Provide functional guidance and mentorship for research coordinators
Engage in professional development, including workshops and trainings; make presentations as conferences
Assist with materials management, supply, inventory, and ordering of program materials
Participate in other responsibilities, meetings, projects and other activities as needed