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Job Summary
We are seeking a highly motivated and experienced Clinical Research Program Manager to lead the clinical research operations of a multidisciplinary program investigating inflammatory diseases.
Qualifications
What You Will Do
Manage the day-to-day operations of multiple clinical research studies in inflammatory and immune-mediated conditions.
Work closely with principal investigators and multidisciplinary scientific teams to design, initiate, and implement human subjects research protocols and safety monitoring plans.
Directly supervise, train, and support Clinical Research Coordinators and other study staff, including oversight of patient recruitment, medical-record abstraction, biospecimen acquisition and processing, and data quality.
Coordinate study initiation and start-up activities and help ensure that regulatory, operational, and scientific requirements are addressed efficiently.
Prepare and submit human subjects research protocols, amendments, continuing reviews, and related materials to the Institutional Review Board (IRB).
Serve as a key liaison among investigators, study staff, the IRB, sponsors and funding organizations, core laboratories, and collaborating research teams.
Develop study operations manuals, standard operating procedures, Case Report Forms, and other study documentation.
Establish project plans, forecast milestones, track progress, identify risks and dependencies, and ensure that projects remain aligned with scientific and leadership goals.
Report study progress at investigator and project meetings and prepare study-related reports for research teams, funding organizations, and regulatory agencies.
Oversee clinical research databases and workflows to ensure the quality, integrity, and appropriate handling of clinical and research data.
Coordinate the collection, processing, tracking, and transfer of biospecimens used for genomic, transcriptomic, immunologic, microbiome, metabolomic, single-cell, spatial, and other molecular analyses.
Facilitate approved sharing of data and biospecimens with collaborators in accordance with study protocols, Data Use Agreements, and institutional requirements.
Partner closely with researchers at the Broad Institute to connect clinical cohorts and biospecimens with advanced experimental and computational research.
Participate in the development and implementation of recruitment strategies for clinical studies.
Oversee study budgets and associated research expenditures and coordinate subcontracts or other agreements with participating institutions as needed.
Develop and maintain policies, procedures, and systems that support consistent, high-quality clinical research operations.
Identify operational challenges, anticipate study needs, and independently develop practical solutions that allow clinical and scientific teams to work effectively.
Education Qualifications
Bachelor’s degree in a related field required.
Master’s degree in public health, biology, clinical research, or a related field preferred
Can this role accept experience in lieu of a degree? No
Experience Qualifications
5+ years of research-related experience required.
2+ years of supervisory experience preferred
2+ years’ experience managing clinical or human subjects research preferred.
Experience with REDcap clinical research database and data management preferred.
Skills and Abilities
Strong strategic planning and project management skills, with demonstrated ability to lead complex projects from initiation through execution.
Ability to make independent, effective decisions and exercise sound judgment.
Strong organizational skills and exceptional attention to detail.
Excellent written and verbal communication and interpersonal skills.
Ability to effectively supervise, train, and support 2 or more research staff.
Demonstrated ability to work across clinical, scientific, computational, and administrative teams.
Ability to manage multiple studies and priorities simultaneously while anticipating problems and maintaining timelines.
Strong database management and computer skills.
Demonstrated analytical and problem-solving skills.
Strong budget management skills.
Ability to build productive working relationships with investigators, clinicians, research staff, institutional offices, and scientific collaborators.
Additional Job Details (if applicable)
Research Environment
The Clinical Research Program Manager will participate in an unusually integrated clinical and translational research environment in which carefully characterized patient cohorts provide the foundation for mechanistic studies of human disease.
Recent work involving these clinical research programs has used multi-omic profiling to identify microbial features associated with response to biologic therapy, single-cell approaches to define immune dysregulation in Crohn’s disease, and single-cell and spatial transcriptomics to identify cellular networks associated with intestinal fibrosis. While inflammatory bowel disease remains a central focus of the program, related studies are extending these approaches to other inflammatory and immune-mediated diseases, including allergic disease, cardiovascular disease as well as selected conditions at the gut–brain interface.
These projects illustrate the broader goal of the program: to build deeply characterized clinical cohorts and connect observations in patients to biological mechanisms that can ultimately inform diagnosis, patient stratification, intervention, and treatment
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
$63,252.80 - $102,596.00/Annual
Grade
7