Full Job Description
Emp Status
Regular Full time
Work Shift
Day (United States of America)
Compensation Range
The base pay scale for this position is $86,000.00 - $131,375.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.
What you will be doing
Essential Duties and Responsibilities
• Direct and oversee all aspects of the institutional Scientific Review Committee program, including scientific review operations, reviewer engagement, committee governance and performance metrics.
• Independently assess protocol submissions for scientific merit, methodological rigor, operational feasibility, and compliance with institutional scientific review requirements, determining whether submissions are ready to advance through the review process.
• Exercise independent judgment in assigning reviewers, determining review pathways, identifying specialized scientific expertise, and resolving complex review issues.
• Manage SRC meeting schedules, agendas, meeting materials, reviewer assignments, and documentation of committee determinations.
• Maintain records of SRC reviews, approvals, stipulations, and study outcomes.
• Serve as the primary point of contact for investigators and research personnel throughout the scientific review process.
• Analyze scientific review trends, performance metrics, and operational challenges and implement process improvements to enhance review quality, efficiency, and consistency.
• Conduct preliminary reviews of protocol submissions for completeness, scientific quality, study design, and operational readiness.
• Coordinate statistical review with institutional biostatisticians and ensure appropriate statistical input is incorporated into study design and analysis plans.
• Work with investigators to address reviewer comments and recommendations prior to IRB submission.
• Provide guidance to investigators, faculty, fellows, and research staff regarding protocol development and scientific review requirements.
• Assist investigators in preparing high-quality protocols and supporting study documents.
• Promote best practices in clinical research design and ensure scientific rigor.
• Develop and lead institutional training and educational initiatives designed to ensure and improve protocol quality, scientific rigor, and investigator success.
• Deliver presentations and workshops for faculty, fellows, coordinators, and research staff.
• Develop and implement policies, procedures, guidance documents, and review tools supporting SRC operations.
• Contribute and/or lead special projects and strategic initiatives, including presentations to leadership, committee participation, process improvement efforts, operational retreats, and other institutional priorities as assigned.
Minimum Qualifications
Education
• Master's degree in Public Health, Clinical Research, Health Sciences, Epidemiology, Biostatistics, Healthcare Administration, or related field required.
Experience
• Minimum of 5 -7 years of experience in clinical research administration, protocol development, research compliance, scientific review, or related research oversight activities.
• Experience working within an academic medical center, healthcare institution, or research-intensive environment preferred.
• Demonstrated experience coordinating multidisciplinary scientific review processes preferred.
Knowledge, Skills, and Abilities
• Strong understanding of clinical research methodology and study design.
• Working knowledge of statistical analysis plans and biostatistical principles.
• Knowledge of IRB processes, human subjects protections, and applicable federal regulations.
• Excellent scientific writing, editing, and communication skills.
• Strong project management and organizational skills.
• Ability to effectively collaborate with investigators, statisticians, clinicians, administrators, and executive leadership.
• Ability to analyze complex scientific protocols and identify methodological or operational concerns.