Project Policy Analyst IV

University of California, San Francisco•San Francisco, CA

15h

About The Position

This role involves the development of and ensures compliance with clinical study protocols that involve human subjects. It oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. The position may be responsible for finances, clinical operations, and site and vendor selection. As a technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas, problem-solving frequently requires analysis of unique issues/problems without precedent and/or structure. This role may manage programs that include formulating strategies and administering policies, processes, and resources, functioning with a high degree of autonomy. Specifically, this role applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity. The Senior Human Research Program Manager is the senior operational leader for the Bodansky Laboratory's human research portfolio and the CHAMP program. With a high degree of autonomy, the incumbent establishes program strategy, governance, infrastructure, and performance standards across prospective clinical research, CRC operations, multi-protocol participant and biospecimen workflows, the CHAMP biorepository, regulatory compliance, data quality, and internal and external partnerships. The incumbent analyzes novel and highly complex operational, policy, and organizational problems; negotiates solutions across clinical, laboratory, administrative, and collaborating institutions; advises the Principal Investigator on risk and resource priorities; and leads implementation of scalable systems as the program grows. The role requires recognized expertise in human research operations, exceptional judgment and diplomacy, and the ability to inspire accountable, mission-aligned teamwork in a sensitive pediatric environment.

Requirements

Minimum five years of progressively responsible experience in human-subjects research, clinical research operations, research program administration, or a closely related field, including at least four years leading complex programs, cross-functional teams, or multi-protocol operations.
Advanced knowledge of human-subjects research operations and demonstrated responsibility for regulatory, participant-enrollment, clinical-data, and/or human-biospecimen programs in an academic medical center, health system, or comparable research organization.
Demonstrated success designing and implementing new programs, governance structures, SOP frameworks, quality systems, and performance metrics across organizational boundaries.
Advanced leadership and project-management skills, including prioritization of a complex portfolio, direction of staff or cross-functional teams, change management, and delivery under demanding and shifting timeframes.
Exceptional written, verbal, and interpersonal communication skills, with demonstrated ability to influence and negotiate with faculty, clinical leaders, research staff, institutional offices, patients and families, and external partners.
Advanced analytical and problem-solving skills, including evaluation of ambiguous or unprecedented issues, assessment of operational and compliance risk, development of alternatives, and presentation of clear recommendations to leadership.
Demonstrated ability to exercise a high degree of autonomy, discretion, diplomacy, and sound judgment while protecting confidential participant, personnel, and program information.
Advanced proficiency with program-management and research information systems, such as REDCap, clinical research management systems, electronic regulatory systems, biospecimen inventory/LIMS platforms, and Microsoft Office or Google Workspace.
Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology.
Advanced knowledge of regulatory requirements.
Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment.
Adaptable to quickly changing priorities.
In depth critical thinking skills to evaluate issues and identify a potential solution.
Creatively addresses complex or new problems.
Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills.
Clear and concise communicator.
Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members.
Works well with others to achieve common goals.
Proven ability to perform all commonly applicable functions in word processing and spreadsheet software.
Advanced knowledge of clinical information and documentation application programs.
Proven ability utilizing clinical trial management systems.
In depth ability to work collaboratively with other cross-functional teams.
In depth ability to interface, collaborate and influence / persuade other members of an extended study team.
Bachelor's degree in public health, biological or health sciences, clinical research, health administration or a related area and / or equivalent experience / training.

Nice To Haves

Experience establishing or directing a biorepository or complex human-biospecimen program, including governance, chain of custody, inventory, quality management, storage, shipping, and continuity planning.
Experience in pediatrics, critical care, immunology, infectious disease, neurology, rare disease, or another medically and scientifically complex research area.
Experience leading, mentoring, and developing clinical research coordinators, program managers, or research operations staff.
Demonstrated leadership in a patient-centered or mission-driven research program focused on serious illness, rare disease, or underserved populations.
Master's degree in public health, clinical research, health administration, biological sciences, business administration, or a related field.
Current CITI Human Subjects Research and Good Clinical Practice training, or ability to complete before beginning study duties.
Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Project Management Professional (PMP), or equivalent certification.

Responsibilities

Functions as a lead in development of new processes and protocols with project team for highly complex clinical trials.
Oversees and manages protocol amendments.
Provides senior operational leadership for the Bodansky Lab human research portfolio and CHAMP program.
Establishes strategy, governance, operating models, priorities, metrics, and decision pathways across multiple protocols and collaborations.
Translates scientific goals into scalable implementation plans.
Anticipates program-wide risk and advises the Principal Investigator on operational choices and sequencing.
As a technical lead, provides guidance to all levels of management on ways to improve effectiveness.
Proactively recommends interventions / corrective actions to meet project goals.
Functions as a lead with other team members.
Provides direction and guidance to project team members.
Leads the integrated human-research workforce and operating cadence.
Directs or provides functional leadership to CRCs and other program staff.
Defines roles and coverage models.
Sets performance and quality expectations.
Develops onboarding and training.
Resolves workload and accountability problems.
Creates a collaborative culture centered on participants, scientific rigor, and reliable execution.
Monitors, evaluates and coordinates data from multiple systems to recommend new actions / procedures from research analysis.
Participates in preparation of manuscripts, abstracts and scientific presentations.
Designs and oversees the CHAMP biorepository and end-to-end biospecimen system across clinical and laboratory settings.
Establishes SOPs, governance, access and prioritization principles, chain-of-custody and inventory controls, quality metrics, storage and continuity plans, and processes for retrieval, shipment, and collaboration.
Leads resolution of high-impact specimen, capacity, or system failures.
Assesses policies and processes to ensure the proposed project plan is compliant with applicable guidelines.
Revises research / trial documents so they are consistent with protocol revisions.
Ensures reporting is consistent with external guidelines, university policies and regulations.
Owns the program's regulatory, compliance, and operational risk framework in partnership with the Principal Investigator and UCSF offices.
Oversees IRB strategy and submissions, reliance arrangements, consent architecture, privacy and data/specimen sharing requirements, delegation and training systems, protocol implementation, audit readiness, deviation review, and corrective and preventive actions.
Conducts large project feasibility assessments.
Analyzes risks, strategies and solutions.
Develops project timelines and key milestones for assigned projects.
Recommends adjustments to budgets and vendor agreements as necessary.
Leads program evaluation, reporting, and resource planning.
Develops dashboards and executive analyses.
Monitors milestones, capacity, quality, and financial/resource assumptions.
Contributes operational strategy and content to grants and progress reports.
Evaluates new opportunities.
Recommends investments, staffing, systems, and process changes to support sustainable growth.
Builds and manages high-level relationships with clinical services, patients and families, research and laboratory leaders, institutional offices, funders, and collaborating sites.
Negotiates workable cross-organizational processes.
Leads sensitive communications.
Represents CHAMP in planning groups.
Aligns stakeholders with differing constraints and priorities.