Clinical Research Program Manager — Spokane, WA
Kelly® Science & Clinical is seeking a Clinical Research Program Manager for a Direct Hire opportunity supporting research site client. If you are an experienced clinical research leader who is dedicated to advancing high-quality research, upholding Good Clinical Practice, and thriving in a fast-paced, professional environment, trust The Experts at Hiring Experts to guide your next career move.
This on-site leadership role oversees the operational execution, quality, and growth of a portfolio of industry-sponsored clinical trials, primarily within neurology and neurodegenerative disease research. The Clinical Research Program Manager will lead Clinical Research Coordinators, drive study startup and execution, build productive sponsor/CRO relationships, and support expansion of the clinical trial pipeline.
What You’ll Do
- Lead day-to-day operations for a portfolio of Phase I-IV industry-sponsored clinical trials, from feasibility and startup through closeout.
- Directly supervise, train, mentor, and develop a team of Clinical Research Coordinators.
- Assign study responsibilities based on protocol complexity, workload, participant volume, and coordinator experience.
- Monitor enrollment, participant visits, data quality, protocol deviations, monitoring findings, sponsor requests, and operational risks.
- Ensure studies are appropriately staffed, inspection-ready, and conducted in alignment with protocols, ICH-GCP, FDA regulations, IRB requirements, sponsor expectations, and site SOPs.
- Lead operational startup activities, including feasibility assessments, site qualification and initiation visits, workflow development, training plans, and cross-functional readiness.
- Partner with regulatory, laboratory, pharmacy, nursing, investigator, vendor, budget/contract, and administrative teams to prepare studies for enrollment.
- Serve as a senior point of contact for sponsors, CROs, monitors, and study vendors; address requests and resolve operational concerns promptly.
- Support business-development efforts by evaluating potential studies, completing feasibility questionnaires, participating in site-selection activities, and maintaining sponsor/CRO relationships.
- Develop recruitment, prescreening, enrollment, and retention strategies with study teams and leadership.
- Identify opportunities to strengthen workflows, training materials, SOPs, quality practices, and scalable research operations.
- Support sponsor audits, CRO audits, internal quality reviews, CAPA activities, and regulatory inspection readiness.
Required Qualifications
- Bachelor’s degree in health, science, clinical research, business, or a related field; an equivalent combination of education and substantial clinical research experience may be considered.
- At least 5 years of progressively responsible clinical research experience.
- Demonstrated experience independently managing industry-sponsored interventional clinical trials.
- Experience across clinical trial startup, enrollment, monitoring, data quality, protocol compliance, and closeout.
- Prior experience supervising, mentoring, training, or leading Clinical Research Coordinators or comparable research staff.
- Strong working knowledge of FDA-regulated clinical research, ICH-GCP, informed consent, protocol adherence, source documentation, and data-integrity standards.
- Experience communicating directly with pharmaceutical sponsors, CROs, monitors, and investigators.
- Current Good Clinical Practice and Human Subjects Protection training.
- Current ACRP certification, such as ACRP-CP, CCRC, or CCRA.
- Ability to work fully on-site in Spokane, Washington.
Preferred Qualifications
- Seven or more years of progressive clinical research experience.
- Prior experience as a Clinical Research Manager, Program Manager, Site Manager, Lead CRC, or similar leadership role.
- Experience in neurology, movement disorders, Parkinson’s disease, Huntington’s disease, multiple system atrophy, essential tremor, or other neurodegenerative conditions.
- Experience with Phase I or other operationally complex clinical trials.
- Experience with sponsor outreach, feasibility assessments, site selection, or clinical research business development.
- Experience leading startup across multiple concurrent studies.
- Experience supporting FDA inspections, sponsor audits, CAPAs, or formal quality-management and inspection-readiness programs.
- Additional certification through ACRP, SOCRA, or another recognized clinical research organization.
Skills for Success
- Strong leadership, coaching, communication, and relationship-management skills.
- Ability to translate complex protocols into practical site workflows and study plans.
- Excellent project-management, organization, prioritization, and problem-solving abilities.
- Comfortable managing multiple studies, team priorities, sponsor relationships, and competing deadlines.
- Proficiency with EDC systems, sponsor portals, CTMS/eSource platforms, EMR systems, Microsoft Office, and electronic scheduling tools.
- Strong commitment to participant safety, confidentiality, ethical research conduct, data integrity, and continuous improvement.
This is a primarily on-site role in a professional clinical research setting. The position involves frequent interaction with participants, caregivers, investigators, coordinators, sponsors, CROs, monitors, vendors, and internal leadership. Some travel and occasional protocol-driven early morning, evening, or weekend work may be required.