Research Manager, Startup Regulatory Operations
New
F
Fred Hutchinson Cancer CenterClinical research
Source API remote eligibility restrictions: United StatesFull-TimeManager
Salary99,486 - 157,227 USD per year
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Job Details
- Experience
- 5+ years of clinical research experience, including significant experience in regulatory operations, regulatory affairs and regulatory startup operations; at least 2 years of leadership, supervisory or team lead experience.
- Required Skills
- Project Management
Requirements
- Bachelor’s degree or equivalent combination of education and experience.
- 5+ years of clinical research experience, including significant experience in regulatory operations, regulatory affairs, and regulatory startup operations.
- At least 2 years of leadership, supervisory, or team lead experience.
- Experience supporting regulatory submissions and study startup activities.
- Experience working with IRBs, sponsors, CROs, FDA regulations, and GCP requirements.
- Strong project management and organizational skills.
- Ability to interpret clinical protocols and regulatory guidance documents.
- Ability to manage multiple studies and competing priorities within aggressive timelines.
- Preferred: Direct experience with investigator-initiated trials.
- Preferred: Experience leading and developing geographically dispersed teams in a remote or hybrid environment.
- Preferred: Knowledge of FDA regulations, ICH-GCP guidelines, OHRP requirements, and human subjects protection regulations.
- Preferred: Florence eBinders, Veeva, CTMS, or REDCap expertise.
- Preferred: RAC, CCRP, CCRC, ACRP, or CIP certification.
Responsibilities
- Lead regulatory startup and activation activities for industry-sponsored and investigator-initiated studies.
- Coordinate required documentation, approvals, training, system access, and cross-functional startup activities.
- Monitor startup metrics, regulatory milestones, and activation timelines; identify risks and implement mitigation strategies.
- Review and collect protocols, informed consents, Investigator’s brochures, regulatory files, essential documents, investigator credentials, training records, and study documentation.
- Maintain inspection readiness and support audits, monitoring visits, quality assurance, and regulatory systems and document management processes.
- Develop standardized processes, best practices, and continuous improvement initiatives to enhance efficiency and reduce activation timelines.
- Serve as the primary regulatory liaison for investigators, sponsors, CROs, research teams, and institutional stakeholders.
- Manage, coach, and develop regulatory staff through hiring, onboarding, performance management, workload oversight, and professional development.
- Lead resource planning, workload distribution, and prioritization across the study portfolio.
- Champion adoption of new technologies, regulatory processes, and organizational initiatives.
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