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WVU Online
WVU Online
1.001 – 5.000 Angajați
B2CComerț electronicEducație
WVU Online este inițiativa de învățare online a Universității West Virginia, o instituție care a primit terenuri federale și a fost fondată în 1867. Oferă educație online flexibilă pentru studenții care își echilibrează studiile cu munca, familia sau alte responsabilități, asigurând acces la programe de studii, resurse academice și sprijin pentru cursanți într-un format digital. Ca parte a organizației educaționale a Universității West Virginia, WVU Online sprijină studenții care doresc să își dezvolte educația de la distanță.
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Regulatory Operations Manager, Clinical Research - WVU Online

Lead clinical trial activation, regulatory compliance, and staff operations for the WVU Cancer Institute. Manage study workflows from feasibility and startup through ongoing oversight and closeout.

USStatele Unite ale AmericiiVAVirginiaWVVirginia de VestHibridNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăOperațiuni

Descriere

  • Lead operational and supervisory oversight for protocol activation and regulatory management across industry-sponsored and cooperative-group clinical trials.
  • Manage the full regulatory lifecycle, from site selection and feasibility through activation, maintenance, and closeout.
  • Supervise assigned staff through performance management, work allocation, workload balancing, time and leave approvals, and professional development.
  • Support staff recruitment, selection, onboarding, training, and performance management.
  • Set performance expectations and operating standards for protocol activation and study management.
  • Provide mentorship, technical direction, and subject-matter expertise in study activation, regulatory obligations, protocol management, sponsor expectations, and clinical research operations.
  • Partner with CRU leadership and institutional stakeholders to resolve complex operational and regulatory issues.
  • Create standardized workflows, tools, and training materials.
  • Assess operational performance and identify opportunities to improve processes, allocate resources, and optimize workflows.
  • Direct site selection, feasibility assessment, protocol activation, regulatory startup, IRB and ancillary reviews, coverage analysis, budget and contract activities, and operational readiness.
  • Track activation schedules, workloads, portfolio metrics, barriers, and study advancement.
  • Maintain CTMS and research-system records covering study status, milestones, and activation requirements.
  • Coordinate communication among investigators, sponsors, CROs, CRU staff, and institutional departments.
  • Evaluate activation results and present pipeline, timeline, workload, barrier, and operational-performance updates to leadership.
  • Oversee ongoing regulatory management for active studies, including amendments, continuing reviews, personnel updates, document maintenance, study closures, and related requirements.
  • Coordinate regulatory support for sponsor monitoring visits, audits, inspections, and external reviews.
  • Track regulatory workload, portfolio health, and key performance indicators.
  • Work with investigators and study teams to implement regulatory updates and study-specific requirements.
  • Promote regulatory compliance through staff education, quality control, process improvement, and partnership with CRU Compliance.
  • Manage the handoff from study activation to ongoing regulatory oversight and ensure timely closeout.

Cerințe

  • Bachelor’s degree in a relevant area and three years of experience.
  • At least three years of experience in clinical research coordination, regulatory operations, project management, or a combination of these areas.
  • Equivalent combinations of related education and experience will be considered.
  • Ability to manage multiple studies and priorities, assess operational performance, identify obstacles, and implement improvements.
  • Strong project-management capability spanning planning, prioritization, delegation, risk identification, problem solving, timelines, and deliverables.
  • Ability to interpret complex protocols, regulations, policies, and sponsor requirements and convert them into operational procedures and staff guidance.
  • Proficiency with clinical trial management systems, electronic regulatory systems, IRB platforms, and other clinical research information systems.
  • Strong written, verbal, consultative, and interpersonal communication skills.
  • Sound judgment and discretion, with the independence to make decisions and manage competing priorities.
  • Preferred: Master’s degree in Clinical Research, Health Sciences, Basic Sciences, Healthcare Administration, or a related discipline.
  • Preferred: At least three years of progressively responsible clinical research experience in an academic medical center, cancer center, research institution, or industry environment.
  • Preferred: Knowledge of federal regulations, ICH Good Clinical Practice, IRB requirements, and institutional policies for human-subject clinical research.
  • Preferred: Experience with clinical trial activation, including site selection, feasibility, regulatory startup, IRB submissions, ancillary reviews, and budget, contract, and coverage analysis coordination.
  • Preferred: Experience managing ongoing trial regulations, including protocol amendments, continuing reviews, regulatory documentation, sponsor monitoring, audits, and study closeout.
  • Preferred: Experience with industry-sponsored and National Cancer Institute NCTN/ECTCN cooperative-group trials and their regulatory and operational requirements.
  • Preferred: Experience supervising staff, leading teams or projects, or coordinating the work of others.

Beneficii

  • 37.5-hour workweek.
  • 13 paid holidays.
  • 24 annual vacation days.
  • 18 sick days per year.
  • Health insurance and other benefits.
  • 401(a) retirement savings plan with a 6% employee contribution match.
  • Eligibility to continue health insurance and other retiree benefits.
  • Wellness programs.

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