WVU Online
WVU Online
1,001 – 5,000 कर्मचारी
B2Cई-कॉमर्सशिक्षा
WVU Online वेस्ट वर्जीनिया विश्वविद्यालय की ऑनलाइन शिक्षा पहल है। यह विश्वविद्यालय 1867 में स्थापित एक भूमि-अनुदान संस्थान है। WVU Online उन छात्रों के लिए लचीली ऑनलाइन शिक्षा प्रदान करता है, जो पढ़ाई के साथ काम, परिवार या अन्य जिम्मेदारियों का संतुलन बना रहे हैं। डिजिटल माध्यम से यह डिग्री कार्यक्रमों, शैक्षणिक संसाधनों और शिक्षार्थी सहायता तक पहुँच उपलब्ध कराता है। वेस्ट वर्जीनिया विश्वविद्यालय के शिक्षा संगठन के हिस्से के रूप में, WVU Online उन छात्रों की सेवा करता है जो दूरस्थ रूप से अपनी शिक्षा को आगे बढ़ाना चाहते हैं।

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.

विवरण

  • 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.

आवश्यकताएँ

  • 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.

लाभ

  • 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.

संबंधित नौकरियाँ

Worldwide Clinical Trials

Senior Clinical Research Associate, Psychiatry and Alzheimer’s

Worldwide Clinical Trials

Monitor psychiatry and Alzheimer’s clinical trials for Worldwide Clinical Trials across East Coast sites. Oversee site visits, regulatory compliance, and data quality.

खोलें
Carle Health

Clinical Research Coordinator

Carle Health

Coordinate clinical trials across Carle Health’s Illinois healthcare system, from recruitment and regulatory submissions through data collection and study close-out.

खोलें
GMS

Workers’ Compensation Subrogation and Civil Litigation Attorney

GMS

Associate attorney handling workers’ compensation subrogation claims and civil litigation for California employers, insurers, and self-insured businesses. The role is with GMS, a California defense firm.

खोलें
GMS

Workers’ Compensation Defense Attorney

GMS

Associate attorney defending workers’ compensation claims for Goldman Magdalin Straatsma, LLP. Handles varied California cases with in-person, hybrid, or fully remote work options.

खोलें
GMS

Workers’ Compensation Defense Attorney

GMS

Defend employers, insurers, and public entities in workers’ compensation cases at a California defense firm. Handle matters from discovery and negotiation through trial.

खोलें
Segal McCambridge

Remote Associate Attorney, Asbestos Defense — Segal McCambridge

Segal McCambridge
201 – 500 कर्मचारी
B2Bकानूनी

Join Segal McCambridge as an associate attorney defending complex asbestos and toxic tort claims. Support coordinated defense work across discovery, depositions, case strategy, and trial preparation.

खोलें
Crédit Agricole Charente-Maritime Deux-Sèvres

Personal Banking Relationship Manager

Crédit Agricole Charente-Maritime Deux-Sèvres

Advise personal banking customers at Crédit Agricole, a French mutual bank, on savings, loans and financial services while growing a client portfolio.

खोलें
Daimler Truck North America

Legal Summer Intern — Daimler Truck North America

Daimler Truck North America

Support Daimler Truck North America’s vehicle compliance work over the summer. Research regulatory inquiries, audits, and filings with guidance from experienced attorneys.

खोलें
Oregon Department of Human Services

Assistant Attorney General, Economic Justice

Oregon Department of Human Services

Investigate and litigate antitrust and false claims cases for the Oregon Department of Justice. Help protect consumers and promote fair competition through enforcement actions and negotiated settlements.

खोलें
Gordon Rees Scully Mansukhani, LLP

Civil Litigation Attorney – Tulsa, Oklahoma

Gordon Rees Scully Mansukhani, LLP

Represent clients in civil defense matters across a range of practice areas at Gordon Rees Scully Mansukhani. The role includes litigation research and writing, client contact, and appearances in court and depositions from the Tulsa office.

खोलें