Clinical Trial Operations Lead - Remote Opportunity!

About the role

Greene Resources is seeking a Clinical Trial Operations Lead to join a growing and dynamic team! Greene Resources is part of Array Corporation, the leading technology-enabled workforce solutions company whose mission is to fix how work is bought, sold and delivered to enable access to the American Dream.

Responsibilities

• Oversee the ongoing operations and execution of an assigned clinical trial.
• Coordinate the development, distribution, implementation, and revision of study protocols, amendments, informed consent and assent forms, manuals of procedures, training materials, recruitment materials, payment and capitation triggers, and other study-related documents.
• Cross-check study documents for consistency, accuracy, and alignment with protocol requirements.
• Develop and manage study timelines, milestones, deliverables, and project objectives.
• Identify operational risks and implement appropriate risk-management strategies.
• Coordinate communication across project leadership, clinical sites, vendors, laboratories, and cross-functional teams.
• Oversee activities related to investigational-product development, shipment, utilization, tracking, and accountability.
• Coordinate biospecimen operations, including specimen collection, tracking, shipment, laboratory-vendor coordination, and sample analysis.
• Work closely with clinical sites, vendors, laboratories, and internal project teams to maintain efficient study operations.
• Address operational issues and ensure study activities remain aligned with approved protocols, regulatory requirements, and project timelines.
• Support site-level operational needs and, when necessary, travel to a clinical site to address issues requiring in-person review.
• Handle protected health information (PHI) in accordance with applicable privacy, security, and regulatory requirements.
• Work independently and effectively in a remote environment while maintaining consistent communication with project stakeholders.

Requirements

• Direct experience running and managing clinical trials; experience must extend beyond supporting or assisting with trials.
• Demonstrated ability to understand and manage an entire clinical trial and its operational requirements.
• Experience working on FDA-regulated clinical studies.
• Experience with protocol development and amendments.
• Exposure to Investigational New Drug (IND) submissions.
• Strong operational project management skills, including the ability to manage timelines, milestones, deliverables, and risks.
• Demonstrated cross-functional leadership and communication skills.
• Experience coordinating clinical sites, vendors, laboratories, and other study partners.
• Ability to work independently in a remote environment.
• Interest in remaining engaged with the project beyond the initial contract period.

Qualifications

• Bachelor's degree with at least 12 years of relevant experience; or Master's degree with at least 10 years of relevant experience; or PhD with at least 6 years of relevant experience.
• Preferred experience includes biospecimen operations (specimen tracking, shipment, laboratory-vendor coordination, or sample analysis).
• Preferred experience includes investigational-product development, shipment, utilization, or accountability.
• Preferred experience includes Clinical Trial Management System (CTMS) experience.
• Preferred experience includes Electronic Data Capture (EDC) experience.
• Preferred experience includes experience with electronic clinical research systems.
• Preferred experience includes Medidata experience.
• Preferred experience includes experience with Advarra eClinical or similar clinical research platforms.
• Preferred experience includes federally funded clinical research experience.
• Preferred experience includes experience in Long COVID, infectious disease, or similarly complex therapeutic areas.
• Candidates do not need experience with one specific CTMS or EDC platform; experience with comparable systems is acceptable.

Pay

$76/hour

Schedule

Monday - Friday, 8:00am to 5:00pm