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Clinical Trial Operations Lead – Remote Opportunity!

Greene Resources - GAP

Position: Clinical Trial Operations Lead 

Location: Research Triangle Park, NC (Remote)

Pay: $76/hour

Experience/Education:

  1. Bachelor’s degree with at least 12 years of relevant experience; or
  2. Master’s degree with at least 10 years of relevant experience; or
  3. PhD with at least 6 years of relevant experience. 

Type: Full-time; Contract  

Schedule: Monday – Friday, 8:00am to 5:00pm 

 

Greene Resources is seeking a Clinical Trial Operations Lead to join a growing and dynamic team!   

 

Job Description: 

  1. Oversee the ongoing operations and execution of an assigned clinical trial.
  2. 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.
  3. Cross-check study documents for consistency, accuracy, and alignment with protocol requirements.
  4. Develop and manage study timelines, milestones, deliverables, and project objectives.
  5. Identify operational risks and implement appropriate risk-management strategies.
  6. Coordinate communication across project leadership, clinical sites, vendors, laboratories, and cross-functional teams.
  7. Oversee activities related to investigational-product development, shipment, utilization, tracking, and accountability.
  8. Coordinate biospecimen operations, including specimen collection, tracking, shipment, laboratory-vendor coordination, and sample analysis.
  9. Work closely with clinical sites, vendors, laboratories, and internal project teams to maintain efficient study operations.
  10. Address operational issues and ensure study activities remain aligned with approved protocols, regulatory requirements, and project timelines.
  11. Support site-level operational needs and, when necessary, travel to a clinical site to address issues requiring in-person review.
  12. Handle protected health information (PHI) in accordance with applicable privacy, security, and regulatory requirements.
  13. Work independently and effectively in a remote environment while maintaining consistent communication with project stakeholders.

 

Position Requirements:    

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

Preferred Experience:

  1. Biospecimen operations, including specimen tracking, shipment, laboratory-vendor coordination, or sample analysis.
  2. Investigational-product development, shipment, utilization, or accountability.
  3. Clinical Trial Management System (CTMS) experience.
  4. Electronic Data Capture (EDC) experience.
  5. Experience with electronic clinical research systems.
  6. Medidata experience.
  7. Experience with Advarra eClinical or similar clinical research platforms.
  8. Federally funded clinical research experience.
  9. Experience in Long COVID, infectious disease, or similarly complex therapeutic areas.
  10. Candidates do not need experience with one specific CTMS or EDC platform; experience with comparable systems is acceptable.

 

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. 

 

We are proud to be an Equal Employment Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

#GRAP

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