Please note that due to the COVID-19 pandemic, this position is currently remote however once we return to the office this position will be based in Durham, NC.

Position Summary

Nuventra is looking for a Clinical Operations Associate to join our internal Clinical Operations team. The ideal candidate will apply knowledge of ICH/GCP regulations, clinical operations best practices, and scientific experience to assist with specific components of clinical studies against time, budget, and quality parameters.

Essential Functions

  • Assist with the coordination and management of activities of study execution including protocol feasibility, site selection, regulatory document collection, site initiation, site monitoring, data management, and site close-out in conformance to all relevant laws, regulations, guidelines, and internal SOPs/policies.
  • Develop solutions for day-to-day study issues.
  • Ensure the approval of GCP essential documents required for release of investigational product to investigational sites.
  • Ensure ongoing review of blinded study data and deviations from clinical protocol.
  • Develop corrective and/or preventative action plans to address any deficiencies in conduct of clinical study.
  • Assist with the development of study documents, plans and processes, such as protocol, informed consent, and case report forms.
  • Assist with the development, implementation, and maintenance of study plans, including, but not limited to, data management plan and clinical monitoring plan.
  • In collaboration with internal stakeholders, ensure detailed study schedule and timelines are created that are in line with estimates.

Required Education

  • Bachelor's Degree in a science related field

Required Skills And Experience

  • One to three years of Clinical Operations experience
  • Knowledge of clinical study guidelines (FDA, ICH, and GCP)
  • Knowledge of the clinical trials process
  • Excellent oral and written communication skills

Benefits and Perks

  • Great Medical, Dental, and Vision plans (Vision is covered 100% for all employees and their families)
  • 401(k) and student loan matching
  • Flexible work environment including weekly remote work options
  • Paid childbirth and childcare leave
  • Paid 5 week sabbatical after 5 years of employment
  • Stocked kitchen with drinks, goodies, and snacks
  • Frequent company and team-building events
  • Monthly gym reimbursement
  • 8 hours of paid volunteer time-off

Diversity is a key to success. We are an equal opportunity employer and welcome applicants of all backgrounds, experiences, and perspectives.

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