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.
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.
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.
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.