Clinical Operations Lead

6 days ago

🇺🇸 United States – Remote

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

💵 $83.5k - $139k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Alimentiv

WebsiteLinkedInAll Job Openings

Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management

201 - 500 employees

Founded 2020

⚕️ Healthcare Insurance

🔬 Science

💊 Pharmaceuticals

Description

• Responsible for clinical operations of a project within a defined regional/global level. • Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites. • Acts as a primary liaison between the CRAs and the clinical project team. • Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs. • Implementation of enrollment and recruitment strategies, preparation of the monitoring plan, oversight of monitoring visit scheduling. • Develop study tools for site and CRA use, review visit reports, review and track protocol deviations.

Requirements

• College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading • OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training • Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation. • Minimum of 3 years CRA experience, strong experience with EDC systems, proficient with MS Office. • Strong written and verbal communication skills and highly effective interpersonal and organizational skills. • Proactive, detail oriented, task-driven and highly organized. • Demonstrates critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities. • Demonstrated ability in report writing and strong ability to critically understand clinical research documents. • Ability to handle multiple tasks to meet deadlines in a dynamic environment.