Clinical Operations Lead

📋 Description

• Accountable for the clinical operations of a project at a specified regional or global level.

• Oversees project deliverables, manages assigned Clinical Research Associates (CRAs), and supervises Investigator sites in alignment with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and applicable local regulations.

• Serves as the primary point of contact between the CRAs and the clinical project team.

• Additional duties include providing project-specific training for CRAs, conducting assessment visits alongside CRAs, executing enrollment and recruitment strategies, preparing the monitoring plan along with other structural documentation, and overseeing the scheduling of monitoring visits, site performance metrics, issue escalation, and corrective actions.

• The COL will create study tools for both site and CRA utilization, review visit reports, monitor and track protocol deviations, and support other objectives relevant to clinical operations and the clinical project team.

⛳️ Requirements

• A college diploma or degree coupled with 7-9 years of relevant experience, including continuous training and skill enhancement.

• Alternatively, an undergraduate university degree (Bachelor's or Honors Bachelor's) along with 4-6 years of experience and considerable ongoing job-related training.

• Preference for candidates with specialties in Health Sciences, Life Sciences, or Nursing, or who hold SoCRA and/or ACRP Certification/Designation.

• Must possess at least 3 years of CRA experience, demonstrate strong familiarity with EDC systems, be proficient in MS Office, and exhibit strong written and verbal communication abilities, along with exceptional interpersonal and organizational skills.

• Must display attributes such as proactivity, detail orientation, task-driven mindset, and high levels of organization.

• Should demonstrate a solid understanding of the key elements of GCPs and local regulations in relation to clinical monitoring, IRB/EC, and Investigator responsibilities.

• Proven capability in report writing and a strong aptitude for critically analyzing clinical research documents.

• Ability to manage multiple tasks effectively to meet deadlines in a fast-paced environment.

🏝️ Benefits

• Accommodations for individuals with disabilities are available upon request throughout all phases of the recruitment and selection lifecycle.

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