Clinical Operations Lead

This is a fully remote position, open to applicants in Romania.

📋 Description

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

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

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

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

• Develops study tools for use by sites and CRAs, reviews visit reports, monitors protocol deviations, and supports various objectives for clinical operations and the clinical project team.

⛳️ Requirements

• College diploma or degree AND 7-9 years of relevant experience, along with continuous training and skills enhancement.

• OR an Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years of experience plus substantial ongoing job-related training.

• At least 3 years of CRA experience is required.

• Strong familiarity with EDC systems.

• Proficient in MS Office applications.

• Excellent written and verbal communication skills.

• Highly effective interpersonal and organizational capabilities.

• Proactive, detail-oriented, task-driven, and exceptionally organized.

• In-depth understanding of critical aspects of GCPs and local regulations concerning clinical monitoring, IRB/EC, and Investigator responsibilities.

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

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

🏝️ Benefits

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

• Preference for candidates with a background in Health Sciences, Life Sciences, or Nursing specialties.

• SoCRA and/or ACRP Certification/Designation is preferred.