Clinical Project Coordinator

ClinicalPro is seeking a Clinical Project Coordinator for a leading Biotechnology company located in the USA.

This individual will be responsible for planning and coordination, comprising all operational aspects of a clinical project from protocol conception to clinical study report, in accordance with worldwide GCP standards and recommendations.

Must be eligible to work in the USA.

Responsibilities

• Support important daily clinical trial tasks.
• Regulatory inspection preparation, in line with established procedures.
• Support clinical study activities as specified by the clinical trial operational model.
• Work closely with the clinical operations manager, study teams, and clinical research organisations (CROs).
• Carry out departmental duties as required.
• Under the direction of the CTA Manager, carry out developing duties as necessary.
• Helps with the planning of investigator meetings and monitoring visits.
• Offers administrative assistance to the clinical project teams.
• Review and/or approval of study document.
• Assisting with or supervising risk-based monitoring.
• Attending important team meetings as necessary; making presentations (of data, etc.) as desired.
• Assisting with regulatory inspection preparations.
• Taking part in regulatory inspections.
• Assisting with extra ad hoc tasks as required and as agreed upon with the CTA Manager.

Skills and Requirements

• 1-2 years of experience in a relevant position in the pharmaceutical business or a clinical research organisation.
• Having a track record of working in several therapeutic fields.
• Understanding of the compliance and regulatory requirements for clinical research on a global/regional level.
• Excellent task management.
• Cross-functional cooperation demonstrated.
• Outstanding communication abilities.
• Excellent organisational, interpersonal, problem-solving, and collaborative skills.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

---

To explore more opportunities, visit Opportunities at ClinicalPro