Onsite Oncology Clinical Trials Coordinator

Actalent; Chapel Hill (NC); Sur place; USD 45 000 - 48 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) plan

Life Insurance

Disability Insurance

HSA

Transportation benefits

Employee Assistance Program

PTO / Vacation

Résumé du poste

Actalent is seeking a Clinical Research Coordinator to independently manage multiple oncology trials from startup through closeout at an academic medical center in Chapel Hill. You will act as the primary contact for patients, physicians, sponsors, and staff, coordinating visits, data entry, regulatory compliance, and study coordination.

The role requires 1+ year CRC experience, proficiency with EDC systems, and knowledge of GCP/FDA regulations.

Qualifications

• CRC or Study Coordinator with at least 1 year of experience.
• Experience in recruitment, screening, consent, enrollment and scheduling.
• Proficiency with Electronic Data Capture systems (e.g., Medidata Rave, Oracle, Inform).
• Regulatory experience including IRB submissions/maintenance and study documentation.
• Experience managing study data, source documentation, and CRFs.
• Experience with monitoring visits, audits and query resolution.
• Knowledge of GCP, FDA regulations, and clinical research compliance.
• Oncology and/or Cardiovascular/CNS experience.

Responsabilités

• Coordinate all phases of clinical trials from activation to closeout.
• Recruit, screen, consent, and enroll participants.
• Schedule protocol-required visits and follow-ups.
• Educate patients and serve as a study resource.
• Enter study data and maintain source documentation.
• Maintain regulatory records and ensure compliance.
• Support sponsor monitoring visits, audits, and inspections.
• Coordinate collection, processing and shipment of specimens.
• Report adverse events and protocol deviations.
• Collaborate with investigators and staff on startup, closeout and process improvements.

Connaissances

CRC Experience

Patient Recruitment

EDC Systems

Regulatory Knowledge

Study Data Management

Monitoring & Audits

GCP & FDA Regulations

Oncology/Cardio/CNS

Formation

Bachelor's degree in science/healthcare

Outils

Medidata Rave

Oracle

Inform

Epic/EMR

SOCRA/ACRP certification

Description du poste

Actalent is seeking a Clinical Research Coordinator to independently manage multiple oncology trials from startup through closeout at an academic medical center in Chapel Hill. You will act as the primary contact for patients, physicians, sponsors, and staff, coordinating visits, data entry, regulatory compliance, and study coordination.

The role requires 1+ year CRC experience, proficiency with EDC systems, and knowledge of GCP/FDA regulations.