Work Location: Middlesex County, New Jersey

Summary:
Seeking a Clinical Research Coordinator (CRC) to support early phase oncology clinical trials. The CRC will ensure accurate and timely conduct of clinical research, maintain compliance with protocols and regulatory requirements, and interact directly with patients. This role involves data collection, protocol implementation, and coordination of multiple studies, with a focus on patient safety and Good Clinical Practice (GCP).

Responsibilities:

• Coordinate and oversee daily activities for multiple oncology clinical trial protocols, ensuring adherence to study requirements and regulatory standards.
• Communicate regularly with study sponsors, contract research organizations, and internal staff to address protocol questions and provide status updates.
• Assist with patient screening, eligibility determination, and facilitate the informed consent process for trial participation.
• Implement protocol amendments and train staff involved in patient management and treatment.
• Maintain accurate study documentation, including source documents and standardized filing procedures.
• Identify and document protocol deviations, collaborating with leadership to implement corrective actions.
• Support data management activities, including case report form completion and query resolution.
• Work with investigators to report serious adverse events and participate in protocol-specific closeout activities.

Qualifications:

• High School Diploma or GED required.
• Minimum 2 years of clinical research experience.
• Basic understanding of oncology clinical trials, especially Phase 1 studies.
• Strong attention to detail and accuracy in data collection and documentation.
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
• Excellent organizational, time-management, and communication skills (written and verbal).
• Professional interaction skills with patients, study staff, and external stakeholders.
• Working knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Proficiency in Microsoft Office Suite and clinical trial management software.
• Experience in an oncology setting preferred.

Published Category: Clinical Operations & Development