Clinical Research Coordinator

Actalent - New Brunswick, NJ

Full-time - Entry Level

New Brunswick, NJ

10,001+ employees

Administrative and Support Services

About the position

The Clinical Research Coordinator will oversee the initiation and activation of new clinical trial protocols, ensuring compliance with regulatory requirements and coordinating the preparation of necessary study tools and documentation. This role is essential for maintaining the integrity of clinical trials and supporting the research team in achieving study objectives.

Responsibilities

• Verify Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals prior to study activation.
• Coordinate the preparation of study tools, including study binders, medication diaries, eligibility checklists, and flow sheets.
• Develop study tools using computer software such as Excel, Word, and Access.
• Review patients' charts and medical history to confirm protocol eligibility and obtain source documents in collaboration with the Research Nurse Clinician (RNC) and/or physician.
• Ensure that IRB approved informed consent forms are obtained, signed, and properly documented.
• Register consented research patients with study sponsors and input data into the clinical trials database.
• Maintain research records for all patients enrolled in clinical trials, including patient consent, eligibility, Case Report Forms (CRF), and corresponding source documents.
• Complete Serious/Unexpected Adverse Event (SAE) forms as required by study sponsors, federal requirements, and institutional guidelines.
• Provide regular reports to tumor study group members and Principal Investigators on all assigned studies.
• Serve as study liaison with study sponsors, schedule monitoring visits and conference calls, and respond to sponsors' queries accurately and timely.
• Ensure that personnel, including investigators, conduct the study according to the treatment plan and Good Clinical Practice (GCP) guidelines.

Requirements

• 1-3 years of clinical research coordinator experience.
• Bachelor's Degree.
• Solid knowledge of computer software programs such as Excel, Word, and Access.
• Experience and comfortability communicating with patients.

Nice-to-haves

• Detail-oriented with excellent organizational, communication, and interpersonal skills.
• Ability to hold oneself accountable to high standards of professional excellence.
• Resourceful and able to maximize available resources.
• Capable of seeking and accepting personal and professional responsibility on a continual basis.