Job Title: Clinical Research Coordinator

Job Description

The Clinical Research Coordinator will play a pivotal role in coordinating the initiation and activation of new clinical trial protocols, ensuring all necessary study tools are prepared and utilized effectively. This position requires a robust background in data management and clinical research, with a strong focus on oncology trials.

Responsibilities

• Coordinate the initiation and activation of all new clinical trial protocols.
• Prepare study tools including study binders, medication diaries, eligibility checklists, and flow sheets using Oncore®, Excel®, and Word.
• Collaborate with the Research Nurse Clinician and/or physician to review patients' charts and medical history to confirm protocol eligibility and obtain necessary source documents.
• Ensure IRB-approved informed consent forms are obtained, signed, and correctly filed in medical records, providing copies to patients.
• Maintain comprehensive research records for all patients enrolled in studies, including consent, eligibility, Case Report Forms, and registration confirmations.
• Assist with grading adverse events and complete Serious/Unexpected Adverse Event forms as required by study sponsors and institutional guidelines.
• Provide regular reports to tumor study group members and Principal Investigators on assigned studies using Oncore®.
• Serve as a liaison with study sponsors, scheduling monitoring visits and conference calls, and respond accurately and timely to sponsors' queries.

Essential Skills

• Minimum of 4 years of clinical research experience.
• At least 4 years of oncology experience.
• Experience working in multiple EDC systems, specifically Medidata and Inform.
• Strong background in data management, with 60% of the role focusing on data coordination.
• Experience in recruiting, screening, and consenting patients for clinical trials.
• Blood processing experience is required.

Additional Skills & Qualifications

• Bachelor's Degree is required.
• Experience can come from clinical research, school, or nursing backgrounds, particularly in gynecology oncology groups.

Work Environment

This position requires onsite work in the Bronx four days a week. The work involves collaboration with tumor study group members, Principal Investigators, and study sponsors, utilizing multiple EDC systems in a clinical setting.