Job Title: Clinical Research Coordinator

Job Description

We are seeking a detail-oriented Clinical Research Coordinator to play a crucial role in coordinating the initiation and activation of new clinical trial protocols. This role involves developing and preparing study tools, collaborating with research professionals, and ensuring compliance with study protocols.

Responsibilities

• Coordinate the preparation of study tools including study binders, medication diaries, eligibility checklists, and flow sheets.
• Develop study tools using Oncore®/Excel®/Word in collaboration with the Research Nurse Clinician and/or physician.
• Review patients’ charts and medical history to confirm protocol eligibility and obtain source documents as needed.
• Ensure that IRB approved informed consent forms are obtained, signed, and properly filed in the medical record.
• Maintain research records for all patients enrolled in studies, ensuring accuracy and compliance.
• Assist with grading adverse events using National Cancer Institute common toxicity criteria or protocol-specific grading scales.
• Complete Serious/Unexpected Adverse Event forms as required by study sponsors, federal requirements, and institutional guidelines.
• Provide regular reports to tumor study group members and Principal Investigator using Oncore®.
• Serve as a liaison with study sponsors, scheduling monitoring visits and conference calls, and responding to sponsors’ queries.

Essential Skills

• 4+ years of clinical research experience.
• 4+ years of oncology experience.
• Experience in data management and coordination, with 60% of the job focused on data management.
• Experience working in multiple EDC systems, with preference for Medidata and Inform.
• Experience in recruiting, screening, and consenting patients for clinical trials.
• Blood processing experience.

Additional Skills & Qualifications

• Bachelor's Degree minimum.
• Experience in clinical research or related fields such as school or nursing, particularly in gynecology oncology.

Work Environment

This position requires working on-site in the Bronx four times per week. The role involves collaboration with research professionals and sponsors, requiring effective communication and organizational skills.