Job Title: Sr. Clinical Research Coordinator

Job Description

The Clinical Research Coordinator is responsible for coordinating the initiation and activation of all new clinical trial protocols. This role involves preparing study tools, reviewing patient charts, and ensuring informed consent forms are obtained and properly documented.

Responsibilities

• Coordinate the preparation of study tools including study binders, medication diaries, eligibility checklists, and flow sheets using Oncore®, Excel®, and Word.
• Review patients' charts and medical history with the Research Nurse Clinician (RNC) and/or physician to confirm protocol eligibility and obtain necessary source documents.
• Ensure IRB-approved informed consent forms are obtained, signed, and filed in the medical record, and copies provided to patients.
• Maintain research records such as patient consent, eligibility, case report forms, registration confirmation, and source documents for all patients enrolled in studies.
• Assist with grading adverse events using the latest NCI common toxicity criteria or protocol-specific grading scales, and complete SAE forms for internal and multicenter adverse events.
• Provide regular reports on all studies to tumor study group members and the Principal Investigator using Oncore®.
• Serve as a study liaison with study sponsors, scheduling monitoring visits and conference calls, and responding accurately and timely to sponsors' queries.

Required Skills & Experience

• 4+ years of clinical research experience, including recruiting patients, data collection, and data entry.
• 4+ years of oncology experience, which can come from clinical research, school, or nursing.
• Experience with multiple EDC systems, with Medidata and Inform highly preferred.
• Robust background in data management, as 60% of the job involves data management and coordination.
• Experience recruiting, screening, and consenting patients for clinical trials.

Additional Skills & Qualifications

• Bachelor's Degree required.
• Experience in blood processing.

Work Environment

The position requires working on-site in the Bronx four times per week.