Job Title: Clinical Research Coordinator I

Job Description

As a Clinical Research Coordinator I, you will be responsible for coordinating the initiation and activation of all new clinical trial protocols. You will collaborate with Research Nurse Clinicians and physicians to ensure accurate eligibility confirmation and informed consent processes for patients.

Responsibilities

• Coordinate the preparation of study tools such as study binders, medication diaries, eligibility checklists, and flow sheets using Oncore®, Excel®, and Word.
• Review patients' charts and medical history to confirm protocol eligibility and obtain necessary source documents.
• Ensure that IRB approved informed consent forms are obtained, signed, placed in medical records, and copies provided to patients.
• Maintain research records for all patients enrolled in studies, including patient consent, eligibility, Case Report Forms, and registration confirmation.
• Assist in grading adverse events using NCI 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 on assigned studies using Oncore®.
• Serve as a liaison with study sponsors, schedule monitoring visits and conference calls, and respond to sponsors’ queries accurately and timely.

Essential Skills

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

Additional Skills & Qualifications

• Bachelor's degree.
• Experience in gynecology oncology group or similar settings.
• Experience in data collection and data entry.

Work Environment

The role will be based on-site in the Bronx, requiring presence four times a week. You will work in a dynamic clinical setting, interacting with diverse technologies and systems to support clinical research efforts.