Clinical Research Coordinator

Job Title: Clinical Research Coordinator

Job Description

We are seeking a dedicated Clinical Research Coordinator to manage the initiation and activation of new clinical trial protocols. The ideal candidate will have a robust background in data management and will play a key role in coordinating various aspects of clinical trials, ensuring smooth operation and compliance with institutional guidelines.

Responsibilities

• Coordinate the preparation of study tools, such as 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 confirm protocol eligibility, while obtaining necessary source documents.
• Ensure that IRB approved informed consent forms are obtained, signed, and properly filed, with copies provided to patients.
• Maintain comprehensive research records for all patients enrolled in studies, including patient consent, eligibility, Case Report Forms, and registration confirmations.
• Assist with grading adverse events using the NCI common toxicity criteria or protocol-specific grading scales and complete Serious/Unexpected Adverse Event forms as required.
• Provide regular reports to tumor study group members and the Principal Investigator on assigned studies using Oncore®.
• Serve as a liaison with study sponsors, scheduling monitoring visits and conference calls, and addressing sponsors’ queries accurately and promptly.

Essential Skills

• 4+ years of clinical research experience, including patient recruitment and data management.
• 4+ years of oncology experience.
• Experience working with multiple EDC systems, particularly Medidata and Inform.
• Strong data management skills, as 60% of the role involves data management and coordination.
• Experience in recruiting, screening, and consenting patients for clinical trials.
• Blood processing experience.

Additional Skills & Qualifications

• Bachelor's Degree minimum.
• Experience in gynecological oncology, even if not directly from clinical research settings, is acceptable.

Work Environment

The position is based on-site in the Bronx, requiring attendance four times a week.

Job Type & Location

This is a Contract to Hire position based out of bronx, New York.