Sr. Clinical Research Coordinator

This role coordinates and supports oncology clinical trials by managing protocol initiation, patient recruitment, data collection, and regulatory documentation. The Clinical Research Coordinator works closely with research nurses and physicians to ensure that all aspects of clinical trials—including informed consent, eligibility confirmation, data management, and adverse event reporting—comply with institutional, sponsor, and regulatory requirements. The position combines substantial data management responsibilities with direct patient-facing activities in a clinical setting.

Responsibilities

• Coordinate the initiation and activation of new clinical trial protocols in oncology.
• Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets as required.
• Use Oncore, Excel, and Word to develop and maintain study tools, including eligibility checklists, medication diaries, calendars, and flow sheets.
• Collaborate with the Research Nurse Clinician and/or physicians to review patients’ charts and medical histories to confirm protocol eligibility.
• Obtain and organize source documents, including medical record documentation, to support eligibility and study requirements.
• Under the direction of the Research Nurse Clinician and/or physician, ensure that IRB-approved informed consent forms are properly obtained, signed, documented in the medical record, and that copies are provided to patients.
• Maintain complete and accurate research records for all enrolled patients, including consent forms, eligibility documentation, case report forms, registration confirmations, and all corresponding source documents.
• Assist the Research Nurse Clinician and physicians in grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales.
• Complete Serious/Unexpected Adverse Event forms for internal and multicenter events in accordance with study sponsor requirements, federal regulations, and institutional guidelines.
• Ensure all research records remain current, organized, and audit-ready for every patient enrolled on a study.
• Use Oncore to generate and provide regular reports to tumor study group members and Principal Investigators for assigned studies.
• Serve as a primary liaison with study sponsors, anticipating their needs and maintaining clear and professional communication.
• Schedule and coordinate sponsor monitoring visits and conference calls, ensuring all required documentation and data are available and accurate.
• Provide accurate, timely, and well-supported responses to sponsor queries related to data, documentation, and study conduct.
• Recruit, screen, and consent patients for clinical trials, working closely with clinic staff to identify eligible participants.
• Collect and enter clinical trial data accurately and promptly into electronic data capture systems, ensuring consistency with source documents.
• Manage and coordinate data across multiple EDC systems, ensuring data integrity, completeness, and compliance with protocol requirements.
• Perform blood processing procedures as required by study protocols and ensure proper handling, labeling, and documentation of specimens.
• Balance data management responsibilities (approximately 60% of the role) with clinic-based patient recruitment, screening, and consenting activities (approximately 40% of the role).

Requirements

• Minimum of a bachelor’s degree.
• At least 4 years of clinical research experience, including patient recruitment, data collection, and data entry.
• At least 4 years of oncology experience; oncology experience may come from clinical research, academic programs, or nursing roles, including gynecologic oncology.
• Demonstrated experience recruiting, screening, and consenting patients for clinical trials.
• Strong background in data management, with approximately 60% of prior responsibilities focused on data management and coordination.
• Experience working with multiple electronic data capture systems, with Medidata and Inform highly preferred.
• Proficiency using Oncore for study management and reporting.
• Ability to use Microsoft Excel and Word to create and maintain study tools and documentation.
• Experience with blood processing procedures in a clinical or research setting.
• Familiarity with oncology clinical trial workflows, including eligibility assessment and source documentation.
• Ability to apply National Cancer Institute common toxicity criteria or protocol-specific grading scales to adverse events.
• Strong organizational skills with the ability to maintain complete, accurate, and compliant research records.
• Excellent written and verbal communication skills to interact effectively with investigators, research nurses, sponsors, and patients.
• Ability to respond promptly and accurately to sponsor queries and regulatory documentation requirements.

Work Environment

This position is primarily onsite in the Bronx, with an expectation to be on site four days per week. The role involves a combination of office-based work for data management and documentation, and clinic-based work for patient recruitment, screening, consenting, and blood processing. You will work with clinical research technologies such as Oncore, multiple electronic data capture systems (including Medidata and Inform), and standard office applications such as Excel and Word. The environment is fast-paced and detail-oriented, with frequent interaction with clinical staff, investigators, and study sponsors. Professional attire appropriate for a clinical and research setting is expected.

Pay

The pay range for this position is $35.00 - $42.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental, and vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a Contract to Hire hybrid position based in the Bronx, NY, with an expectation to be on site four days per week.