Clinical Research Data Coordinator

Clinical Research Data Coordinator

This role coordinates the initiation, activation, and ongoing conduct of oncology clinical trial protocols with a primary focus on data-related activities such as data entry and query resolution. The Clinical Research Coordinator (Data) supports research nurses and physicians by preparing study tools, managing research records, facilitating patient screening and consent, and ensuring accurate, timely reporting of adverse events and study data in alignment with institutional, sponsor, and regulatory requirements.

Responsibilities

• Coordinate the initiation and activation of new oncology clinical trial protocols, ensuring all required elements are in place before enrollment begins.
• Prepare and maintain study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, ensuring they align with protocol requirements.
• Use Oncore, Excel, and Word to develop and update study tools and documentation needed for effective trial conduct and data collection.
• Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical history to confirm protocol eligibility and obtain necessary source documents.
• Ensure that Institutional Review Board (IRB) approved informed consent forms are properly obtained, signed, filed in the medical record, and that copies are provided to patients under the direction of the Research Nurse Clinician and/or physician.
• Maintain complete and accurate research records for all enrolled patients, including informed consent documentation, eligibility confirmation, Case Report Forms, registration confirmations, and all corresponding source documents.
• Assist Research Nurse Clinicians and physicians in grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales.
• Complete Serious and Unexpected Adverse Event (SAE) forms for internal and multicenter serious or unexpected adverse events in accordance with sponsor requirements, federal regulations, and institutional guidelines.
• Provide regular status reports using Oncore to tumor study group members and Principal Investigators on all assigned studies, including enrollment, data status, and outstanding queries.
• Serve as a liaison with study sponsors by understanding and anticipating sponsor needs, scheduling monitoring visits and conference calls, and providing accurate, timely, and well-supported responses to sponsor queries.
• Support screening, enrolling, and consenting patients into research studies based on study protocols, ensuring adherence to eligibility criteria and regulatory requirements.
• Coordinate medication-related activities for patients on study as required by protocol and institutional procedures.
• Focus on data entry and query resolution for oncology trials, ensuring data quality, completeness, and adherence to timelines.
• Support onboarding and training of new Clinical Research Coordinators by sharing best practices and assisting with supervision as needed.

Essential Skills

• 12 years of experience as a Clinical Research Coordinator with a primary focus on data entry and query resolution for oncology trials.
• 12 years of oncology clinical research experience, preferably within an NCI-designated cancer setting or similar oncology research environment.
• Experience screening, enrolling, and consenting patients into research studies based on study protocols.
• Experience with adverse event reporting, including identification, documentation, and communication of AEs and SAEs.
• Proficiency using Oncore for clinical trial management and reporting.
• Proficiency with Microsoft Excel and Word for creating and maintaining study tools and documentation.

Job Type & Location

This is a Contract position based out of Bronx, NY.

Pay and Benefits

The pay range for this position is $25.00 - $35.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan…