Clinical Research Coordinator Must have experience with oncology clinical trials

NYU Langone Health • New York, NY

14h • $70,482 - $74,794

About The Position

The Oncology Clinical Research Coordinator (CRC) coordinates oncology clinical trials from research planning through trial conduct. Under the direction of the principal investigator or treating investigator and supervision of CTO management and leadership, the CRC works closely with Oncology Clinical Research Nurses, other coordinators, Data Coordinator Unit staff, and other CTO and PCC staff. The role supports patient safety, compliance with approved protocols, and the collection of quality clinical-trial data.

The coordinator helps identify and screen potentially eligible patients, supports consent and eligibility workflows under appropriate clinical supervision, coordinates study visits and protocol-required services, and prepares research orders and documentation. The role also supports study feasibility and activation, maintains trial tracking resources, communicates with patients and study teams about non-clinical trial matters, and contributes to quality improvement, audits, and effective clinical research workflows. Clinical assessments and medical or nursing education are performed by licensed clinicians; CRC documentation and reporting activities requiring clinical verification must be reviewed and signed by licensed clinicians.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• Two years of relevant experience.
• Computer literacy and effective oral, written, interpersonal, and communication skills.
• Ability to work under supervision and direction.
• Ability to identify, analyze, and solve problems.
• Time-management skills and ability to work well under pressure.
• Proficiency with Microsoft Office applications, including Word, Excel, Access, PowerPoint, and Outlook, and familiarity with internet applications.
• Ability to communicate effectively with all levels of the organization.
• Experience with oncology clinical trials (specified in the job title line).

Nice To Haves

• Bachelor’s degree, preferably in science, public health, health education, or a related field.
• Professional certification such as ACRP CCRC or SOCRA CCRP; employees without certification will be encouraged to obtain it within one year of starting in the CRC role.
• Three years of research or related experience.
• Experience in an oncology setting.
• Experience with EPIC EHR.

Responsibilities

• Conduct recruitment and pre-screening activities to identify potentially eligible patients, promptly follow up on requests, and support training of assistant Clinical Research Coordinators (aCRCs).
• Coordinate patient navigation through prescreening, consent, screening, and eligibility processes in collaboration with investigators, CTO staff, clinical research nurses, and other departments.
• Support informed-consent discussions under the direct supervision of the investigator and/or in collaboration with a clinical research nurse; explain non-clinical study information such as schedules, reporting requirements, and reimbursement.
• Follow institutional and departmental policies, standard operating procedures, Good Clinical Practice guidelines, federal regulations, IRB requirements, and human-subjects research procedures.
• Understand protocol requirements and maintain study tracking forms throughout each protocol’s lifecycle, collaborating with CRCs and CRNs to support patient safety and quality data collection.
• Perform study-specific coordination tasks under investigator and CTO leadership supervision and communicate protocol-related workflow or patient-specific changes to the study team.
• Communicate with patients about non-clinical study matters, including study schedules, reimbursement, and transportation.
• Schedule study participants and coordinate protocol-required tests, procedures, appointments, and ancillary services through screening, treatment, and follow-up.
• Prepare for study visits by placing or preparing research biospecimen, laboratory, and EKG orders; arranging biopsies and scans; facilitating investigator completion of RECIST forms; and coordinating AE and concomitant medication forms with licensed professionals.
• Maintain knowledge of active and pipeline clinical trials within the DMG, update DMG schemas, and train aCRCs in schema maintenance.
• Understand and support adverse-event reporting according to protocols, institutional requirements, and FDA guidance, including AE, SAE, ECI, UADE, SUSAR, and RNI reporting.
• Maintain trackers and follow-up calendars to monitor protocol-specific requirements, patient compliance, and survival follow-up assessments.
• Follow CTO processes for treatment clearance and communicate clearly about clearance status.
• Serve as the primary point of contact for biospecimen collections and use EPIC and LabVantage to complete research biospecimen orders in a timely manner.
• Compile and submit weekly patient treatment lists to investigational pharmacy, RBMU, and other departments as needed.
• Monitor infusion chair assignments and request changes to align assignments with protocol requirements.
• Perform EKGs when trained, track and maintain study-specific EKG machines, address sponsor machine issues, and oversee documentation and inventory of DMG study equipment.
• Review concomitant medications, reconcile medication lists, verify drug and dose information, review diaries where applicable, and document appropriately in EPIC and study-specific records under investigator direction or with a licensed RN or APP.
• Initiate vial assignments and coordinate with infusion nurses and pharmacy for timely investigational-product dispensing under CTO processes.
• Self-audit work for protocol compliance and patient safety.
• Conduct protocol feasibility assessments using institutional guidelines and CTO resources, escalate feasibility barriers, and support safe and compliant study activation, including training aCRCs.
• Attend DMG and CTO meetings, and tumor board or clinical meetings as applicable, to support patient care, research quality, and trial recruitment; track prescreening requests as needed.
• Lead timely reconciliation of clinical discrepancies and queries in collaboration with CCU and DCU team members.
• Prepare study-visit materials and arrangements, including research orders, scheduling, interpreter requests, assessment forms, quality-of-life forms, and EPIC smart phrases; demonstrate and support proficiency in LabVantage.
• Maintain quality source documentation in accordance with ALCOA-C standards and CTO documentation requirements.
• Protect patient confidentiality and protected health information and comply with HIPAA.
• Use CRMS and Research Navigator for daily work, including verifying that participating investigators and staff are listed on the IRB-approved study before visits or activities.
• Apply high-reliability organization principles in daily work and communication; support internal audits and external audit preparation as needed.
• Assist patients with understanding protocol assessment schedules, appointment coordination, and ancillary services under licensed-clinician supervision.
• Under investigator supervision, participate in adverse-event and concomitant-medication documentation and reporting when applicable; ensure licensed-clinician verification and signature before submission where required.
• Write research notes in EPIC to support clinical-trial documentation without making clinical assessments.
• Cross-cover other CCU DMGs as needed.
• Contribute to tools and workflows that improve CCU DMG efficiency, address protocol or sponsor concerns, and help solve operational barriers.
• Perform other assigned duties, including supporting SOP development, policy changes, education sessions, and quality-improvement projects.

Benefits

• Comprehensive benefits and wellness package.
• Financial security benefits.
• Generous time-off program.
• Employee resource groups for peer support.
• Holistic employee wellness program covering physical, mental, nutritional, sleep, social, financial, and preventive-care well-being.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level