Clinical Data Coordinator

Clinical Data Coordinator

The Clinical Data Coordinator plays a key role in supporting clinical research studies by maintaining essential study documents, entering and verifying data on Case Report Forms, and ensuring strict compliance with regulatory and protocol requirements. This position combines meticulous data management with hands-on involvement in specimen processing and regulatory documentation, contributing directly to high-quality clinical research outcomes in a fast-paced, high-volume environment.

Responsibilities:

• Maintain essential study documents and regulatory binders for clinical research studies in accordance with FDA guidelines and institutional policies.
• Enter accurate and complete data onto paper and electronic Case Report Forms (CRFs), ensuring all study-specific data points are correctly captured.
• Prepare reports and assist with statistical analysis, including enrollment logs and other tracking tools that support institutional statistical review.
• Ensure timely submission of research data, laboratory specimens, and query responses to research affiliates, sponsors, and statistical centers.
• Assist research nurse coordinators and other team members in preparing for audits conducted by governing agencies, study monitors, and internal affairs.
• Obtain and maintain valid Dangerous Goods Shipping Certification and adhere to all Federal Regulations for shipping human specimens and biologic agents.
• Collaborate daily with principal investigators, research nurse coordinators, sponsors, contract research organizations, and other research team members.
• Obtain patient consent for minimal-risk studies and verify that informed consent is documented before entering any study-specific data.
• Compare protocol schedules of events to CRFs to ensure accurate capture of required data points and adherence to study timelines.
• Resolve data queries accurately and within study-specific timeframes, maintaining clear documentation of all corrections and clarifications.
• Maintain adequate inventory of research supplies and kits necessary for research activities, ensuring materials are current and safely disposing of expired or closed items.
• Centrifuge human specimens according to study-specific laboratory manuals and process and ship specimens per protocol and regulatory guidelines.
• Collect, copy, and file research-related documents such as curricula vitae, medical licenses, laboratory certifications, lab normals, and financial disclosures in study-specific regulatory binders, including items required on FDA Form 1572.
• Ensure regulatory binders remain complete and up to date with all essential study documents throughout the life of each study.
• Review study-specific follow-up schedules in the protocol and complete follow-up CRFs to maintain timely and accurate patient follow-up data.
• Report, track, and file off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within required timeframes.
• Use SAE reporting logs to track receipt, submission, and acknowledgement of off-site SAEs in accordance with protocol requirements.
• Organize and prepare for all sponsor-related visits, including pre-site initiation, site initiation, routine monitoring, close-out visits, internal audits, and sponsor audits.
• Lift a minimum of 5 lbs., push and pull a minimum of 10 lbs., and stand for at least 4 hours per day as required by research activities.
• Sit and concentrate at a computer workstation for a minimum of 4 hours at a time to complete data entry, reporting, and documentation tasks.
• Identify the needs of the patient population served and modify communication and interactions to be appropriate for age, culture, language, and any hearing or visual impairments.
• Communicate effectively with patients, parents, and primary caregivers at their developmental, educational, and literacy level to support understanding of study-related information.
• Adhere to organizational competencies and standards, including ethical conduct, quality, safety, and compliance expectations.
• Maintain regular professional contact with medical center personnel, patients, and visitors to support smooth study operations and patient-centered care.

Essential Skills:

• Minimum of 2 years of clinical research experience; internship or school-based clinical research experience is acceptable if it involves real clinical exposure.
• Bachelor's degree, preferably a four-year degree in a science discipline such as Chemistry, Biology, or Nursing.
• Alternatively, a minimum of 3 years of extensive research experience that includes data abstraction, CRF completion, and research regulatory reporting.
• Hands-on experience entering data into Case Report Forms for clinical research studies.
• Demonstrated experience maintaining regulatory binders in compliance with FDA guidelines and institutional requirements.
• Proven ability to ensure timely submission of research data, laboratory specimens, and query correspondences.
• Strong attention to detail and accuracy in data entry, documentation, and record keeping.
• Ability to interpret study protocols and schedules of events and translate them into accurate CRF completion.
• Capability to resolve data queries within specified study timelines while maintaining data integrity.
• Comfort working in a fast-paced, high-volume, and high-pressure research environment.
• Physical ability to lift at least 5 lbs., push and pull at least 10 lbs., stand for at least 4 hours per day, and sit at a computer for extended periods.
• Effective interpersonal and communication skills for daily collaboration with multidisciplinary research teams and interaction with patients and caregivers.
• Commitment to regulatory compliance, ethical standards, and adherence to institutional competencies.

Additional Skills & Qualifications:

• Oncology research experience, particularly within cancer-focused studies, is highly desirable.
• Experience working with blood processing, including centrifugation and preparation of specimens for shipment.
• Clinical research experience in hospital, contract research organization, or pharmaceutical settings is a strong plus.
• Valid or willingness to obtain Dangerous Goods Shipping Certification.
• Familiarity with IRB processes, SAE reporting, and use of SAE reporting logs.
• Experience organizing and supporting sponsor visits, monitoring visits, and audits.
• Knowledge of FDA Form 1572 requirements and associated documentation such as investigator CVs, medical licenses, lab certifications, lab normals, and financial disclosures.
• Ability to adapt communication style to meet the needs of diverse patient populations, including varying ages, cultures, languages, and levels of health literacy.
• Strong organizational skills with the ability to manage multiple studies, deadlines, and competing priorities.
• Comfort using electronic data capture systems and standard office software for data entry and reporting.

Work Environment:

This role is based in a cancer center environment with approximately 80 professionals engaged in research activities and a dedicated team of 21 data coordinators. The setting is fast-paced, high volume, and high pressure, requiring the ability to manage multiple tasks and deadlines while maintaining high standards of accuracy and compliance. The team culture is collaborative and supportive, welcoming hard-working individuals who integrate quickly and contribute to shared research goals. The position follows a daytime schedule, with an initial training period from 8:00 a.m. to 4:30 p.m., followed by a regular schedule around standard business hours. Work is primarily performed in an office and clinical research setting, involving extended computer use, handling and processing of human specimens according to protocol and safety guidelines, and frequent interaction with clinical staff, patients, and visitors.

Job Type & Location:

This is a Contract position based out of Hackensack, NJ.

Pay and Benefits:

The pay range for this position is $23.00 - $26.00/hr. 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 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)

Workplace Type:

This is a hybrid position in Hackensack, NJ.

Application Deadline:

This position is anticipated to close on Jul 31, 2026.