Clinical Data Coordinator

Job Title:

Clinical Data Coordinator

Job Description

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 time frames, 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 time frames.

* 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…