Clinical Research Coordinator

Job Title:

Clinical Research Coordinator

Job Description

This role coordinates and manages all aspects of clinical research studies in prostate and bladder oncology under the general supervision of the Research Director and Principal Investigator. The Clinical Research Coordinator oversees subject screening and recruitment, ensures accurate data entry and abstraction, and conducts ongoing assessments in accordance with research protocols and regulatory requirements. The position serves as a central point of contact across services and departments to support high-quality, compliant clinical trials.

Responsibilities

+ Execute, manage, and coordinate clinical research protocols as directed by the Research Director and Principal Investigator, ensuring adherence to study guidelines and regulating agency policies.

+ Coordinate the data collection and day-to-day operations of several concurrent clinical research studies, adjusting support based on each studys size and complexity.

+ Screen and pre-screen potential participants, recruit eligible subjects, and facilitate the informed consent process in alignment with ethical and regulatory standards.

+ Act as an intermediary between clinical services and departments to support smooth study workflows, including scheduling visits and coordinating procedures and specimen collection.

+ Oversee data and specimen collection, including phlebotomy and sample processing when applicable, and ensure accurate labeling, handling, and documentation.

+ Manage and report on study results by creating, cleaning, updating, and maintaining databases and comprehensive datasets for all assigned trials.

+ Prepare and maintain protocol-related documentation, including renewals, amendments, and modifications of protocol applications, and support the implementation of new studies.

+ Document and maintain all required records for study activities in accordance with local, state, and FDA Good Clinical Practice (GCP) requirements.

+ Monitor and document adverse events, ensuring timely reporting and appropriate follow-up in line with regulatory and protocol requirements.

+ Interpret and gather detailed medical histories from study participants and ensure that clinical information is accurately captured in study records.

+ Perform and record vital signs and cardiograms (ECGs) as required by study protocols, ensuring data quality and participant safety.

+ Support regulatory and Institutional Review Board (IRB) processes related to assigned trials, contributing to compliant study start-up and ongoing conduct.

+ Manage a workload of approximately 57 clinical trials at any given time and organize daily activities to see an expected 34 patients per day.

+ Collaborate with research leadership and clinical teams to identify process improvements that enhance study efficiency, data quality, and participant experience.

Essential Skills

+ Minimum of 2 years of experience as a Clinical Research Coordinator in a clinical trial setting.

+ Hands-on experience working on clinical trial phases I, II, and III, with understanding of protocol requirements across different phases.

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Experience with pre-screening patients and conducting subject recruitment for clinical studies.

+ Demonstrated experience handling and documenting adverse events in accordance with regulatory and protocol requirements.

+ Ability to interpret and gather comprehensive medical histories from study participants.

+ Proficiency in performing and documenting vital signs and cardiograms (ECGs) as part of clinical research assessments.

+ Working knowledge of oncology clinical research processes, including consenting, regulatory requirements, and IRB procedures.

+ Strong skills in data entry, data abstraction, and database management, with attention to accuracy and completeness.

+ Familiarity with FDA Good Clinical Practice (GCP) standards and local and state regulations related to clinical research.

+ Ability to manage multiple concurrent trials and organize workload to support 57 studies and 34 patient visits per day.

Additional

Skills & Qualifications

+ Phlebotomy skills and experience with sample processing are preferred.

+ Experience performing cardiograms (ECGs) in a clinical or research environment.

+ Oncology, urology, and ear, nose, and throat (ENT) clinical research experience is a major plus but not required.

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Experience with phase IV studies in addition to phases IIII is beneficial.

+ Knowledge of regulatory processes and IRB submissions related to oncology trials.

+ Strong…