Key Responsibilities and Required Skills for Urology Research Coordinator

🎯 Role Definition

The Urology Research Coordinator is responsible for managing and operationalizing clinical research projects within urology — including investigator-initiated studies, industry-sponsored trials, and observational registries. The coordinator ensures protocol adherence, patient safety, regulatory compliance (IRB, FDA, HIPAA), and high quality data capture using EDC systems. This role interfaces with patients, surgeons, study sponsors, regulatory bodies and multidisciplinary clinical teams to drive enrollment, follow-up, and deliverables while maintaining Good Clinical Practice (GCP) standards.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Assistant or Clinical Trial Assistant with experience in outpatient or surgical settings
Registered Nurse (RN) transitioning into research coordination
Medical or health sciences graduate with internship/assistant experience in clinical studies

Advancement To:

Senior Research Coordinator / Lead Clinical Research Coordinator
Clinical Research Manager or Research Program Manager
Clinical Operations Specialist for urology or surgical trials

Lateral Moves:

Regulatory Affairs Associate (clinical trial submissions and compliance)
Clinical Data Manager or Clinical Research Quality Specialist

Core Responsibilities

Primary Functions

Coordinate all aspects of urology clinical trials from start-up through closeout, including protocol implementation, site initiation, monitoring visits, and study closeout activities to ensure on-time delivery and high-quality results.
Screen, identify and recruit eligible study participants from clinic schedules, inpatient services, and referral networks, using pre-defined inclusion/exclusion criteria while maintaining an ethical and patient-centered approach.
Conduct informed consent discussions in accordance with IRB-approved forms and institutional policies, documenting consent and ensuring volunteers understand the study, procedures, risks, and alternatives.
Schedule and manage participant visits, procedures, and follow-up assessments (pre-op, peri-op, and post-op as applicable), coordinating with surgical teams, imaging, pathology, and ancillary services to minimize no-shows and protocol deviations.
Collect, process, label, and ship biological specimens (blood, urine, tissue) per protocol, SOPs and biospecimen handling guidelines; maintain chain-of-custody and temperature logs where required.
Perform and document source data collection and complete timely, accurate entry into electronic data capture (EDC) systems (e.g., REDCap, Medidata Rave, Oracle Clinical) and resolve queries in partnership with clinical data management.
Monitor participant safety by assessing adverse events (AEs) and serious adverse events (SAEs), performing timely reporting to sponsor and IRB, and documenting safety follow-up measures according to regulatory requirements.
Maintain regulatory files, including IRB submissions and approvals, protocol amendments, informed consent forms, delegation logs, CVs, and training records, ensuring audit readiness at all times.
Manage site budgets, track study-related expenses, coordinate invoicing and payment reconciliation with finance or study sponsors, and document resource utilization for each protocol.
Liaise with industry sponsors, CRO monitors, and clinical trial monitors to support monitoring visits, respond to monitoring reports, and implement corrective action plans to address findings.
Train and supervise clinic staff, research assistants, and students in study procedures, consenting processes, and documentation standards to ensure consistent protocol adherence across the team.
Implement quality control checks for data accuracy and completeness; perform source document verification and prepare documentation for internal and external audits and inspections.
Coordinate imaging, laboratory, and pathology requisitions and ensure collection timing aligns with protocol-specified windows and processing requirements.
Facilitate multidisciplinary study meetings, investigator teleconferences, and steering committee calls; prepare meeting materials, status reports, and milestone updates for investigators and sponsors.
Develop and maintain SOPs and study-specific process documents to streamline workflows, reduce variability and support continuous improvement initiatives within the research program.
Assist with protocol development and grant applications by contributing site feasibility assessments, recruitment strategies, and operational input to improve study design and feasibility.
Track enrollment metrics, retention rates, screen failures and other KPIs; prepare recruitment forecasts and implement targeted outreach or retention plans to meet enrollment goals.
Ensure HIPAA-compliant handling of protected health information (PHI), applying appropriate access controls, de-identification methods and secure storage procedures for research data.
Coordinate and support investigator-initiated projects, registries, and quality improvement (QI) efforts in urology, providing operational oversight and helping translate QI findings into practice.
Maintain and update study-specific training logs, certification records (e.g., GCP), and site delegation logs to demonstrate staff qualification and role assignments for regulatory review.
Evaluate and troubleshoot protocol deviations and non-compliance events, implement corrective and preventative actions (CAPAs), and track outcomes to reduce recurrence and risk.
Facilitate subject reimbursement, travel arrangements, and compensation in alignment with institutional policies and sponsor guidelines to support retention and equitable participation.
Participate in patient-facing education and outreach activities (in clinic, community events, or digital communications) to increase awareness of research opportunities and foster trust with potential participants.

Secondary Functions

Support investigator-led data analyses by curating datasets, assisting with statistical code hand-offs, and verifying data integrity prior to analysis or manuscript submission.
Maintain study-specific recruitment and outreach materials, ensuring IRB approval for advertising and community engagement content.
Assist in preparing abstracts, posters, and manuscript drafts by compiling methods, participant flow, and operational details that accurately reflect study conduct.
Participate in institutional research committees, safety review boards, and protocol feasibility assessments to advise on operational implications and resource needs.
Contribute to process-improvement projects aimed at reducing screening-to-randomization times, improving retention, and optimizing clinic-research workflows.
Manage and archive closed study files according to retention policies; coordinate disposition of investigational products and study materials at study end.

Required Skills & Competencies

Hard Skills (Technical)

Clinical trial coordination and study management in urology or surgical specialties.
In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and IRB submission processes.
Proficient use of electronic data capture (EDC) systems such as REDCap, Medidata Rave, or Oracle Clinical.
Adverse event and SAE reporting, safety monitoring, and regulatory compliance documentation.
Experience with informed consent processes and clinical ethics considerations.
Protocol development support, amendments implementation, and source document verification.
Specimen handling, processing, labeling, and shipping (biospecimen management).
Familiarity with HIPAA, 21 CFR Part 11, and clinical trial financial tracking.
Use of electronic health records (EHR) for screening and source documentation (e.g., Epic, Cerner).
Basic statistical literacy and experience preparing datasets or working with biostatisticians.
Budget management, invoicing, and sponsor billing reconciliation.
Proficiency with Microsoft Office suite (Excel for tracking, Word for SOPs) and project management tools.

Soft Skills

Strong verbal and written communication skills for patient interactions, sponsor coordination, and documentation.
Excellent organizational skills with high attention to detail and ability to prioritize competing timelines.
Patient-focused empathy and cultural sensitivity to recruit and retain diverse participant populations.
Problem-solving mindset and ability to troubleshoot operational barriers in fast-paced clinical settings.
Team collaboration across clinical, administrative, and scientific stakeholders.
Time management and ability to independently drive tasks from initiation to completion.
Adaptability to changing protocol requirements and evolving regulatory environments.
Critical thinking for evaluating protocol feasibility and suggesting practical workflow improvements.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Nursing, Biology, Public Health, Health Sciences, or related field.

Preferred Education:

Master’s degree in Public Health, Clinical Research, Nursing, or related discipline; RN or NP preferred for some institutions.

Relevant Fields of Study:

Nursing (BSN)
Biology / Biomedical Sciences
Public Health / Clinical Research

Experience Requirements

Typical Experience Range:

2–5 years of clinical research experience, with at least 1–2 years in urology, surgical trials, or related outpatient surgical specialties.

Preferred:

3+ years coordinating clinical trials in urology, urologic oncology, or genitourinary surgery; prior experience with industry-sponsored studies and investigator-initiated trials. Certification such as Certified Clinical Research Coordinator (CCRC) / SOCRA / ACRP preferred; prior RN license advantageous.