Key Responsibilities and Required Skills for Urology Research Specialist

🎯 Role Definition

The Urology Research Specialist is a clinical and translational research professional responsible for managing and executing urology-focused research projects and clinical trials from start-up through close-out. This role bridges patient-facing activities (screening, consenting, enrollment, follow-up) with operational, regulatory, and data management tasks (EDC/REDCap, adverse event reporting, specimen tracking). The ideal candidate combines hands-on experience in urologic research or clinical trials with strong organizational skills, excellent communication, and a proactive approach to recruitment, quality assurance, and cross-functional collaboration.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator I or II
Laboratory Research Technician (molecular/biorepository)
Registered Nurse with research experience

Advancement To:

Senior Urology Research Specialist / Lead Clinical Research Coordinator
Clinical Trial Manager / Research Program Manager
Research Operations Manager or Project Manager
Clinical Research Scientist or Study Director

Lateral Moves:

Clinical Data Manager
Regulatory Affairs Specialist
Grants and Contracts Administrator

Core Responsibilities

Primary Functions

Manage day-to-day operations of urology clinical trials and investigator-initiated studies, including screening, enrollment, informed consent, scheduling, and longitudinal follow-up to ensure protocol adherence and high retention rates.
Serve as the primary point of contact for study participants, providing clear explanation of study procedures, risks/benefits, and maintaining compassionate, HIPAA-compliant communication throughout the study lifecycle.
Coordinate regulatory start-up activities for new urology studies: prepare IRB submissions and amendments, compile regulatory binders, ensure timely renewals, and maintain complete documentation for audits and inspections.
Execute informed consent discussions and documentations according to IRB-approved procedures and ICH-GCP requirements; evaluate participant capacity and escalate complex consent cases to the Principal Investigator.
Collect, process, label, track, and ship biological specimens (blood, urine, tissue biopsies) in compliance with biospecimen SOPs, cold-chain requirements, and biorepository standards; coordinate with pathology and central labs.
Maintain and update study-specific electronic databases and EDC systems (REDCap, Medidata Rave, Oracle Clinical) with accurate, source-verified data and timely query resolution to support data integrity.
Conduct chart review and source documentation abstraction from Electronic Health Records (Epic, Cerner) and enter accurate clinical outcome, medication, and procedure data for case report forms (CRFs).
Monitor and report adverse events and serious adverse events (AEs/SAEs) per protocol, sponsor, IRB and FDA timelines; prepare safety reports and follow-up documentation.
Coordinate study visits, procedures, and imaging appointments (CT, MRI, cystoscopy) with clinical teams and imaging centers; ensure protocol-mandated imaging protocols and timelines are followed.
Train, supervise and mentor junior research staff, study coordinators, and student assistants; develop and maintain study-specific SOPs, checklists, and training materials.
Collaborate with investigators to develop and refine study protocols, consent forms, case report forms, recruitment materials, and standard operating procedures for urology studies.
Support grant proposals, protocol budgets, and financial tracking: prepare study budgets, perform billing compliance checks, and reconcile study-related expenses with clinical research finance teams.
Coordinate and support sponsor monitoring visits and audits by preparing regulatory binders, source documents, and study logs; implement CAPA items and follow-up corrective actions.
Manage participant recruitment strategies targeted to urology populations, including clinic prescreening, outreach to referring physicians, community engagement, and development of recruitment materials.
Perform specimen accessioning and maintain biospecimen inventory in sample tracking systems and biobank databases; ensure accurate labeling, storage conditions, and chain-of-custody documentation.
Conduct quality control and quality assurance activities including source-to-CRF verification, query generation and resolution, and proactive data cleaning in collaboration with data managers and statisticians.
Support translational research activities by coordinating tissue processing with pathology, arranging courier services for frozen specimens, and liaising with core labs for molecular assays.
Draft and contribute to scientific abstracts, posters, manuscripts, and regulatory reports; work closely with investigators and biostatisticians to prepare analyses and publications.
Implement and maintain HIPAA-compliant participant registries and longitudinal databases for urologic patient cohorts, ensuring data linkage, de-identification, and secure storage.
Manage study supplies and investigational product accountability including ordering, storage, reconciliation, dispensing logs and temperature monitoring for drugs and biologics used in urology trials.
Act as a liaison between principal investigators, clinical teams, sponsors, CROs, IRB, and institutional offices to facilitate study operations and resolve operational bottlenecks.
Coordinate multidisciplinary tumor board research activities and pathway enrollment for urologic oncology studies, ensuring timely data capture of clinical decision-making and outcomes.
Participate in protocol feasibility assessments and site selection activities; provide input on expected recruitment rates, resource requirements, and clinic workflow integration.
Support data transfer agreements, material transfer agreements (MTAs) and other regulatory documents to enable multi-site collaborations and specimen sharing.
Drive continuous process improvements by analyzing recruitment metrics, visit adherence, and data query trends to propose and implement workflow efficiencies that increase study performance.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis.
Contribute to the organization's data strategy and roadmap.
Collaborate with business units to translate data needs into engineering requirements.
Participate in sprint planning and agile ceremonies within the data engineering team.

Required Skills & Competencies

Hard Skills (Technical)

Clinical research coordination and trial management (site operations, enrollment, visit scheduling).
Regulatory knowledge: IRB submissions, ICH-GCP, FDA reporting requirements, human subjects protections.
Electronic Data Capture (EDC) systems: REDCap, Medidata Rave, Oracle Clinical, or similar.
Electronic Health Record systems: Epic, Cerner, or equivalent chart review proficiency.
Biospecimen handling and biobanking: specimen processing, cold chain logistics, MTA coordination.
Adverse event reporting and safety surveillance processes (AE/SAE documentation).
Proficient with study documentation and regulatory binder maintenance.
Basic statistical understanding and experience working with biostatisticians; familiarity with SAS, R, or SPSS is a plus.
Data quality assurance: source verification, query management, and data cleaning techniques.
Clinical procedure coordination knowledge (imaging protocols, urologic procedures scheduling).
Project management tools and methods (MS Project, JIRA, Asana) and experience coordinating cross-functional teams.
Clinical trial budgeting and billing compliance basics.
Phlebotomy and basic clinical/lab technique experience (preferred in many postings).
Microsoft Office Suite (Excel pivot tables, Word, PowerPoint) and experience preparing reports and presentations.
Experience with regulatory submissions and study start-up activities (feasibility, contracts, budgets).

Soft Skills

Excellent written and verbal communication tailored to patients, clinicians, sponsors, and regulatory bodies.
Strong organizational skills with the ability to manage multiple concurrent studies and competing priorities.
High attention to detail, reliability, and commitment to data accuracy and participant safety.
Problem-solving mindset with ability to escalate appropriately and implement corrective actions.
Empathy and professional bedside manner when interacting with research participants and families.
Collaboration and team orientation across clinical, laboratory, and administrative stakeholders.
Adaptability in fast-paced research environments and willingness to learn new protocols and technologies.
Time management and prioritization in a deadline-driven environment.
Ethical decision-making and commitment to research integrity and compliance.
Presentation skills for internal meetings, investigator conferences, and scientific dissemination.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Biological Sciences, Nursing, Public Health, Health Sciences, or related field; or equivalent clinical research experience.

Preferred Education:

Master's degree (MPH, MS) or RN; or advanced degree (MS/PhD) in a relevant scientific discipline for translational research roles.

Relevant Fields of Study:

Biology, Biomedical Sciences, Nursing
Public Health, Clinical Research, Health Services Research
Molecular Biology, Pathology, Biostatistics

Experience Requirements

Typical Experience Range:

2–5 years of clinical research experience, preferably with at least 1–2 years focused on urology or oncology trials.

Preferred:

3–7 years of progressive experience coordinating complex clinical trials (Phase I–III), translational studies, or leading a research program in urology.
Demonstrated track record with IRB submissions, EDC systems (REDCap), specimen management, and successful participant recruitment in urologic populations.