Clinical Research Coordinator - Urology (31159)

Role Qualifications

• Knowledge of and experience with relevant federal and state regulatory guidelines.
• Experience with conducting clinical trials.
• Urology based clinical experience preferred.
• Experience with evaluating and implementing study protocols and budgets.
• Certification via ACRP or the equivalent preferred.
• Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
• Effective time management and the ability to prioritize work.
• Excellent communication skills and the ability to interact with all levels of management, staff, and physicians.

Essential Job Responsibilities

• Work to build the research department in scope, size, reputation, and professionalism.
• Absorb and assist with recruitment of studies, budget evaluation and negotiation, protocol evaluation, communication with study sponsors.
• Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
• Obtain and maintain consent of patients with the highest ethical standards.
• Work with other research department staff in a leadership role including management, training, delegation of responsibilities, hiring, etc.
• Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc.
• Communicate with and support patients and their families as necessary.
• Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records.
• Must have or gain knowledge of relevant software/programs.
• Have a basic and working knowledge of trial design, statistical methods, etc.
• Triage, record, and report adverse events.
• Record and report any protocol deviations.
• Work closely with IRB and study sponsors, PIs and Sub-Is.
• Attend necessary meetings and calls.
• Create and maintain department SOPs, NDAs, CVs, certifications, etc.
• Evaluate, purchase, maintain necessary equipment.
• Maintain HIPAA compliant communication and confidentiality, at all times.
• Maintain study budgets and monitor invoicing, billing, and payments.
• Participate in site visits, SIVs, monitoring, etc.
• Complete necessary study close-out steps and documentation.
• Absorb and assist with other duties assigned.

Performance Requirements

• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
• Understanding of medical terminology.

Reporting To This Position

No direct reports at this time, can change as department grows.

Physical Demands And Work Environment

• Primarily office setting.
• Noise level in the work environment is usually moderate.
• Clean, well-lighted office environment.