Clinical Research Coordinator (31205)

POSITION SUMMARY

Educates and supports Clinical Research Coordinators I and Research Assistants during new hire training, newly initiated trials, and trial transitions.

ROLE QUALIFICATIONS

• Able to handle a high volume of coordinating work, including managing multiple studies at a time of varying indications.
• Demonstrates the ability to successfully oversee complex trials.
• Demonstrates the ability to understand and navigate Urology Austin and the various roles of stakeholders to ensure continuity of patient care.
• Must have knowledge of and experience with relevant federal and state regulatory guidelines.
• Must have > 2 years previous experience conducting clinical trials.
• Urology based clinical experience preferred.
• Willingness to perform urology required procedures to conduct urology research.
• Experience with evaluating and implementing study protocols.
• 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

• Leads the recruitment of studies, protocol conduction, and 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 directly with patients to conduct all study visits.
• Ex: screen, consent, take medical history, complete necessary procedures including EKG, blood draw, vitals, etc.
• Communicate with and support patients end to end during trial participation and their families as necessary.
• Work with the EMR and data management systems to complete all data and source requirements for visits.
• Must have or gain knowledge of relevant software/programs, including the CTMS.
• 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.
• Directly work with the Regional Manager and Research Director to assist overseeing all daily operations and implementation of policies and procedures in the department.
• Maintain HIPAA compliant communication and confidentiality, at all times.
• Participate in site visits, SIVs, monitoring, etc.
• Complete necessary study close-out steps and documentation.
• Conduct blood draws and laboratory procedures as required per study.
• Manage IP accountability and perform drug dosing and instillations per study requirements.
• Assist with other duties assigned.

Performance Requirements

• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices.
• Understanding of medical terminology.
• Ability to use multi-line phone systems and basic computer systems.
• Interpersonal and communication both with internal staff and external customers.
• Ability to read and understand information and ideas presented in writing.
• Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.