Clinical Research Coordinator II (32752)

POSITION SUMMARY:

Experienced Clinical Research Coordinator that supporting a growing research department. Will have the opportunity to help develop a premier research facility. Will be provided with the necessary support, budget, staff, etc. This position works closely with PI and Sub-Is on various studies. Will be working in highly motivated large private practice urology group.

JOB RELATIONSHIPS:

• Reports to the Clinical Research Director, Vice President of Research, Market President, and the physicians at the local Market Clinic
• Collaborates with experienced patient navigators, IT, and data management.

ROLE QUALIFICATIONS: (experience, education, and skills)

• Able to handle a high volume of coordinating work, including managing multiple studies at a time of varying indications.
• Acts as an experienced resource for Clinical Research Coordinators I and Research Assistants during new hire training, newly initiated trials, and trial transitions.
• Demonstrate the ability to successfully oversee complex trials.
• Demonstrate 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 yrs 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 RESPONSIBLITIES:

• 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 in 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.