Clinical Research Coordinator II (31515)

Clinical Research Coordinator II FSLA Status: Exempt Position Summary Experienced Research Coordinator that builds and leads a newly growing research department, creating a premier research facility with support, budget, staff, and more. Works closely with PI and Sub-Is on various studies within a 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 Handle high volume of coordinating work, managing multiple studies and varying indications. Act as experienced resource for Clinical Research Coordinators I and Research Assistants during new hire training, newly initiated trials, and trial transitions. Successfully oversee complex trials. Understand and navigate Urology Austin and stakeholders to ensure continuity of patient care. Have knowledge of and experience with relevant federal and state regulatory guidelines. Have > 2 years previous experience conducting clinical trials. Urology-based clinical experience preferred; willingness to perform urology required procedures to conduct research. Experience evaluating and implementing study protocols. Certification via ACRP or equivalent preferred. Proficiency in Microsoft Office, EMR and Practice Management systems. Effective time management and ability to prioritize work. Excellent communication skills and ability to interact with all levels of management, staff, and physicians. Essential Job Responsibilities Lead recruitment of studies, protocol conduction, and communication with study sponsors. Maintain certifications and continually update knowledge of FDA, GCP, ICH, and regulations. Obtain and maintain consent of patients with highest ethical standards. Work directly with patients to conduct all study visits (screen, consent, medical history, procedures including EKG, blood draw, vitals). Communicate with and support patients end to end during trial participation, including families as necessary. Use EMR and data management systems to complete all data and source requirements for visits. Gain knowledge of relevant software/programs, including CTMS. Basic working knowledge of trial design and statistical methods. Triage, record, and report adverse events and protocol deviations. Work closely with IRB, study sponsors, PIs, and Sub-Is; attend necessary meetings and calls. Collaborate with Regional Manager and Research Director to oversee daily operations and implementation of policies and procedures. 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 Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices. Understanding of medical terminology. Skills Ability to use multi‑line phone systems and basic computer systems. Interpersonal and communication with internal staff and external customers. Skill in reading medical chart terminology. Time management. Phlebotomy. Effective communication with patients, staff, and external contacts via phone, in person, and email. Elicit appropriate information for patients and clinic staff. Ability to read and understand information and ideas presented in writing. Apply general rules to specific problems to produce answers that make sense – deductive reasoning. Physical Demands And Work Environment The physical demands and work environment characteristics described here represent those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Physical demands: Sitting approximately 90% of the day; walking or standing for the remainder. May require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds. Work environment: Primarily office setting; noise level typically moderate. Clean, well‑lighted office environment. #J-18808-Ljbffr GI Alliance