Clinical Research Coordinator II

The Clinical Research Coordinator II will coordinate and conduct the day-to-day operations of TRIAD ongoing studies in cardiovascular diseases. The Clinical Research Coordinator II is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for protocols, the Clinical Research Coordinator acts as a liaison between the patient, investigator, Institutional Review Board and sponsor. The Clinical Research Coordinator II screens, enrolls and follows study patients, ensuring protocol compliance, and effective monitoring of clinical trial subjects. The Clinical Research Coordinator II is also responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files.
• Proven ability to oversee day-to-day operations of clinical trials including their respective regulatory and administrative processes including informed consent, eligibility review, protocol implementation, IRB approval, DSMP, and event reporting Experience supervising and training research staff, including organizing, prioritizing, and scheduling work assignments in a medical setting. Willingness to travel to visit trial clinic sites Flexibility to work evenings and weekends, as needed, and to be available to respond promptly to all communications from study participants, trial clinical research coordinators, and clinic staff on for emergency situations or answer questions In-depth knowledge of federal regulations pertaining to Good Clinical Practice and conducting clinical trials set forth in the Code of Federal Regulations In-depth knowledge of IRB submission process and requirements as well as regulatory documentation Must be able to interact well with patients and the general public Excellent organization, analytical, interpersonal, and communication skills Ability to maintain confidentiality in all work performed Ability to perform, manage, and balance multiple projects and tasks simultaneously, work under time constraints, and meet deadlines Proficient in various software programs (including database management e.g. Access , presentation packages e.g. PowerPoint , spreadsheets e.g. Excel , and advanced word processing e.g. Word ). Ability to acquire and maintain all required CITI training certificates Ability to acquire and maintain credentialing at all required institutions, including Tulane Medical Center and all Federally-Qualified Health Centers included in the trial Skilled in coordinating and organizing meetings and/or special events and willingness to assume additional duties when necessary Highly organized and detail oriented in order to ensure all study procedures are completed as described in the study protocol, ensure participants are contacted at the correct date and time for the conduct of study assessments REQUIRED BACKGROUND CHECK, PHYSICAL, AND DRUG SCREENING FOR INCUMBENTS WHO HAVE CONTACT OR EXPOSURE TO ANIMALS OR ANIMAL TISSUES: Selected candidates must complete and pass a background check and an occupational health screening as a condition of employment. For identified jobs, a drug screening will also be required. The background investigation, required occupational health screening, and any required drug screening will be conducted after a conditional employment offer has been extended. Bachelor's Degree in public health or other science area or RN with current state licensure at the time of hire and one (1) year of related work experience OR LPN with current state licensure at the time of hire and four (4) years of related work experience; OR Master's Degree in a related field Knowledge of IRB submission process and requirements. Knowledge of good clinical practices as set forth by federal regulations.