Clinical Research Coordinator II

Job Description

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.

Responsibilities

• 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
  
  

Qualifications

REQUIRED EDUCATION AND EXPERIENCE:

• 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
• LPN with current state licensure at the time of hire and four (4) years of related work experience; or a Master’s degree in a related field
  
  

Preferred Qualifications

• Knowledge of IRB submission process and requirements.
• Knowledge of good clinical practices as set forth by federal regulations.
  
  

About Us

Tulane University is an equal opportunity educator and employer committed to providing an education and employment environment free of unlawful discrimination, harassment, and retaliation. Legally protected demographic classifications (such as a person’s race, color, religion, age, sex, national origin, shared ancestry, disability, genetics, veteran status, or any other characteristic protected by federal, state, or local laws) are not relied upon as an eligibility, selection or participation criteria for Tulane’s employment or educational programs or activities.

Tulane University is responsible for providing reasonable accommodations to individuals with disabilities throughout the applicant screening process. If you need assistance in completing an application or during any phase of the interview process, please contact the Office of Human Resources by phone at 504-865-4748 or by email at hr@tulane.edu .