Description

Summary

The primary responsibility of the Senior Clinical Research Coordinator is to coordinate and oversee a clinical trial, including the day-to-day operations, training and supervising research staff, recruiting patients, communicating with study clinic staff, and monitoring patient safety. The Senior Clinical Research Coordinator 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 the protocol, the Senior Clinical Research Coordinator acts as a liaison between the patient, staff, investigator, collaborators, Institutional Review Board and sponsor. The Senior Clinical Research Coordinator performs and supervises patient recruitment, enrollment, and follow-up, data collection, entry, and quality control activities, ensuring protocol compliance and close patient monitoring, and works independently in designing, coordinating, and implementing all assigned research projects. The Senior Clinical Research Coordinator is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files. The Senior Clinical Research Coordinator trains other staff in conducting, and may also perform as needed, simple procedures (vital signs, etc.) as called for by the study protocol(s).The Senior Clinical Research Coordinator serves as a key management and administrative role for the research project by supervising Clinical Research staff to ensure compliance with protocol, federal, and institutional requirements, and by frequently travelling to clinics to conduct trainings and site visits.

Required Knowledge, Skills, and Abilities

• 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.

Required Education and/or Experience

• Bachelor's Degree
OR

• RN with current state licensure at the time of hire and five (5) years of related work experience

OR

• Master's Degree in a related field and two (2) years of related work experience

Preferred Qualifications

• Certification as a Certified Clinical Research Coordinator (CCRC through the Association of Clinical Research Professionals or ACRP) OR Certified Clinical Research Professional (CCRP through the Society of Clinical Research Associates or SoCRA) is strongly desired.
• Supervisory experience is strongly desired