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.
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REQUIRED EDUCATION AND 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
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
Knowledge of good clinical research practice is required
In-depth knowledge of IRB submission process and requirements
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
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
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
Knowledge of good clinical research practice is required
In-depth knowledge of IRB submission process and requirements
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
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