Description

Job Summary

Under direction of a Research Clinical Trial Operations leader, the Lead Clinical Research Coordinator will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies within the Clinical Trials Office, requiring advanced-level knowledge and skills, involving human subjects that are being conducted within the Nicklaus Children's Research Institute. Ensures processes are in place and roles are defined in order for studies to be conducted smoothly and compliantly, avoiding delays or errors with patient registration/enrollment and/or documentation and in accordance with protocol requirements. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Provides guidance, training, and mentorship to Clinical Research Coordinators, Research Assistants and/or other support personnel.

Job Specific Duties

• Serves as a subject-matter expert and resource for the research team on the compliant conduct of assigned studies. 
  
• Facilitates communication between investigators and Clinical Research Coordinators on subject-matter or technical matters. 
  
• Oversees study conduct including all support data collection for study start-up activities.
  
• Oversees collection, maintenance, and reporting of accurate patient data for submissions to sponsors, maintaining patient records, and coordinating the collection and shipments of specimens as required by protocol.
  
• Reviews and confirms subject study eligibility with PI/Sub-I of assigned studies.
  
• Oversees study registration, patient screening/enrollment, and overall study requirements. 
  
• Registers and enrolls research participants. 
  
• Aggregates, tracks, trends, and reports research study and patient screening/enrollment data as required. 
  
• Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol.
  
• Complies with the Research Finance Compliance policies and procedures including time and effort reporting for grants.
  
• Submits protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notifies CTMS support staff for protocol digitization.
  
• Enters Research Patient information into CTMS within 72 hours of enrollment, patient visit, or patient-related event. 
  
• Pre-screens potential research participants and enters information into CTMS within real time (if possible) or within 24 hours. 
  
• Compiles accurate CTMS metrics data for updating SAC CTO slides and runs weekly enrollment reports for management review. 
  
• Updates study statuses in CTMS and ensures study enrollment changes are communicated to Research Regulatory Affairs team and CTO Management.
  
• Attends meetings with Research management, research team, and/or PI/Sub-Is and is prepared to discuss research portfolio and/or patient status. 

Qualifications

Minimum Job Requirements

• Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience
• Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 1 year in position
  

Knowledge, Skills, and Abilities

• Knowledge of rules and regulations governing the designated research.
  
• Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems.
  
• Bilingual in English/Spanish.
  
• Excellent communication skills in working with both children and adults.
  
• Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.
  
• Experience with relevant hospital equipment for each clinical trial project.
  
• Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
  
• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.
  
• Ability to train, guide, and mentor peers.
  
• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.
  
• Ability to respond calmly under stressful conditions.
  
• Ability to maintain confidentiality of sensitive information.
  
• Ability to effectively work in a team.
  
• Excellent interpersonal skills.
  
• Excellent time management skills.

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