Description

Job Summary

Under direction of the Senior Manager of Clinical Trial Operations, the Clinical Research Coordinator (CRC) manages and conducts the day-to-day activities of a research study. In general, the CRC ensures the study maintains in accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a CRC may include subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, collection and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities.

Job Specific Duties

• Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
  
• Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol.
  
• Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance.
  
• Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives.
  
• Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff. 
  
• Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol. 
  
• Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies. 
  
• Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. 
  
• Follows NCRI’s Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines. 
  
• Enters required data into CTMS. 
  
• Provides new Protocols, Amendments, and study status updates to necessary research staff for digitization/entry into CTMS. 
  
• Keeps electronic patient files and required documents up-to-date within e-regulatory system. 

Qualifications

Minimum Job Requirements

• Bachelor's degree and previous research experience (OR) Associate's degree and 2 years of research experience (OR) 3 years of research experience (OR) 5 years of healthcare experience

Knowledge, Skills, and Abilities

• Experience in pediatric clinical research in a hospital setting highly preferred.
  
• Experience with relevant hospital equipment for each clinical trial project.
  
• Bilingual in English/Spanish preferred.
  
• Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred.
  
• Excellent communication skills in working with both children and adults.
  
• Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change.
  
• Excellent time management skills.
  
• Knowledge of protocols and its process.
  
• Experience with software applications including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.
  
• Availability to work adjusted hours to accommodate subject visits.

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