Clinical Research Coord II

2 months ago

Miami, Florida, United States Nicklaus Children's Health System Full time

Job Summary

Coordinates clinical research studies on human subjects. 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. Responsible for new research application (including study start-up processes and requirements) and submission of protocols with subsequent amendments. Participates in protocol writing as needed and maintains initial and continuing education for Good Clinical Practice compliance.

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.
  • Submits new protocols to Research Regulatory Affairs team (for IRB submission/approval) and verifies proper document were received with the proper format.
  • Submits amendments of protocols to Research Regulatory Affairs team and verifies the required corrections were inserted following the established procedures.
  • Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol.
  • Follows NCHS RI's Standard Operating Procedures, AAHRPP, HIPAA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.
  • Enters Research Patient information into CTMS within 72hours of enrollment, patient visit or patient-related event.
  • Provides new Protocols, Amendments and study status updates to necessary research staff for digitization/entry into CTMS.

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