Clinical Research Coordinator

2 weeks ago

Doral, Florida, United States Miami Children's 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.
Minimum Job Requirements

  • AA/medical/technical school or 2 years of research and/or healthcare experience required
Knowledge, Skills, and Abilities

  • AA or medical/technical school preferred.
  • Experience in pediatric clinical research in a hospital setting preferred.
  • 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.
  • 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.
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