Description
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.
Qualifications
Minimum Job Requirements
- AA or medical/technical school and 3 years research or clinical experience (OR) 5 years of clinical or research experience (OR) Bachelor's Degree (Required)
Knowledge, Skills, and Abilities
- Experience in pediatric clinical research in a hospital setting preferred.
- Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred.
- 3 years of research experience preferred.
- Bilingual in English/Spanish preferred.
- Excellent communication skills in working with both children and adults.
- Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change.
- 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.
- Experience with relevant hospital equipment for each clinical trial project.
Job : Research
Primary Location : Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus
Department : RI - ADMINISTRATION-50
Job Status
:Full Time
