Job Description

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/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.

 

Job :

Research

Primary Location :

Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus

Department :

RI - ADMINISTRATION-2100-380950

Job Status

:Full Time

Job Tags

Full time, Flexible hours, Day shift,

Similar Jobs