Clinical Research Coordinator - Oncology (Full Time, Day Shift)
Company: Nicklaus Children's Hospital
Posted on: November 23, 2021
Description Job Summary
Coordinates clinical research studies on human subjects.
Responsible for subject recruitment, follow-up, data management,
detailed record keeping and regulatory compliance, report writing,
and correspondence with investigators, IRBs, and regulatory
authorities. Responsible for the new submission of protocols with
subsequent amendments. Some participation in protocol writing, and
initial and continuing education for Good Clinical Practice
Minimum Job Requirements
AA/medical/technical school or 3 year of research and/or healthcare
Qualifications Essential Duties and Responsibilities
Assists Management with Business Development efforts.
Attends and participates in investigator meetings, pre-study
visits, and initiation meetings or coordinator meetings as
Collects and maintains accurate patient data for submission to
Sponsor, maintaining proper patient records and coordinating the
collection and shipments of specimens as required by protocol.
Communicates study objectives and procedures to all relevant
hospital units involved with the study, including the establishment
of good rapport with the Principal Investigator and providing
him/her with the 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
Complies with the Health System's -Research Finance Compliance
policies and procedures.
Interacts with patients and families to recruit study subjects and
ensures compliance with the protocol.
Responsible for speedy and adequate patient enrollment as
determined by the -Research Management in -all assigned
Submits new protocols to WIRB and verifies proper documents were
received with the proper MCH format.
Submits amendments of protocols to IRB and verifies that the
required corrections were inserted following the established
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.
AA or medical/technical school preferred.
Experience in pediatric clinical research in a hospital setting
2 years in research experience preferred.
Bilingual in English/Spanish preferred.
Clinical research certification (such as CCRC, CCRP, CRA) and IATA
Excellent communication skills in working with both children and
Good organizational skills, detail-oriented, people-oriented,
self-confident, flexible and adaptable to change.
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.
Relevant hospital equipment for each clinical trial project.
Job : Research
Primary Location : Florida-Miami-Nicklaus Children's Hospital -
Main Hospital Campus
Department : RI - CHILDREN'S ONCOLOGY GROUP-2100-380660
Keywords: Nicklaus Children's Hospital, Miami , Clinical Research Coordinator - Oncology (Full Time, Day Shift), Healthcare , Hallandale, Florida
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