Clinical Research Coordinator (Full Time, Day Shift)
Company: Nicklaus Children's Hospital
Location: Key Biscayne
Posted on: April 10, 2021
Clinical Research Coordinator (Full Time, Day
Shift)-19491DescriptionJob SummaryCoordinates 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 compliance.Minimum Job
- AA/medical/technical school or 3 year of research and/or
healthcare experience requiredQualificationsEssential Duties and
- 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
- Complies with the Health System'sResearch 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 theResearch Management inall assigned studies.
- 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, HIPPA
and FDA guidelines for clinical research, and keeps updated in
those procedures and/or guidelines.Knowledge/Skills/Abilities
- 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 certification preferred.
- Excellent communication skills in working with both children
- 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 experienceincluding word processing,
scheduling and contact database, email, web browsing, hospital
records, other database software, and office equipment.
- Relevant hospital equipment for each clinical trial
Location:Florida-Miami-Nicklaus Children's Hospital - Main Hospital
CampusDepartment:RI - CLINICAL TRIAL OPERATIONS-2100-380863Job
Keywords: Nicklaus Children's Hospital, Key Biscayne , Clinical Research Coordinator (Full Time, Day Shift), Healthcare , Key Biscayne, Florida
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