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Nicklaus Children's Health System · 1 day ago

Clinical Research Coordinator

Fort Lauderdale, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

Nicklaus Children's Health System is seeking a Clinical Research Coordinator II to manage and conduct day-to-day activities of research studies. The role involves ensuring compliance with protocols and regulations, subject recruitment, data management, and communication with various stakeholders.

Health CareHospital

Hiring Manager

Laura Carrasquillo

Responsibilities

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

Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol

Follows NCRIs Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines

Enters required data into CTMS

Provides new Protocols, Amendments, and study status updates to necessary research staff for digitization/entry into CTMS

Works adjusted hours to accommodate subject visits

Keeps electronic patient files and required documents up-to-date within e-regulatory system

Qualification

Clinical research certificationExperience in pediatric clinical researchClinical trialsProtocolsBilingual in English/SpanishTime management skillsFlexibleSoftware applicationsHospital equipmentCommunication skillsOrganizational skillsDetail-orientedAdaptable

Required

Bachelor's degree and 2 years of research experience (OR) Associate's degree and 4 years of research experience

(OR) 5 years of research experience

Experience in pediatric clinical research in a hospital setting

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

Availability to work adjusted hours to accommodate subject visits