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Nicklaus Children's Health System · 1 day ago

Lead Clinical Research Coordinator - Onsite

Miami, FL

Full-time

Onsite

Senior Level

5+ years exp

Nicklaus Children's Health System is dedicated to advancing pediatric healthcare, and they are seeking a Lead Clinical Research Coordinator to manage multiple clinical studies. This role involves overseeing study conduct, ensuring compliance with protocols, and mentoring other research staff.

Health CareHospital

Responsibilities

Serves as a subject-matter expert and resource for the research team on the compliant conduct of assigned studies

Facilitates communication between investigators and Clinical Research Coordinators on subject-matter or technical matters

Oversees study conduct including all support data collection for study start-up activities

Oversees collection, maintenance, and reporting of accurate patient data for submissions to sponsors, maintaining patient records, and coordinating the collection and shipments of specimens as required by protocol

Reviews and confirms subject study eligibility with PI/Sub-I of assigned studies

Oversees study registration, patient screening/enrollment, and overall study requirements

Registers and enrolls research participants

Aggregates, tracks, trends, and reports research study and patient screening/enrollment data as required

Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol

Complies with the Research Finance Compliance policies and procedures including time and effort reporting for grants

Submits protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notifies CTMS support staff for protocol digitization

Enters Research Patient information into CTMS within 72 hours of enrollment, patient visit, or patient-related event

Pre-screens potential research participants and enters information into CTMS within real time (if possible) or within 24 hours

Compiles accurate CTMS metrics data for updating SAC CTO slides and runs weekly enrollment reports for management review

Updates study statuses in CTMS and ensures study enrollment changes are communicated to Research Regulatory Affairs team and CTO Management

Attends meetings with Research management, research team, and/or PI/Sub-Is and is prepared to discuss research portfolio and/or patient status

Qualification

Clinical research certificationAdvanced knowledge of protocolsResearch experienceData managementBilingual in English/SpanishCommunication skillsSoftware applications experienceTrainRespond calmlyOrganize workloadMentorInterpersonal skillsTime management skillsMaintain confidentialityWork in a teamMeticulous attention to detail

Required

Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience

Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 1 year in position

Knowledge of rules and regulations governing the designated research

Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems

Excellent communication skills in working with both children and adults

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

Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation)

Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital

Ability to train, guide, and mentor peers

Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail

Ability to respond calmly under stressful conditions

Ability to maintain confidentiality of sensitive information

Ability to effectively work in a team

Excellent interpersonal skills

Excellent time management skills