Lead Clinical Research Coordinator (Full Time, Days)

Miami Children’s Hospital; Miami (FL); On-site; USD 85,000 - 105,000; Full time

Job summary

Nicklaus Children's Hospital in Miami is seeking a Lead Clinical Research Coordinator (Full Time, Days) to oversee multiple clinical studies within the Clinical Trials Office. You will coordinate study activities, ensure protocol compliance, and manage patient enrollment and data handling.

Under direction of a Research Clinical Trial Operations leader, you will provide guidance to coordinators, maintain CTMS data within 72 hours of events, and communicate with investigators, IRBs, sponsors, and

Qualifications

• Bachelor's degree or higher with 5+ years of clinical research experience.
• Certification in SOCRA or ACRP required within 16 months of start date.

Responsibilities

• Coordinate and oversee multiple clinical studies within the Clinical Trials Office.
• Recruit, screen, consent, and enroll study participants.
• Manage data collection, entry, and reporting; ensure regulatory compliance.
• Maintain accurate records and prepare reports for sponsors and IRBs.
• Provide guidance and mentorship to junior staff.
• Communicate with investigators, sponsors, and regulatory authorities.
• Ensure timely CTMS entries and enrollment updates.
• Attend meetings and discuss portfolio status.

Skills

Subject recruitment and enrollment

Data management and reporting

Regulatory compliance

Mentorship and coaching

Interdisciplinary communication

Clinical trial coordination

Education

Bachelor's Degree or higher (Scientific/Healthcare)

SOCRA/ACRP clinical research certification (CCRC/CCRP/CRA) within 16 months

Tools

CTMS

Job description

Job Description - Lead Clinical Research Coordinator (Full Time, Days) (301975)

Job Description

Lead Clinical Research Coordinator (Full Time, Days) - 301975

Description

Job Summary

Under direction of a Research Clinical Trial Operations leader, the Lead Clinical Research Coordinator CTO will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies within the Clinical Trials Office, requiring advanced-level knowledge and skills, involving human subjects that are being conducted within the Nicklaus Children's Research Institute. Ensures processes are in place and roles are defined in order for studies to be conducted smoothly and compliantly, avoiding delays or errors with patient registration/enrollment and/or documentation and in accordance with protocol requirements. 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. Provides guidance, training, and mentorship to Clinical Research Coordinators, Research Assistants and/or other support personnel.

Job Specific Duties

• 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 in 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.

Qualifications

• Bachelor's Degree Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience. (Required)
• Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 16 months in position

Knowledge, Skills, and Abilities

• Bachelor's degree in Nursing (BSN) and/or current RN licensure strongly preferred.
• Ability to train, guide, and mentor peers.
• 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.
• Experience working on clinical trials, interventional studies all phases.
• 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.
• 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 time management and interpersonal skills.