Sr Clinical Research Coordinator (Full Time, Days)

Nicklaus Children's Health System; Miami (FL); On-site; USD 85,000 - 115,000; Full time

Job summary

Nicklaus Children's Health System is seeking a Senior Clinical Research Coordinator to manage day-to-day activities of complex pediatric trials under the Senior Manager of Clinical Trial Operations. The role ensures adherence to the protocol, GCP, IRB requirements, and sponsor expectations while coordinating data entry, regulatory documents, and site operations.

Responsibilities include subject recruitment, enrollment, follow-up, data management, and collaboration with investigators, sponsors,

Qualifications

• Bachelor's degree with 3.5+ years in research or 7+ years overall experience.
• CCR/CCRP/CRA certification beneficial.
• Bilingual in English/Spanish advantageous.
• Experience in pediatric hospital clinical research preferred.

Responsibilities

• Assists management with business development efforts.
• Attends investigator meetings, pre-study visits, initiation meetings or coordinator meetings as appropriate.
• Collects and maintains accurate patient data for submission to Sponsor; coordinates collection and shipments of specimens as required by protocol.
• Communicates study objectives to hospital units and builds rapport with the Principal Investigator and Sponsor.
• Schedules and facilitates study monitor visits and communication between Principal Investigator and Sponsor.
• Maintains Research Finance Compliance documentation and reports to research finance staff.
• Interacts with patients and families to recruit subjects and ensure protocol compliance.
• Oversees patient enrollment and ensures timely enrollment across studies.
• Utilizes Good Clinical Practices; follows NCRI, AAHRPP, HIPAA, and FDA guidelines.
• Enters required data into CTMS and provides status updates to staff.
• Trains junior staff and maintains up-to-date electronic patient files in e-regulatory systems.
• Works adjusted hours to accommodate subject visits.
• Collaborates with investigators to recruit patients for available trials.

Skills

Pediatric clinical research

Bilingual English/Spanish

GCP/IRB knowledge

Certification: CCRC/CCRP/CRA

Excellent communication

Education

Bachelor's degree + 3.5+ years research

Associate's degree + 6+ years research

7+ years research experience

Tools

CTMS

eRegulatory systems

Hospital records/software

Job description

Job Summary

Under direction of the Senior Manager of Clinical Trial Operations, the Senior Clinical Research Coordinator, CTO (SCRC) works independently on complex projects/assignments and manages and conducts the day-to-day activities of a research study. In general, the SCRC ensures the study maintains accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a SCRC may include subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, collection and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Additionally, the SCRC will help train and mentor junior Clinical Trial Office staff.

Description

Job Summary

Under direction of the Senior Manager of Clinical Trial Operations, the Senior Clinical Research Coordinator, CTO (SCRC) works independently on complex projects/assignments and manages and conducts the day-to-day activities of a research study. In general, the SCRC ensures the study maintains accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a SCRC may include subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, collection and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Additionally, the SCRC will help train and mentor junior Clinical Trial Office staff.

Job Specific Duties

• Assists management with business development efforts.
• 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 & 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 study subjects and ensures compliance with the protocol.
• Responsible for speedy and adequate patient enrollment as determined by Research Management in all assigned studies.
• Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol.
• Follows NCRI’s 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.
• Assists with training initiatives (including mentoring) with new and junior research staff (Research Assistants, Data Assistants and Research Volunteers).
• Keeps electronic patient files and required documents up-to-date within e-regulatory system.
• Works adjusted hours to accommodate subject visits as needed.
• Works on clinical trials, interventional studies all phases.
• Collaborates with study investigators to screen and recruit patients to available clinical trials.

Qualifications

Minimum Job Requirements

• Bachelor's degree and 3.5 years of research experience (OR) Associate's degree and 6 years of research experience (OR) 7 years of research experience

Knowledge, Skills, And Abilities

• Experience in pediatric clinical research in a hospital setting.
• Clinical research certification (CCRC, CCRP, CRA) and IATA certification.
• 5+ years research or Clinical Research Experience preferred.
• Experience with interventional (PI Initiated, IND and/or Device) clinical trials.
• Experience working on clinical trials, interventional studies all phases.
• Bilingual in English/Spanish.
• Excellent communication skills in working with both children and adults.
• Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change.
• Excellent 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.

Job

Professional

Department

RI - ADMINISTRATION-2100-380950

Job Status

Professional