Sr. Clinical Research Coordinator - Neurology - Onsite (Full Time, Days)

Nicklaus Children's Health System; Miami (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

Nicklaus Children's Health System is seeking a Senior Clinical Research Coordinator to manage complex clinical trials in Miami, Florida. You will work independently, ensuring compliance with protocols and regulations, while also responsible for subject recruitment, data management, and collaboration with investigators.

The ideal candidate will have a Bachelor’s degree with research experience, along with pediatric clinical research experience and excellent communication skills. Certification in clinical research is preferred.

Qualifications

• Bachelor's degree with 4 years of research experience (or) Associate's degree with 6 years of research experience.
• 5+ years of research or clinical research experience preferred.
• Experience with interventional clinical trials.

Responsibilities

• Manage day-to-day activities of a research study.
• Ensure compliance with protocols and regulations.
• Recruit study subjects and maintain patient records.

Skills

Pediatric clinical research experience

Bilingual in English/Spanish

Excellent communication skills

Time management skills

Excellent organizational skills

Education

Bachelor's degree

Associate's degree

Tools

Clinical trial management systems (CTMS)

Word processing software

Database 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. 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, collecting and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CROs and regulatory authorities. The SCRC also helps 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 establishing good rapport with the Principal Investigator and providing required assistance.
• Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between the 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 stays 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 and 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.

Minimum Job Requirements

• Bachelor's degree and 4 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 when 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 their processes.
• 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.