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.

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.

Nicklaus Children's Hospital

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