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

Nicklaus Children's Hospital•Miami, FL

3d•Onsite

About The Position

Under the direction of the Senior Manager of Clinical Trial Operations, the Senior Clinical Research Coordinator (SCRC) independently manages and conducts the day-to-day activities of research studies, ensuring compliance with protocols, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Responsibilities include subject recruitment, consenting support, enrollment, follow-up, data management, record keeping, regulatory compliance, data collection and review, and communication with investigators, IRBs, sponsors, CROs, and regulatory authorities. The SCRC also trains and mentors junior Clinical Trial Office staff.

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
Experience in pediatric clinical research in a hospital setting.
Experience with interventional (PI Initiated, IND and/or Device) clinical trials.
Experience working on clinical trials, interventional studies all phases.
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.

Nice To Haves

Clinical research certification (CCRC, CCRP, CRA)
IATA certification
5+ years research or Clinical Research Experience preferred.
Bilingual in English/Spanish.

Responsibilities

Manages and conducts day-to-day activities of research studies.
Ensures study compliance with protocol, applicable regulations, GCP, and IRB requirements.
Performs subject recruitment, including screening, consenting support, and enrollment.
Conducts subject follow-up.
Manages data entry and reporting.
Maintains detailed records.
Ensures regulatory compliance.
Collects and reviews study data for entry into study and site systems.
Communicates with investigators, IRBs, sponsors, CROs, and regulatory authorities.
Trains and mentors junior Clinical Trial Office staff.
Assists management with business development efforts.
Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings.
Collects and maintains accurate patient data for submission to Sponsor.
Maintains proper patient records.
Coordinates the collection and shipments of specimens as required by protocol.
Communicates study objectives/procedures to relevant hospital units.
Establishes good rapport with the Principal Investigator and provides required assistance.
Communicates with the Sponsor or their representatives.
Schedules and facilitates study monitor visits.
Facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives.
Complies with Research Finance Compliance policies and procedures, including reporting requirements.
Interacts with patients and families to recruit study subjects and ensures compliance with the protocol.
Responsible for speedy and adequate patient enrollment.
Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials.
Follows NCRI’s Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research.
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.
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 and interventional studies of all phases.
Collaborates with study investigators to screen and recruit patients to available clinical trials.