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

Nicklaus Children's•Miami, FL

32d•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, and communication with investigators, IRBs, sponsors, CROs, and regulatory authorities. The SCRC also assists with training and mentoring junior 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.
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.

Nice To Haves

Clinical research certification (CCRC, CCRP, CRA).
IATA certification.
5+ years research or Clinical Research Experience.

Responsibilities

Manages and conducts day-to-day activities of research studies.
Ensures study compliance with protocol, regulations, GCP, and IRB requirements.
Performs subject recruitment, 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.
Assists management with business development efforts.
Attends investigator meetings, pre-study visits, and initiation meetings.
Collects and maintains accurate patient data for submission to sponsors.
Maintains proper patient records.
Coordinates collection and shipment of specimens as required by protocol.
Communicates study objectives and procedures to relevant hospital units.
Establishes 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 the Principal Investigator and Sponsor or Sponsor's Representatives.
Complies with Research Finance Compliance policies and procedures.
Interacts with patients and families to recruit study subjects and ensures protocol compliance.
Ensures speedy and adequate patient enrollment in assigned studies.
Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials.
Follows 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 research staff for CTMS entry.
Assists with training initiatives and mentoring new and junior research staff.
Keeps electronic patient files and required documents up-to-date within the 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.