Sr Clinical Research Coordinator (Full Time, Days)

Nicklaus Children's Hospital•Miami, FL

About The Position

Under the direction of the Senior Manager of Clinical Trial Operations, the Senior Clinical Research Coordinator (SCRC) independently manages complex assignments and the day-to-day activities of research studies. The role ensures studies are conducted in accordance with their protocols, applicable regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements. Duties may include subject recruitment, screening, consent support and enrollment; follow-up; data management and reporting; detailed record keeping; regulatory compliance; collecting and reviewing study data for entry into study and site systems; and communicating with investigators, IRBs, sponsors, contract research organizations (CROs), and regulatory authorities. The SCRC also helps train and mentor junior Clinical Trial Office staff. The role supports clinical trials and interventional studies across all phases. It involves working with patients and families, investigators, hospital units, sponsors, and research staff; maintaining patient and regulatory records; coordinating study data and specimen collection and shipments; and supporting study monitoring visits. Adjusted hours may be required to accommodate subject visits.

Requirements

Bachelor's degree and 3.5 years of research experience, or an 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 clinical trials, including PI-initiated, IND, and/or device trials.
Experience working on clinical trials and interventional studies across all phases.
Excellent communication skills when working with children and adults.
Excellent organizational skills; detail-oriented, people-oriented, flexible, and adaptable to change.
Excellent time management skills.
Knowledge of protocols and the processes associated with them.
Experience with software applications including word processing, scheduling and contact databases, 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, or CRA) and IATA certification.
Five or more years of research or clinical research experience.
Bilingual in English and Spanish.

Responsibilities

Assist management with business development efforts.
Attend and participate in investigator meetings, pre-study visits, initiation meetings, and coordinator meetings as appropriate.
Collect and maintain accurate patient data for submission to sponsors, maintain patient records, and coordinate specimen collection and shipments as required by study protocols.
Communicate study objectives and procedures to relevant hospital units, build rapport with the Principal Investigator, and provide required assistance.
Communicate with sponsors or their representatives; schedule and facilitate study monitor visits; and facilitate communication between the Principal Investigator and sponsors or their representatives.
Comply with Research Finance Compliance policies and procedures, including reporting requirements to research finance staff.
Interact with patients and families to recruit study subjects and ensure compliance with study protocols.
Support speedy and adequate patient enrollment in assigned studies as determined by Research Management.
Apply Good Clinical Practices in the conduct of clinical trials according to established protocols.
Follow and stay current with NCRI Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research.
Enter required data into the CTMS.
Provide new protocols, amendments, and study status updates to relevant research staff for digitization and entry into the CTMS.
Assist with training and mentoring new and junior research staff, including Research Assistants, Data Assistants, and Research Volunteers.
Keep electronic patient files and required documents up to date in the e-regulatory system.
Work adjusted hours as needed to accommodate subject visits.
Collaborate with study investigators to screen and recruit patients for available clinical trials.