Sr Clinical Research Coordinator (Full Time, Days)

Nicklaus Children's•Miami, FL

About The Position

Under the direction of the Senior Manager of Clinical Trial Operations, the Senior Clinical Research Coordinator (SCRC) works independently on complex projects and manages and conducts the day-to-day activities of research studies. The SCRC helps ensure studies comply with their protocols, applicable regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements. The role may include subject screening, recruitment, consent support and enrollment; follow-up; data entry and reporting; detailed record keeping; regulatory compliance; collecting and reviewing study data for entry into study and site systems; and correspondence with investigators, IRBs, sponsors, contract research organizations (CROs), and regulatory authorities. The SCRC also helps train and mentor junior Clinical Trial Office staff. The SCRC works on clinical trials and interventional studies in all phases, collaborates with investigators to screen and recruit patients, and may work adjusted hours 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.
Clinical research certification (CCRC, CCRP, or CRA) and IATA certification.
Experience with interventional clinical trials, including PI-initiated, IND, and/or device trials.
Bilingual in English and Spanish.
Excellent communication skills when working with children and adults.
Excellent organizational skills; detail-oriented and people-oriented; flexible and adaptable to change.
Excellent time-management skills.
Knowledge of protocols and their processes.
Experience with 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

Five or more years of research or clinical research experience is preferred.

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 shipment as required by protocol.
Communicate study objectives and procedures to relevant hospital units, build rapport with the Principal Investigator, and provide required assistance.
Communicate with sponsors and their representatives.
Schedule and facilitate study monitor visits and facilitate communication between the Principal Investigator and the sponsor or sponsor 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 the protocol.
Support timely and adequate patient enrollment in assigned studies, as determined by Research Management.
Conduct clinical trials in accordance with Good Clinical Practices and established protocols.
Follow NCRI Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and stay current with applicable procedures and guidelines.
Enter required data into the CTMS and provide new protocols, amendments, and study status updates to research staff for digitization or 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.
Work on clinical trials and interventional studies across all phases.
Collaborate with study investigators to screen and recruit patients for available clinical trials.