Research Coordinator II, Pediatrics, Full Time, Days

Clinical Trial Research Coordinator

Inspire health. Serve with compassion. Be the difference.

Responsible for the implementation, management and oversight of clinical trial research studies including the education of research staff, healthcare team member, participants and their caregivers. Registers, compiles, submits and oversees clinical data, monitors study compliance and maintains a system for effective data flow for patients on clinical trials. Manages patient visits and implements protocol related procedures. Responsible for monitoring and communicating study participant progress and safety issues with the investigators, applicable regulatory agencies, health care team and study staff.

Essential Functions

• All team members are expected to be knowledgeable and compliant with Prisma Health's purpose: Inspire health. Serve with compassion. Be the difference.
• Manages study operations by coordinating day today study operations and developing strategies to contribute to the program growth.
• Monitors study progress and maintains compliance with protocols and regulations
• Supports investigator-initiated studies by assisting with protocol development, literature reviews, and creation of data collection tools. Coordinates industry sponsored clinical trials by implementing sponsor provided protocols, completing required regulatory submissions, and ensuring adherence to study procedures and timelines.
• Assists in coordinating resources to conduct trials including the development of data collection tools and communication with ancillary departments to implement study related procedures.
• Collaborates with Research Services offices and sponsoring or local agencies to submit required study documents and ensure awareness of study progress, amendments, and regulatory activities.
• Performs other duties as assigned.

Supervisory/Management Responsibilities

• This is a non-management job that will report to a supervisor, manager, director or executive.

Minimum Requirements

• Education - Bachelor's Degree in Health Sciences or Business-related field of study.
• Experience - Two (2) years of research experience in at least one of the following areas: pharmaceutical, academic, device, National Institute of Health (NIH), investigator-initiated studies or registry trials.

In Lieu Of

• In lieu of education and experience noted above an equivalent combination of work experience and academic experience may be considered.

Required Certifications, Registrations, Licenses

• BLS is required within six (6) months of employment.
• Collaborative Institutional Training Initiative (CITI) preferred.
• If Allied Health Degree: State certification/license in field.
• Some team members may be required to have a valid driver's license to perform the essential functions of the role. In these situations, an acceptable motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and proof of auto insurance is required.

Knowledge, Skills and Abilities

• Ability to apply Good Clinical Practice (GCP) principles independently across studies
• Knowledge of clinical research regulations to daily operations
• Ability to apply protocol requirements and troubleshoot visit issues
• Ability to effectively use specialty?specific terminology
• Ability to independently interpret medical records with minimal assistance
• Ability to independently manage quality data abstraction and ensure high-quality source documentation standards
• Ability to maintain ongoing professional development by participating in seminars, workshops, in-service trainings, and by staying current with relevant literature and emerging trends in the field.

Work Shift

Day (United States of America)

Location

Patewood Outpt Ctr/Med Offices

Facility

2507 Upstate Administrative Research Staff

Department

25071000 Upstate Administrative Research Staff-Practice Operations

Share your talent with us! Our vision is simple: to transform healthcare for the benefits of the communities we serve. The transformation of healthcare requires talented individuals in every role here at Prisma Health.