Research Coordinator II, Administrative Research, Full Time, Days

Prisma Health•Greenville, SC

25d•Onsite

About The Position

Responsible for implementing and managing the day-to-day operations of clinical trial research studies. The role includes educating research staff, health care team members, participants, and caregivers; coordinating clinical data collection, submission, and oversight; monitoring protocol compliance; and maintaining systems that support accurate, timely data flow. The Research Coordinator II manages participant visits and protocol-required procedures, monitors participant progress and safety, and communicates relevant updates to investigators, regulatory offices, the health care team, and study staff. The position coordinates study operations and supports program growth, investigator-initiated studies, and industry-sponsored clinical trials. It assists with protocol development, literature reviews, data collection tools, regulatory submissions, study resources, and coordination with ancillary departments. The role collaborates with Research Services offices and sponsoring or local agencies to submit required documents and communicate study progress, amendments, and regulatory activities. This is a non-management role that reports to a supervisor, manager, director, or executive.

Requirements

Bachelor's degree in Health Sciences or a business-related field, or an equivalent combination of work and academic experience.
Two years of research experience in at least one of the following areas: pharmaceutical, academic, device, NIH, investigator-initiated studies, or registry trials.
BLS certification is required within six months of employment.
If the candidate has an Allied Health degree, state certification or licensure in the field is required.
Some team members may need a valid driver's license, an acceptable motor vehicle record, and proof of auto insurance to perform essential job functions.
Ability to independently apply Good Clinical Practice (GCP) principles across studies.
Knowledge of clinical research regulations and their application to daily operations.
Ability to apply protocol requirements and troubleshoot visit issues.
Ability to use specialty-specific terminology effectively.
Ability to interpret medical records independently with minimal assistance.
Ability to independently manage quality data abstraction and ensure high-quality source documentation standards.
Ability to maintain professional development through seminars, workshops, in-service training, and staying current with relevant literature and emerging trends.

Nice To Haves

Collaborative Institutional Training Initiative (CITI) certification is preferred.

Responsibilities

Coordinate day-to-day study operations and develop strategies that contribute to program growth.
Monitor study progress and maintain compliance with protocols and regulations.
Support investigator-initiated studies by assisting with protocol development, literature reviews, and data collection tools.
Coordinate industry-sponsored clinical trials by implementing sponsor-provided protocols, completing required regulatory submissions, and ensuring adherence to study procedures and timelines.
Coordinate resources needed to conduct trials, including developing data collection tools and communicating with ancillary departments about study-related procedures.
Collaborate with Research Services offices and sponsoring or local agencies to submit required study documents and communicate study progress, amendments, and regulatory activities.
Educate research staff, health care team members, participants, and caregivers.
Coordinate clinical data collection, submission, and oversight, and maintain systems for accurate and timely data flow.
Manage participant visits and carry out protocol-required procedures.
Monitor participant progress and safety, and communicate relevant updates to investigators, regulatory offices, the health care team, and study staff.
Perform other duties as assigned.