Research Coordinator II, OB/GYN Research, Full Time, Days

Prisma Health•Richland, SC

17h•Onsite

About The Position

Responsible for the implementation and day-to-day management of clinical trial research studies, including educating research staff, health care team members, participants, and caregivers. Coordinates the collection, submission, and oversight of clinical data; monitors protocol compliance; and maintains systems to support accurate and timely data flow. Manages participant visits and carries out protocol required procedures. Monitors participant progress and safety, and communicates relevant updates to investigators, regulatory offices, the health care team, and study staff.

Requirements

Bachelor's Degree in Health Sciences or Business-related field of study.
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.
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.

Nice To Haves

Collaborative Institutional Training Initiative (CITI) preferred.
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.

Responsibilities

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.