Research Coordinator (PT or PRN)

Gastroenterology Associates of the Piedmont•Winston-Salem, NC

About The Position

Gastroenterology Associates of the Piedmont (GAP) is seeking a detail-oriented Research Coordinator to join their team. This role works closely with investigators, study participants, sponsors, and regulatory agencies to support the successful execution of clinical trials and research initiatives. GAP is an independent, physician-owned organization dedicated to delivering exceptional digestive healthcare and has been a trusted healthcare provider for decades. As an independent medical practice, GAP offers a different experience than large healthcare systems, fostering a close-knit team environment where employee voices are heard and their work makes a direct impact. They focus on building lasting relationships and offer predictable schedules and opportunities for growth in a supportive environment.

Requirements

Knowledge of clinical trial documentation requirements, study start-up activities, and study closeout procedures.
Familiarity with healthcare systems, clinical research regulations, policies, and industry standards, including Good Clinical Practice (GCP) guidelines.
Understanding of Clinical Trial Agreements (CTAs) and regulatory requirements associated with conducting clinical research.
Strong customer service and interpersonal skills, with the ability to communicate effectively with study participants, sponsors, investigators, and research partners.

Responsibilities

Coordinating and conducting clinical research activities in accordance with study protocols while ensuring compliance with sponsor, FDA, IRB, and Good Clinical Practice (GCP) requirements.
Maintaining accurate and timely study documentation, ensuring data integrity and participant safety.
Preparing and submitting IRB applications and related materials.
Organizing research records to ensure all study files remain complete, current, and audit-ready.
Performing financial administrative duties for the research department, including preparing invoices, tracking payments, maintaining financial records, and assisting with fiscal documentation.
Monitoring regulatory requirements and implementing updates as needed to maintain compliance with applicable guidelines and study protocols.
Attending monthly staff meetings.
Reporting errors of commission or omission, injuries and illnesses and adverse events to supervisor or management.
Proactively protecting GAP’s systems, databases and network by being vigilant with safe cyber security practices.
Participating in in-services and continuing education to maintain knowledge and skills.
Performing other duties as assigned.