Stroke Research Coordinator II, Administrative Research, FT Days
Job Summary
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.
Essential Functions
- Manages study operations by coordinating day today study operations and developing strategies to contribute to the program growth.
- Maintains compliance with protocols and regulations.
- Supports investigator-initiated studies by assisting with protocol development, literature reviews, and creation of data collection tools.
- 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.
- 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.
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: 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.
- CITI preferred.
- If Allied Health Degree: State certification/license in field.
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
Greenville Memorial Hospital Facility 2507 Upstate Administrative Research Staff Department 25071000 Upstate Administrative Research Staff-Practice Operations