Inspire health. Serve with compassion. Be the difference.
Job Summary
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 operationsby coordinatingday todaystudyoperationsand developing strategies to contribute tothe programgrowth.
Monitorsstudy progress andmaintainscompliance with protocols and regulations
Supportsinvestigator-initiatedstudies byassistingwith protocol development, literature reviews, and creation of data collection tools. Coordinatesindustry sponsoredclinical trials by implementingsponsor providedprotocols, completing required regulatory submissions, and ensuring adherence to study procedures and timelines.
Assistsincoordinatingresources to conduct trialsincluding the development of data collection toolsandcommunication with ancillary departments to implement study related procedures.
Collaborates withResearch Services officesandsponsoringor local agencies tosubmitrequiredstudy 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.
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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 applyGood Clinical Practice (GCP)principlesindependently across studies
Knowledgeof clinical research regulationsto daily operations
Ability toapplyprotocol requirementsandtroubleshoot visit issues
Ability to effectively use specialty‑specific terminology
Ability toindependently interpret medical records with minimalassistance
Ability to independently manage quality dataabstractionandensure high-quality sourcedocumentation standards
Ability tomaintainongoing professional development byparticipatingin seminars, workshops, in-servicetrainings, 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 OfficesFacility
2507 Upstate Administrative Research StaffDepartment
25071000 Upstate Administrative Research Staff-Practice OperationsShare 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.