Inspire health. Serve with compassion. Be the difference.
Job Summary
Performs all duties of a Research Coordinator II and assists in the coordination of administrative and operational activities for clinical research trials and investigator/resident research performed within a division/unit. Assists to develop research areas and maintain compliance with GCP, FDA Rules and Regulations and Prisma Health SOPs and policies in relation to clinical trials.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.
Acts as primary interdepartmental liaison, advising clinic staff and research teams on study requirements and operational considerations.Assistsin planning and directinginvestigatorand coordinator meetings.
Leads external audits and internal process improvement strategies, advising the manager on findings and making recommendations to promote consistent best practices.
Advisesthe vetting ofnew studiesand makes recommendationsregardingfeasibility, site qualification, and study startup activities.
Assistsin financial and regulatory requirementspertaining toa portfolioof studies.Works with finance team members to resolve discrepancies and to review account balances on an as needed basis.
Under direction,leads quality assurance activities, advises team members on best practices, and makes recommendations based on deviation trends and audit findings.
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.
Experience - Five (5) yearsofresearch experience in at least one of the following areas: pharmaceutical, academic, device,National Institutes of Health (NIH), investigator-initiatedstudiesor registry trials.
In Lieu Of
In lieu of education and experience noted above equivalent combination of work and academic experience may be considered.
Required Certifications, Registrations, Licenses
BLS isrequiredwithin six (6) months of employment.
CITI Cert-Collaborative Institute Training Initiative
Some team membersmaybe requiredto have a valid driver’s license to perform the essential functions of the job. 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.
CCRC Certified Clinical Research Coordinatoror CCRP Certified Clinical Research Professional preferred.
Knowledge, Skills and Abilities
Ability todemonstratehigh level organization/time management skills and leadershipskills
Ability to independently interpret andapplyGood Clinical Practice (GCP) principles
Ability to serve as akey regulatoryandcompliance standardsresource
Ability toindependently applyprotocol requirementswith accuracy and consistency
Ability todemonstrateproficiencywith specialty‑specific terminology andinterpretmedical records with minimalassistance.
Ability to oversee data quality across studies
Ability toassistin developing documentation best practices.
Ability tomaintainongoing professional development byparticipatingin seminars, workshops,in-servicetrainings, and by staying current with relevant literature and emerging trends in the field.
Work Shift
Variable (United States of America)Location
8 Medical Park Rd RichlandFacility
3954 Midlands Administrative Research StaffDepartment
39541000 Midlands 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.