Sr. Research Coordinator, FT

Inspire health. Serve with compassion. Be the difference.

Job Summary

Essential Functions

• All team members are expected to be knowledgeable and compliant with Prisma Health's values: Inspire health. Serve with compassion. Be the difference.

• Interdepartmental liaison with clinic staff. Assists in planning and directing investigator and coordinator meetings including but not limited to team meetings, initial orientations, study audits, and closeout visits. Works with finance team members to resolve discrepancies and to review account balances on an as needed basis.

• Primary clinical research coordinator and may carry a patient load as needed for team coverage and understanding of clinical tasks and job functions.

• Primary lead for external audits and internal process improvement strategies to promote consistent best practices. Assists with reviewing and tracking deviation trends leading to review of processes, as needed.

• Primary lead for determination of effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials

• Assists with vetting new studies, facilitates site qualification, study initiation, and study start up including budgeting, communicating with the sponsor and internal departments. Assists with monthly report, as needed

• Assists in financial and regulatory requirements pertaining to portfolio of studies

• Provides team oversight and training / personnel development including Arranges orientation and provides training, supervision and leadership to the clinical research staff. Assigns trials to staff with guidance from Clinical Research Manager or Director as needed. Supervises team vacation, out of office coverage, time management of direct reports. Assists clinical research staff with technical issues, problem solving and intervention when appropriate, delegates responsibility for elements of the conduct of selected clinical trials.

• Provides team quality assurance, guidance development, and collaboration including participation in external audits and internal process improvement strategies to promote consistent best practices. Participates in reviewing and tracking deviation trends leading to review of processes. Performs quality assurance checks by reviewing EDC entries, monitor letters, audit results.

• 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) years research experience in at least one of the following areas: pharmaceutical, academic, device, NIH, investigator-initiated studies or 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 is required within six (6) months of employment.

• CITI Cert-Collaborative Institute Training Initiative

• Sr. Research Coordinator may be required to have a valid driver's license, an acceptable motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and proof of auto insurance.

• CCRC Certified Clinical Research Coordinator or CCRP Certified Clinical Research Professional preferred.

Knowledge, Skills and Abilities

• Knowledge of office equipment (fax/copier)

• Proficient computer skills (word processing, spreadsheets, database)

• Data entry skills

• Knowledge GCP, FDA Rules and Regulations and policies in relation to clinical trials.

• Familiar with Electronic Medical Record (EMR) and Electronic Data Capture (EDC) systems

• High level organization and time management skills and leadership abilities.

• Ability to learn, interpret and master complex protocol information

Work Shift

Location

Facility

Department

Share 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.