Senior Research Coordinator, Heart & Vascular, Full Time, Variable

Prisma Health • Columbia, SC

1d

About The Position

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. Assists in planning and directing investigator and coordinator meetings. Leads external audits and internal process improvement strategies, advising the manager on findings and making recommendations to promote consistent best practices. Advises the vetting of new studies and makes recommendations regarding feasibility, site qualification, and study startup activities. Assists in financial and regulatory requirements pertaining to a portfolio of 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.

Requirements

• Education - Bachelor's Degree in Health Sciences or Business.
• Experience - Five (5) years of research experience in at least one of the following areas:  pharmaceutical, academic, device, National Institutes of Health (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.
• BLS is required within six (6) months of employment.
• CITI Cert-Collaborative Institute Training Initiative
• Some team members may be required to 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.
• Ability to demonstrate high level organization/time management skills and leadership skills
• Ability to independently interpret and apply Good Clinical Practice (GCP) principles
• Ability to serve as a key regulatory and compliance standards resource
• Ability to independently apply protocol requirements with accuracy and consistency
• Ability to demonstrate proficiency with specialty‑specific terminology and interpret medical records with minimal assistance.
• Ability to oversee data quality across studies
• Ability to assist in developing documentation best practices.
• 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.

Nice To Haves

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

Responsibilities

• Acts as primary interdepartmental liaison, advising clinic staff and research teams on study requirements and operational considerations.
• Assists in planning and directing investigator and coordinator meetings.
• Leads external audits and internal process improvement strategies, advising the manager on findings and making recommendations to promote consistent best practices.
• Advises the vetting of new studies and makes recommendations regarding feasibility, site qualification, and study startup activities.
• Assists in financial and regulatory requirements pertaining to a portfolio of 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level