RN Study Activation Coordinator

OneOncology • Holland, MI

1d

About The Position

Position Summary The Study Activation Coordinator is responsible for collecting study and site data feasibility, assessing institutional interest, and assisting in the determination of the appropriateness for CHC implementation. This position implements and manages study activation activities as applicable with study sponsors, CROs, and current CHC sites. This individual will work closely with the Director of Research Operations and other staff members to facilitate study selection and study activation activities supporting pharmaceutical, investigator initiated and consortia clinical trials. The Study Activation Coordinator reports directly to the Senior Director of Research Operations responsible for the study activation process.

Requirements

• Exceptional communication skills, both oral and written
• Strong knowledge and understanding of study activation processes
• Strong organizational and time management skills, attention to detail, efficiency, and a strong team orientation are essential
• Solid understanding of FDA regulations and Good Clinical Practice (GCP) guidelines governing the conduct of research in human subjects
• Must be proficient with the following software: Word, Excel, and Power Point; Zoom, Microsoft Teams, etc.
• Bachelor’s Degree in nursing required.
• Clinical research study management experience or an equivalent combination of education and applicable clinical research experience –healthcare project management experience beneficial
• Minimal Travel required

Nice To Haves

• Management experience preferred
• ACRP or SOCRA certified a plus
• Experience with databases preferred

Responsibilities

• Primary point of contact for existing practice sites for new study opportunities
• Oversee receipt of study document from sponsor/CRO for review with internal teams
• Oversight responsibility for timely completion of Study Feasibility for each site
• Serve as the primary contact for correspondence between the sponsor and sites and ensure a seamless study activation process
• Interface internally with appropriate staff in each department including finance, billing, project management, regulatory, investigators, and quality assurance.
• Serve as primary point of contact and interface externally working closely with the Sponsor, CRO, and vendors
• Institute a periodic review and revision of policies/processes for review of study activation and provide training and education for staff as needed and in coordination with other departments/managers
• Clinical trial website maintenance
• Communicate Clinical Trial monthly enrollments with outside institutions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees