Global Research Site Trainer I - remote

We are looking for a Global Research Site Trainer I to join our team!

APPLY DIRECTLY at https://cpcclinicalresearch.org/careers/ (internal job listing Site Endpoint Evaluation Visit Specialist I)

Do you have clinical research background? Are you open to travel of up to 80% of the time? Do you adapt to change easily? Can you quickly connect and build strong relationships with others? Can you proactively identify a problem and develop solutions? If you have answered yes to these questions, then keep reading!

Remote applicants are welcome to apply!

In this position you will:

• Review and provide feedback on EQuIP® study-specific documents (e.g., Study Manual, CRFs, Source Document, SEEV Plan, SEEV Report Templates).
• Contact study site and schedule Site Endpoint Evaluation Visits (SEEV) as assigned. Provide sites with confirmation documentation regarding the SEEV.
• Conduct SEEVs domestically and internationally including hands-on training with site staff on endpoint data collection, source document/reference tools review for endpoint data and equipment assessment according to the CPC SOP.
• Understand and comply with all CPC Polices, SOPs and WIs related to assigned activities.
• Provide detailed, accurate and comprehensive written reports of the SEEVs within the allowable timeframe.
• Report any study site concerns to the study Project Manager within a timely manner.
• Conduct online CRA/Sponsor endpoint trainings.
• Process Core Lab submissions; including tracking, distribution of materials to appropriate CPC staff members, filing and uploading documents to the TMF.
• Distribute feedback to sites on quality issues, as required by project. Follow up with appropriate individuals (site staff or site CRA) to ensure complete and documented resolution of issues.
• Contact appropriate individuals (site staff or site CRA) regarding incomplete, inaccurate or missing submissions and other documents as required by project.
• Maintain study recruitment logs, reconcile against Core Lab submissions and follow up with site staff on any missing submissions.
• Participate as a member of designated project teams to support Core Lab staff. Establish and maintain central project and regulatory files, both electronic and paper.
• Assist in scheduling and writing meeting minutes for project team meetings.
• Help assess project issues and propose resolutions to the PM.
• Communicate with sites as necessary.
• Help ensure the overall quality of project services and deliverables.
• Assist in scheduling SEEVs for other team members, as requested.
• Perform additional activities as assigned.

Here’s what you will need to bring to the table:

• Nursing or bachelor’s degree preferred but not required.
• A minimum of 2 years of experience in a clinical research setting or 1 year of experience at CPC as Research Assistant is required.
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical trials.
• Proficiency in Microsoft Office, particularly Outlook, Word and Excel.
• Excellent interpersonal communication skills, organizational and problem-solving skills.
• Great attention to detail.
• Ability to work as a member of a team and to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.
• Ability to manage conflicts.
• Willingness to travel up to 80%.

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $51,000 - $60,000 annually

Deadline to Apply: May 1, 2024