Clinical Site Operations Specialist II

PSI CRO; Durham (NC); On-site; USD 50,000 - 65,000; Full time

Job summary

PSI CRO in Durham, NC is seeking an administrative professional to support site management and TMF processes within a clinical research environment.

You will coordinate documents, maintain records, prepare submissions for regulatory and ethics committees, and assist with site audits and payments to sites, under supervision of senior staff. Strong MS Office skills and attention to detail are essential.

Qualifications

• College or university degree or equivalent combination of education, training and experience.
• Minimum 2 years of experience in clinical research or related administrative roles.
• Basic proficiency in MS Word.
• Basic proficiency in MS Excel.
• Basic proficiency in MS Outlook.
• Basic proficiency in MS PowerPoint.
• Knowledge of applicable software and project systems after training.
• Basic typing skills in English (min. 40 words per minute).

Responsibilities

• Main site contact for non-trial-participant and non-protocol issues, including vendors and access management.
• Manages records flow with sites and off-site facilities.
• Prepares regulatory and ethics submission/notification documents.
• Coordinates payments to sites and off-site facilities.
• Prepares for and follows up on site audits and inspections.
• Reviews and coordinates site-specific query resolution with Monitors and sites.
• Reviews site-specific EDC completion progress and provides updates to Monitors.
• Acts as the main contact point for other departments on administrative site-related issues.
• Organizes and participates in internal project team meetings and reports.
• Collaborates with sites and project team on Investigator Meetings' organization.
• Under supervision, coaches Site Management Associates I and project support staff.
• Arranges and tracks trial training for investigator site teams in vendor systems.
• Provides training in courier management and trial supplies ordering.
• Files trial records in the TMF and performs TMF checks at site/country level.
• Participates in TMF and systems audits.
• Prepares ISF and ISF checklists; coordinates translation of trial records.

Skills

Typing (40 wpm)

Regulatory document coordination

Cross-department communication

Education

College or university degree

Tools

MS Word

MS Excel

MS Outlook

MS PowerPoint

Job description

PSI CRO in Durham, NC is seeking an administrative professional to support site management and TMF processes within a clinical research environment.

You will coordinate documents, maintain records, prepare submissions for regulatory and ethics committees, and assist with site audits and payments to sites, under supervision of senior staff. Strong MS Office skills and attention to detail are essential.