Clinical Documentation Specialist

Job summary

FIXED TERM OPPORTUNITY- 5 MONTHS Overall job purpose - Maintain and develop the clinical department documentation framework, defining templates, work instructions (WIs) and procedures at sponsor level and site level.

Qualifications

• and ensure framework remains compliant.
• Conduct document reviews, audits, and gap analyses to identify compliance risks.
• Work closely with CTA's to create and amend documentation templates and SOPs that minimize data entry errors and reflect best practice.
• Draft and maintain CRF Completion Guidelines (CCGs) for investigator sites.
• Ensure CRF updates are tracked, version-controlled, and integrated into EDC platforms.
• Collaborate clinical trials software engineer and with Support user acceptance testing (UAT) of EDC CRFs and system configuration.
• o Translate CRF into EDC format
• o Develop UAT scripts for system testing
• o Participate in and document UAT activities
• o Validated EDC system
• o Signed UAT logs
• o Audit trail documentation

Responsibilities

• CRF & Data Collection Documentation
• Collaborate with Medical Writer, Clinical Biostatistician and CRA to design CRFs, eCRFs and logs that align with study protocols and regulatory

Skills

Degrees

Industry

Contract length