CTA

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Administration, coordination, management of delegated study activities

o Proactive communication with clinical service providers

o Review of all homecare documentation in accordance with GCP and study specific

requirements within target turnaround timeframes

o Coordination of responses from clinical service providers to queries

o Maintain Documents and Study Files, in accordance with GCP and study specific

requirements

o Assist with audits to ensure inspection readiness

• Assist with Home Health Design, study conduct, and close-out procedures

o Assist with standard metric reporting and distribution

• Keeping all internal stakeholders informed in a timely manner
• Ensure high satisfaction of all internal stakeholders
• Comply with ICH/GCP, IATA, Data Privacy and other appropriate regulations
• Monitoring flow of incoming study documents
• Follow up with homecare providers for outstanding agency/clinician documents.
• Create and maintain internal files which may include clinician/ CSM documentation and ,and CRM data entry
• Other duties as assigned

ROW Operations Specific:

• Recording, filing, and tracking progress of order fulfillment
• Receipt and input of new and updated Physician Order Forms (POFs).
• Management of supply storage area
• Equipment and supplies inventory management and shipping
• Maintaining adequate shipping and ancillary supplies
• Other duties as assigned

• QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Excellent communication skills (written and verbal)
• Well-organized
• Able to multi-task
• Able to work independently or as an effective member of a team
• Attention to detail
• Decision making
• Proficient computer skills, including Outlook, Word, and Excel
• Adheres to timelines and due dates
• Takes initiative while following directives
• Proactive
• Committed to quality results
• Available to work from ICON Gdansk office