Study Start-Up Clinical Research Associate at ICON plc

• Study Start Up Clinical Research Associate is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU CRA is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time.

Responsibilities:

• Responsible for the selection of study sites by assessing the site’s eligibility for a specific study
• Responsible for study specific start-up activities from country allocation to site greenlight
• Site relationship management to ensure efficient and sustainable study start-up at site.
• Proactive site preparation and early identification of real site needs and issues
• Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP.
• Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
• Preparation, tracking, and distribution of site start up documentation including Investigator Site File
• Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
• Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
• Support start up process improvement implementation
• Assist with audits/inspections of relevant start up activities and/or eTMF
• Attend and actively participate in team meetings by providing site greenlight projections and timelines
• Provide input on site activation strategy
• Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva

Deliverables:

• Site selection visits /SSVs
• Submission package – collection and preparation of site documents
• Timely site greenlight milestone complete

Skillsets:

• Strong site management capabilities
• Demonstrated negotiating and problem-solving skills
• Strong communication and risk identification skills
• Demonstrated ability to quality review documents and identify discrepancies/inconsistencies
• Ability to embrace Veeva Clinical Vault system and associated functionality
• Strong written and verbal English communication skills
• Demonstrated organization skills and attention to detail
• Strong service orientation
• Ability to work independently and manage multiple tasks and priorities

Requirements:

• The incumbent should have a Bachelor’s degree (or equivalent experience) and minimum of 2 years of experience in the capacity of Clinical Research Associate, involved in Start-Up activities.