Current Recruitment at ICON plc

Responsible for leading Local Study Teams within country, in order to effectively deliver on Clinical Studies(Oncology) with regards to budgets, resources, ICH-GCP guidelines and local regulations. Will ensure that all sites are identified, qualified, initiated, monitored and closed out. Will be responsible for all study timelines, commitments and the delivery of quality and timely data.

• Leading of all local study teams, optimize performance, ensuring compliance with local regulations and ICH-GCP.
• Ensuring that all feasibilities are performed at maximum quality standards.
• Coordination of site selection through site and investigator identification, performing of Site Quality Risk assessments and SQV’s.
• Ensuring of all timely submission, collection and verification of all documentation throughout the study: Namely, Financial Study agreements, budgets, Master CSA, MICF, and ICF’s.
• Setting up of CTMS at study country leve
• Overseeing, maintenance, and coordination of all monitoring activities from activation to close-out.
• Consistent development and review of risk management planning, managing sites, stakeholders, vendors, and customers to ensure all risks are mitigated.
• May be required to provide co-monitoring support, and training visits with CRA’s and review of monitoring visit reports.
• Contribution to recruitment strategies for patients, and conducting regular communication with Investigators.
• Ensuring that strong relationships are created and maintained with Local team, site staff and stakeholders globally.
• Consistent progress reporting to Global Leads and teams.
• Leading of all Investigator meetings.
• Forecasting of study timelines, resources, recruitment, budgets, and drug supplies.
• Ensuring that all systems are updated and access is granted at country level.
• Ensuring that payments are accurate and performed according to regulations and agreements
• Training and coaching of members of the Local Study Team ensuring compliance
• Ensuring documentation is completed and ready for inspection
• Leading and planning of all activities associated with audits and regulatory inspections
• Providing of input to process improvement.
• Escalation of issues to line managers on studies and timelines, as well as performance of CRA’s and CSC’s
• Collaboration with all relevant internal teams
• Bachelor’s degree in related discipline
• A Minimum of 3 years of experience in the capacity of Trial Manager or Senior CRA, working on Oncology studies is Non-Negotiable.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to plan, budget and quality.
• Excellent project management, team building and interpersonal skills.
• Excellent attention to details.
• Strong negotiation skills.

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• 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.