ICON plc

Site Care Partner – Oncology

ICON plc

full-time

Posted on:

Location Type: Remote

Location: Canada

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Tech Stack

Google Cloud Platform

About the role

  • Accountable for site start-up and activation
  • Deploy GSSO site strategies by qualifying and activating assigned sites
  • Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
  • Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.
  • Maintain a thorough knowledge of assigned protocols
  • Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
  • Ensure all the site initiation activity including training per site activation checklist, collect and complete necessary documentation/ systems needed for site activation.
  • Support country specific ICD review and deployment when applicable
  • Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV
  • Partners with site monitor to ensure site monitoring readiness in anticipation of first subject first visit
  • Responsible for relationship building and operational oversight of the site
  • Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
  • Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study
  • Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
  • Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals e.g. recruitment, data entry timelines etc).
  • Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable
  • Accountable for study conduct and close-out
  • Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
  • Review Site Monitoring Reports
  • Support the site with revision and submission of ICD documents (and amendments).
  • Working with other roles, maintain system management (e.g., EDC , Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms.
  • During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under DCSO/ Senior SCP supervision.
  • Review and manage site practices that differ from sponsor practices and liaise with study management and Business Process Owners as needed.
  • Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
  • Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures.
  • Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
  • Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc.
  • Assure quality and consistency in the delivery of monitoring
  • Drive monitoring efficiencies and best practices for study/region/program
  • Support shaping the local clinical development environment with a goal to enhance sponsor reputation in scientific leadership.
  • May act as a Subject Matter Expert on sponsor systems and processes.
  • Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships
  • Ensures clear and open communication with Study Operations Manager
  • Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management.
  • Provide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.
  • Provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.

Requirements

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (at least 5 years’ experience)
  • Proficiency in local language preferred. English is required
  • Bilingual French required
  • Demonstrated experience in site management with prior experience as a site monitor
  • Demonstrated experience in start-up activities through site activation
  • Demonstrated experience in conduct and close out activities
  • Demonstrated knowledge of quality and regulatory requirements in applicable countries
  • Oncology experience preferred
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Good communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 75% on a regular basis
  • Demonstrated networking and relationship building skills
  • Demonstrated ability to manage cross functional relationships
  • Ability to communicate effectively and appropriately with internal & external stakeholders
  • Ability to adapt to changing technologies and processes
  • Knowledge of country requirements for GCP that may be different to those of sponsor Procedures
  • Effectively overcoming barriers encountered during the implementation of new processes and systems
  • Identifies and builds effective relationships with investigator site staff and other stakeholders
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
Benefits
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
site managementstart-up activitiessite activationconduct and close-out activitiesquality and regulatory requirementsGood Clinical PracticeICH Guidelinescomputer skillsoncology experienceinvestigational medical product import/export
Soft Skills
communication skillspresentation skillsinterpersonal skillsnetworking skillsrelationship buildingcross functional relationship managementadaptabilityproblem-solvingeffective verbal communicationeffective written communication
Certifications
Bachelor's degreeRN in a related field