Site Care Partner - Oncology - Canada / Montreal
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Site Care Partner is the main point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site.
Responsibilities
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. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
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. (e.g., vendor, site contracts and payment issues etc.)
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 eg. 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. In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current.
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.
Qualifications
Education
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
Based in Canada
Eligible to work in Canada without visa sponsorship
Experience
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
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
