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.
Role Summary
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. The Site Care Partner acts as a Subject Matter Expert aimed to optimize country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and pipeline opportunities. The Site Care Partner is the “face of company” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and companies reputation is upheld throughout study lifecycle. Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study sites (eg. Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. The Site Care Partner is responsible for site oversight utilizing and interpreting data from analytic tools, in conjunction with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. Site Care Partner Level 2 may be expected to support Country Specific Activities that are required to assure end to end Clinical Trial Implementation (start up to close out).
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.
- Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered
- Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable).
- Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required.
- 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. 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 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.
- Inform and educate investigator sites of pipeline opportunities that may be a good fit.
- 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
- Demonstrate leadership within the local clinical development environment with a goal to enhance reputation in scientific leadership.
- May act as a Subject Matter Expert on 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.
Responsible for proactively providing local intelligence
- Provide input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.
- Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with the Study Operations Manager/Global Study Manager
- Provide regional exploration/territory development growing adjacent opportunities where possible.
- 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.
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 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 reputation in scientific leadership.
- May act as a Subject Matter Expert on 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.
Qualifications:
Education
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years’ experience)
- Proficiency in local language preferred. English is required
Experience
- Demonstrated experience in site management with prior experience as a site monitor
- Demonstrated experience in start-up activities through to site activation
- Demonstrated experience in conduct and close out activities
- Demonstrated knowledge of quality and regulatory requirements in applicable countries
Skills and Technical Competencies
- 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.
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 maximise 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
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
