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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP has an exciting opportunity for a Site Care Partner (Lead CRA) in Belgium.
The Site Care Partner (SCP) is the main client 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 SCP contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and client pipeline opportunities under supervision.
Acting as the “face of the client”, the SCP is therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client’s reputation is upheld throughout study lifecycle. Additionally, they will coordinate with other roles and functions that will interface with study sites (e.g., 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 SCP 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.
Accountable for site start-up and activation.
Deploy Global Site and Study Operations (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 Pre-Trial Assessment (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.
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.
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 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 and 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 client 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 and drive efficiencies and best practices for study/region/program.
Support shaping the local clinical development environment with a goal to enhance client reputation in scientific leadership.
May act as a Subject Matter Expert on client 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.
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 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.
Knowledge and Experience
Ability to communicate effectively and appropriately with internal & external stakeholders.
Ability to adapt to changing technologies and processes.
Demonstrated networking and relationship building skills and to manage cross functional relationships.
Demonstrated experience in site management with prior experience as a site monitor.
Demonstrated experience in full lifecycle activities from start-up/site activation through to closeout.
Demonstrated knowledge of quality and regulatory requirements for the country the role is based.
Knowledge of Good Clinical Practice (GCP)/International Council for Harmonization (ICH) Guidelines and other applicable regulatory requirements.
Ability to manage required travel of up to 75% on a regular basis.
Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience (estimate at least 5 years’ experience).
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Originally posted on Himalayas