ALL US Locations********

Job Purpose:
The Site Care Partner I (SCP I) is the “face of the client” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client’s reputation is upheld throughout study lifecycle. The SCP I is the main client point of contact for investigative sites; 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 I 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.

Key Accountabilities:

Intelligence Gathering

Provides input into site recommendations via intimate understanding of country and region, sites, processes and practices, and associated site performance metricsProvides support to the Study Operations Manager (SOM)/Global Study Manager (GSM) to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies

Study Start-Up and Activation

Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned sitesSupports processes to optimize country and site selection activities including review and assessment of the draft potential site list and provide Pre-Trial Assessment (PTA) output for site selectionMaintains a thorough knowledge of assigned protocolsConducts study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV), as applicable, including management of issues that may compromise time to site activationEnsures all the site initiation activities completed including training per site activation checklist, collect and complete necessary documentation and systems neededSupports country specific ICD review and deployment when applicableEnsures follow up activities are completed post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV)Partners with site monitor to ensure site monitoring readiness in anticipation of FSFVResponsible for relationship building and operational oversight of the site Provides support for escalated site issues related to study delivery by coordinating communications and resolution efforts (e.g., vendor, site contracts and payment issues etc.)Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targetsResponsible for enrollment support and ensures progress by responding to recruitment issues from investigatorsMaintains regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g. recruitment, data entry timelines etc.)Partners with local Regulatory Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (SAP) to ensure timely completion on country / local registry when applicable

Study Conduct and Closeout

Acts as operational point of contact for all site level questions, liaising with and escalating to appropriate teams to respond and resolve questionsReviews site monitoring reportsSupports the site with revision and submission of ICD documents (and amendments)Works with other roles to maintain system management (e.g., Electronic Data Capture, Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platformsDuring the conduct of the study, the Site Management Organization (SMO) Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under client/ Senior SCP supervision. In addition, 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 currentReviews and manages site practices that differ from client practices and liaises with study management and Business Process Owners as neededMaintains regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study level feedback Oversees and manages of site deliverables to study targets, (i.e. data cuts and sweeps, interim analyses, database locks), helping to oversee

Collaboration

Ensures clear and open communication with SOMSupports 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 (CTM) and Study ManagementCoordinates with other roles and functions that interface with study sites (e.g., Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) optimizing communications and enhancing overall visibility into and confidence of quality of site level activities

Process, Standards, and Oversight

Oversees site utilizing and interpreting data from analytic tools, with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans for these risks

Skills:

5+ years of experience as a site monitor; specifically Oncology monitoringDemonstrated experience in start up activities through to site activation Demonstrated experience in conduct and close out activitiesDemonstrated knowledge of quality and regulatory requirements in applicable countriesMust demonstrate good computer skills and be able to embrace new technologiesAbility to communicate effectively and appropriately with internal and external stakeholdersAbility to adapt to changing technologies and processesEffective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationEffectively overcomes barriers encountered during the implementation of new processes and systemsDemonstrated networking and relationship building skillsDemonstrated ability to manage cross functional relationshipsIdentifies and builds effective relationships with investigator site staff and other stakeholdersAbility to manage required travel of up to 75% on a regular basis

Education:

Bachelor's Degree or Registered Nurse

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.