Job Purpose: The Site Care Partner II (SCP II) is the \xe2\x80\x9cface of the client\xe2\x80\x9d and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client\xe2\x80\x99s reputation is upheld throughout study lifecycle. The SCP II 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 II 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. The SCP II may be expected to support country specific activities that are required to assure end to end clinical trial implementation (start up to close out). Key Accountabilities: Accountability Supporting Activities may include but not limited to the following Intelligence Gathering

• Provides input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
• Provides input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with the Study Operations Manager (SOM)/Global Study Manager (Global SM)
• Provides regional exploration/territory development growing adjacent opportunities where possible.
• Provides support to the SOM/Global SM 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 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.

• Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered.
• Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care and medical practices (as applicable).
• Provides 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
• Maintains 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, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV, as applicable), including management of issues that may compromise time to site activation
• Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation
• Supports country specific ICD review and deployment when applicable
• Ensures follow up activities completed post PTA and SIV to ensure site readiness for First Subject First Visit
• 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
• Provides 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.)
• Ensures the strategy/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 targets
  • Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators
• Maintains 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 questions, liaising with and escalating to appropriate teams to respond and resolve questions
• Reviews site monitoring reports
• Supports the site with revision and submission of ICD documents (and amendments)
• Works with other roles, maintain system management (e.g., Electronic Data Capture (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

(SMO) 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

• Reviews and manages site practices that differ from client practices and liaises with study management and Business Process Owners as needed
• Maintains regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study level feedback
• Informs and educates investigator sites of client pipeline opportunities that may be a good fit
• Oversees and manages of site deliverables to study targets, (i.e., data cuts and sweeps, interim analyses, database locks), helping to oversee data is up to date and any other site facing deliverables, (i.e., investigator signatures)
• Follows the study oversight plan and proactively put in place mitigations for known and anticipated risks
• Supports development and delivery including issue resolution of decentralized capabilities at investigator sites
• Assures quality and consistency in the delivery of monitoring
• Drives monitoring efficiencies and best practices for study, region and program
• Demonstrates leadership within the local clinical development environment with a goal to enhance client reputation in scientific leadership
• May act as a Subject Matter Expert (SME) on client systems and processes
• Actively pursues efficiencies and develops best practices in the delivery of activities for site performance throughout the life cycle to increase investigator and site satisfaction and strengthen site relationships
• Responsible for site oversight utilizing and interpreting data from analytic tools, and country intelligence to proactively identify risks to quality compliance and to develop and implement mitigation plans for risks
• May be expected to support country specific activities that are required to assure end to end clinical trial implementation (start up to close out)

Collaboration

• Ensures clear and open communication with SOM
• Supports 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 management
• Coordinates with other roles and functions that will interface with study sites (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 Compliance with Parexel standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• 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
• Must demonstrate good computer skills and be able to embrace new technologies
• Ability to communicate effectively and appropriately with internal and external stakeholders
• Ability to adapt to changing technologies and processes
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Effectively overcomes barriers encountered during the implementation of new processes and systems
• Demonstrated networking and relationship building skills
• Demonstrated ability to manage cross functional relationships
• Identifies and builds effective relationships with investigator site staff and other stakeholders
• Proficiency in local language preferred
• English proficiency is required
• Ability to manage required travel of up to 75% on a regular basis

Knowledge and Experience:

• Good communication, presentation and interpersonal skills
• Knowledge of country requirements for GCP that may be different to those of client procedures

Education:

• Bachelor\xe2\x80\x99s degree or Registered Nurse in a related field or equivalent combination of education, training and experience (estimate at least 7 years\xe2\x80\x99 experience)

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