Site Care Partner - FSP

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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 is hiring multiple Site Care Partners in Argentina (Buenos Aires)! Excellent opportunity for experienced Senior CRAs with +5 years of experience, ready to take the next step in their career!

The Site Care Partner (SCP) 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 (may include but not limited to the following):
• Intelligence Gathering

Provides input into site recommendations via intimate understanding of country and region, sites, processes and practices, and associated site performance metrics

Provides 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 sites

Supports 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 selection

Maintains a thorough knowledge of assigned protocols

Conducts 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 activities completed including training per site activation checklist, collect and complete necessary documentation and systems needed

Supports country specific ICD review and deployment when applicable

Ensures 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 FSFV

Responsible 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 targets

Responsible for enrollment support and ensures 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 level 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 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 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 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 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

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 puts 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

Supports shaping 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 strengthening site relationships

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 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

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 knowledg