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Java Software Engineer, AI Imaging (Backend)
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Site Care Partner - FSP

Parexel -
Buenos Aires, Buenos Aires

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Detalles del empleo

Descripción completa del empleo

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 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 (preferred)

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

Education

Bachelor’s degree or Registered Nurse in a related field or equivalent combination of education, training and experience (estimate at least 5 years experience)

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