Site Care Partner I or II - FSP

<p><b>reputed company our values reputed company, there's no limit to reputed company can reputed company.</b><br> <br>At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.</p><p>reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.</p><p></p><p></p><div><p><b>reputed company FSP </b>is hiring multiple <b>Site reputed company</b> in<b> Chile!</b> Excellent opportunity for reputed company Senior CRAs reputed company to take the reputed company in their career!</p><p></p><p>The <b>Site Care Partner</b> (SCP) is the “face of the reputed company” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and reputed company’s reputed company is upheld throughout study lifecycle. The SCP I is the main reputed company reputed company 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 reputed company, and accountable for safeguarding the reputed company 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 reputed company surveys, investigator strategies and reputed company pipeline opportunities under supervision.</p><p></p><p><b><reputed company>Key Accountabilities</reputed company><reputed company> </reputed company></b><reputed company><reputed company>(may include but not limited to the following)</reputed company><reputed company>: </reputed company></reputed company><reputed company> </reputed company></p></div><div><p><u><reputed company>Intelligence Gathering</reputed company><reputed company>:</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>•</reputed company><reputed company> Provides input into site recommendations reputed company intimate understanding of country and region, sites, processes and practices, and associated site performance metrics</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Provides support to the Study Operations Manager (SOM)/Global Study Manager (GSM) to define local requirements for the <reputed company><reputed company style="reputed company-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">importation/exportation</reputed company></reputed company> processes of the investigational medical product and ancillary supplies</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Study Start-Up and Activation</reputed company><reputed company>:</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned site</reputed company><reputed company>s</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Supports processes to </reputed company><reputed company>optimize</reputed company><reputed company> country and site selection activities including review and assessment of the draft potential site list and reputed company reputed company-Trial Assessment (PTA) reputed company for site </reputed company><reputed company>selection</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Maintains</reputed company><reputed company> a thorough knowledge of assigned protocols</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• 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</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Ensures reputed company the site initiation activities completed including training per site activation checklist, collect and complete necessary documentation and systems needed</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Supports country specific ICD review and deployment reputed company applicable</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Ensures follow up activities are completed post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV)</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Partners with site monitor to ensure site monitoring readiness in anticipation of FSFV</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Responsible for relationship building and operational reputed company of the site</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Provides support for escalated site issues reputed company to study delivery by coordinating communications and reputed company efforts (e.g., vendor, site reputed company and payment issues etc.)</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Ensures the reputed company and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Responsible for enrollment support and ensures reputed company by responding to recruitment issues from investigators</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Maintains</reputed company><reputed company> regular communications with investigator sites to reputed company status updates and drive delivery to study goals (</reputed company><reputed company>e.g.</reputed company><reputed company> recruitment, data entry </reputed company><reputed company>timelines</reputed company><reputed company> etc.)</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Partners with local Regulatory Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (reputed company) to ensure </reputed company><reputed company>reputed company</reputed company><reputed company> completion on country / local registry reputed company applicable</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Study Conduct and Closeout</reputed company><reputed company>:</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Acts as operational reputed company of contact for reputed company site level questions, liaising with and escalating to </reputed company><reputed company>appropriate teams</reputed company><reputed company> to respond and resolve questions</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Reviews site monitoring reports</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Supports the site with revision and submission of ICD documents (and amendments)</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Works with other roles to </reputed company><reputed company>maintain</reputed company><reputed company> system management (e.g., Electronic Data Capture, Shared Investigator Platform, Site </reputed company><reputed company>Profile</reputed company><reputed company> and other systems as applicable) at site level ensuring alignment across platforms</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• During the conduct of the study, the Site Management Organization (SMO) Assessment is reviewed with the site, reputed company applicable, on an annual reputed company following site initiation and updated as needed under reputed company/ Senior SCP supervision. In reputed company, SMO Assessment is reviewed and updated reputed company major reputed company, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are reputed company</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Reviews and manages site practices that differ from reputed company practices and liaises with study management and Business Process Owners as needed</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Maintains</reputed company><reputed company> regular communications with investigator sites to reputed company status updates, informal and formal performance metrics, and study level feedback</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Oversees and manages of site deliverables to study targets, (</reputed company><reputed company>i.e.</reputed company><reputed company> data cuts and sweeps, interim analyses, database locks), helping to reputed company</reputed company><reputed company> </reputed company><reputed company>data is up to date and any other site facing deliverables, (i.e., investigator signatures)</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Follows the study reputed company plan and proactively puts in reputed company mitigations for reputed company and </reputed company><reputed company>anticipated</reputed company><reputed company> risks</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Supports development and delivery, including issue reputed company, of decentralized capabilities at investigator sites</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Assures reputed company and consistency in the delivery of monitoring</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Drives monitoring efficiencies and best practices for study, </reputed company><reputed company>region</reputed company><reputed company> and program</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Supports shaping the local clinical development environment with a goal to enhance reputed company reputed company in scientific leadership</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• May reputed company as a Subject Matter Expert (SME) on reputed company systems and processes</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• reputed company 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</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Collaboration</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Ensures reputed company and reputed company communication with SOM</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Supports the site monitor to reputed company reputed company Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager (CTM) and Study Management</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Coordinates with other roles and functions that reputed company with study sites (e.g., Study Monitor, Investigator reputed company reputed company, Site Activation Partner, Clinician, etc.) optimizing communications and enhancing overall visibility into and confidence of reputed company of site level activities</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Process, Standards, and reputed company</reputed company><reputed company>:</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Oversees site </reputed company><reputed company>utilizing</reputed company><reputed company> and interpreting data from analytic tools, with country intelligence to proactively </reputed company><reputed company>identify</reputed company><reputed company> risks to reputed company and compliance and to reputed company and implement mitigation plans for these risks</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Compliance with reputed company standards</reputed company><reputed company>:</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Complies with</reputed company><reputed company> required training curriculum</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Completes timesheets accurately as </reputed company><reputed company>required</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Submits</reputed company><reputed company> expense reports as </reputed company><reputed company>required</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Updates CV as </reputed company><reputed company>required</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Maintains</reputed company><reputed company> a working knowledge of and </reputed company><reputed company>complies with</reputed company><reputed company> reputed company processes, ICH-GCPs and other applicable requirements</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Skills: </reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Demonstrated</reputed company><reputed company> experience in site management with prior experience as a site monitor</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Demonstrated</reputed company><reputed company> experience in </reputed company><reputed company>start up</reputed company><reputed company> activities through to site activation</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Demonstrated</reputed company><reputed company> experience in conduct and reputed company out activities</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Demonstrated</reputed company><reputed company> knowledge of reputed company and regulatory requirements in applicable countries</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Must </reputed company><reputed company>demonstrate</reputed company><reputed company> good computer skills and be reputed company to reputed company </reputed company><reputed company>new technologies</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Ability to communicate effectively and appropriately with reputed company stakeholders</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Ability to adapt to changing technologies and processes</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Effective verbal and written communication skills in relating to colleagues and associates both inside and reputed company of the organization</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Effectively overcomes barriers </reputed company><reputed company>encountered</reputed company><reputed company> during the implementation of new processes and systems</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Demonstrated</reputed company><reputed company> networking and relationship building skills</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Demonstrated</reputed company><reputed company> ability to manage cross functional relationships</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Identifies</reputed company><reputed company> and builds effective relationships with investigator site staff and other stakeholders</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Proficiency</reputed company><reputed company> in local language preferred</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• English proficiency is </reputed company><reputed company>required</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Ability to manage required travel of up to 75% on a regular reputed company</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Knowledge and Experience (preferred):</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• </reputed company><reputed company>Good communication</reputed company><reputed company>, </reputed company><reputed company>presentation</reputed company><reputed company> and interpersonal skills</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Knowledge of country requirements for GCP that may be different to those of reputed company procedures</reputed company></reputed company><reputed company> </reputed company></p></div><div><p><reputed company> </reputed company></p></div><div><p><u><reputed company>Education:</reputed company></u><reputed company> </reputed company></p></div><div><p><reputed company><reputed company>• Bachelor’s degree or Registered reputed company in a reputed company field or equivalent combination of education, </reputed company><reputed company>training</reputed company><reputed company> and experience (estimate at least 5 </reputed company><reputed company>years experience</reputed company><reputed company>)</reputed company></reputed company><reputed company> </reputed company></p></div>