Site Access Specialist with English and Portuguese based in Argentina

Incresearch (Buenos Aires, Argentina) Publicado hace 29 días

JOB SUMMARY





Key supportive role on the Site Access team providing local country and site outreach and site knowledge to the site identification/feasibility process on full service and/or standalone feasibility projects.





JOB RESPONSIBILITIES






  1. Acts as primary contact to the Site Access Lead in an assigned country/region for awarded or ongoing trials. May also act as primary contact to pre-award team for blinded site level feasibility performed in response to a Request for Proposal.





  1. Utilizes local knowledge and relationships to contribute to the local country and site plan for the study (number of sites proposed, type of sites, recruitment rates, competitive studies and key challenges). Validates feasibility/site ID assessment during the study and supports the preparation of the final feasibility report by collecting feasibility data from potential sites.





  1. Acts as primary contact to the investigational sites and study staff to collect and QC data from feasibility surveys, includes the tracking and documentation of such activities into the Syneos Health Investigator database and interaction with internal study team members as required.





  1. Builds local relationships with key research sites and Key Opinion Leaders.





  1. Leads the collection and review of country specific historical site/investigator experience data and data entry in to a centralized Syneos Health Investigator database. Performs searches of external data sources to identify additional investigators to build the database.





  1. Performs review of regulatory sources to determine if regulatory actions exist against investigators. Documents and shares any findings with the study team. Conducts validation and verification checks of site/investigator contact details for the purposes of finalizing a Site/Investigator list for a planned study.





  1. Distributes and collects privacy notice and consent forms, confidentiality agreements, feasibility questionnaires, and other site access documents (e.g. protocol synopsis) to potential study sites. Liaise with representatives from Legal during site confidentiality agreement negotiations.







  1. Supports Site Access Lead (SAL) with preparation and documentation of corrective and preventive actions associated with quality issues. Communicates compliance and performance to relevant stakeholders as appropriate.





  1. Ensures submission of site access related documents to the dedicated project file in the collaborative workspace and manages Study Specific folders in accordance with the corporate and departmental processes.





  1. Contributes to the development and maintenance of site access related internal tools and processes.




Serves as back-up for colleagues, when required



JOB SUMMARY





Key supportive role on the Site Access team providing local country and site outreach and site knowledge to the site identification/feasibility process on full service and/or standalone feasibility projects.





JOB RESPONSIBILITIES






  1. Acts as primary contact to the Site Access Lead in an assigned country/region for awarded or ongoing trials. May also act as primary contact to pre-award team for blinded site level feasibility performed in response to a Request for Proposal.





  1. Utilizes local knowledge and relationships to contribute to the local country and site plan for the study (number of sites proposed, type of sites, recruitment rates, competitive studies and key challenges). Validates feasibility/site ID assessment during the study and supports the preparation of the final feasibility report by collecting feasibility data from potential sites.





  1. Acts as primary contact to the investigational sites and study staff to collect and QC data from feasibility surveys, includes the tracking and documentation of such activities into the Syneos Health Investigator database and interaction with internal study team members as required.





  1. Builds local relationships with key research sites and Key Opinion Leaders.





  1. Leads the collection and review of country specific historical site/investigator experience data and data entry in to a centralized Syneos Health Investigator database. Performs searches of external data sources to identify additional investigators to build the database.





  1. Performs review of regulatory sources to determine if regulatory actions exist against investigators. Documents and shares any findings with the study team. Conducts validation and verification checks of site/investigator contact details for the purposes of finalizing a Site/Investigator list for a planned study.





  1. Distributes and collects privacy notice and consent forms, confidentiality agreements, feasibility questionnaires, and other site access documents (e.g. protocol synopsis) to potential study sites. Liaise with representatives from Legal during site confidentiality agreement negotiations.







  1. Supports Site Access Lead (SAL) with preparation and documentation of corrective and preventive actions associated with quality issues. Communicates compliance and performance to relevant stakeholders as appropriate.





  1. Ensures submission of site access related documents to the dedicated project file in the collaborative workspace and manages Study Specific folders in accordance with the corporate and departmental processes.





  1. Contributes to the development and maintenance of site access related internal tools and processes.




Serves as back-up for colleagues, when required





JOB SUMMARY





Key supportive role on the Site Access team providing local country and site outreach and site knowledge to the site identification/feasibility process on full service and/or standalone feasibility projects.





JOB RESPONSIBILITIES






  1. Acts as primary contact to the Site Access Lead in an assigned country/region for awarded or ongoing trials. May also act as primary contact to pre-award team for blinded site level feasibility performed in response to a Request for Proposal.





  1. Utilizes local knowledge and relationships to contribute to the local country and site plan for the study (number of sites proposed, type of sites, recruitment rates, competitive studies and key challenges). Validates feasibility/site ID assessment during the study and supports the preparation of the final feasibility report by collecting feasibility data from potential sites.





  1. Acts as primary contact to the investigational sites and study staff to collect and QC data from feasibility surveys, includes the tracking and documentation of such activities into the Syneos Health Investigator database and interaction with internal study team members as required.





  1. Builds local relationships with key research sites and Key Opinion Leaders.





  1. Leads the collection and review of country specific historical site/investigator experience data and data entry in to a centralized Syneos Health Investigator database. Performs searches of external data sources to identify additional investigators to build the database.





  1. Performs review of regulatory sources to determine if regulatory actions exist against investigators. Documents and shares any findings with the study team. Conducts validation and verification checks of site/investigator contact details for the purposes of finalizing a Site/Investigator list for a planned study.





  1. Distributes and collects privacy notice and consent forms, confidentiality agreements, feasibility questionnaires, and other site access documents (e.g. protocol synopsis) to potential study sites. Liaise with representatives from Legal during site confidentiality agreement negotiations.







  1. Supports Site Access Lead (SAL) with preparation and documentation of corrective and preventive actions associated with quality issues. Communicates compliance and performance to relevant stakeholders as appropriate.





  1. Ensures submission of site access related documents to the dedicated project file in the collaborative workspace and manages Study Specific folders in accordance with the corporate and departmental processes.





  1. Contributes to the development and maintenance of site access related internal tools and processes.




Serves as back-up for colleagues, when required



Job Description





JOB TITLE: Site Access Specialist







SELECT ONE: Clinical Solutions





JOB CODE: SH2391





JOB FAMILY: Site and Patient Access





BUSINESS UNIT



(COMMERCIAL ONLY):





REPORTS TO: Senior Director, Site and Patient Access; or designee







JOB SUMMARY





Key supportive role on the Site Access team providing local country and site outreach and site knowledge to the site identification/feasibility process on full service and/or standalone feasibility projects.





JOB RESPONSIBILITIES






  1. Acts as primary contact to the Site Access Lead in an assigned country/region for awarded or ongoing trials. May also act as primary contact to pre-award team for blinded site level feasibility performed in response to a Request for Proposal.





  1. Utilizes local knowledge and relationships to contribute to the local country and site plan for the study (number of sites proposed, type of sites, recruitment rates, competitive studies and key challenges). Validates feasibility/site ID assessment during the study and supports the preparation of the final feasibility report by collecting feasibility data from potential sites.





  1. Acts as primary contact to the investigational sites and study staff to collect and QC data from feasibility surveys, includes the tracking and documentation of such activities into the Syneos Health Investigator database and interaction with internal study team members as required.





  1. Builds local relationships with key research sites and Key Opinion Leaders.





  1. Leads the collection and review of country specific historical site/investigator experience data and data entry in to a centralized Syneos Health Investigator database. Performs searches of external data sources to identify additional investigators to build the database.





  1. Performs review of regulatory sources to determine if regulatory actions exist against investigators. Documents and shares any findings with the study team. Conducts validation and verification checks of site/investigator contact details for the purposes of finalizing a Site/Investigator list for a planned study.





  1. Distributes and collects privacy notice and consent forms, confidentiality agreements, feasibility questionnaires, and other site access documents (e.g. protocol synopsis) to potential study sites. Liaise with representatives from Legal during site confidentiality agreement negotiations.







  1. Supports Site Access Lead (SAL) with preparation and documentation of corrective and preventive actions associated with quality issues. Communicates compliance and performance to relevant stakeholders as appropriate.





  1. Ensures submission of site access related documents to the dedicated project file in the collaborative workspace and manages Study Specific folders in accordance with the corporate and departmental processes.





  1. Contributes to the development and maintenance of site access related internal tools and processes.





  1. Serves as back-up for colleagues, when required.








QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)






  • BA/BS in the biological sciences or related discipline in the natural sciences/health care field (e.g. RN

  • Experience in the clinical research field and/or patient recruitment experience

  • Experience working in a pharmaceutical, biotech, contract research organization or clinical research site preferred

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications), email, and internet

  • Strong presentation skills, interpersonal skills, as well as a team oriented approach.

  • Excellent verbal, written, communication and time management skills

  • Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high quality work

  • Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment. Bilingual skills preferred


Primary Location: Latin America - ARG-BuenosAires-Avda-del-Liber

Other Locations:

Job: Site Services

Schedule: Full-time

Travel: No

Employee Status: Regular

Site Access Specialist with English and Portuguese based in Argentina

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