Site Care Partner, Lead CRA
Job Description:
• The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance.
• Conducts study start-up activities at the site level including Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation
• Responsible for relationship building and operational quality of the site.
• Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV.
• Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for enrollment delivery during study conduct.
• Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
Requirements:
• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience)
• Demonstrated experience in site management with prior experience as a CRA in Oncology
• Demonstrated experience in start-up activities through site activation
• Demonstrated experience in conduct and close out activities
• Demonstrated knowledge of quality and regulatory requirements in applicable countries
• Proficiency in local language preferred. English is required
Benefits:
• N/A
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• The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance.
• Conducts study start-up activities at the site level including Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation
• Responsible for relationship building and operational quality of the site.
• Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV.
• Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for enrollment delivery during study conduct.
• Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
Requirements:
• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience)
• Demonstrated experience in site management with prior experience as a CRA in Oncology
• Demonstrated experience in start-up activities through site activation
• Demonstrated experience in conduct and close out activities
• Demonstrated knowledge of quality and regulatory requirements in applicable countries
• Proficiency in local language preferred. English is required
Benefits:
• N/A
Apply tot his job
Apply To this Job