Site Care Partner I
Pfizer
10 days ago
Remote
United States
Operations
Accountable for:
- Site start-up activities through site activation
- Building and retaining investigator site relationships; provide support from site recommendation through the lifecycle of studies
- Site-level recruitment and safeguarding quality and patient safety at the investigator site
- Contributing to country and site selection activities by collaborating with key stakeholders and providing local intelligence (under supervision)
- Ensuring sites receive necessary support and engagement; resolving issues and upholding Pfizer’s reputation throughout the study lifecycle
- Coordinating with interfacing roles/functions (e.g., CRA, Investigator Contracts Lead, Site Activation Partner, Country Operations, Clinician) to optimize communications and visibility into site quality activities
- Using and interpreting data from analytic tools (with country intelligence and IRMS) to identify quality/compliance risks and develop/implement mitigation plans
- Deploying site strategies by qualifying and activating assigned sites
- Supporting processes to optimize country & site selection (review/assess draft potential site list; provide PTA output)
- Maintaining knowledge of assigned protocols
- Conducting site start-up activities (including PTA, site activation checklist coordination, ICD finalization, SIV as applicable) and managing issues impacting time to activation
- Ensuring site initiation activities, training, and completion of documentation/systems for site activation
- Supporting country-specific ICD review and deployment at Site Activation
- Ensuring follow-up completion post-PTA and SIV for site readiness for FSFV
- Partnering with CRA/site monitor for monitoring readiness prior to first subject first visit
- Relationship building and operational quality of the site; establishing/maintaining relationships with Site Organizations and Strategic Partners
- Providing support on escalated site issues (e.g., vendor, site contracts and payment issues) by coordinating communications and resolution
- Ensuring IP and ancillary supplies strategy/approach meets site and country requirements throughout the study lifecycle
- Effective site recruitment planning and delivery aligned with global/country plans and local targets
- Supporting CRA/site monitor to develop positive investigator relationships and escalate training/compliance concerns with Study Management
Requirements and Experience:
- Bachelor’s degree or RN in a related field (or equivalent education/training/experience; estimate at least 5 years)
- English required; local language proficiency preferred
- Demonstrated site management experience (prior site monitor/CRA experience)
- Demonstrated experience in site start-up through site activation
- Demonstrated experience in conduct and closeout activities
- Demonstrated knowledge of quality and regulatory; Good Clinical Practice/ICH and applicable regulatory requirements
- Strong computer skills; ability to embrace new technologies
- Good communication, presentation, interpersonal skills
- Ability to manage required travel (U.S.)
- Networking/relationship-building; cross-functional relationship management
- Ability to communicate effectively with internal/external stakeholders; adapt to changing technologies/processes
Work location: Remote
- Site start-up activities through site activation
- Building and retaining investigator site relationships; provide support from site recommendation through the lifecycle of studies
- Site-level recruitment and safeguarding quality and patient safety at the investigator site
- Contributing to country and site selection activities by collaborating with key stakeholders and providing local intelligence (under supervision)
- Ensuring sites receive necessary support and engagement; resolving issues and upholding Pfizer’s reputation throughout the study lifecycle
- Coordinating with interfacing roles/functions (e.g., CRA, Investigator Contracts Lead, Site Activation Partner, Country Operations, Clinician) to optimize communications and visibility into site quality activities
- Using and interpreting data from analytic tools (with country intelligence and IRMS) to identify quality/compliance risks and develop/implement mitigation plans
- Deploying site strategies by qualifying and activating assigned sites
- Supporting processes to optimize country & site selection (review/assess draft potential site list; provide PTA output)
- Maintaining knowledge of assigned protocols
- Conducting site start-up activities (including PTA, site activation checklist coordination, ICD finalization, SIV as applicable) and managing issues impacting time to activation
- Ensuring site initiation activities, training, and completion of documentation/systems for site activation
- Supporting country-specific ICD review and deployment at Site Activation
- Ensuring follow-up completion post-PTA and SIV for site readiness for FSFV
- Partnering with CRA/site monitor for monitoring readiness prior to first subject first visit
- Relationship building and operational quality of the site; establishing/maintaining relationships with Site Organizations and Strategic Partners
- Providing support on escalated site issues (e.g., vendor, site contracts and payment issues) by coordinating communications and resolution
- Ensuring IP and ancillary supplies strategy/approach meets site and country requirements throughout the study lifecycle
- Effective site recruitment planning and delivery aligned with global/country plans and local targets
- Supporting CRA/site monitor to develop positive investigator relationships and escalate training/compliance concerns with Study Management
Requirements and Experience:
- Bachelor’s degree or RN in a related field (or equivalent education/training/experience; estimate at least 5 years)
- English required; local language proficiency preferred
- Demonstrated site management experience (prior site monitor/CRA experience)
- Demonstrated experience in site start-up through site activation
- Demonstrated experience in conduct and closeout activities
- Demonstrated knowledge of quality and regulatory; Good Clinical Practice/ICH and applicable regulatory requirements
- Strong computer skills; ability to embrace new technologies
- Good communication, presentation, interpersonal skills
- Ability to manage required travel (U.S.)
- Networking/relationship-building; cross-functional relationship management
- Ability to communicate effectively with internal/external stakeholders; adapt to changing technologies/processes
Work location: Remote