Senior Clinical Research Associate

Role Summary

The Site Care Partner is the main Pfizer point of contact for investigative sites throughout a study life cycle; 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 Site Care Partner contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Pfizer pipeline opportunities under supervision. The Site Care Partner is the face of Pfizer and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizers reputation is upheld throughout study lifecycle. Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study sites (eg. Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. The Site Care Partner is responsible for site oversight utilizing and interpreting data from analytic tools, in conjunction with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.

Responsibilities

Accountable for site start-up and activation

• Deploy GSSO site strategies by qualifying and activating assigned sites
• Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
• Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.
• Maintain a thorough knowledge of assigned protocols
• Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
• Ensure all the site initiation activity including training per site activation checklist, collect and complete necessary documentation/ systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
• Support country specific ICD review and deployment when applicable
• Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV
• Partners with site monitor to ensure site monitoring readiness in anticipation of first subject first visit
• Responsible for relationship building and operational oversight of the site
• Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.)
• Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study
• Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
• Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals eg. recruitment, data entry timelines etc).
• Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable

Accountable for study conduct and close-out

• Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
• Review Site Monitoring Reports
• Support the site with revision and submission of ICD documents (and amendments).
• Working with other roles, maintain system management (e.g., EDC , 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 Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under DCSO/ Senior SCP supervision. In addition, the 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.
• Review and manage site practices that differ from Pfizer practices and liaise with study management and Business Process Owners as needed.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
• Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures.
• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
• Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc.
• Assure quality and consistency in the delivery of monitoring
• Drive monitoring efficiencies and best practices for study/region/program
• Support shaping the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership.
• May act as a Subject Matter Expert on Pfizer systems and processes.
• Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships
• Ensures clear and open communication with Study Operations Manager
• Support 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 and Study Management.
  
  

Responsible for proactively providing local intelligence

• Provide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.
• Provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.

Qualifications

Education

• Bachelors degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years experience)
• Proficiency in local language preferred. English is required

Experience

• 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

Skills and Technical Competencies

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Good communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• Demonstrated networking and relationship building skills
• Demonstrated ability to manage cross functional relationships
• Ability to communicate effectively and appropriately with internal & external stakeholders
• Ability to adapt to changing technologies and processes
• Knowledge of country requirements for GCP that may be different to those of Pfizer Procedures

Behavioral Competencies

• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Identifies and builds effective relationships with investigator site staff and other stakeholders
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Organizational Relationships

Direct Report to DCSO (or Site Care Partner Manager / FSP Line Manager)

• Indirect relationships with:
• Global Study Manager/Study Operations Manager
• Start Up PM
• SAP
• CTA
• CTRO
• ICL
• Site Monitor
• Feasibility Strategy and Analytics Lead
• Signal Interpretation Lead

Coordinates with institutions and investigators at the country level