Pfizer is seeking a Clinical Research Associate to support the successful execution of clinical trials. The role manages investigator site relationships, monitoring, compliance, patient safety, enrollment, protocol-related issues, and site close-out activities in accordance with applicable regulations, Good Clinical Practices, and Pfizer standards.
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site initiation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meetings when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct remote assessment of e diary data
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the Study Monitoring Plan, SOPs and commensurate with emerging issues and technologies
Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
Support database release as needed
May undertake the responsibilities of an unblinded monitor where appropriate
Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
Interact with investigator site health care professionals in a manner which enhances Pfizer’s credibility, scientific leadership and in order to facilitate Pfizer’s clinical development goals
Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
Drive Quality Event submission and remediation, when applicable
Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable
Qualification
Required
Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
Monitoring Experience: Minimum 1-year relevant experience in clinical research site monitoring and management
Must be fluent in English and in the native language(s) of the country they will work in
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
Ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Valid driver's license and passport required
Candidates must be authorized to be employed in the U.S. by any employer
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future
This position requires permanent work authorization in the United States
Preferred
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience preferred
Benefits
Participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary
A 401(k) plan with Pfizer Matching Contributions
An additional Pfizer Retirement Savings Contribution
Paid vacation
Paid holidays
Paid personal days
Paid caregiver/parental leave
Paid medical leave
Medical coverage
Prescription drug coverage
Dental coverage
Vision coverage
Relocation assistance may be available based on business needs and/or eligibility
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
