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The Senior Clinical Research Associate II is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards.
The Senior Clinical Research Associate II role is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders.
The Senior Clinical Research Associate II is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner, and other members of the study team, as required, in activities associated with the set-up, running and close out of sites in a clinical trial. Responsible for investigator site management and monitoring for assigned sites.
Clinical Trial Monitoring
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 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 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 required
Clinical/Scientific and Site Monitoring Risk :
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 heath 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 remediation, when applicable
Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable.
Other
Mentor/train Clinical Research Associates and Senior Clinical Research Associates I, as assigned
Serve as an SME for CRA-related processes
Participate in or lead global, regional or local working groups/process improvement initiatives
Perform the duties of a Site Care Partner for small projects or under guidance of a Site Care Partner in larger projects e.g. feasibility and site selection, PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation
Conduct co-monitoring activities.
Work Location Assignment: Remote
Pay Transparency Note:
Minimum annual gross base salary: 217 500 PLN
Annual bonus: 15%
Corporate benefits as per Pfizer Pay Policy, including Medicover, Multisport, life insurance, private pension plan and other.
Purpose
Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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