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 MonitoringEnsure 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 qualityManage 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 metDuring 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 deliveryInterface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sitesPartner 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 risksAttend 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 levelConduct 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 resolutionSubmit 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 metricsIdentify 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 issuesResolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelinesEnsures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities.Support database release as neededMay undertake the responsibilities of an unblinded monitor where requiredClinical/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 teamInteract 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 goalsSupport the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigatorsDrive Quality Event remediation, when applicableServe as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicableOther:Mentor/train Clinical Research Associates and Senior Clinical Research Associates I, as assignedServe as an SME for CRA-related processesParticipate in or lead global, regional or local working groups/process improvement initiativesPerform 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 activationConduct co-monitoring activitiesQUALIFICATIONS / SKILLSBachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalentExtensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulationsMonitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious DiseasesGlobal clinical trial experienceMust be fluent in English and in the native language(s) of the country they will work inSuperior knowledge of clinical research and development processes and ability to gain command of process detailsDemonstrated knowledge of global and local regulatory requirementsSuperior understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)Superior knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)Demonstrated ability to support sponsor regulatory interactions/inspectionsAdvanced knowledge of the processes around protocol design and feasibility assessmentAdvanced understanding of region/country, culture, and medical practice and how they affect clinical trial deliveryProven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trialSuperior ability to critically evaluate, interpret and present complex issues and data to support risk management and mitigationSuperior verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationDemonstrated ability to motivate and align monitoring community through leadership and mentorshipNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSSignificant travel (60-80%) within cluster is required. May require some international travel and some weekend travelValid passport and driver’s license The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview. Relocation assistance may be available based on business needs and/or eligibility. 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. Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. 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