Clinical Research Associate

The Clinical Research Associateis responsible for the site management, site monitoring and close-out of assignedclinicaltrialsinvestigatorsitestoensurepatientsafetyandqualitystudyexecutioninaccordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards.

 

The Clinical Research Associaterole is accountable for site management and monitoring,managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release),tosafeguardthequalityofinvestigatorsites(e.g.patientsafety,sitequalityandcompliancewith GCP), tomaintain investigator and site staffengagement and satisfaction, and to enhance the company’s image with its external stakeholders.

 

The Clinical Research Associate is responsible for the resolution of all protocol-related issues for assigned investigatorsitesandwillworkcloselywiththeSiteCarePartner,andothermembersofthestudyteam,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 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

Clinical/ScientificandSiteMonitoringRisk:

• 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

QUALIFICATIONS

• Bachelor’sdegreeinlifesciencesorprofessionaldegreeinlifesciencessuchasnursing,pharmacy, medical background or equivalent

• Knowledgeofclinicaltrialmethodologies,ICH/GCP,FDAandlocalcountryregulations

• MonitoringExperience:Minimum1-yearrelevantexperienceinclinicalresearchsitemonitoring and management

• PreferredtherapeuticexperienceinOncology,Vaccines,InternalMedicineorInfectiousDiseases

• Globalclinicaltrialexperiencepreferred

• MustbefluentinEnglishandinthenativelanguage(s)ofthecountrytheywillworkin

• Demonstratedknowledgeofclinicalresearchanddevelopmentprocessesandabilitytogain command of process details

• Demonstratedknowledgeofglobalandlocalregulatoryrequirements

• Demonstratedunderstandingofkeyoperationalelementsofclinicalresearch(e.g.,monitoring, data acquisition and cleaning, reporting, etc.)

• Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledgeofcompanydirection,investigationalproduct(s),andassociateddevelopmentplan(s)

• Demonstratedunderstandingofregion/country,culture,andmedicalpracticeandhowtheyaffect clinical trial delivery

• Abilitytoworkinamatrixteamenvironmentwiththeabilitytoinfluence,drive/leadandwork through others for successful delivery of clinical trial

• Abilitytoevaluate,interpretandpresentcomplexissuesanddatatosupportriskmanagementand mitigation

• Effectiveverbalandwrittencommunicationskillsinrelatingtocolleaguesandassociatesboth inside and outside of the organization

NON-STANDARDWORK SCHEDULE,TRAVELORENVIRONMENTREQUIREMENTS

• Significanttravel(60-80%)withinareaisrequired.Mayrequiresomeinternationaltraveland some weekend travel

• Validdriver’slicenseandpassport

The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. 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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

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