Clinical Research Associate

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’slicenseandpassportrequired

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Pfizer endeavors to makewww.pfizer.com/careersaccessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please emaildisabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

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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