Analista de Pesquisa Clínica Jr

The Clinical Research Associate 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 Clinical Research Associate 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 companys image with its external stakeholders.

The Clinical Research Associate 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.

JOB RESPONSIBILITIES:

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 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 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 health care professionals in a manner which enhances Pfizers credibility scientific leadership and in order to facilitate Pfizers 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:

• Bachelors 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
• Preferred therapeutic experience in Oncology Vaccines Internal Medicine or Infectious Diseases
• Global clinical trial experience preferred
• Must be fluent in English and in the native language(s) of the country they will work in.

PHYSICAL/MENTAL REQUIREMENTS:

• 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.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS:

Significant travel (60-80%) within area is required. May require some international travel and some weekend travel.

ORGANIZATIONAL RELATIONSHIPS:

• Partners with Site Care Partner and Country SOM
• Reports to Director of Clinical Site Operations or Director of Site Management and Monitoring or Site Care Partner III in some countries
• When required Partners with other Study Team members e.g. Clinician Recruitment Specialist Clinical Data Scientist

Work Location Assignment:Remote

Last date to apply for job: Aug 10th

EEO (Equal Employment Opportunity) & 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 or disability.

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