[Hiring] Clinical Research Associate @Pfizer

Role Description

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)
• Safeguarding the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP)
• Maintaining investigator and site staff engagement and satisfaction
• Enhancing the company’s 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.

Job Responsibilities

• Responsible for investigator site management and monitoring for assigned sites:
• 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.
• Serve as the primary point of contact for assigned investigator sites during study conduct.
• Interface with the study team as needed, facilitating 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.
• Attend investigator meetings when required (virtual or F2F).
• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.
• 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.
• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit.
• Submit all required reports, documentation, updates and tracking within required timeframes.
• Identify and resolve investigator site issues within required timeframes.
• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines.
• Ensure adequate oversight of the investigational product at the investigator site.
• Support database release as needed.
• May undertake the responsibilities of an unblinded monitor where appropriate.
• Clinical/Scientific and Site Monitoring Risk:
• Maintain thorough understanding of the product, protocol and therapy area.
• Interact with investigator site health care professionals to enhance Pfizer’s credibility.
• Support the study clinician in ensuring patient safety and eligibility.
• 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’s 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.
• 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.

Requirements

• Demonstrated knowledge of clinical research and development processes.
• Demonstrated knowledge of global and local regulatory requirements.
• Demonstrated understanding of key operational elements of clinical research.
• Demonstrated knowledge in disease and technical areas pertaining to clinical studies.
• Demonstrated understanding of region/country, culture, and medical practice.
• Ability to work in a matrix team environment.
• Ability to evaluate, interpret and present complex issues and data.
• Effective verbal and written communication skills.

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

Oct 21st

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.