Senior Clinical Research Associate, II

This is a fully remote position, open to applicants in New York.

📋 Description

• Oversee, evaluate, and finalize assigned clinical trial investigator sites.

• Ensure the safety of patients and the quality of study execution in compliance with applicable laws, Good Clinical Practices, and Pfizer standards.

• Manage relationships with investigator sites and handle operational aspects from site initiation to database lock.

• Act as the primary contact for designated investigator sites and escalate issues to the Site Care Partner when necessary.

• Facilitate communication among study team members, vendors, and investigator sites.

• Provide coaching and training to site personnel, including protocol training.

• Assist with enrollment and recruitment initiatives while addressing activation and recruitment challenges.

• Conduct onsite and remote/electronic monitoring for site initiation, routine oversight, and site closure.

• Monitor adverse events and serious adverse events, collaborating with the Drug Safety Unit.

• Submit trial documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply information, and study metrics.

• Identify and resolve issues at the site and develop corrective and preventive actions.

• Address data queries and engage in investigator site close-out activities.

• Oversee the receipt, handling, accounting, storage, and destruction of investigational products.

• Support database release and conduct unblinded monitoring as required.

• Maintain knowledge of products, protocols, and therapy areas while supporting patient safety and eligibility.

• Lead quality event remediation and audit observation CAPA activities when appropriate.

• Mentor and train Clinical Research Associates and Senior Clinical Research Associates I.

• Serve as a subject matter expert in CRA-related processes.

• Participate in or lead global, regional, or local process improvement initiatives.

• Perform Site Care Partner duties for smaller projects or under guidance on larger projects.

• Conduct co-monitoring activities.

⛳️ Requirements

• Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or medical background, or an equivalent qualification.

• Minimum of 5 years of relevant experience in clinical research site monitoring.

• Preferably 3 years of experience in Oncology.

• Comprehensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Experience in global clinical trials.

• Must be fluent in English and in the native language(s) of the country in which they will work.

• Extensive knowledge of clinical research and development processes.

• Demonstrated understanding of global and local regulatory requirements.

• Strong grasp of monitoring, data collection and cleaning, reporting, and related operational aspects.

• In-depth knowledge of disease and technical areas relevant to clinical studies.

• Proven ability to support sponsor regulatory interactions and inspections.

• Advanced knowledge of protocol design and feasibility assessment.

• Advanced understanding of regional/country culture and medical practices as they influence clinical trial execution.

• Ability to thrive in a matrix team environment, influencing and driving initiatives through others.

• Capability to critically assess, interpret, and present complex issues and data for risk management and mitigation.

• Excellent verbal and written communication skills.

• Ability to inspire and align the monitoring community through leadership and mentorship.

• Significant travel (60–80%) within the cluster; some international and weekend travel may be necessary.

• Possession of a valid passport and driver’s license.

• Must be authorized to work in the U.S. by any employer.

• Permanent work authorization in the United States is required; U.S. work visa sponsorship is not available.

🏝️ Benefits

• Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary.

• Eligibility to participate in Pfizer’s share-based long-term incentive program.

• 401(k) plan with Pfizer Matching Contributions.

• Additional Pfizer Retirement Savings Contributions.

• Paid vacation, holidays, and personal days.

• Paid caregiver/parental and medical leave.

• Comprehensive medical, prescription drug, dental, and vision coverage.

• Relocation assistance may be available based on business needs and/or eligibility.