Senior Clinical Research Associate I

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

📋 Description

• Oversee relationships with investigator sites and manage assigned clinical trial locations.

• Execute site initiation, conduct regular monitoring, perform remote/electronic monitoring, and handle site close-out processes.

• Ensure that clinical trials adhere to the Study Monitoring Plan, relevant laws, Good Clinical Practices, and Pfizer standards.

• Manage the operational execution from site initiation up to database lock.

• Act as the primary point of contact for designated investigator sites.

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

• Provide coaching and training to site personnel on protocols, compliance, and patient safety.

• Assist with enrollment and address site activation and recruitment challenges.

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

• Submit documentation for the Trial Master File, including site reports, follow-up letters, protocol deviations, recruitment updates, supply information, study progress, and metrics.

• Identify and address site-related issues and develop corrective and preventive actions.

• Resolve data queries and prepare and execute site close-out plans.

• Supervise the receipt, handling, accounting, storage, and disposal of investigational products.

• Support database release and act as an unblinded monitor when necessary.

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

• Drive remediation of Quality Events, supporting the development and review of CAPAs in response to audit observations.

• Mentor and train Clinical Research Associates.

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

• Engage in working groups and initiatives for process improvement.

• Conduct pre-activation activities including feasibility assessments, site selection, PTA, coordination of the site activation checklist, finalization of ICD, and SIV.

• Perform co-monitoring activities as needed.

⛳️ Requirements

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

• In-depth knowledge of clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and local country laws.

• At least 3 years of relevant experience in clinical research site monitoring.

• Preferably 2 years of experience in Oncology.

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

• Experience in global clinical trials.

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

• Advanced understanding of clinical research and development processes.

• Proven knowledge of global and local regulatory requirements.

• Advanced comprehension of monitoring, data acquisition and cleaning, reporting, and associated operational components.

• Advanced knowledge of disease areas and technical topics relevant to clinical studies.

• Demonstrated capability to support sponsor regulatory interactions and inspections.

• Proven knowledge of protocol design and feasibility assessment processes.

• Understanding of regional/country culture and medical practices and their impact on clinical trial delivery.

• Ability to work effectively in a matrix team environment and influence, lead, and collaborate with others.

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

• Strong verbal and written communication skills.

• Willingness to travel significantly, including 60–80% travel within the area, as well as some international and weekend travel.

• Valid driver’s license and passport are required.

• Must be authorized for employment in the U.S. by any employer.

• Permanent work authorization in the United States is required.

• U.S. work visa sponsorship is not available now or in the future.

🏝️ Benefits

• Global Performance Plan with a bonus target of 10.0% of base salary.

• 401(k) plan featuring Pfizer Matching Contributions.

• Additional Pfizer Retirement Savings Contribution.

• 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.