Clinical Research Associate

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

📋 Description

• Oversee and evaluate assigned investigator sites throughout clinical trials.

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

• Manage all clinical trial activities from the initiation of the site to database lock.

• Act as the main point of contact for the assigned investigator sites.

• Collaborate with the Site Care Partner and study team to ensure high-quality site delivery.

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

• Develop, mentor, and train site personnel on protocols and compliance matters.

• Attend investigator meetings as necessary, either virtually or in person.

• Support initiatives for enrollment and recruitment, addressing activation and recruitment challenges.

• Conduct remote assessments of e-diary data.

• Perform onsite and remote/electronic monitoring during site initiation, routine monitoring, and site closure.

• Monitor site-level adverse events (AEs) and serious adverse events (SAEs) and work in partnership with the Drug Safety Unit.

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

• Identify and troubleshoot site issues while developing corrective and preventive actions.

• Resolve data queries and execute investigator site close-out activities.

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

• Support database release and assume unblinded monitor responsibilities as needed.

• Maintain knowledge of the product, protocol, and therapy area.

• Provide support for patient safety, eligibility, and clinical guidance for investigators.

• Drive the submission and remediation of Quality Events.

• Serve as a contact point for audits and lead the development and review of Audit Observation CAPAs.

⛳️ Requirements

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

• Familiarity with clinical trial methodologies, ICH/GCP, FDA standards, and local regulations.

• At least 1 year of relevant experience in monitoring and managing clinical research sites.

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

• Experience with global clinical trials is preferred.

• Must be fluent in English and the native language(s) of the country of employment.

• Proven knowledge of clinical research and development processes.

• Demonstrated understanding of global and local regulatory requirements.

• Solid understanding of key operational elements of clinical research, including monitoring, data acquisition and cleaning, and reporting.

• Knowledge in disease and technical areas related to clinical studies, including investigational products and associated development plans.

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

• Ability to function effectively in a matrix team environment, influencing and leading others.

• Capable of evaluating, interpreting, and presenting complex issues and data for risk management and mitigation.

• Strong verbal and written communication skills.

• Willingness to travel significantly (60-80%) within the area, including possible international and weekend travel.

• A valid driver’s license and passport are required.

• Candidates must have authorization to be employed 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

• Participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.

• 401(k) plan featuring Pfizer Matching Contributions along with an 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.