Clinical Research Associate

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

📋 Description

• Oversee, monitor, and complete the closure of assigned clinical trial investigator sites.

• Ensure the proper execution of clinical trials in accordance with the Study Monitoring Plan, relevant laws, Good Clinical Practices, and Pfizer's standards.

• Manage operational components of clinical trial activities from site initiation to database lock.

• Act as the primary liaison for assigned investigator sites and nurture relationships with them.

• Collaborate with study teams, vendors, and investigator sites to streamline information exchange.

• Partner with the Site Care Partner for site development, coaching, and training initiatives.

• Provide training on protocols and address any protocol-related inquiries.

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

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

• Perform remote assessments of e-diary data.

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

• Track 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, clinical supply information, study progress, and metrics.

• Identify and resolve issues at investigator sites and formulate corrective and preventive actions.

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

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

• Provide support for database release as required.

• Assume unblinded monitor responsibilities when appropriate.

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

• Engage with healthcare professionals to further Pfizer’s clinical development objectives.

• Assist the study clinician in ensuring patient safety, eligibility, and offering clinical guidance.

• Drive the submission and remediation of Quality Events.

• Act as the point of contact for audits and guide the development and verification of Audit Observation CAPA.

⛳️ Requirements

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

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

• A minimum of 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 is preferred.

• Fluency in English and the native language(s) of the country of employment is essential.

• Proven understanding of clinical research and development processes, with an ability to master process details.

• Demonstrated knowledge of both global and local regulatory requirements.

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

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

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

• Capability to work within a matrix team environment and influence, lead, and collaborate with others for the successful delivery of clinical trials.

• Ability to assess, interpret, and present complex issues and data to support risk management and mitigation efforts.

• Strong verbal and written communication skills.

• Significant travel (60-80%) within the area is required; occasional international and weekend travel may also be necessary.

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

• Candidates 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 now or in the future.

🏝️ Benefits

• Bonus target of 7.5% of base salary through Pfizer’s Global Performance Plan.

• 401(k) plan with Pfizer Matching Contributions.

• Additional Pfizer Retirement Savings Contribution.

• Paid vacation, holiday, 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.