Senior Clinical Research Associate II

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

📋 Description

• Oversee designated investigator sites for the initiation of clinical trials, routine monitoring, and closure activities.

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

• Manage the execution of clinical trial operations from site initiation through to database lock.

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

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

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

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

• Deliver protocol training and address any protocol-related inquiries or risks.

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

• Support participant enrollment and address site activation and recruitment challenges.

• Conduct both onsite and remote electronic monitoring activities.

• Monitor adverse events and serious adverse events at the site level and collaborate with the Drug Safety Unit.

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

• Identify and address site issues, developing corrective and preventive measures.

• Resolve data queries and conduct close-out activities for investigator sites.

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

• Provide support for database releases as necessary.

• Assume responsibilities as an unblinded monitor when required.

• Maintain a comprehensive understanding of the product, protocol, and therapeutic area.

• Ensure patient safety, eligibility, and provide clinical guidance to investigators.

• Lead Quality Event remediation and Audit Observation CAPA activities when applicable.

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

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

• Participate in or lead working groups and initiatives for process improvement.

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

• Carry out co-monitoring activities.

⛳️ Requirements

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

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

• Ideally, 3 years of experience in Oncology.

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

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

• Experience with global clinical trials.

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

• Extensive knowledge of clinical research and development processes.

• Proven understanding of global and local regulatory requirements.

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

• Advanced knowledge of disease areas and technical aspects related to clinical studies, investigational products, and associated development plans.

• Demonstrated capability to support sponsor regulatory interactions and inspections.

• Advanced understanding of protocol design and feasibility assessment processes.

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

• Ability to thrive in a matrix team environment, influencing, leading, and working collaboratively with others.

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

• Exceptional verbal and written communication skills.

• Proven ability to inspire and align monitoring communities through leadership and mentorship.

• Willingness to travel significantly (60–80%) within the cluster, including potential international and weekend travel.

• Valid passport and driver’s license required.

• 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

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

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

• Comprehensive and generous benefits and programs designed to support healthy lifestyles and important life moments.

• 401(k) plan with contributions matched by Pfizer.

• Additional Pfizer Retirement Savings Contributions.

• Paid vacation, holidays, and personal days.

• Paid caregiver/parental and medical leave.

• Coverage for medical, prescription drugs, dental, and vision.

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