Senior Clinical Research Associate II

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $99.2k - $165.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• Manage assigned investigator sites for clinical trial site initiation, routine monitoring, and close-out • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices, and Pfizer standards • Manage operational implementation of clinical trial activities from site initiation through database lock • Serve as primary point of contact for assigned investigator sites during study conduct • Partner with and escalate to the Site Care Partner to ensure quality site delivery • Facilitate information flow among study team members, vendors, and investigator sites • Coach and train site personnel on protocols, compliance, and patient safety • Provide protocol training and address protocol-related questions and risks • Attend investigator meetings when required, virtually or face-to-face • Support enrollment and resolve site activation and recruitment issues • Conduct onsite and remote/electronic monitoring activities • Monitor site-level adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply management information, study progress, and metrics • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release as needed • Undertake unblinded monitor responsibilities when required • Maintain thorough understanding of the product, protocol, and therapy area • Support patient safety, eligibility, and clinical guidance to investigators • Drive 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 for CRA-related processes • Participate in or lead working groups and process improvement initiatives • Perform Site Care Partner duties for small projects or under guidance on larger projects • Conduct co-monitoring activities

🎯 Requirements

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Minimum 5 years relevant experience in clinical research site monitoring • Preferably 3 years in Oncology • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Global clinical trial experience • Must be fluent in English and in the native language(s) of the country they will work in • Superior knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Superior understanding of clinical research operational elements, including monitoring, data acquisition and cleaning, and reporting • Superior knowledge of disease and technical areas pertaining to clinical studies, investigational products, and associated development plans • Demonstrated ability to support sponsor regulatory interactions and inspections • Advanced knowledge of protocol design and feasibility assessment processes • Advanced understanding of regional/country culture and medical practice and their effects on clinical trial delivery • Ability to work in a matrix team environment and influence, drive/lead, and work through others • Ability to critically evaluate, interpret, and present complex issues and data for risk management and mitigation • Superior verbal and written communication skills • Demonstrated ability to motivate and align monitoring communities through leadership and mentorship • Significant travel readiness (60–80%) within the cluster, with possible international and weekend travel • Valid passport and driver’s license • Must be authorized to be employed in the U.S. by any employer • Permanent work authorization in the United States required; U.S. work visa sponsorship is unavailable

🏖️ Benefits

• Participation in 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 • Comprehensive and generous benefits and programs to support healthy lives and life’s moments • 401(k) plan with Pfizer Matching Contributions • Additional Pfizer Retirement Savings Contribution • Paid vacation, holiday and personal days • Paid caregiver/parental and medical leave • Medical, prescription drug, dental and vision coverage • Relocation assistance may be available based on business needs and/or eligibility