Clinical Research Associate

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $68.6k - $114.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 and monitor assigned investigator sites for clinical trials • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Manage clinical trial activities from site initiation through database lock • Serve as the primary contact for assigned investigator sites • Partner with the Site Care Partner and study team to ensure quality site delivery • Facilitate information flow among study team members, vendors and investigator sites • Develop, coach and train site personnel on protocols and compliance • Attend investigator meetings when required, virtually or face-to-face • Support enrollment and recruitment initiatives and resolve activation and recruitment issues • Conduct remote assessment of e-diary data • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure • Monitor site-level AEs and SAEs and collaborate with the Drug Safety Unit • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply 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 and undertake unblinded monitor responsibilities when appropriate • Maintain understanding of the product, protocol and therapy area • Support patient safety, eligibility and clinical guidance for investigators • Drive Quality Event submission and remediation • Serve as a point of contact for audits and drive Audit Observation CAPA development and checks

🎯 Requirements

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Minimum 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 preferred • Must be fluent in English and in the native language(s) of the country they will work in • Demonstrated knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Demonstrated understanding of key operational elements of clinical research, including monitoring, data acquisition and cleaning, and reporting • Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including investigational products and associated development plans • Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery • Ability to work in a matrix team environment and influence, drive/lead and work through others • Ability to evaluate, interpret and present complex issues and data for risk management and mitigation • Effective verbal and written communication skills • Significant travel (60-80%) within area, with possible international and weekend travel • Valid driver’s license and passport required • Candidates 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 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 with Pfizer Matching Contributions and an 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