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, monitor and close out assigned clinical trial investigator sites • Ensure proper conduct of clinical trials according to the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Manage operational aspects of clinical trial activities from site initiation through database lock • Serve as primary contact for assigned investigator sites and manage investigator site relationships • Interface with study teams, vendors and investigator sites to facilitate information flow • Partner with the Site Care Partner on site development, coaching and training • Provide protocol training and address protocol-related questions • Attend investigator meetings when required, virtually or face-to-face • Support enrollment and resolve site 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 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 information, study progress and metrics • Identify and resolve investigator site issues and develop corrective and preventative 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 where appropriate • Maintain understanding of the product, protocol and therapy area • Interact with healthcare professionals to support Pfizer’s clinical development goals • Support the study clinician in ensuring patient safety and eligibility and providing clinical guidance • Drive Quality Event submission and remediation • Serve as 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 and ability to gain command of process details • 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 company direction, 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 for successful delivery of clinical trials • Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation • Effective verbal and written communication skills • Significant travel (60-80%) within area required; some international and weekend travel may be required • 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

• 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 • Medical, prescription drug, dental and vision coverage • Relocation assistance may be available based on business needs and/or eligibility