Senior Clinical Research Associate

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $82.7k - $137.9k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 from site initiation through database lock and close-out • Conduct onsite, remote/electronic monitoring in accordance with the Study Monitoring Plan, SOPs, applicable laws, GCP and Pfizer standards • Serve as primary point of contact for assigned investigator sites during study conduct • Manage investigator site relationships, enrollment, database release, site quality, compliance, engagement and satisfaction • Facilitate information flow among study team members, vendors and investigator sites • Partner with the Site Care Partner to develop, coach and train site personnel • Provide protocol training and address protocol-related questions and operational or clinical trial risks • Attend investigator meetings when required • Support enrollment and resolve site activation and recruitment issues • Monitor site-level AEs and SAEs, collaborate with the Drug Safety Unit, and follow up with investigators • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supply, study progress and metrics documentation • Identify and resolve investigator 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 perform unblinded monitor responsibilities when required • Maintain product, protocol and therapy-area knowledge and support patient safety, eligibility and clinical guidance • Drive Quality Event remediation and support audit observation CAPA development and checks • Mentor/train Clinical Research Associates and serve as an SME for CRA-related processes • Participate in working groups and process improvement initiatives • Support pre-activation activities including feasibility, site selection, PTA, site activation checklists, ICD finalization and SIV • Conduct co-monitoring activities as requested

🎯 Requirements

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Minimum 3 years relevant experience in clinical research site monitoring • Preferably 2 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 • Advanced knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Advanced understanding of monitoring, data acquisition and cleaning, reporting, and related operational elements • Advanced knowledge of disease and technical areas pertaining to clinical studies • Demonstrated ability to support sponsor regulatory interactions/inspections • Demonstrated knowledge of protocol design and feasibility assessment processes • Demonstrated understanding of regional/country culture and medical practice as 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 the area; 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 unavailable

🏖️ Benefits

• Pfizer Global Performance Plan bonus target of 10.0% of base salary • 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