Senior Clinical Research Associate I

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $82.7k - $137.9k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 investigator site relationships and assigned clinical trial sites • Conduct site initiation, routine monitoring, remote/electronic monitoring, and site close-out activities • Ensure clinical trials follow the Study Monitoring Plan, applicable laws, Good Clinical Practices, and Pfizer standards • Manage operational implementation from site initiation through database lock • Serve as primary contact for assigned investigator sites • Facilitate information flow among study team members, vendors, and investigator sites • Coach and train site personnel on protocols, compliance, and patient safety • Support enrollment and resolve site activation and recruitment issues • 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, supply information, study progress, and metrics • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and prepare and execute site close-out plans • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release and serve as an unblinded monitor when required • Maintain product, protocol, and therapy-area knowledge and support patient safety and eligibility • Drive Quality Event remediation and support audit observation CAPA development and checks • Mentor and train Clinical Research Associates • Serve as a subject matter expert for CRA-related processes • Participate in working groups and process improvement initiatives • Perform pre-activation activities including feasibility, site selection, PTA, site activation checklist coordination, 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 • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Minimum 3 years relevant experience in clinical research site monitoring • Preferably 2 years in Oncology • 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 in 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 region/country, culture, and medical practice and their effect on 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 capability, including 60–80% travel within the area, some international and weekend travel • Valid driver’s license and passport required • 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

• Global Performance Plan with a 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