Senior Clinical Research Associate

This is a fully remote position, open to applicants in New York.

📋 Description

• Oversee designated investigator sites from initiation to database lock and closure.

• Perform onsite and remote/electronic monitoring in line with the Study Monitoring Plan, SOPs, applicable legislation, GCP, and Pfizer standards.

• Act as the primary liaison for assigned investigator sites throughout the study duration.

• Manage relationships with investigator sites, including enrollment, database access, site quality, compliance, engagement, and satisfaction.

• Facilitate communication among study team members, vendors, and investigator sites.

• Collaborate with the Site Care Partner to train and mentor site personnel.

• Provide training on protocols and address questions related to protocols, operational, or clinical trial risks.

• Attend investigator meetings as necessary.

• Assist with enrollment and tackle site activation and recruitment challenges.

• Monitor site-level adverse events (AEs) and serious adverse events (SAEs), coordinate with the Drug Safety Unit, and follow up with investigators.

• Submit documentation for the Trial Master File, including site reports, follow-up letters, protocol deviations, recruitment data, clinical supply, study updates, and metrics.

• Identify and address issues at investigator sites and formulate corrective and preventive measures.

• Resolve data queries and carry out close-out activities for investigator sites.

• Supervise the receipt, handling, accounting, storage, and destruction of investigational products.

• Assist with database releases and carry out unblinded monitoring duties when necessary.

• Maintain knowledge of products, protocols, and therapy areas to support patient safety, eligibility, and clinical guidance.

• Drive remediation of Quality Events and assist in developing and checking CAPA following audit observations.

• Mentor and train Clinical Research Associates, acting as a Subject Matter Expert (SME) for CRA-related processes.

• Participate in working groups and initiatives aimed at process improvement.

• Support pre-activation activities, including feasibility assessments, site selection, PTA, checklists for site activation, ICD finalization, and Site Initiation Visits (SIV).

• Conduct co-monitoring activities as requested.

⛳️ Requirements

• Bachelor’s degree in life sciences or equivalent professional degree in life sciences such as nursing, pharmacy, or medicine.

• At least 3 years of relevant experience in clinical research site monitoring.

• Preferably 2 years of experience in Oncology.

• Extensive understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Experience in global clinical trials.

• Must be fluent in English and the native language(s) of the country of employment.

• Advanced knowledge of clinical research and development processes.

• Proven understanding of global and local regulatory requirements.

• Advanced comprehension of monitoring, data acquisition, cleaning, reporting, and operational elements.

• In-depth knowledge of diseases and technical areas relevant to clinical studies.

• Proven capability to support sponsor regulatory interactions and inspections.

• Demonstrated knowledge of protocol design and feasibility assessment processes.

• Understanding of regional or country cultures and medical practices affecting clinical trial delivery.

• Ability to work within a matrix team environment and influence, lead, and collaborate with others.

• Competence in evaluating, interpreting, and presenting complex issues and data for risk management and mitigation.

• Strong verbal and written communication skills.

• Substantial travel (60–80%) within the area; some international and weekend travel may be required.

• A valid driver’s license and passport are required.

• Candidates must be authorized to work in the U.S. by any employer.

• Permanent work authorization in the United States is required; U.S. work visa sponsorship is not available.

🏝️ 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, holidays, 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.