Senior Clinical Research Associate – FSP

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee designated investigator sites from the point of site activation until database lock.

• Ensure that clinical trials adhere to the Study Monitoring Plan, relevant regulations, GCP, and client standards.

• Act as the main contact for assigned investigator sites throughout the study process.

• Manage relationships with investigator sites and facilitate communication among study teams, vendors, and sites.

• Collaborate with the Site Care Partner to develop, mentor, and train site staff.

• Provide training on protocols and address any protocol-related inquiries and risks.

• Attend investigator meetings and assist with site enrollment and recruitment strategies.

• Perform onsite and remote/electronic monitoring for site initiation, routine checks, and site closure.

• Monitor adverse events and serious adverse events, and work with the Drug Safety Unit.

• Submit necessary reports, documentation, tracking, and materials for the Trial Master File.

• Maintain knowledge of products, protocols, and therapy areas.

• Support patient safety, eligibility, and provide clinical guidance to investigators.

• Lead Quality Event remediation and audit CAPA activities when necessary.

• Collaborate with the DCSO/DSMM, SCP, Country Study Operations Manager, clinicians, recruitment specialists, and clinical data scientists.

• May provide mentorship to Clinical Research Associates.

• Complete mandatory training, timesheets, expense reports, and updates to CVs.

• Adhere to Parexel processes, ICH-GCP, and relevant requirements.

⛳️ Requirements

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

• Ideally, 2 years of experience in Oncology.

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

• Experience with global clinical trials.

• Proficient in English and the native language(s) of the country of employment.

• Significant travel (60-80%) within the region is required; some international and weekend travel may also be necessary.

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

• Comprehensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• Familiarity with clinical research and development processes.

• Understanding of global and local regulatory standards.

• Knowledge of monitoring, data acquisition and cleaning, reporting, and other operational aspects.

• Understanding of disease and technical areas related to clinical studies.

• Ability to support sponsor regulatory interactions and inspections.

• Knowledge of protocol design and feasibility assessment.

• Awareness of regional and country-specific culture and medical practices.

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

• Ability to evaluate, interpret, and present complex issues and data effectively.

• Strong verbal and written communication skills.

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

🏝️ Benefits

• Equal opportunity employer.

• Significant travel (60-80%) within the area is required; some international and weekend travel may be necessary.