Senior Clinical Research Associate – FSP

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

📋 Description

• Ensure the appropriate execution of clinical trials in accordance with the Study Monitoring Plan, relevant regulations, GCP, and client standards.

• Oversee clinical trial operations at designated investigator sites from the initiation phase through to database closure.

• Act as the main point of contact for the assigned investigator sites.

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

• Conduct site development, coaching, and training alongside the SCP.

• Provide training on protocols and address inquiries from site staff.

• Attend investigator meetings and assist in enrollment and recruitment efforts.

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

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

• Prepare necessary reports, TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, study progress, and metrics.

• Maintain knowledge of product, protocol, and therapy areas.

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

• Drive remediation of quality events and manage audit CAPA activities as necessary.

• Collaborate with the SCP, Country Study Operations Manager, and other study team members.

• Report directly to the Director of Clinical Site Operations or Director of Site Management and Monitoring.

• May provide mentorship to Clinical Research Associates.

• Complete all required training, timesheets, expense reports, and CV updates.

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

⛳️ Requirements

• A minimum of 3 years of relevant experience in clinical research site monitoring, preferably with 2 years in Oncology.

• In-depth knowledge 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.

• Fluency in English and the native language(s) of the country of employment is essential.

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

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

• Proven knowledge of clinical research and development processes.

• Demonstrated understanding of global and local regulatory requirements.

• Familiarity with monitoring, data acquisition, cleaning, and reporting.

• Knowledge of diseases and technical areas pertinent to clinical studies.

• Ability to support sponsor regulatory interactions and inspections.

• Understanding of protocol design and feasibility assessments.

• Awareness of regional/country culture and medical practices.

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

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

• Strong verbal and written communication skills.

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

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Generous paid time off and holiday leave policies.