Senior Clinical Research Associate – FSP

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

📋 Description

• Oversee designated investigator sites from activation until database lock.

• Execute site management, monitoring, and close-out tasks for assigned clinical trials.

• Ensure compliance of clinical trials with monitoring plans, relevant laws, GCP, and client standards.

• Act as the main point of contact for assigned investigator sites, managing site relationships.

• Facilitate the flow of information among study team members, vendors, and investigator sites.

• Provide coaching and training for site personnel, including protocol training.

• Assist with site activation, recruitment, enrollment, and investigator meeting initiatives.

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

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

• Submit necessary TMF documentation, site reports, follow-up communications, protocol deviations, recruitment updates, clinical supply information, study progress, and metrics.

• Identify and address site issues while developing corrective and preventive actions.

• Resolve data queries and execute investigator site close-out activities.

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

• Support database release and may perform unblinded monitoring as needed.

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

• Lead Quality Event remediation and CAPA activities for audit observations when applicable.

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

• Collaborate with Site Care Partners, Country Study Operations Managers, and other study team members.

• Mentor Clinical Research Associates when necessary.

• Complete mandatory training, timesheets, expense reports, and CV updates.

• Ensure compliance with Parexel processes, ICH-GCP, and applicable regulations.

⛳️ Requirements

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

• Ideally, 2 years of experience in Oncology.

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

• In-depth knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• Experience with global clinical trials.

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

• Willingness to travel significantly (60-80%) within the area; occasional international and weekend travel may be necessary.

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

• Proven understanding of clinical research and development processes.

• Familiarity with global and local regulatory requirements.

• Comprehension of monitoring, data acquisition, cleaning, reporting, and other key operational aspects of clinical research.

• Knowledge of disease and technical areas related to clinical studies, investigational products, and relevant development plans.

• Ability to assist in sponsor regulatory interactions and inspections.

• Familiarity with protocol design and feasibility assessment processes.

• Understanding of regional/country culture and medical practices and their impact on clinical trial execution.

• Proven capability to work in a matrix team environment, influencing and leading through collaboration.

• Ability to assess, interpret, and present complex issues and data for risk management and mitigation.

• Strong verbal and written communication abilities.

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

🏝️ Benefits

• Equal opportunity employment consideration.

• Significant travel within the area and occasional international/weekend travel may be necessary (job-related compensation/condition, not a benefit).