Senior Clinical Research Associate – FSP

🔥 4 minutes ago

🇹🇷 Turkey – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan, applicable laws, GCP, and client standards • Manage operational aspects of clinical trial activities at assigned investigator sites from site activation through database lock • Serve as the primary point of contact for assigned investigator sites • Partner with and/or escalate to the SCP to ensure quality of site delivery • Attend investigator meetings when required, virtually or face-to-face • Provide enrollment support and address site activation and recruitment issues • Support recruitment initiatives at site level with the SCP and study team • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure • Monitor site-level adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit required reports, documentation, updates, and tracking within required timeframes, including TMF documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supply management, study progress, and metrics • Identify and resolve investigator site issues and develop corrective and preventative actions • Resolve data queries and prepare and conduct investigator site close-out activities

🎯 Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (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 • Significant travel across whole Turkey • Valid driver’s license and passport required • Demonstrated knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Demonstrated understanding of key operational elements of clinical research, including monitoring, data acquisition and cleaning, and reporting • Demonstrated 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 evaluate, interpret and present complex issues and data to support risk management and mitigation • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent