Senior Clinical Research Associate – Temporary Contract

🔥 0 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 according to 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 primary point of contact for assigned investigator sites • Partner with or escalate to the Study Clinical Project team to ensure quality site delivery • Attend investigator meetings when required, virtually or face-to-face • Provide enrollment support and address site activation and recruitment issues • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure • Monitor site-level adverse events and serious adverse events, collaborating with the Drug Safety Unit and investigators • Submit required reports, documentation, updates and tracking, 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 preventive actions • Resolve data queries and prepare and conduct investigator site close-out activities

🎯 Requirements

• Minimum 3 years of relevant experience in clinical research site monitoring • Preferably 2 years of experience in Oncology • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Global clinical trial experience • Fluency in English • Significant travel across whole Turkey • Valid driver’s license and passport required • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Demonstrated knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Demonstrated understanding of monitoring, data acquisition and cleaning, reporting, and other key operational elements of clinical research • Demonstrated knowledge of disease and technical areas pertaining to clinical studies • Demonstrated ability to support sponsor regulatory interactions and inspections • Demonstrated knowledge of protocol design and feasibility assessment processes • Demonstrated understanding of regional/country culture and medical practice as they affect 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, or medical background, or equivalent

🏖️ Benefits

• Temporary contract • Full-time employment