IQVIA
IQVIA Türkiye is looking for an Experienced Clinical Research Associate (CRA) to join our growing clinical operations teams. The ideal candidate will have a minimum of 6 months of hands-on experience in oncology studies and will play a key role in ensuring the successful execution of clinical trials in compliance with applicable regulations and sponsor requirements.
Key Responsibilities
- Perform monitoring and site management activities to ensure that clinical trial sites conduct studies and report data in accordance with the study protocol, applicable regulations, and sponsor requirements.
- Conduct site monitoring visits including site selection, initiation, routine monitoring, and close‑out visits in line with contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
- Work closely with sites to adapt, drive, and track subject recruitment plans to support project timelines and predictability.
- Deliver protocol, study‑specific, and ongoing training to investigative sites and maintain regular communication to manage expectations and address issues.
- Evaluate the quality and integrity of site practices related to protocol compliance, patient safety, and regulatory adherence; escalate quality issues when necessary.
- Manage study progress by tracking regulatory submissions and approvals, enrollment status, CRF completion, and data query resolution; may support study start‑up activities when required.
- Ensure essential documents are complete and properly filed within the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained in compliance with GCP, ICH, and local regulatory requirements.
- Prepare and maintain accurate and timely documentation, including monitoring visit reports, follow‑up letters, and action plans.
- Collaborate effectively with cross‑functional study team members to support overall project delivery.
- Where applicable, support site‑level subject recruitment strategies and site financial management in line with Clinical Trial Agreements and local requirements.
Qualifications
- Bachelor’s degree in a scientific discipline or healthcare field preferred; an equivalent combination of education, training, and experience may be considered.
- Minimum 6 months of on-site monitoring experience in oncology clinical studies is required.
- Previous CRA experience is required.
- Solid understanding of clinical research regulations, including GCP and ICH guidelines.
- Strong therapeutic and protocol knowledge, supported by company‑provided training.
- Proficiency in Microsoft Word, Excel, and PowerPoint; ability to work effectively using a laptop and mobile devices.
- Strong written and verbal communication skills, including a good command of English.
- Excellent organizational, time management, and problem‑solving skills.
- Ability to establish and maintain effective working relationships with colleagues, line managers, and external stakeholders.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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