Senior Clinical Research Associate - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About the Role

We are seeking a Senior Clinical Research Associate to join our team in a hybrid/on-site capacity based in Istanbul or Ankara. As a Senior CRA, you will serve as the primary point of contact for assigned clinical sites, directly influencing the quality, compliance, and performance of clinical trial execution from site identification through close-out.

This role is accountable for managing site quality and delivery end-to-end - building strong site relationships, driving sites successfully to initiation, developing robust patient recruitment strategies, assessing regulatory compliance and site capability, and applying problem-solving to address and resolve site issues.

The Senior CRA oversees the conduct of the trial at designated sites, ensuring the rights and well-being of human subjects are protected, evaluating the quality and integrity of reported data, assessing the efficacy of site staff training and requiring retraining where necessary, and ensuring trial conduct is in compliance with the currently approved protocol and amendments, GCP, and applicable regulatory requirements.

You will join a fast-paced, growth-oriented environment where your work directly shapes study outcomes, patient safety, and data integrity across global clinical programs. With diverse teams and continuous learning opportunities, the CRA can explore career paths and expand skills across the full spectrum of clinical research.

Key Responsibilities

• Evaluate site recruitment plans in collaboration with site staff on an ongoing basis and provide strategy for improvements.
• Perform on-site visits including Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions, and concerns.
• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues, and determine and implement appropriate follow-up action.
• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site-level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS), ensure timely and high-quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF) ensuring first-time quality, and distribute study documents to sites including configuration of Investigator Site Files where applicable.
• Ensure that assigned sites are audit and inspection ready, and monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, sponsor training requirements, and study-specific procedures, plans, and training.
• Collect, review, and approve (where applicable) updated and amended site documentation, including regulatory documents.
• Follow up on CRF data entry, query status, and SAEs.
• Recognize the impact of study non-compliance, issues, delays, and changes on study timelines, and communicate study issues that require immediate action with a proposed strategy for resolution.
• Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and support team members where required.

You will thrive in this role if you bring:

• Sound problem-solving skills and the ability to take initiative, work independently, and proactively seek guidance when necessary.
• The ability to prioritize multiple tasks and achieve project timelines, utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of issues that arise.
• A client-focused approach to work and the ability to interact professionally within a client organization.
• A willingness to work in a matrix environment and to value the importance of teamwork.
• Strong interpersonal, verbal, and written communication skills.
• Strong computer skills including knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.

Required Qualifications

Educated to degree level in biological science, pharmacy, or other health-related discipline, or equivalent nursing qualification or other equivalent experience

Site management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.

• Knowledge of ICH-GCP, applicable international and local regulatory requirements, and clinical trial processes.
• Experience working with clinical systems including CTMS, EDC, and TMF platforms.

Strong communication, organization, and problem-solving skills.

Benefits and Compensation

• Medical plan
• Life assurance
• Voluntary pension plan
• Mandatory pension plan
• Company car

If this role is not the right next step for you, but you know someone who would be a great fit, please share this posting with them.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.