Senior Clinical Research Associate - FSP

ATLAS MEDICAL SERVICES LTD. STI.; Turkey; Hybrid; TRY 350,000 - 550,000; Full time

Benefits offered by this job

Medical plan

Life assurance

Pension plan (mandatory)

Company car

Job summary

Parexel seeks a Senior Clinical Research Associate for Türkiye (Türkiye, Remote) to manage clinical sites and ensure high-quality trial execution. The role emphasizes site initiation, data integrity, and regulatory compliance within a fast-paced global program.

You will work in a hybrid capacity based in Istanbul or Ankara, coordinating with cross-functional teams and ensuring patient safety and protocol adherence while supporting continuous learning and career growth.

Qualifications

• Educated to degree level in biological science, pharmacy, or other health-related discipline or equivalent experience.
• Site management experience or equivalent in clinical research and understanding of trial processes.
• Knowledge of ICH-GCP and regulatory requirements; experience with clinical systems (CTMS, EDC, TMF).

Responsibilities

• Serve as primary contact for assigned clinical sites and oversee trial conduct from site initiation through close-out.
• Perform on-site or remote visits, address site issues, and ensure data quality and regulatory compliance.
• Update CTMS/EDC/TMF and ensure timely, accurate data entry and TMF documentation.
• Maintain audit readiness and compliance with ICH-GCP and local regulations.
• Monitor follow-up on CRFs, queries, and SAEs; communicate issues with proposed resolutions.
• Collaborate with cross-functional teams to meet project goals and timelines.

Skills

CTMS

EDMS

TMF

Regulatory knowledge

Communication

Problem solving

Teamwork

Education

Bachelor's degree in biological sciences or health-related discipline

Tools

CTMS

EDMS

TMF

MS Office

Job description

Senior Clinical Research Associate - FSP Türkiye, Remote

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

Benefits vary by country, but Parexel is passionate about our team’s overall wellness.

Career Advancement

We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career.

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.