CRA - Future Roles (Turkey)

Syneos Health, Inc.; Fatih; On-site; Full time

Benefits offered by this job

Career development opportunities

Comprehensive total rewards program

Job summary

A leading biopharmaceutical solutions organization in Turkey is seeking a Site Management Associate II to perform site qualification, monitoring, and ensure compliance with regulatory guidelines. The ideal candidate will possess a Bachelor’s degree or RN in a related field, demonstrate strong communication and computer skills, and be willing to travel up to 75%. This role offers the opportunity to work with various stakeholders to manage project activities effectively and contribute to the success of clinical trials.

Qualifications

• Knowledge of Good Clinical Practice and ICH Guidelines.
• Accepts required travel of up to 75%.
• Ability to adopt new technologies.

Responsibilities

• Perform site qualification, initiation, monitoring, and close-out visits.
• Verify informed consent procedures and protect confidentiality.
• Assess site processes and ensure data accuracy.
• Manage project scope, budgets, and timelines.
• Act as primary liaison with study site personnel.

Skills

Strong computer skills

Excellent communication skills

Presentation skills

Interpersonal skills

Education

Bachelor’s degree or RN in a related field

Job description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business‑critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Why Syneos Health

• We are passionate about developing our people through career development, supportive line management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself.
• We continuously build the company we all want to work for, embracing diversity of thoughts, backgrounds, cultures, and perspectives to create a place where everyone feels they belong.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate overall site performance, provides recommendations, escalates serious issues, and develops action plans. Maintains knowledge of ICH/GCP guidelines, regulations, and company SOPs/processes.
• Verifies informed consent procedures are adequately performed and documented for each subject/patient. Protects confidentiality, assesses factors affecting safety and data integrity such as protocol deviations, violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): assesses site processes, conducts source document review, verifies clinical data entered in the case report form (CRF) is accurate and complete, applies query resolution techniques, drives query closure, and ensures electronic data capture compliance.
• May perform investigational product (IP) inventory, reconciliation, storage and security reviews, and verify IP dispensing and administration per protocol.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciles with the Trial Master File (TMF), and ensures archiving in accordance with local guidelines.
• Documents activities via letters, trip reports, communication logs and other required project documents. Supports recruitment, retention and awareness strategies, and enters data into tracking systems.
• Manages project scope, budgets and timelines; coordinates site‑level activities to meet objectives and deadlines. Adapts quickly to changing priorities.
• Acts as primary liaison with study site personnel or in collaboration with a Central Monitoring Associate, ensuring training and compliance.
• Prepares for and attends Investigator Meetings and sponsor face‑to‑face meetings. Participates in global monitoring staff meetings and attends clinical training sessions.
• Provides guidance toward audit readiness and supports audit preparation and follow‑up actions.
• Maintains ICH/GCP knowledge, completes required training, and for Real World Late Phase, uses the Business Card title of Site Management Associate II. Handles site support throughout the study lifecycle and may train junior staff. Identifies out‑of‑scope activities and proactively suggests potential sites based on local knowledge.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
• Strong computer skills and ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.
• Accepts required travel of up to 75%.
• US‑ONLY: Employment may involve deployment to sites requiring certain medical and personal information for facility access; compliance with privacy notices is mandatory.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Any language herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Get to Know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo in a highly competitive and ever‑changing environment.