Senior / Clinical Research Associate - Sponsor Dedicated, Full-Service - Turkey

2+ years

Not Disclosed

Remote - Europe

10 Oct. 16, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate I

Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to deliver impactful outcomes that address modern market realities. Our Clinical Development model prioritizes both the customer and the patient, continuously seeking ways to simplify and enhance our processes.

Why Syneos Health?

We are passionate about developing our people through career progression, supportive management, technical training, and a comprehensive rewards program. Our Total Self culture encourages authenticity, fostering a diverse environment where everyone feels they belong.

Job Responsibilities:

Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) to ensure compliance with regulatory, ICH-GCP, and protocol standards.
Evaluate site performance and provide recommendations for improvements, escalating serious issues as needed.
Verify informed consent processes and ensure patient confidentiality, assessing safety and data integrity at investigator sites.
Review source documents and medical records to ensure the accuracy and completeness of clinical data entered in case report forms (CRFs).
Resolve queries effectively and guide site staff to achieve timely resolutions.
Ensure compliance with electronic data capture requirements and manage investigational product inventory and security.
Maintain the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF).
Document all activities in compliance with SOPs and support patient recruitment and retention strategies.
Understand project scope, budgets, and timelines, managing site-level communications to meet project objectives.
Act as a liaison with project site personnel and ensure compliance with training requirements.
Prepare for and attend Investigator Meetings, contributing to audit readiness standards and supporting audit preparation.

Additional Responsibilities:

Provide site support throughout the study lifecycle and collaborate with sponsors and local staff.
Identify potential sites based on local treatment patterns and healthcare provider relationships.
Propose operational efficiencies and process improvements.
Develop country-specific informed consent forms and ensure regulatory compliance.
Participate in bid defense meetings.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent experience.
Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
Proficient in computer skills and adaptable to new technologies.
Excellent communication, presentation, and interpersonal skills.
Basic critical thinking skills and the ability to manage travel requirements of up to 75%.

Get to Know Syneos Health:

Over the past five years, we have contributed to 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, participating in over 200 studies across 73,000 sites with more than 675,000 trial patients.

Join us in challenging the status quo and driving innovation in a dynamic environment.

Additional Information:

This job description is not exhaustive. The Company may assign additional tasks and responsibilities as needed. Syneos Health is committed to diversity and inclusion and encourages applicants with transferable skills to apply.

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Senior / Clinical Research Associate - Sponsor Dedicated, Full-Service - Turkey

Job Description

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