Cra Ii - New Sponsor - Fsp - Based In Istanbul

Syneos Health

2+ years

Not Disclosed

Remote, USA

10 Dec. 10, 2024

Job Description

Job Type: Full Time 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

Clinical Research Associate II - CRA II - New Sponsor - FSP - Based in Istanbul
Syneos Health®

About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into real-world outcomes to meet the challenges of today’s market. Our Clinical Development model centers the customer and patient in everything we do, while continually refining processes to make Syneos Health a better partner to work with and for.

Whether you join us in a Functional Service Provider (FSP) partnership or a Full-Service environment, you will collaborate with passionate professionals to help our customers reach their goals. Our agile and driven approach accelerates the delivery of therapies, because we are committed to changing lives.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health?
At Syneos Health, we are committed to developing our people through career development, progression, and a supportive work environment. With opportunities for technical and therapeutic training, peer recognition, and a comprehensive rewards program, we value diversity, inclusivity, and engagement.

We foster a Total Self culture, encouraging you to be authentically yourself in everything you do. This culture unites us globally, driving us to create a workplace where everyone belongs.

Job Responsibilities

Site Monitoring and Management: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure adherence to regulatory requirements, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol compliance. Evaluate site performance and escalate issues to the project team.
Informed Consent and Patient Safety: Ensure that informed consent is obtained and documented appropriately. Protect patient confidentiality and evaluate any safety or data integrity concerns at study sites.
Data Management and Query Resolution: Conduct Source Document Reviews, verify data accuracy, resolve data queries remotely and on-site, and ensure the site’s compliance with electronic data capture (EDC) systems.
Investigational Product (IP) Management: Oversee IP inventory, reconciliation, storage, and dispensation, ensuring compliance with study protocols and local regulations.
Documentation and Site Support: Maintain accurate documentation, including confirmation letters, follow-up letters, and trip reports. Support subject recruitment and retention, tracking action items through completion.
Project and Budget Management: Understand project scope, budgets, and timelines. Manage communication and site-level activities to meet project goals and deadlines.
Audit Preparation and Compliance: Maintain readiness for audits, support preparations, and follow-up actions.
Real World Late Phase: For Real World Late Phase studies, the CRA II will support site management from identification to close-out. Responsibilities include chart abstraction, data collection, and collaboration with medical science liaisons and local teams. The CRA II may also mentor junior staff and suggest potential sites based on local insights.

Qualifications

Bachelor’s degree or RN in a related field, or equivalent education and experience.
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and relevant regulatory requirements.
Strong computer skills and an ability to adopt new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel requirements of up to 75%.

About Syneos Health
Over the past 5 years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites and 675,000+ trial patients. We continuously challenge the status quo, striving to make an impact in a highly competitive and evolving environment.

Learn more about Syneos Health and discover why WORK HERE MATTERS EVERYWHERE.

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Cra Ii - New Sponsor - Fsp - Based In Istanbul

Job Description

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