Sr Cra I - New Sponsor In Fsp - Turkey

5+ 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

Senior Clinical Research Associate I - Sr CRA I - New Sponsor in FSP - Turkey (Primarily in Istanbul)
Syneos Health®

About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We bridge clinical, medical affairs, and commercial insights into real-world outcomes, addressing the evolving needs of the market.

Our Clinical Development model places the customer and patient at the heart of everything we do. We continuously seek ways to simplify and streamline our processes, not only making Syneos Health easier to work with, but also making it a better place to work for.

Whether you join us in a Functional Service Provider (FSP) partnership or a Full-Service environment, you will collaborate with passionate problem-solvers to drive customer success. We are agile, driven, and committed to accelerating the delivery of therapies that will change lives.

Why Syneos Health?
We are dedicated to developing our people, fostering career growth and progression through supportive leadership, technical and therapeutic training, and a comprehensive rewards program. Our Total Self culture encourages you to be authentically yourself, uniting us globally and making us a company where everyone belongs.

Job Responsibilities

Site Monitoring and Management: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol. Evaluate site performance, escalate issues to the project team, and develop action plans.
Informed Consent and Patient Safety: Ensure informed consent is properly obtained and documented. Safeguard patient confidentiality and assess any risks affecting data integrity or safety at investigator sites.
Data Management and Query Resolution: Conduct Source Document Reviews and verify that clinical data is accurate and complete. Apply query resolution techniques remotely and on-site, and ensure site compliance with electronic data capture (EDC) systems.
Investigational Product (IP) Management: Oversee IP inventory, storage, security, and administration, ensuring adherence to protocols. Address any risks related to blinded or randomized information associated with IP.
Documentation and Reporting: Maintain accurate records of site activities, including confirmation letters, trip reports, and communication logs. Support patient recruitment, retention, and awareness, and track action items to resolution.
Project and Budget Management: Understand project scope, budgets, and timelines. Manage site-level communication to ensure project objectives, timelines, and deliverables are met.
Audit Preparation: Maintain readiness for audits, and support audit preparation and follow-up actions.
Real World Late Phase: For Real World Late Phase studies, responsibilities include site management, chart abstraction, and data collection. Collaborate with sponsor affiliates, medical science liaisons, and local country staff.
Mentorship and Training: May provide training and mentorship to junior CRAs. Participate in the development of country-specific informed consent forms and identify operational efficiencies.

Qualifications

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
In-depth knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other relevant regulations.
Strong computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage required travel up to 75%.
Basic critical thinking skills and problem-solving abilities.

About Syneos Health
Over the past 5 years, Syneos Health has worked on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and managed over 200 studies across 73,000 sites and 675,000+ trial patients. We are committed to challenging the status quo in a highly competitive and dynamic environment.

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

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Sr Cra I - New Sponsor In Fsp - Turkey

Job Description

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