Cra Ii - Fsp - Anywhere In Turkey

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) - Oncology Experience Preferred - FSP - Anywhere in Turkey
Syneos Health®

About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We leverage unique clinical, medical affairs, and commercial insights to deliver outcomes that address modern market realities. Our Clinical Development model centers on the customer and the patient, continuously streamlining processes to make Syneos Health easier to work with and for.

Whether working in a Functional Service Provider (FSP) partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals. We are agile, driven, and passionate about accelerating the delivery of therapies that change lives.

Join Syneos Health and discover why 29,000 employees across 110 countries are dedicated to making an impact: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?
At Syneos Health, we focus on career development and progression through supportive management, training in therapeutic areas, peer recognition, and a total rewards program. We foster a Total Self culture that encourages you to be authentic and thrive in a diverse, inclusive, and engaged environment. Together, we create a workplace where everyone belongs.

Job Responsibilities

Site Qualification and Monitoring: Perform site initiation, monitoring, interim monitoring, and close-out visits (both on-site and remotely) while ensuring regulatory, ICH-GCP, and protocol compliance. Use judgment and experience to assess site performance and escalate any serious issues to the project team.
Informed Consent & Patient Safety: Ensure informed consent is obtained and documented for all subjects/patients, protecting their confidentiality and monitoring clinical data integrity at investigator sites.
Source Document Review and Data Accuracy: Conduct Source Document Reviews to ensure clinical data entered in case report forms (CRF) is accurate and complete. Resolve data queries and drive query closure in a timely manner.
Investigational Product Management: Oversee investigational product (IP) inventory, reconciliation, storage, and security. Ensure IP dispensation and administration follow protocol requirements.
Documentation and Reporting: Maintain accurate records through confirmation letters, trip reports, communication logs, and other required documents. Ensure proper archiving of essential documents and support subject recruitment and retention efforts.
Project Management and Site Liaison: Manage site-level communication, ensuring project timelines, deliverables, and objectives are met. May act as the primary liaison with study site personnel and collaborate with other teams for training and compliance.
Audit Preparation and Compliance: Guide sites in maintaining audit readiness standards, preparing for audits, and addressing any follow-up actions.
Investigator Meetings and Training: Attend and prepare for investigator meetings, sponsor meetings, and clinical training sessions according to project requirements.

Qualifications

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Strong knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements.
Proficiency in computer systems and ability to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75% for monitoring visits.

About Syneos Health
Syneos Health has been at the forefront of clinical trials, working with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. We have conducted over 200 studies across 73,000 sites and with 675,000+ trial patients.

As part of Syneos Health, you’ll have the opportunity to innovate, challenge the status quo, and grow in a competitive, dynamic environment.

Learn more about Syneos Health and explore how WORK HERE MATTERS EVERYWHERE.

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Cra Ii - Fsp - Anywhere In Turkey

Job Description

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