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Cra Ii (Perth/ Adelaide)

2+ years
Not Disclosed
10 July 25, 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, 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

Description

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 outcomes that address the evolving market landscape.

Our Clinical Development model centers on our customers and patients, continuously striving to simplify and streamline our processes, making Syneos Health an organization that's not only easy to work with but also a desirable place to work. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers who innovate as a team to help our customers achieve their goals. Our agility and commitment to speeding up therapy delivery stem from our passion for making a positive impact on 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 opportunities, engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program. Our Total Self culture fosters an environment where you can be your authentic self, uniting us globally and demonstrating our commitment to our people. We continuously build the company we all want to work for and our customers want to partner with, emphasizing diversity of thought, background, culture, and perspective.

Job Responsibilities

  • Site Management: Conducts site qualification, initiation, monitoring, and close-out visits, ensuring compliance with regulatory, ICH-GCP, GPP, and protocol requirements. Evaluates site and staff performance, escalates serious issues, and develops action plans.
  • Informed Consent and Safety: Ensures proper informed consent processes, protects subject/patient confidentiality, and assesses safety and data integrity factors at sites.
  • Clinical Data Review: Performs source document review, verifies clinical data accuracy in case report forms (CRFs), and resolves queries. Utilizes technology for effective study conduct and data capture.
  • Investigational Product (IP) Management: Manages IP inventory, ensures proper dispensing and administration, and verifies compliance with GCP/local regulations.
  • Documentation and Communication: Maintains Investigator Site Files, ensures accurate documentation, supports recruitment and retention strategies, and enters data into tracking systems.
  • Project Management: Manages site-level activities, communications, and project-specific training, ensuring compliance with project objectives and timelines.
  • Audit and Inspection Readiness: Provides guidance on audit readiness, supports preparation for audits, and follows up on required actions.

Qualifications

  • Bachelor's degree or RN in a related field, or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other regulatory requirements.
  • Proficiency with computer systems and adaptability to new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage regular travel up to 75%.

Additional Information

Tasks and responsibilities in this job description are not exhaustive. The company may assign other duties as necessary. Syneos Health is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations to assist employees or applicants in performing essential job functions.

Apply for this job

Not ready to apply? Join our Talent Network to stay connected to additional career opportunities. At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your experience doesn't align perfectly, we encourage you to apply and consider transferable skills from previous roles.