Cra Ii

5+ years

Not Disclosed

Remote, USA

10 Sept. 5, 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 - Sponsor Dedicated
Immunology/Oncology/Hematology

Syneos Health® is a premier biopharmaceutical solutions organization designed to accelerate success for our clients. We leverage unique clinical, medical affairs, and commercial insights to deliver impactful results that address the evolving market landscape.

Our Clinical Development model prioritizes the customer and patient at the core of our operations. We are committed to simplifying and streamlining our processes to make Syneos Health not only an excellent partner but also an outstanding place to work.

Join our team of dedicated professionals and collaborate with passionate problem-solvers who are driven to advance therapy delivery and make a meaningful impact. With over 29,000 employees across 110 countries, we know that:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health?

Career Development: We invest in our people through career growth opportunities, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program.
Total Self Culture: Our Total Self culture fosters authenticity and unity globally, ensuring everyone feels valued and included.
Continuous Improvement: We are dedicated to creating a workplace that reflects our diverse perspectives and promotes a sense of belonging.

Job Responsibilities:

Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely), ensuring adherence to regulatory standards, ICH-GCP, and protocol compliance. Assess site performance and address serious issues with the project team, developing action plans as needed.
Informed Consent: Ensure informed consent is properly obtained and documented, safeguarding patient confidentiality and assessing factors that might impact patient safety and data integrity.
Data Verification: Assess site processes, perform source document reviews, verify the accuracy and completeness of clinical data in case report forms (CRFs), and resolve queries both remotely and on-site.
Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and security. Ensure IP is dispensed and administered per protocol, and manage any issues related to blinded or randomized information.
Documentation: Maintain and reconcile Investigator Site File (ISF) and Trial Master File (TMF) documentation, ensuring compliance with archiving requirements. Document activities through various means such as confirmation letters, trip reports, and communication logs.
Project Management: Understand project scope, budgets, and timelines; manage site-level activities and communication to meet project objectives. Adapt quickly to changing priorities to achieve goals.
Liaison Role: Serve as the primary contact with study site personnel or collaborate with Central Monitoring Associates. Ensure site and project team compliance with requirements.
Meetings and Training: Prepare for and attend Investigator Meetings and sponsor face-to-face meetings. Participate in global clinical monitoring/project staff meetings and relevant training sessions.
Audit Readiness: Provide guidance on audit readiness standards, support audit preparations, and follow-up actions.
Real World Late Phase (if applicable): For Real World Late Phase studies, perform site support from identification through close-out, conduct chart abstraction and data collection, collaborate with sponsor affiliates, and suggest potential sites based on local knowledge.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Strong knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
Proficiency in computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel regularly.

Get to Know Syneos Health

Over the past five years, Syneos Health has been involved with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and more than 675,000 trial patients.

At Syneos Health, you'll challenge the status quo in a dynamic and competitive environment. Learn more about us and explore opportunities to join our team.

Additional Information:

The responsibilities outlined in this job description are not exhaustive. Syneos Health may assign other tasks or responsibilities at its discretion. We consider equivalent experience and qualifications, and the company determines the equivalency of qualifications. Nothing in this description should be interpreted as creating an employment contract. We are committed to compliance with the Americans with Disabilities Act and offer reasonable accommodations to assist employees or applicants in performing essential job functions.

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At Syneos Health, we value diversity and encourage all qualified individuals to apply, even if your experience does not align perfectly with the listed requirements. We also consider transferable skills from previous roles.

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