Sr Cra I - Oncology / Gen Med

5+ years

$72,540 - $145,000

Remote - Europe

10 Aug. 12, 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

Job Title: Senior Clinical Research Associate I

Company Overview

Syneos Health® is a global leader in biopharmaceutical solutions, dedicated to accelerating customer success by translating unique clinical, medical affairs, and commercial insights into impactful outcomes. Our mission is to keep the customer and patient at the center of our work, continuously seeking ways to simplify and enhance our processes.

Why Join Us?

At Syneos Health, we are committed to developing our people through career progression, supportive management, technical training, and a total rewards program. Our Total Self culture encourages authenticity and diversity, creating an inclusive environment where everyone feels they belong.

Job Responsibilities

Site Management: Perform site qualification, initiation, monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory, ICH-GCP, and protocol standards.
Compliance and Quality: Evaluate site performance, address serious issues, and develop action plans. Ensure informed consent processes are properly conducted and documented.
Data Verification: Review site source documents and medical records, verify clinical data accuracy, resolve queries, and ensure compliance with electronic data capture requirements.
Investigational Product Management: Manage IP inventory, verify dispensing, and ensure compliance with labeling and storage regulations.
Documentation and Reporting: Maintain and reconcile Investigator Site Files and Trial Master Files, document activities, and support recruitment and retention strategies.
Project Management: Understand project scope, budgets, and timelines, adapt to changing priorities, and act as a primary liaison with site personnel. Provide guidance on audit readiness and mentor junior CRAs.
Additional Duties: Support real-world late-phase study activities, collaborate with various teams, suggest site improvements, and participate in bid defense meetings.

Qualifications

Education: Bachelor’s degree or RN in a related field, or equivalent education and experience.
Experience: Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements. Experience with site management and clinical data review.
Skills: Strong computer skills, excellent communication and interpersonal abilities, critical thinking, and the ability to travel up to 75% regularly.

Additional Information

Salary Range: $72,540 - $145,000 annually, based on qualifications and experience.
Benefits: Includes a company car or allowance, health benefits (Medical, Dental, Vision), 401k match, Employee Stock Purchase Plan eligibility, performance-based bonuses, and flexible PTO and sick time.

Apply Now

Interested candidates are encouraged to apply. If you are not ready to apply, join our Talent Network to stay connected with future opportunities.

Syneos Health values diversity and encourages all qualified individuals to apply. We consider transferrable skills and are committed to providing reasonable accommodations for applicants with disabilities.

For more information or to apply, visit our careers page.

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Sr Cra I - Oncology / Gen Med

Job Description

Job Title: Senior Clinical Research Associate I

Company Overview

Why Join Us?

Job Responsibilities

Qualifications

Additional Information

Apply Now

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