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Clinical Trial Coordinator I

1+ years
Not Disclosed
10 Oct. 14, 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 Description

At Thermo Fisher Scientific, you'll find meaningful work that positively impacts the world. Join our dedicated team in bringing our mission to life—enabling our customers to create a healthier, cleaner, and safer planet. We equip our employees with the resources they need to achieve their career goals while advancing science through innovative research, development, and the delivery of life-changing therapies. With clinical trials conducted in over 100 countries, our PPD clinical research portfolio spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will enhance health outcomes that communities depend on now and in the future.

Discover Impactful Work

As part of our team, you'll provide administrative and technical support, ensuring audit readiness by reviewing files according to established schedules and guidelines. You'll contribute to developing critical paths for site activation within assigned projects to facilitate rapid site activations. Using local insights, organizational systems, and sponsor directives, you’ll help create and review site lists that align with feasibility activities and local tiering processes.

A Day in the Life

  • Conduct internal and investigator file reviews and document findings in the appropriate systems.

  • Ensure tasks are completed on time, within budget, and to a high-quality standard, proactively communicating risks to project leads.

  • Provide system support (e.g., Activate & eTMF) and maintain current databases.

  • Handle administrative tasks for assigned trials, including processing documents for the Client (e)TMF, performing (e)TMF reviews, and distributing communications.

  • Assist in scheduling client and internal meetings as needed.

  • Review and track local regulatory documents.

  • Maintain vendor trackers and support the start-up team in regulatory submissions.

  • Collaborate with sites to gather necessary documents for site selection.

  • Work closely with teammates to achieve project goals and communicate site issues and risks effectively.

Keys to Success

Education

  • Relevant formal academic or vocational qualification; a Bachelor's degree is preferred.

Experience

  • Previous experience that provides the knowledge and skills necessary for the role (6 months to 1 year preferred).

Knowledge, Skills, Abilities

  • Ability to work independently or as part of a team.

  • Flexibility to adjust priorities based on changing project timelines.

  • Strong understanding of applicable country regulations, ICH Good Clinical Practices, and organizational/Client SOPs and WPDs.

  • Proficient English language skills, with strong local language skills as needed.

  • Good digital literacy, including proficiency in MS Office (Word, Excel, PowerPoint) and familiarity with clinical trial database systems.

  • Effective oral and written communication skills.

  • Strong judgment and decision-making capabilities.

  • Ability to accurately follow project work instructions.

Benefits

We offer competitive remuneration, an annual incentive plan bonus, comprehensive healthcare, and a variety of employee benefits. At Thermo Fisher Scientific, you’ll join an innovative, forward-thinking organization with excellent career development prospects. Our company culture embodies integrity, intensity, involvement, and innovation!