Clinical Trial Coordinator I

2+ years

Not Disclosed

India Remote

10 Oct. 16, 2024

Job Description

Job Type: Full Time Remote 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, we provide meaningful work that positively impacts communities worldwide. Join our team to help fulfill our mission of enabling customers to create a healthier, cleaner, and safer world. We equip our teams with the resources needed to achieve individual career aspirations while advancing science through the research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries, our PPD clinical research portfolio is at the forefront of innovative clinical research solutions, including laboratory, digital, and decentralized trial services. Your commitment to quality and accuracy will help enhance health outcomes that communities rely on—now and in the future.

Discover Impactful Work:

In this role, you will provide essential administrative and technical support, contributing to our audit readiness by ensuring compliance with established SOPs and departmental guidelines. You will assist in developing critical paths for rapid site activation within assigned projects. Leveraging local knowledge, organizational systems, and sponsor directives, you will help create and review site lists tailored to our feasibility activities and site tiering processes.

A Day in the Life:

Conduct internal, country, and investigator file reviews as assigned, documenting findings appropriately.
Ensure timely completion of tasks, maintaining high-quality standards while proactively communicating any project risks to leads.
Provide system support (e.g., Activate & eTMF) and ensure databases are current.
Perform administrative tasks for assigned trials, including document processing for Client (e)TMF, (e)TMF reviews, and distributing communications.
Assist in scheduling client and internal meetings.
Review and track local regulatory documents.
Maintain vendor trackers and support the start-up team in regulatory submissions.
Collaborate with sites to gather documents related to site selection.
Work with teammates to achieve targeted goals for assigned projects and address site issues and risks.

Keys to Success:

Education:

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

Experience:

Previous experience that equips you with the knowledge, skills, and abilities necessary for this role (approximately 6 months to 1 year).

Knowledge, Skills, Abilities:

Ability to work both independently and collaboratively within a team.
Flexibility to adapt 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 and local language skills as needed.
Good digital literacy, particularly in MS Office (Word, Excel, PowerPoint), with the ability to master all clinical trial database systems.
Effective oral and written communication skills.
Sound judgment and decision-making abilities.
Capability to accurately follow project work instructions.

Benefits: We offer competitive remuneration, an annual incentive plan, comprehensive healthcare, and a variety of employee benefits. At Thermo Fisher Scientific, you'll find an innovative, forward-thinking organization with outstanding career development opportunities. Experience a company culture rooted in integrity, intensity, involvement, and innovation!

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Clinical Trial Coordinator I

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