Job Description
Job Description
Under the oversight of the line-manager, this role is responsible for comprehensive trial andsite administrationand involves preparing, collating, distributing and archiving clinical documents.
The Clinical Trial Coordinator, CTC Shipment, supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
Responsibilities include, but are not limited to:
Trial and site administration:
- Clinical supply and Non-clinical supply management (mainly focus on import and export activities), in collaboration with other country roles.
- Update clinical trial databases, report and trackers as required.
- Ensure collaboration and distribution of study tools and documents
Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents
- Assist with eTMF reconciliation and execute eTMF Quality Control Plan
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
Agreement and Payments:Collaborate with finance/budgeting representatives for:
- Be responsible for payment request and issuance of payment for import/export activities
- Ensure adherence to financial and compliance procedures
- Monitor and track adherence and disclosures
- Maintain tracking tools
- Obtain and process FCPA documentation in a timely manner
Skills:
- Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
- ICH-GCP Knowledge appropriate to role
- Excellent negotiation skills for CTCs in finance area
- Effective time management, organizational and interpersonal skills, conflict management
- Effective communication with external customers (e.g. sites and investigators)
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus, both internally and externally.
- Able to work independently
- • Proactive attitude to solving problems / proposing solutions
- Positive mindset, growth mindset
Qualification & Experience:
- Bachelor’s Degree
- Having a background in logistics would be beneficial for this position, although it is not a requirement.
Current Contingent Workers apply
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