Clinical Trial Coordinator
3 weeks ago
**Clinical Trial Coordinator (CTC Shipment)**
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and 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.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level
closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.
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
- 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.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
12/27/2024
**Requisition ID**:R325252
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