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Clinical Trial Coordinator
3 weeks ago
**ASSIGNMENT PROFILE**
**Clinical Trial Coordinator (CTC)**
**Description of Roles and Responsibilities**
- **Trial and site administration**:
- Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request
**Document management**:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents
- Assist with eTMF reconciliation
- Updating manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Execute eTMF Quality Control Plan
- Obtain translations of documents
- **Regulatory & Site Start-Up responsibilities**:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
- **Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for**:
- Develop country and site budgets (including Split site budget)
- Tracking, and reporting of negotiations
- Maintenance of tracking tools
- Contract development, negotiation, approval and maintenance (e.g. CTRAs)
- Update and maintain contract templates (in cooperation with Legal Department)
- Payment calculation and execution (investigators, vendors, grants)
- Ensure compliance with financial procedures
- Monitor and track adherence and disclosures,
- Budget closeout.
- **Meeting Planning**:
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
**Experience Required**
Minimum 1-2 years in Clinical Research or relevant healthcare experience
Note - Specific experience requirements may vary depending on the Country
CRA R CTC Role Profile 07-Jun-2017
**Educational Requirements**
B.A./B.S. (Life Science preferred) or equivalent healthcare experience
CORE Competency Expectations
- 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
Behavioural Competency Expectations
- 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.
- Able to work independently
- Proactive attitude to solving problems / proposing solutions
