Sr/ Clinical Trial Coordinator - Clintec position
Descripción del trabajo
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 o Clinical supply & non-clinical supply management, in collaboration with other country roles o Manage Labeling requirements and coordinate/sign translation change request
- Prepare documents and correspondence o Collate, distribute/ship, and archive clinical documents
- Assist with eTMF reconciliation o Updating manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies. o 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.
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
- Minimum 1-2 years in Clinical Research or relevant healthcare experience
- B.A./B.S. (Life Science preferred) or equivalent healthcare experience
- 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
- Location: Hibrid model in Athens (3 days in the office)
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
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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