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Clinical Trials Coordinator

Aplica ya
Mapa de ubicación: Tel Aviv, Israel Full time R1250657

Descripción del trabajo

Responsibilities include, but are not limited to: 


Trial and site administration: 
- Track (e.g. essential documents) and report (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, e.g. eTMF 
- Assist with eTMF reconciliation 
- Execute eTMF Quality Control Plan 
- Update manuals/documents (e.g., patient diaries, instructions) 
- Document proper destruction of clinical supplies. 
- Prepare Investigator trial file binders 
- Obtain translations of documents 

Regulatory & Site Start-Up responsibilities:

-Collaborate with other country roles to: 
- 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, control, update and close-out country and site budgets (including Split site budget) 
- Develop, negotiate, approve and maintain contracts (e.g. CTRAs) 
- Track and report contract negotiations 
- Update and maintain contract templates (in cooperation with Legal Department) 
- Calculate and execute payments (to investigators, vendors, grants) 
- Ensure adherence to financial and compliance procedures 
- Monitor and track adherence and disclosures, 
- Maintain tracking tools 

- Meeting Planning: 
- Organize meetings (create & track study memos/letters/protocols) 
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable) 

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 
- 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 

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, both internally and externally. 
- Able to work independently 
- Proactive attitude to solving problems / proposing solutions 

Experience Requirements: 
• Minimum 1 - 2 years in Clinical Research or relevant healthcare experience 

Educational Requirements: 
• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience

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.

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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