SUMMARY: The Site Contracts Specialist is responsible for the development, dissemination, negotiation and finalization of clinical study and investigator agreements and related documents between sponsors and clinical research sites.
Tasks may include but are not limited to
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
- Drafting, reviewing and analyzing site, investigator and other project-related contracts
- Negotiation and finalization or assistance in negotiation and finalization of clinical trial contracts and services contracts with WCT Legal Department, study team, Sponsors, investigators and/or clinical sites, amending and terminating such contracts
- Development and negotiation or assistance in development and negotiation of new investigators/site contracts and/or country contract templates as well as addenda to them
- Manage execution (including signature process) of contracts with sites, investigators and other project-related contracts as applicable
- Reviewing study budgets and costs pertaining to contract negotiation
- Liaising with WCT Legal Department, study teams, sponsor, sites and investigators
- Representation of the Company in relations with clinical sites, investigators, other parties and project-related vendors, as applicable
- Performing legal translation and/or proofreading of contracts with clinical sites/investigators
- Develop, monitor, track and process new and amended investigator/site contracts and other project-related contracts.
- Review contracts and other documents for completeness and accuracy.
- Maintain and update hard-copy and electronic contract files.
- CTMS entry, maintenance and regular update as assigned
OTHER SKILLS AND ABILITIES:
- Excellent negotiation skills and knowledge of clinical trial agreements.
- Computer literacy and confidence in working with legislation databases, document, spreadsheet and other office software
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
- Bachelor's Degree or equivalent in business administration, finance, science or related field.
- At least 1 year of experience working with investigator/site contracts.
- Experience in Clinical Research Pharmaceutical or CRO industry.
- Knowledge of ICH CGP and local country legislation in the sphere of clinical trials
Worldwide Clinical Trials - 22 months ago
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About Worldwide Clinical Trials
Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...