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Job Description
Responsibilities include, but are not limited to:
o Trial and site administration:
• Track (e.g. essential documents) and report
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
o 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.
o 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
• 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
• Obtain and process FCPA documentation in a timely manner
Current Contingent Workers apply
Language(s) Job Description:
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
Behavioral 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
• Positive mindset, growth mindset, capable of working independently with assigned tasks
• Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required
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.
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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