Job Description
Under the oversight of the line-manager, this role is charge of the comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents.
The Clinical Trial Coordinator works with clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to the Health Authorities. The role will work closely with the different Clinical Research roles, at the local level.
Primary Responsibilities:
Trial and site administration:
Document management:
- Prepares documents and correspondence.
- Collates, distributes/ships, and archives clinical documents.
- Assists with reconciliations.
- Executes Quality Control Plan.
- Updates manuals/documents (e.g., patient diaries, instructions).
- Documents proper destruction of clinical supplies.
- Prepares Investigator trial file binders.
- Obtains translations of documents.
Regulatory & Site Start-Up:
Requirements:
- Bachelor´s Degree in Office Management, Business Administration or a related field.
- Minimum two (2) years of experience in clinical research and regulatory processes.
Skills:
- Fluent in Spanish and business proficient in English (verbal and written).
- Effective communication skills.
- Knowledge of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proficient in with Microsoft office, use of some clinical Information Technology applications on computer) and ability to adapt to new IT applications.
- Proficient in Excel.
- Negotiation skills.
- Effective time management, organizational and interpersonal skills.
- 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.
- Customer focused, internally and externally.
- Able to work independently.
- Proactive attitude to solving problems / proposing solutions
- Positive mindset, growth mindset
Current Contingent Workers apply
No Travel Required
1st - Day
*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.