MSD Clinical Trial Coordinator 

Guatemala, Sacatepéquez, Antigua Guatemala 

469424808

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:

• Tracks and reports.
• Ensures collation and distribution of study tools and documents.
• Updates clinical trial databases and trackers.
• In charge of clinical supply & non-clinical supply management, working with other clinical research roles.
• Manages Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable).

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:

• In a timely manner, provides to and collects from investigators forms/lists for site evaluation/validation, site start-up and submissions.
• Obtains, tracks and updates study insurance certificates.
• Work with the preparation of submission packages and with regulatory agencies submissions.
• Publishes study results for clinical research and regulatory affairs where required per local legislation.

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.