Clinical Trial Coordinator

Job Description

Under the oversight of the line-manager this role is responsible for comprehensive trial and site administration and involves preparing collating distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools as applicable.

The role is critical to meeting planned Site Ready dates including assisting finance/budgeting representatives in managing CTRAs and payments. The role will collaborate closely at the local level with COM CRM and CRA.

Responsibilities include but are not limited to:

Trial and site administration:

o Track (e.g. essential documents)

o Ensure collation and distribution of study tools and documents

o Update clinical trial databases (CTMS) and trackers

Document management:

o Prepare documents and correspondence

o Collate distribute/ship and archive clinical documents e.g. eTMF

o Assist with eTMF reconciliation

o Execute eTMF Quality Control Plan

o Prepare Investigator trial file binders

o Obtain translations of documents

Budgeting Agreement and Payments:

Collaborate with finance/budgeting representatives for:

o Develop control update and close-out country and site budgets (including Split site budget)

o Develop negotiate approve and maintain contracts (e.g. CTRAs)

o Track and report contract negotiations

o Update and maintain contract templates (in cooperation with Legal Department)

o Calculate and execute payments (to investigators vendors grants)

o Ensure adherence to financial and compliance procedures

o Monitor and track adherence and disclosures

o Maintain tracking tools

o Obtain and process FCPA documentation in a timely manner

Main requirements:

• Bachelors Degree;

• Fluent in Portuguese and business proficient in English (verbal and written) andexcellent communication skills;

• Good understanding of Global Country/Regional Clinical Research Guidelines and ability towork within these guidelines;

• Hands on knowledge of Good Documentation Practices;

• Good Information Technology skills. Strong Microsoft Excel skills required;

• International Conference on Harmonisation Good Clinical Practice Knowledge appropriate to role;

• Excellent negotiation skills;

• Effective time management organizational and interpersonal skills conflict management;

• Effective communication with external customers;

• High sense of accountability / urgency. Ability to set priorities and handle multiple taskssimultaneously in a changing environment;

• Works effectively in a matrix multicultural environment. Ability to establish and maintainculturally sensitive working relationships;

• Demonstrates commitment to Customer focus both internally and externally;

• Able to work independently.

#ClinicalTrialsBR

Required Skills:

Preferred Skills:

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Relocation:

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