Clinical Trial Coordinator

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Deliver both administrative and technical assistance to the Project Team.

• Facilitate audit preparedness through organized file evaluations.

• Offer administrative aid for site activation processes.

• Assist in the creation of critical paths for site activation.

• Compile and assess site lists for feasibility studies and participate in local site tiering.

• Coordinate, manage, and finalize assigned trial tasks in accordance with the task matrix.

• Conduct reviews of departmental, internal, country, and investigator files and document observations.

• Complete assigned duties punctually, within budget, and according to quality benchmarks; communicate risks effectively.

• Support Activate and eTMF systems while ensuring databases are up-to-date.

• Process and examine eTMF documents, disseminate communications, and generate reports.

• Evaluate and reconcile study metrics and findings reports.

• Organize Investigator Site File and Pharmacy binder materials along with non-clinical supplies.

• Assist with translation materials specific to the study and oversee translation quality control.

• Stay informed about SOPs, client directives, and regulatory standards.

• Aid in scheduling meetings with clients/internal teams and track local regulatory documentation.

• Support Risk-Based Monitoring (RBM) activities and maintain study documentation/systems.

• Transmit documents to clients and centralized Institutional Review Board/Ethics Committee (IRB/IEC).

• Maintain vendor trackers and assist with regulatory submissions.

• Acquire site-selection documents directly from sites.

• Prepare packages for regulatory compliance review.

• Collaborate with internal departments to coordinate site start-up activities.

• Complete Site Interest Plans and gather related investigator/site documents.

• Document site communications, follow-ups, and survey feedback in real time.

• Review survey data for logical consistency and completeness.

• Work with teammates and clinical staff to address site-related issues and risks.

• Maintain plans for site contact and follow-ups while escalating non-compliance as necessary.

• Provide local insights on site capacity and experience, and suggest additional sites as needed.

• Collaborate with Global Investigator Services to address investigator inquiries and keep contact information updated.

• Contribute to global feasibility methodologies and best practices.

• Train new staff on processes and systems.

• Leverage local insights to identify and develop new sites.

⛳️ Requirements

• High/Secondary school diploma or equivalent, along with relevant formal academic/vocational qualifications.

• Bachelor's degree is preferred.

• Prior experience ranging from 0 to 1 year is desirable.

• A combination of appropriate education, training, and/or related experience may be acceptable.

• Ability to collaborate in a team setting or work independently.

• Strong organizational skills with meticulous attention to detail.

• Capability to manage multiple tasks efficiently and effectively.

• Ability to analyze project-specific data/systems for precision and efficiency.

• Strong customer service orientation.

• Flexibility to adjust workload priorities as needed.

• Familiarity with applicable country regulations, ICH Good Clinical Practices, organization/client SOPs, and WPDs.

• Proficient in the English language and grammar, with adequate local language skills as required.

• Skilled in using MS Office applications (Word, Excel, and PowerPoint).

• Ability to learn and excel in clinical trial database systems.

• Must complete the organization's clinical training program successfully.

• Strong oral and written communication abilities.

• Sound judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Good negotiation skills.

• Proficient in risk management and appropriate escalation of risks.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.