Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and execute designated trial activities as per the task matrix.

• Conduct reviews of department, internal, country, and investigator files, documenting the findings.

• Ensure that assigned tasks are completed punctually, within budget, and to a high quality standard.

• Communicate project risks to project leaders and the line manager.

• Maintain documentation, systems, tools, trackers, and (e)TMF records specific to the study.

• Provide support for GoBalto and eTMF systems.

• Assist with RBM activities.

• Handle trial administration tasks, including document processing, (e)TMF reviews, mass mailings, communications, and reporting.

• Schedule and organize meetings with clients and internal teams, and document meeting minutes.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Aid in clarifying and resolving site documentation findings.

• Maintain vendor trackers.

• Assist with materials for the Investigator Site File and Pharmacy binder, as well as non-clinical study supplies.

• Support the preparation of study-specific translation materials and ensure translation quality control.

• Attend kickoff meetings and take notes when necessary.

• Act as a cross-functional liaison and potential study lead.

• Facilitate onboarding by serving as a buddy and training new staff members.

• Contribute to departmental and cross-functional process improvement initiatives.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• A minimum of 4 years of comparable experience.

• A combination of relevant education, training, and/or directly related experience may be considered as equivalent.

• Capability to work independently or collaboratively within a team.

• Strong organizational abilities and attention to detail.

• Proficient in managing multiple tasks both efficiently and effectively.

• Ability to analyze project-specific data and systems.

• Strong customer-focused mindset.

• Flexibility and adaptability to changing project timelines.

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

• Excellent command of the English language and grammar, with proficient local language skills as necessary.

• Good presentation capabilities.

• Proficient computer skills, particularly in MS Office, including Word, Excel, and PowerPoint.

• Ability to learn and master clinical trial database systems.

• Capability to successfully complete the PPD clinical training program.

• Self-motivated with a positive attitude and strong interpersonal skills.

• Occasional driving to site locations and potential travel may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Potential for occasional travel.

• Reasonable accommodations for individuals with disabilities.

• Benefits and privileges of employment.