Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and execute assigned trial activities in accordance with the task matrix.

• Assist with department, internal, country, and investigator file reviews while documenting findings.

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

• Communicate potential project risks to project leads and the line manager.

• Maintain study documentation, team lists, training trackers, system access, and project activity plans.

• Keep the electronic Trial Master File (eTMF) updated and document findings from file reviews.

• Provide system support using GoBalto and eTMF platforms.

• Process documents directed to the Client eTMF, conduct eTMF reviews, handle mass mailings, communications, and generate reports.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Assist with clarifying and resolving site documentation findings.

• Maintain vendor trackers.

• Coordinate, compile, and distribute materials for the Investigator Site File, Pharmacy binder, and non-clinical study supplies.

• Assist with study-specific translation materials and ensure translation quality control.

• Coordinate and facilitate project activities; may serve as the study lead and cross-functional liaison.

• Mentor new staff during onboarding and provide training as required.

• Support departmental and cross-functional initiatives aimed at process improvement.

• Occasionally travel to site locations.

⛳️ Requirements

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

• Bachelor's degree.

• Previous experience that provides the necessary knowledge, skills, and abilities to perform the job is preferred (equivalent to at least 4 years).

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

• Ability to work effectively in a team or independently as necessary.

• Strong organizational skills and attention to detail, with the ability to manage multiple tasks efficiently and effectively.

• Capacity to analyze project-specific data/systems to ensure accuracy and efficiency.

• Strong customer focus.

• Flexibility and adaptability to reprioritize workload and meet changing project timelines.

• Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

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

• Good presentation skills.

• Excellent computer skills; proficiency in MS Office applications (Word, Excel, and PowerPoint).

• Ability to learn and master clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

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

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.