Clinical Trial Coordinator

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

📋 Description

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

• Organize and facilitate project activities, potentially taking on the role of study lead.

• Serve as a cross-functional intermediary for the project team.

• Support onboarding processes by acting as a buddy and offer training to new staff as required.

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

• Coordinate, supervise, and complete designated trial activities in line with the task matrix.

• Aid in department, internal, country, and investigator file reviews, documenting findings as necessary.

• Ensure that assigned tasks are completed punctually, within budget, and meet quality standards.

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

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

• Keep the electronic Trial Master File updated and provide support for GoBalto and eTMF systems.

• Process documents, conduct eTMF reviews, manage mass mailings, and generate reports for internal team members.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Assist in resolving issues related to site documentation.

• Maintain trackers for vendors.

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

• Assist with translation materials specific to the study and ensure quality control for translations.

⛳️ Requirements

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

• Bachelor’s degree.

• Previous experience that equips you with the knowledge, skills, and abilities to perform the job, preferably at least 4 years.

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

• Ability to work collaboratively in a team or independently as needed.

• Strong organizational skills and attention to detail, capable of managing multiple tasks efficiently and effectively.

• Proficient in analyzing project-specific data/systems accurately and efficiently.

• Strong focus on customer service.

• Flexibility and adaptability to adjust workload priorities and meet evolving project timelines.

• Familiarity with applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

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

• Good presentation abilities.

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

• Capacity 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.