Clinical Trial Coordinator

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

📋 Description

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

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

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

• Provide system support for Activate and eTMF, ensuring that system databases are kept up to date.

• Process documents for Client (e)TMF, carry out (e)TMF reviews, distribute communications, and generate reports.

• Analyze and reconcile study metrics and findings reports.

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

• Help with study-specific translation materials and oversee translation quality control.

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

• Conduct on-site feasibility visits as necessary for Asia Pacific roles.

• Aid in scheduling client and internal meetings.

• Review and monitor local regulatory documents.

• Support risk-based monitoring activities.

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

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers updated.

• Assist with regulatory submissions and site start-up activities.

• Acquire site-selection documents directly from sites.

• Prepare packages for regulatory compliance reviews.

• Complete Site Interest Plans in CTMS and gather corresponding investigator/site documents.

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

• Review survey data to ensure logical, complete, and relevant responses.

• Collaborate with team members and clinical personnel regarding deadlines, site issues, and risks.

• Ensure effective site contact and follow-up plans while escalating concerns or non-compliance as needed.

• Provide local insights on site capacity and experience, recommending additional sites when appropriate.

• Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information.

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

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

• Equivalency through a combination of suitable education, training, and/or directly related experience may be considered.

• Ability to work effectively in a team or independently.

• Strong organizational skills and a keen attention to detail.

• Ability to accurately and efficiently analyze project-specific data/systems.

• Strong customer orientation.

• Flexibility to adjust workload priorities as needed.

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

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

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

• Capability to learn and master clinical trial database systems.

• Ability to successfully complete the organization's clinical training program.

• Effective oral and written communication skills.

• Essential judgment and decision-making abilities.

• Ability to accurately adhere to project work instructions.

• Good negotiation skills.

• Ability to manage risk and escalate issues appropriately.

• Occasional travel may be necessary.

• Occasional driving to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.