Clinical Trial Coordinator

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

📋 Description

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

• Facilitate audit preparedness by conducting scheduled reviews of department, internal, country, and investigator files.

• Organize, supervise, and execute assigned trial activities as per the task matrix.

• Assist in site activation tasks and the development of critical paths for site activation.

• Create and evaluate site lists for feasibility tasks and contribute to local site tiering efforts.

• Ensure timely completion of assigned responsibilities within budget and quality standards; communicate potential risks to project leads.

• Provide system support for Activate and eTMF while ensuring databases are up to date.

• Process documents for the client eTMF, conduct eTMF reviews, distribute communications, and generate reports.

• Analyze and reconcile study metrics and findings reports; assist in resolving site documentation discrepancies.

• Coordinate materials for the Investigator Site File and Pharmacy binder, as well as non-clinical supplies and translation resources.

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

• Conduct on-site feasibility visits when applicable (Asia Pacific region only).

• Assist in scheduling client/internal meetings and tracking local regulatory documentation.

• Facilitate RBM activities and manage study documentation, training requirements, system access, and project activity plans.

• Transmit documents to the client and centralized IRB/IEC.

• Maintain vendor trackers.

• Support regulatory submissions and the collection of site selection documents.

• Prepare packages for regulatory compliance reviews.

• Collaborate with internal departments to synchronize site start-up activities with the activation critical path.

• Complete Site Interest Plans in CTMS and gather associated investigator/site personnel documents when applicable.

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

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

• Work collaboratively with teammates and clinical personnel regarding deadlines, site issues, and risks.

• Ensure effective site contact and follow-up plans, escalating concerns or instances of non-compliance.

• Act as a local expert on site capacity and experience, recommend additional sites, and support local site tiering efforts.

• Liaise with Global Investigator Services to address investigator inquiries 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.

• May serve as a buddy during the onboarding process.

⛳️ Requirements

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

• Bachelor's degree is preferred.

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

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

• Capability to work both independently and as part of a team.

• Strong organizational skills and meticulous attention to detail; adept at managing multiple tasks efficiently and effectively.

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

• Strong customer-centric approach.

• Flexibility to adjust workload priorities in response to changing project timelines.

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

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

• Proficiency in MS Office (Word, Excel, and PowerPoint) and a willingness to learn clinical trial database systems.

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

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

• Effective verbal and written communication abilities.

• Essential judgment and decision-making capabilities.

• Skill in accurately following project work instructions.

• Good negotiation skills.

• Independent thinking capability.

• Ability to manage risks and perform appropriate risk escalation.

• Occasional travel to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.