Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Facilitate audit readiness by conducting scheduled file reviews in accordance with SOPs and departmental guidelines.

• Provide administrative support for site activation processes.

• Assist in creating critical paths for site activation.

• Develop and assess site lists for feasibility studies and offer local insights regarding site tiering.

• Coordinate and execute assigned trial tasks as outlined in the task matrix.

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

• Complete assigned tasks punctually, within budget, and to quality standards; communicate risks to project leads.

• Support Activate and eTMF systems while ensuring databases are up-to-date.

• Process documents for client eTMF, perform eTMF 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 non-clinical study supplies.

• Provide support for translation materials and quality control of translations.

• Conduct on-site feasibility visits when necessary in the Asia Pacific region.

• Organize client and internal meetings as required.

• Review and monitor local regulatory documents as needed.

• Support RBM activities along with study-specific documentation and systems.

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

• Maintain vendor trackers.

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

• Collaborate with sites to gather site-selection documentation.

• Prepare packages for regulatory compliance reviews.

• Coordinate with internal departments to synchronize site start-up tasks.

• Complete Site Interest Plans in CTMS and gather related investigator/site documents as necessary.

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

• Evaluate survey data for logical consistency, completeness, and relevance.

• Work collaboratively with teammates and clinical personnel on deadlines, site-related issues, and risks.

• Maintain site contact and follow-up plans, escalating non-compliance as needed.

• Provide local expertise regarding site capacity and experience, recommending additional sites as necessary.

• Liaise with Global Investigator Services to address investigator inquiries and maintain account/contact information.

• Contribute to global feasibility processes and best practices.

• Train new staff on processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience of approximately 0 to 1 year is desirable.

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

• Ability to work effectively within a team or independently.

• Strong organizational skills and keen attention to detail.

• Capacity to manage multiple tasks efficiently and effectively.

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

• Strong customer focus is essential.

• Flexibility to adjust workload priorities as needed.

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

• Good command of the English language and grammar.

• Proficient in the local language as required.

• Competence in MS Office (Word, Excel, PowerPoint).

• Ability to learn and master clinical trial database systems.

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

• Effective oral and written communication skills.

• Essential judgment and decision-making abilities.

• Ability to strictly follow project work instructions.

• Good negotiation skills.

• Ability to manage risk and appropriately escalate concerns.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.

• Potential for occasional travel.

• Training and onboarding support.

• Opportunity to collaborate with global pharmaceutical and biotech companies.

• Professional development through a clinical training program.