Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and finalize designated trial activities as per the task matrix.

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

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

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

• Process and review trial documentation, distribute communications, and generate reports for internal team members.

• Analyze and reconcile study metrics along with findings reports.

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

• Assist with translation materials specific to studies and ensure translation quality control.

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

• Support tasks including meeting scheduling, local regulatory document tracking, RBM activities, documentation, access management, and activity planning.

• Send documents to clients and centralized IRB/IEC.

• Maintain vendor tracking records and assist with regulatory submissions.

• Collaborate directly with sites to collect site-selection documents.

• Aid in the preparation of regulatory compliance review packages and site activation efforts.

• Complete Site Interest Plans in CTMS and gather relevant investigator/site documents when necessary.

• Record communications with sites, follow-ups, and survey responses in real-time.

• Evaluate survey data for logical consistency, completeness, and accuracy of responses.

• Work collaboratively with teammates and clinical staff to meet deadlines and address site challenges and risks.

• Develop and implement site contact and follow-up strategies, raising concerns or instances of non-compliance as needed.

• Provide local insights on site capacity, experience, tiering, and identification of new sites.

• Coordinate with Global Investigator Services to address investigator inquiries and maintain account/contact details.

• Contribute to global feasibility assessments and best practices.

• Train new staff on procedures and systems.

⛳️ Requirements

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

• Prior experience ranging from 0 to 1 year is preferred.

• A Bachelor's degree is preferred.

• Strong English language skills and proficient local language skills as required.

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

• Capability to learn and master all clinical trial database systems.

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

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

• Capacity to accurately adhere to project work instructions.

• Skill in managing risk and appropriately escalating issues.

• Occasional driving to site locations and potential for occasional travel may be required.

🏝️ Benefits

• Fully remote work environment.

• Standard work schedule from Monday to Friday.

• Occasional travel may be needed.

• Training provided for new staff along with a clinical training program.