Clinical Trial Coordinator II

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

📋 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 all assigned tasks are completed punctually, within budget, and meet high-quality standards.

• Process client (e)TMF documents, conduct (e)TMF reviews, distribute communications, and supply documents and reports.

• Review and monitor local regulatory documents.

• Analyze and reconcile study metrics and findings reports.

• Assist in clarifying and resolving documentation issues at the site level.

• Maintain vendor tracking records.

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

• Support the creation of study-specific translation materials and oversee translation quality control.

• Provide technical and administrative project support in collaboration with internal teams and departments.

• Keep accurate trial status information in databases.

• Build and sustain relationships with local client affiliates where applicable.

• Train new staff on processes and systems.

• Assist with study documentation, systems, tools, trackers, training requirements, and system access management.

• Offer system support for Activate and eTMF, and assist with RBM activities as necessary.

• Transmit documents to clients and centralized IRB/IEC when applicable.

• Attend kickoff meetings, take notes, and organize or schedule meetings and minutes.

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

• Assist with regulatory compliance review packages and regulatory submissions.

• Gather site-selection documents and construct site lists from both internal and external sources.

• Maintain contact details for investigators and site staff in company systems.

• Complete Site Interest Plans in CTMS and document communications and follow-ups with sites.

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

• Work closely with teammates and clinical staff regarding site issues and risks.

• Ensure effective site-contact and follow-up plans, escalating any concerns or non-compliance as necessary.

• Act as a local expert on site capacity and experience, supporting local site tiering initiatives.

• Conduct interviews with physicians and site personnel concerning standard of care and protocol-level input.

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

• Contribute to global strategic feasibility processes and best practices.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• A minimum of 2 years of relevant prior experience.

• An equivalent combination of appropriate education, training, and directly related experience may be considered.

• Capability to work independently as well as collaboratively within a team.

• Strong organizational skills and meticulous attention to detail.

• Ability to effectively manage multiple tasks simultaneously.

• Competence in analyzing project-specific data and systems for both accuracy and efficiency.

• Strong focus on customer service.

• Flexibility and adaptability to changing project timelines.

• Working knowledge of relevant country regulations, ICH Good Clinical Practices, organization/client SOPs, and WPDs.

• Excellent command of the English language, with proficient local language skills as required.

• Strong presentation, negotiation, verbal, and written communication skills.

• Proficient computer skills, particularly in MS Office, including Word, Excel, and PowerPoint.

• Ability to learn and master clinical trial database systems and relevant software.

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

• Effective interpersonal skills and an ability to build relationships.

• Strong documentation quality with a keen attention to detail.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Basic organizational and planning abilities.

• Basic knowledge of local health systems.

• Familiarity with GCP and applicable SOPs.

• Ability to function effectively in a matrix environment.

• Ability to manage risks and escalate them appropriately.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Potential for occasional travel.

• Accessibility and disability accommodations during the application, interview, and job functions.

• Equal employment opportunity.