Clinical Trial Coordinator

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

📋 Description

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

• Facilitate audit preparedness by ensuring that files are reviewed in accordance with organizational SOPs and departmental guidelines.

• Provide administrative support during site activation activities and assist in the development of the site activation critical path.

• Create and assess site lists for feasibility activities while contributing local insights for site tiering.

• Coordinate, supervise, and complete assigned trial activities per the task matrix.

• Conduct department, internal, country, and investigator file reviews and document the findings.

• Ensure that assigned tasks are completed punctually, within budget, and to a high-quality standard; communicate any risks to project leads.

• Offer system support for Activate and eTMF while maintaining current system databases.

• Process documents to the Client eTMF, carry out eTMF reviews, disseminate communications, and provide documents and reports to internal team members.

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

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

• Aid in the creation of study-specific translation materials and ensure translation quality control.

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

• Assist with scheduling client/internal meetings, tracking local regulatory documents, RBM activities, 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 site activation critical path.

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

• Document communications, follow-ups, and survey responses in real time; review survey data for completeness and logical consistency.

• Work collaboratively with teammates and clinical personnel regarding site issues, risks, deadlines, and follow-up strategies.

• Serve as a local authority on site capacity and experience; recommend additional sites and conduct local site tiering.

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

• Contribute to global strategic feasibility processes and best practices.

• Train new personnel in processes and systems.

• Leverage local knowledge to identify and develop new sites.

• Conduct on-site feasibility visits as needed in the Asia Pacific region.

⛳️ Requirements

• Bachelor's degree.

• Prior experience that provides the necessary knowledge, skills, and abilities for the role, typically 0 to 1 year.

• An equivalent combination of relevant education, training, and/or directly related experience may be deemed sufficient.

• Capability to work both in a team and independently as needed.

• Strong organizational abilities and keen attention to detail, with a proven track record of efficiently handling multiple tasks.

• Competence in effectively analyzing project-specific data/systems to ensure accuracy and efficiency.

• Strong customer service orientation.

• Adaptability to reprioritize workload in response to changing project timelines.

• Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

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

• Good computer skills, with proficiency in MS Office (Word, Excel, and PowerPoint) and the ability to learn clinical trial database systems.

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

• Effective oral and written communication skills.

• Strong judgment and decision-making capabilities.

• Ability to accurately adhere to project work instructions.

• Good negotiation skills.

• Ability to manage risk and perform risk escalation appropriately.

• Occasional travel to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.