Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and execute assigned trial activities in line with the task matrix.

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

• Deliver assigned tasks punctually, within budget, and to a high-quality standard; raise any risks to project leads.

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

• Process documents for client eTMF, conduct eTMF reviews, manage mass mailings and communications, and produce documents and reports.

• Analyze and reconcile study metrics and findings reports.

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

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

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

• Carry out on-site feasibility visits when applicable for Asia Pacific roles.

• Facilitate scheduling for client and internal meetings.

• Review and monitor local regulatory documents when applicable.

• Assist with risk-based monitoring initiatives.

• Maintain study documentation and systems, including team lists, training requirements, system access, and activity plans.

• Transmit documents to clients and centralized IRB/IEC.

• Manage vendor trackers.

• Support regulatory submission processes.

• Collaborate with sites to gather site-selection documents.

• Assist with regulatory compliance review packages.

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

• Complete Site Interest Plans in CTMS and gather associated documents where applicable.

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

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

• Work collaboratively with teammates and clinical staff regarding deadlines, site challenges, and risks.

• Maintain a proactive site-contact and follow-up strategy, escalating any concerns or instances of non-compliance.

• Provide local insights on site capacity and experience, recommending additional sites as necessary.

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

• Contribute to global feasibility processes and best practices.

• Train new staff on processes and systems.

• Utilize local expertise 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 that equips the candidate with the necessary knowledge, skills, and abilities to perform the job, typically ranging from 0 to 1 year.

• In some instances, a combination of relevant education, training, and/or directly related experience may be deemed sufficient.

• Ability to work effectively in a team setting or independently as needed.

• Strong organizational capabilities and keen attention to detail, with a proven ability to manage multiple tasks efficiently.

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

• Strong customer service orientation.

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

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

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

• Competence in MS Office (Word, Excel, and PowerPoint) and the ability to learn clinical trial database systems.

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

• Strong oral and written communication skills.

• Good judgment and decision-making capabilities.

• Ability to adhere accurately to project work instructions.

• Negotiation skills.

• Proficiency in risk management and appropriate risk escalation.

• Willingness to travel occasionally and drive to site locations as necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.