Clinical Trial Coordinator

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

📋 Description

• Offer 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 activities related to site activation.

• Aid in the development of critical paths for site activation.

• Compile and review site lists for feasibility studies and contribute local insights into site tiering.

• Coordinate, manage, and execute assigned trial activities as per the task matrix.

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

• Ensure that assigned tasks are completed promptly, within budget constraints, and to high-quality standards.

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

• Process documents for client eTMF, conduct eTMF reviews, manage mailings and communications, and supply 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.

• Support the translation of materials and oversee translation quality control.

• Maintain awareness of SOPs, client directives, and regulatory guidelines.

• Assist in scheduling client/internal meetings and tracking local regulatory documents.

• Support RBM activities and maintain study documentation/system.

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers up to date.

• Assist with regulatory submissions and gather site selection documents.

• Prepare packages for regulatory compliance reviews.

• Collaborate with internal departments to synchronize site start-up activities.

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

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

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

• Work with teammates and clinical personnel to address site issues and risks.

• Maintain plans for site contact and follow-ups, escalating concerns or non-compliance as necessary.

• Provide local expertise on site capacity and experience, recommending additional sites as needed.

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

• Contribute to global strategic feasibility processes and best practices.

• Train new staff on processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

• High/Secondary school diploma or an equivalent relevant formal academic/vocational qualification.

• Bachelor's degree is preferred.

• Prior experience of 0 to 1 year in a similar role.

• An equivalency of suitable education, training, and/or directly related experience may be taken into account.

• Capability to work independently or collaboratively in a team setting.

• Strong organizational skills and meticulous attention to detail.

• Proficiency in managing multiple tasks efficiently and effectively.

• Ability to analyze project-specific data/systems with accuracy and efficiency.

• Strong focus on customer service.

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

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

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

• Proficiency in MS Office applications, including Word, Excel, and PowerPoint.

• Capability to learn and master clinical trial database systems.

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

• Effective verbal and written communication skills.

• Strong judgment and decision-making abilities.

• Skill in accurately following project work instructions.

• Good negotiation capabilities.

• Ability to manage risk and perform necessary risk escalation.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.