Clinical Trial Coordinator

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

📋 Description

• Offer administrative and technical support to the Project Team.

• Assist in audit readiness by conducting scheduled reviews of department, internal, country, and investigator files.

• Provide administrative assistance for site activation and contribute to the development of critical paths for site activation.

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

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

• Record findings in relevant systems and proactively communicate any project risks.

• Provide support for Activate and eTMF systems, ensuring databases are kept up to date.

• Process and review eTMF documents, manage mailings and communications, and produce reports for internal teams.

• Analyze and reconcile study metrics and findings reports.

• Coordinate materials for Investigator Site Files and Pharmacy binders, along with non-clinical study supplies.

• Assist with study-specific translation materials and oversee translation quality control.

• Aid in scheduling client and internal meetings and track local regulatory documents.

• Support RBM activities along with study-specific documentation, training tracking, system access, and activity plans.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

• Collaborate with sites to gather site-selection documents and support regulatory compliance review packages.

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

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

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

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

• Collaborate with teammates and clinical personnel to meet project deadlines and resolve site issues and risks.

• Maintain site contact and follow-up plans while escalating any non-compliance concerns.

• Serve as a local expert on site capacity and experience, recommend additional sites, and assist in local site tiering.

• 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 personnel in processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Prior experience equipped with the knowledge, skills, and abilities necessary for the role (typically 0 to 1 year).

• Bachelor's degree is preferred.

• Capability to work collaboratively in a team or independently as needed.

• Strong organizational skills and keen attention to detail; ability to manage multiple tasks efficiently and effectively.

• Proficient in analyzing project-specific data/systems for accuracy and efficiency.

• Strong focus on customer service.

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

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

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

• Proficient in MS Office (Word, Excel, and PowerPoint) and capable of learning clinical trial database systems.

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

• Strong oral and written communication, interpersonal skills, judgment, decision-making, negotiation, risk management, and adherence to work instructions.

• High level of self-motivation and a positive attitude.

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

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.