Clinical Trial Coordinator I

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Facilitate audit preparedness through scheduled file assessments in accordance with SOPs and departmental guidelines.

• Aid in site activation processes and the formulation of critical paths for site activation.

• Create and evaluate site lists for feasibility assessments and assist in local site tiering.

• Organize, supervise, and execute assigned trial activities as per the task matrix.

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

• Complete assigned tasks punctually, within budget, and to quality specifications; communicate risks to project leaders.

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

• Process documents for client eTMF, conduct eTMF evaluations, distribute communications, and generate reports.

• Analyze and reconcile study metrics along with findings reports.

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

• Assist with translation materials and oversee translation quality control.

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

• Support scheduling of client/internal meetings, tracking of regulatory documents, RBM activities, study documentation, training tracking, and access management.

• Send documents to clients and centralized IRB/IEC.

• Maintain vendor trackers.

• Aid in regulatory submissions and the preparation of regulatory compliance review packages.

• Collaborate directly with sites to gather site-selection documentation.

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

• Document site communications and follow-ups in real-time while reviewing survey data.

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

• Keep plans for site contact and follow-up up to date and escalate non-compliance issues.

• Provide local expertise on site capacity and experience while suggesting additional sites.

• Act as a liaison with Global Investigator Services to resolve investigator inquiries and maintain account/contact information.

• Contribute to global feasibility processes and best practices.

• Train new team members on processes and systems.

• Assist in the identification and development of new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

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

• Consideration may be given for equivalency through a mix of relevant education, training, and/or directly related experience.

• Capability to work collaboratively in a team or independently.

• Strong organizational skills and a keen attention to detail.

• Ability to efficiently and effectively manage multiple tasks.

• Competence in analyzing project-specific data/systems for precision and efficiency.

• Strong customer service orientation.

• Flexibility to adjust workload priorities as needed.

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

• Proficient English language and grammar skills, as well as adequate local language skills when necessary.

• Proficiency in MS Office (Word, Excel, and PowerPoint).

• Capability to learn clinical trial database systems.

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

• Strong oral and written communication skills.

• Sound judgment and decision-making abilities.

• Ability to accurately adhere to project work instructions.

• Negotiation skills.

• Ability to manage risks and appropriately escalate risk issues.

• Occasional travel may be necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.