Clinical Trial Coordinator I

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

📋 Description

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

• Facilitate audit readiness by ensuring that files are examined in accordance with the organization's SOP and departmental guidelines.

• Provide administrative support for site activation tasks and contribute to the development of the site activation critical path.

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

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

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

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

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

• Process documents for the Client eTMF, conduct eTMF reviews, distribute communications, and provide necessary documents and reports.

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

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

• Assist in the preparation of study-specific translation materials and ensure translation quality control.

• Conduct on-site feasibility assessments as applicable in the Asia Pacific region.

• Facilitate client/internal meeting scheduling and track local regulatory documents.

• Support Risk-Based Monitoring (RBM) activities and maintain study documentation/systems.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor tracking systems.

• Assist with regulatory submissions and site initiation activities.

• Collaborate with sites to secure site-selection documents and complete regulatory compliance review packages.

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

• Collaborate with team members and clinical staff to meet deadlines and address site-related issues and risks.

• Ensure that site contact and follow-up plans are executed, escalating concerns or instances of non-compliance as necessary.

• Provide local expertise on site capacity and experience, recommend additional sites, and assist with local site tiering.

• Work with Global Investigator Services to resolve investigator inquiries and maintain account/contact information.

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

• Leverage local knowledge to identify and develop new sites.

• May serve as a buddy during the onboarding process.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (equivalent to 0 to 1 year).

• In certain cases, a combination of relevant education, training, and/or directly related experience may suffice to meet the role's requirements.

• Ability to work collaboratively within a team or independently as needed.

• Strong organizational skills and a keen attention to detail, with a proven track record of managing multiple tasks efficiently and effectively.

• Proven ability to analyze project-specific data/systems to ensure precision and efficiency.

• Strong customer orientation.

• Flexibility to adjust workload priorities to accommodate changing project timelines.

• Proven ability to acquire and maintain a thorough understanding of applicable Country Regulations, ICH Good Clinical Practices, as well as organization/Client SOPs and WPDs related to all non-clinical/clinical facets of project implementation, execution, and closeout.

• Proficient English language skills along with strong local language abilities as required.

• Competent computer skills, with proficiency in MS Office (Word, Excel, and PowerPoint) and the capability to master all clinical trial database systems.

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

• Self-motivated with a positive attitude and strong interpersonal skills.

• Effective oral and written communication abilities.

• Essential judgment and decision-making capabilities.

• Competent in accurately following project work instructions.

• Strong negotiation skills.

• Independent thinker.

• Ability to manage risk and perform risk escalation appropriately.

• Occasional travel to site locations may be required.

🏝️ Benefits

• Comprehensive health and wellness plans.

• Opportunities for professional development and advancement.

• Flexible working hours and the possibility of remote work.

• A supportive and collaborative team environment.