FSP Clinical Trial Coordinator I

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

📋 Description

• Coordinate, supervise, and execute assigned trial activities in accordance with the task matrix.

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

• Complete designated tasks punctually, within budget, and to a high-quality standard; communicate potential risks to project leads.

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

• Process documents for client eTMF, conduct eTMF reviews, manage mass mailings and communications, and provide documents and reports to internal team members.

• Analyze and reconcile study metrics and findings reports; assist in addressing site documentation issues.

• Coordinate, compile, and distribute materials for the Investigator Site File and Pharmacy binder, as well as non-clinical study supplies.

• Support the development of study-specific translation materials and ensure translation quality control.

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

• Conduct on-site feasibility visits as necessary for Asia Pacific projects.

• Assist in scheduling client and internal meetings.

• Review and monitor local regulatory documents and support RBM activities.

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

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers.

• Support regulatory submissions and site start-up activities.

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

• Prepare regulatory compliance review packages.

• Coordinate with internal departments to ensure alignment of site start-up activities with the critical path for site activation.

• Complete Site Interest Plans in CTMS and gather and deliver associated investigator and site personnel documents.

• Document all communications with site contacts, including attempts, 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 address site issues and risks.

• Maintain efficient site-contact and follow-up plans; ensure compliance and escalate concerns or non-compliance as necessary.

• Serve as a local expert on site capacity and experience, recommending additional sites as needed.

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

• Contribute to global strategic feasibility processes and best practices.

• Train new personnel on processes and systems.

• Leverage local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience providing the necessary knowledge, skills, and abilities to perform the job, typically ranging from 0 to 1 year.

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

• Strong organizational skills and attention to detail, capable of managing multiple tasks efficiently and effectively.

• Ability to analyze project-specific data/systems for precision and efficiency.

• Strong focus on customer service.

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

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

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

• Competency in MS Office (Word, Excel, and PowerPoint) and ability to master clinical trial database systems.

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

• Effective oral and written communication skills.

• Strong judgment and decision-making abilities.

• Ability to accurately adhere to project work instructions.

• Good negotiation skills.

• Independent and critical thinking capabilities.

• Ability to manage risk and appropriately escalate risk concerns.

• Occasional travel may be required.

• In certain instances, an equivalency of appropriate education, training, and/or directly related experience may be deemed sufficient.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.