FSP Clinical Trial Coordinator

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

📋 Description

• Deliver 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 site activation and assist in creating critical paths for site activation.

• Generate and assess site lists for feasibility activities and offer local insights for site tiering.

• Organize, manage, and execute assigned trial activities in line with task matrices.

• Conduct department, internal, country, and investigator file evaluations and document the findings.

• Complete assigned tasks punctually, within budget, and adhering to quality standards; communicate any risks to project leads.

• Maintain Activate, eTMF, and other study-related systems and databases.

• Process and evaluate eTMF documents, manage communications, and supply documents and reports.

• Analyze and reconcile study metrics and findings reports.

• Coordinate and distribute materials for the Investigator Site File, pharmacy binders, and study supplies.

• Assist with translation materials and ensure translation quality control.

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

• Support RBM activities along with study documentation, training, access, and activity plan tracking.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

• Acquire site-selection documents directly from sites.

• Prepare packages for regulatory compliance reviews.

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

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

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

• Review survey data for logical, complete, and pertinent responses.

• Work alongside teammates and clinical personnel on deadlines, site challenges, and risks.

• Maintain efficient site-contact and follow-up plans and escalate instances of non-compliance.

• Offer local expertise regarding site capacity and experience, recommending additional sites as necessary.

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

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

• Utilize local knowledge to identify and develop new sites.

• When applicable, conduct on-site feasibility visits in the Asia Pacific region.

⛳️ Requirements

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

• Previous experience ranging from 0 to 1 year is preferred.

• A Bachelor's degree is an advantage.

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

• Excellent organizational skills and a strong attention to detail.

• Proficient in analyzing project-specific data/systems accurately and efficiently.

• Strong focus on customer service.

• Flexibility to adjust workload priorities as necessary.

• Familiarity with applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

• Proficient English language and grammar skills, with local language skills as required.

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

• Ability to learn and master clinical trial database systems.

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

• Strong oral and written communication skills.

• Good judgment and decision-making abilities.

• Ability to accurately follow project work instructions.

• Negotiation skills.

• Capability to manage risk and appropriately escalate risks.

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

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.