FSP Clinical Trial Coordinator II

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

📋 Description

• Coordinate, manage, 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 and the line manager.

• Process client (e)TMF documents, conduct (e)TMF reviews, manage mailings and communications, and provide necessary documents and reports.

• Review and monitor local regulatory documentation.

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

• Maintain vendor tracking and study status information in databases.

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

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

• Provide technical and administrative project support in collaboration with internal departments and team members.

• Stay updated on SOPs, client directives, and current regulatory guidelines.

• Maintain relationships with client local affiliates where applicable.

• Train new staff and assist in departmental process enhancements.

• Keep study documentation, team lists, training requirements, system access, activity plans, and (e)TMF records organized.

• Provide system support for Activate and eTMF and may assist with RBM activities.

• Transmit documents to clients and centralized IRB/IEC.

• Attend kick-off meetings, take notes, and assist with scheduling and minutes.

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

• Prepare regulatory compliance review packages and assist with regulatory submissions.

• Obtain site-selection documents and compile site lists from both internal and external sources.

• Maintain contact details for investigators/site staff and complete Site Interest Plans in CTMS.

• Review survey data and ensure effective site contact and follow-up strategies.

• Work with teammates and clinical personnel to address site issues, risks, deadlines, and escalations.

• Serve as a local expert on site capacity and experience; support site tiering and recommend additional sites.

• Conduct phone interviews with physicians and site staff regarding standard of care and protocol input.

• Liaise with Global Investigator Services and contribute to global feasibility processes and best practices.

⛳️ Requirements

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

• A Bachelor's degree is preferred.

• Minimum of 2 years of relevant experience demonstrating applicable knowledge, skills, and abilities.

• Equivalency may be considered through a combination of appropriate education, training, and/or directly related experience.

• Ability to work independently or collaboratively in a team environment.

• Strong organizational skills and attention to detail; capability to efficiently manage multiple tasks.

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

• Strong customer focus, flexibility, adaptability, and skills in reprioritization.

• Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

• Excellent English language and grammar skills along with proficient local language skills as required.

• Strong presentation, negotiation, interpersonal, and both oral and written communication skills.

• Proficiency in MS Office (Word, Excel, and PowerPoint) and the ability to learn clinical trial database systems and relevant software.

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

• Basic understanding of medical/therapeutic areas and medical terminology.

• Basic knowledge of organizational, planning, and local health systems.

• Ability to acquire and maintain knowledge of GCP and applicable SOPs.

• Ability to operate in a matrix environment, effectively manage risk, and execute risk escalation as needed.

• Fluency in the local language with a good command of English.

• Potential for occasional travel and drives to site locations.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.