Clinical Trial Coordinator

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

📋 Description

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

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

• Complete designated tasks promptly, within budget constraints, and maintain quality standards.

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

• Process documents sent to the Client eTMF, conduct eTMF reviews, facilitate communications, and generate reports.

• Analyze and reconcile study metrics along with findings reports.

• Assist with materials for the Investigator Site File and Pharmacy binder, as well as study supplies.

• Support the translation of materials and oversee translation quality control.

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

• Assist in scheduling meetings for clients and internal teams.

• Review and track local regulatory documents.

• Support RBM activities and documentation related to the study and its systems.

• Send documents to the client and centralized IRB/IEC.

• Maintain trackers for vendors.

• Assist with regulatory submissions and site start-up processes.

• Acquire site-selection documents directly from sites.

• Prepare packages for regulatory compliance review.

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

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

• Review survey data to ensure logical, complete, and accurate responses.

• Collaborate with team members and clinical staff regarding site-related issues and risks.

• Maintain site-contact plans and escalate any concerns or instances of non-compliance.

• Provide local expertise on site capacity and experience, recommending additional sites as necessary.

• Address investigator queries while maintaining account and contact information.

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

• Offer local insights in identifying and developing new sites.

• Conduct on-site feasibility visits where applicable in the Asia Pacific region.

• Occasionally drive to site locations and engage in potential travel.

⛳️ Requirements

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

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

• Bachelor's degree is desirable.

• A combination of suitable education, training, and/or directly related experience may be accepted.

• Ability to work effectively in a team or independently.

• Strong organizational skills and attention to detail.

• Capability to efficiently manage multiple tasks.

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

• Strong focus on customer service.

• Flexibility to adjust workload priorities as needed.

• Knowledge of relevant Country Regulations, ICH Good Clinical Practices, and organizational/Client SOPs and WPDs.

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

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

• Ability to learn and master clinical trial database systems.

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

• Strong oral and written communication skills.

• Good judgment and decision-making abilities.

• Ability to follow project work instructions with precision.

• Strong negotiation skills.

• Ability to manage risk effectively and perform appropriate risk escalation.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.