Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Aid in audit readiness through regular file evaluations in line with SOPs and departmental guidelines.

• Provide administrative support for site activation processes and assist in developing critical paths for site activation.

• Create and assess site lists for feasibility studies, contributing local insights to site tiering.

• Coordinate, manage, and execute assigned trial activities as per the task matrix.

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

• Ensure timely completion of tasks within budget and quality standards; communicate any risks to project leads.

• Offer system support for Activate and eTMF, keeping databases up to date.

• Process documents for the Client eTMF, carry out eTMF reviews, send communications, and generate reports.

• Analyze and reconcile study metrics along with findings reports.

• Organize Investigator Site File and Pharmacy binder materials along with non-clinical study supplies.

• Assist with translation materials and oversee translation quality control.

• Schedule client and internal meetings as required.

• Review and monitor local regulatory documents.

• Support RBM activities along with study-specific documentation and systems.

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

• Maintain vendor trackers.

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

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

• Prepare regulatory compliance review packages.

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

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

• Evaluate survey data for logical consistency, completeness, and relevance.

• Work together with teammates and clinical staff regarding site-related issues and risks.

• Maintain site contact and follow-up strategies, escalating concerns or instances of non-compliance.

• Provide local expertise regarding site capacity and experience, recommending additional sites as needed.

• Act as a liaison with Global Investigator Services to address investigator inquiries and maintain account and contact details.

• Contribute to global feasibility processes and advocate for best practices.

• Train new staff on processes and systems.

• Utilize local insights to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

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

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

• Ability to work collaboratively within a team or independently.

• Strong organizational skills and a keen attention to detail.

• Capability to manage multiple tasks efficiently and effectively.

• Proficiency in accurately analyzing project-specific data/systems.

• Strong customer-centric approach.

• Flexibility to adjust workload priorities as needed.

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

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

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

• Ability to learn clinical trial database systems.

• Capable of successfully completing the organization's clinical training program.

• Effective verbal and written communication abilities.

• Essential judgment and decision-making capabilities.

• Ability to meticulously follow project work instructions.

• Strong negotiation skills.

• Capability to manage risks and execute risk escalations appropriately.

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

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.