Clinical Trial Coordinator

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

📋 Description

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

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

• Ensure that assigned tasks are accomplished on schedule, within budget, and uphold high-quality standards.

• Communicate project risks to project leads and the line manager.

• Maintain documentation specific to the study, along with systems, tools, trackers, and (e)TMF files.

• Provide support for systems, including GoBalto and eTMF.

• Assist with risk-based monitoring (RBM) efforts.

• Manage trial administration tasks, including document processing, (e)TMF reviews, mailings, communications, and reports.

• Schedule and arrange client/internal meetings and take meeting minutes.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports; aid in resolving site documentation issues.

• Maintain vendor tracking records.

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

• Assist with the preparation of study-specific translation materials and ensure translation quality control.

• Attend kick-off meetings and take notes when necessary.

• Serve as a study lead or cross-functional liaison when required.

• Mentor new hires during their onboarding process and provide training as needed.

• Support initiatives for departmental and cross-functional process improvements.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience that equips the individual with the knowledge, skills, and abilities to fulfill the role (equivalent to at least 4 years).

• In certain situations, an equivalent combination of relevant education, training, and/or directly related experience may be deemed adequate for fulfilling the role's requirements.

• Capability to work collaboratively in a team or independently as necessary.

• Exceptional organizational skills and meticulous attention to detail, with a demonstrated ability to manage multiple tasks efficiently and effectively.

• Proven capacity to analyze project-specific data/systems to ensure accuracy and operational efficiency.

• Strong customer service orientation.

• Demonstrated flexibility and adaptability in reprioritizing workload to provide effective support in line with evolving project timelines.

• Proven ability to acquire and maintain thorough knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs regarding all non-clinical/clinical elements of project implementation, execution, and closeout.

• Excellent proficiency in the English language and grammar, along with proficient local language skills as required.

• Strong presentation skills.

• Excellent computer proficiency, especially in MS Office (Word, Excel, and PowerPoint), with the ability to learn and master all clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

• Self-motivated, positive demeanor with effective interpersonal skills.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and growth.

• Flexible working arrangements.

• Competitive compensation package.