Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and finalize designated trial activities as per the task matrix.

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

• Ensure that assigned tasks are finished punctually, within budget, and meet high-quality standards.

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

• Maintain documentation specific to the study, including team rosters, training trackers, system access management, and project activity plans.

• Keep the (e)TMF current by adhering to file review schedules and documenting findings.

• Provide system support for GoBalto and eTMF.

• Assist with Risk-Based Monitoring (RBM) activities.

• Process documents sent to the Client's (e)TMF, perform (e)TMF reviews, conduct mass mailings and communications, and provide required documents and reports.

• Organize and schedule client and internal meetings, and prepare meeting minutes.

• Review and monitor local regulatory documents.

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

• Analyze and reconcile study metrics and findings reports.

• Assist in clarifying and resolving site documentation issues.

• Maintain vendor trackers.

• Help compile and distribute Investigator Site File and Pharmacy binder materials, as well as non-clinical study supplies to sites.

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

• Attend kick-off meetings and take notes as required.

• Serve as a cross-functional liaison, onboarding buddy, trainer, and contributor to process improvement initiatives.

⛳️ Requirements

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

• Prior experience providing the knowledge, skills, and abilities necessary for the role, comparable to a minimum of 4 years.

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

• Bachelor's degree is preferred.

• Ability to work effectively in a team or independently.

• Strong organizational skills and meticulous attention to detail.

• Capability to manage multiple tasks efficiently and effectively.

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

• Strong customer-oriented mindset.

• Flexibility and adaptability to changing project timelines.

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

• Excellent command of the English language and grammar, with proficient local language skills as required.

• Strong presentation skills.

• Proficiency in MS Office, including Word, Excel, and PowerPoint.

• Ability to learn and master clinical trial database systems.

• Capability to successfully complete the PPD clinical training program.

• Self-motivated with a positive attitude and strong interpersonal skills.

🏝️ Benefits

• Fully remote work arrangement.

• Potential for occasional travel.

• Reasonable accommodations for individuals with disabilities.

• Benefits and privileges associated with employment.