Clinical Trial Coordinator

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

📋 Description

• Offer administrative and technical assistance to the Project Team.

• Facilitate audit preparedness by ensuring files are assessed according to organizational SOPs and departmental guidance.

• Provide administrative support for site activation processes and assist in the development of the site activation critical path.

• Create and evaluate site lists for feasibility activities while offering local insights into site tiering.

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

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

• Ensure timely completion of assigned tasks within budget and to a high-quality standard; communicate risks to project leads.

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

• Process documents to the Client eTMF, carry out eTMF reviews, distribute communications, and provide documents and reports to internal team members.

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

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

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

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

• Conduct on-site feasibility visits as necessary (Asia Pac only).

• Assist in scheduling client and internal meetings.

• Review and track local regulatory documents when applicable.

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

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor tracking records.

• Assist with regulatory submissions and collection of site selection documents.

• Help coordinate regulatory compliance review packages and site start-up activities.

• Complete Site Interest Plans in CTMS, documenting site contact, follow-up, and survey responses.

• Review survey data for logical consistency, completeness, and accuracy.

• Collaborate with teammates and clinical personnel to meet deadlines and manage site-related issues and risks.

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

• Serve as a local expert on site capacity and experience, recommend additional sites, and assist with local site tiering.

• Liaise with Global Investigator Services to address investigator queries and maintain account and contact details.

• Contribute to global strategic feasibility processes and best practices.

• Train new personnel on processes and systems.

• Utilize local knowledge to identify and develop new sites.

• May serve as a buddy during onboarding and provide training to new staff.

⛳️ Requirements

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

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the role (equivalent to 0 to 1 year).

• Bachelor’s degree is preferred.

• Ability to work collaboratively in a team or independently as needed.

• Excellent organizational skills and strong attention to detail, with a proven ability to manage multiple tasks efficiently and effectively.

• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.

• Strong focus on customer service.

• Flexibility to adjust workload priorities to accommodate changing project timelines.

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

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

• Competent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems.

• Ability to successfully complete the organization's clinical training program.

• Effective oral and written communication skills.

• Essential judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Good negotiation skills.

• Capability to manage risk and perform risk escalation appropriately.

• Occasional driving to site locations and potential for occasional travel.

• In some instances, an equivalency consisting of appropriate education, training, and/or directly related experience may be deemed sufficient.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.