Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Facilitate audit preparedness through regular file reviews in accordance with SOPs and departmental directives.

• Aid in site activation processes and development of critical paths.

• Create and evaluate site lists for feasibility tasks, providing local insights for site tiering.

• Organize, supervise, and execute assigned trial responsibilities as outlined in the task matrix.

• Conduct department, internal, country, and investigator file assessments, documenting results.

• Complete designated tasks punctually, within budget, and to quality specifications; alert project leads to potential risks.

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

• Manage document processing for client eTMF, execute eTMF reviews, disseminate communications, and generate reports.

• Analyze and reconcile study metrics and findings reports.

• Coordinate and distribute materials for Investigator Site Files, pharmacy binders, and study supplies.

• Assist with translation materials and ensure quality control for translations.

• Support feasibility visits, meetings, regulatory document tracking, RBM activities, and study documentation systems as needed.

• Send documents to clients and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

• Acquire site-selection documents directly from sites.

• Prepare packages for regulatory compliance reviews.

• Collaborate with internal departments to synchronize site start-up activities.

• Complete Site Interest Plans and gather associated investigator/site documentation as necessary.

• Record site communications, follow-ups, and survey responses in real time.

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

• Work with teammates and clinical personnel on site-related issues, risks, and deadlines.

• Ensure adherence to site-contact plans and escalate any concerns or instances of non-compliance.

• Provide local expertise regarding site capacity and experience, and suggest additional sites as appropriate.

• Communicate with Global Investigator Services to address investigator inquiries and maintain account/contact details.

• Contribute to global feasibility processes and the establishment of best practices.

• Train new team members on processes and systems.

• Leverage local knowledge to identify and cultivate new sites.

⛳️ 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.

• A Bachelor's degree is preferred.

• Capability to work collaboratively in a team or independently.

• Strong organizational skills with meticulous attention to detail.

• Ability to manage multiple tasks efficiently and effectively.

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

• Strong focus on customer service.

• Flexibility to adjust workload priorities as necessary.

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

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

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

• Willingness and ability to learn clinical trial database systems.

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

• Strong oral and written communication abilities.

• Good judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Strong negotiation skills.

• Competence in risk management and appropriate escalation of risks.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.