Clinical Trial Coordinator I

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

📋 Description

• Deliver both administrative and technical assistance to the Project Team.

• Facilitate audit preparedness through regular file assessments in line with SOPs and departmental guidelines.

• Provide administrative aid for site activation tasks and assist in creating critical paths for site activation.

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

• Coordinate, manage, and execute assigned trial responsibilities as outlined in the task matrix.

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

• Complete assigned tasks punctually, within budget, and to the required quality standards; communicate potential risks to project leads.

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

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

• Analyze and consolidate study metrics and findings reports.

• Coordinate and disseminate Investigator Site Files, pharmacy binder materials, and non-clinical study supplies.

• Assist with translation materials and ensure translation quality control.

• Stay informed on SOPs, client directives, and relevant regulatory guidelines.

• Conduct on-site feasibility visits as necessary for the Asia Pacific region.

• Aid in scheduling both client and internal meetings.

• Review and monitor local regulatory documents when applicable.

• Support risk-based monitoring initiatives.

• Maintain study documentation and systems, such as team lists, training prerequisites, system access, and activity plans.

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers updated.

• Assist with regulatory submissions and the preparation of compliance review packages.

• Collaborate with sites to obtain site-selection documents.

• Work with internal departments to synchronize site start-up activities with the activation critical path.

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

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

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

• Collaborate with colleagues and clinical personnel regarding deadlines, site challenges, and risks.

• Maintain a site contact and follow-up strategy, escalating concerns or non-compliance as necessary.

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

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

• Contribute to global feasibility processes and best practices.

• Train new staff in processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience of 0 to 1 year is comparable.

• Consideration may be given to equivalency through a combination of relevant education, training, and/or directly related experience.

• Capability to work collaboratively in a team or independently.

• Strong organizational skills and keen attention to detail.

• Ability to manage multiple tasks efficiently and effectively.

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

• Strong customer service orientation.

• Flexibility to adjust workload priorities according to shifting project timelines.

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

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

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

• Ability to learn and master clinical trial database systems.

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

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

• Effective verbal and written communication abilities.

• Sound judgment and decision-making capabilities.

• Ability to follow project work instructions accurately.

• Strong negotiation skills.

• Independent critical thinking.

• Ability to manage risk and execute appropriate risk escalation.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.