FSP Clinical Trial Coordinator

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

📋 Description

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

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

• Offer administrative aid for site activation tasks and critical-path development.

• Create and assess site lists for feasibility studies while providing local insights for site tiering.

• Organize, manage, and finalize designated trial activities in line with the task matrix.

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

• Complete assigned tasks promptly, within budget, and to a high-quality standard; communicate potential risks to project leads.

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

• Process documents for client eTMF, conduct eTMF reviews, distribute communications, and generate reports.

• Analyze and reconcile study metrics alongside findings reports.

• Coordinate materials for the Investigator Site File and Pharmacy binders, as well as non-clinical study supplies.

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

• Arrange client and internal meetings as required.

• Review and monitor local regulatory documents when necessary.

• Support RBM activities and maintain study documentation/systems.

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

• Keep vendor trackers updated.

• Assist with regulatory submissions and the collection of site selection documentation.

• Help with the review packages for regulatory compliance.

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

• Complete Site Interest Plans in CTMS and manage relevant investigator/site documents.

• Document communications, follow-ups, and survey responses from sites in real time.

• Evaluate survey data for logical coherence, completeness, and accuracy.

• Work together with teammates and clinical staff regarding site challenges and risks.

• Maintain plans for site contact and follow-ups, escalating any issues of non-compliance.

• Provide local insights on site capacity and experience while recommending additional sites.

• Collaborate with Global Investigator Services to resolve investigator inquiries and maintain accurate contact information.

• Contribute to global feasibility processes and establish best practices.

• Train new team members in relevant processes and systems.

• Leverage local knowledge to identify and cultivate new sites.

⛳️ Requirements

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

• Prior experience ranging from 0 to 1 year is preferred.

• A Bachelor's degree is advantageous.

• Capability to work in a team setting or independently.

• Strong organizational abilities and meticulous attention to detail.

• Proficient in managing multiple tasks efficiently and effectively.

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

• Strong focus on customer service.

• Adaptability to reprioritize workload as needed.

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

• Proficient in English language and grammar, along with necessary local language skills.

• Competency in MS Office (Word, Excel, PowerPoint).

• Ability to learn clinical trial database systems.

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

• Effective verbal and written communication skills.

• Good judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Strong negotiation skills.

• Proficiency in managing risk and executing appropriate risk escalation.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Potential for occasional travel to site locations.