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.

• Offer administrative aid for site activation processes.

• Assist in the creation of the site activation critical path.

• Create and evaluate site lists for feasibility activities and provide local insights for site tiering.

• Manage, supervise, and execute assigned trial tasks as outlined in the task matrix.

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

• Ensure timely completion of tasks while adhering to budget constraints and maintaining high-quality standards.

• Provide system support for Activate and eTMF while keeping databases updated.

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

• Analyze and reconcile study metrics and findings reports.

• Assist with materials for the Investigator Site File and Pharmacy binder, as well as study supplies.

• Support the translation of materials and oversee translation quality control.

• Conduct on-site feasibility assessments when necessary in the Asia Pacific region.

• Aid in scheduling client and internal meetings.

• Review and monitor local regulatory documentation.

• Assist with Risk-Based Monitoring (RBM) activities and study documentation systems.

• Transmit documents to clients and centralized Institutional Review Board/Independent Ethics Committee (IRB/IEC).

• Maintain vendor tracking systems.

• Support regulatory submissions and the collection of site selection documents.

• Prepare packages for regulatory compliance reviews.

• Coordinate with internal teams on site start-up activities.

• Log site contacts, follow-ups, and survey responses in real time.

• Review survey data for thoroughness and logical consistency.

• Collaborate with team members and clinical staff regarding site-related issues and risks.

• Maintain site contact plans and escalate any instances of non-compliance.

• Liaise with Global Investigator Services to address investigator queries and keep account/contact information updated.

• Contribute to global feasibility processes and best practices.

• Train new staff on processes and systems.

• Identify and establish new sites using local expertise.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Previous experience ranging from 0 to 1 year is comparable.

• Equivalency may be established through a combination of relevant education, training, and/or directly related experience.

• Capability to work independently or collaboratively within a team.

• Exceptional organizational skills and keen attention to detail.

• Proficiency in managing multiple tasks both efficiently and effectively.

• Ability to accurately analyze project-specific data and systems.

• Strong focus on customer service.

• Flexibility to adjust workload priorities as needed.

• Familiarity with applicable country regulations, ICH Good Clinical Practices, and organizational/client Standard Operating Procedures (SOPs) and Work Practice Documents (WPDs).

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

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

• Ability to learn and master clinical trial database systems.

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

• Effective oral and written communication abilities.

• Strong judgment and decision-making skills.

• Ability to accurately follow project work instructions.

• Negotiation skills.

• Ability to manage and appropriately escalate risks.

• Willingness to occasionally drive to site locations and travel as needed.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday to Friday work schedule.

• Training and onboarding support provided.

• Opportunity to act as a buddy and mentor new staff.

• Potential for occasional travel and site visits.