Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

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

• Assist in site activation efforts and the creation of critical paths for site activation.

• Generate and evaluate site lists for feasibility initiatives and contribute to local site tiering.

• Organize, manage, and fulfill assigned trial tasks in accordance with the task matrix.

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

• Complete assigned tasks punctually, within budgetary limits, and to quality standards; communicate risks to project leaders.

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

• Handle documentation for client eTMF, perform eTMF evaluations, manage mailings and communications, and generate reports.

• Analyze and reconcile study metrics and findings reports.

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

• Assist with translation materials and ensure translation quality control.

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

• Support the scheduling of client/internal meetings, regulatory document tracking, and RBM activities.

• Maintain study documentation, team lists, training requirements, system access, and activity plans.

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers and assist with regulatory submissions.

• Collaborate with sites to obtain site-selection documents.

• Prepare packages for regulatory compliance reviews.

• Coordinate with internal departments to align on site start-up activities.

• Complete Site Interest Plans and gather/deliver documents for investigators and site personnel.

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

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

• Work closely with teammates and clinical staff regarding site issues and risks.

• Establish and track site contact and follow-up plans, escalating concerns as necessary.

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

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

• Contribute to global feasibility processes and best practices.

• Train new personnel in relevant processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience of 0 to 1 year in a comparable role.

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

• Capability to work independently as well as collaboratively within a team.

• Excellent organizational skills and keen attention to detail.

• Competence in managing multiple tasks efficiently and effectively.

• Ability to analyze data and systems specific to projects.

• Strong customer-oriented mindset.

• Flexibility to adjust workload priorities as needed.

• Understanding of relevant country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

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

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

• Ability to learn and master clinical trial database systems.

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

• Strong oral and written communication skills.

• Sound judgment and decision-making abilities.

• Capacity to accurately follow project work instructions.

• Negotiation skills.

• Ability to manage risk and appropriately escalate risk-related issues.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Potential for occasional travel.

• Comprehensive training and onboarding support.

• Opportunity to serve as a buddy during the onboarding process.

• Participation in the clinical training program.