FSP Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and finalize assigned trial activities in accordance with the task matrix.

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

• Ensure that assigned tasks are completed punctually, within budget, and to high-quality standards.

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

• Process documents for the Client eTMF, conduct eTMF reviews, disseminate communications, and generate reports.

• Analyze and reconcile study metrics and findings reports.

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

• Assist with study-specific translation materials and ensure translation quality control.

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

• Facilitate scheduling for client and internal meetings.

• Review and monitor local regulatory documents.

• Support risk-based monitoring activities and manage study documentation systems.

• Maintain study team lists, track training requirements, manage system access, and oversee project activity plans.

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers updated.

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

• Collaborate with sites to gather site-selection documents.

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

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

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

• Review survey data to ensure logical, complete, and relevant responses.

• Work together with teammates and clinical personnel to address site issues and risks.

• Ensure implementation of site-contact and follow-up plans, escalating concerns or non-compliance as necessary.

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

• Collaborate with Global Investigator Services to resolve investigator queries and maintain account/contact information.

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

• Train new personnel in processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

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

• An equivalent combination of relevant education, training, and/or directly related experience may be considered.

• Ability to work effectively both in a team and independently.

• Strong organizational skills and attention to detail.

• Capability to manage multiple tasks efficiently and effectively.

• Ability to analyze project-specific data/systems for accuracy and efficiency.

• Strong customer focus.

• Flexibility to adjust workload priorities as necessary.

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

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

• Proficiency 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.

• Effective oral and written communication skills.

• Essential judgment and decision-making abilities.

• Ability to accurately follow project work instructions.

• Strong negotiation skills.

• Ability to manage risk effectively and perform appropriate risk escalation.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.