Clinical Trial Coordinator

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

📋 Description

• Offer both administrative and technical assistance to the Project Team

• Facilitate audit preparedness through organized file assessments

• Provide administrative support for activities related to site activation

• Assist in the creation of critical paths for site activation

• Develop and evaluate site lists for feasibility tasks while contributing local insights into site tiering

• Coordinate, supervise, and fulfill designated trial activities per the task matrix

• Conduct departmental, internal, country, and investigator file evaluations and document observations

• Ensure timely completion of tasks within budget and adhering to quality standards

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

• Manage documents for Client (e)TMF, carry out (e)TMF reviews, disseminate communications, and generate reports

• Analyze and reconcile study metrics and findings reports

• Assist with materials for the Investigator Site File and Pharmacy binder, along with study supplies

• Support the creation of study-specific translation materials and oversee translation quality control

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

• Conduct on-site feasibility visits when necessary for Asia Pacific roles

• Aid in scheduling client and internal meetings

• Review and monitor local regulatory documents

• Support RBM activities and study documentation systems

• Transmit documents to clients and centralized IRB/IEC

• Maintain vendor trackers

• Assist in regulatory submissions and the collection of site selection documents

• Prepare packages for regulatory compliance reviews

• Collaborate with internal departments regarding site start-up activities

• Complete Site Interest Plans in CTMS when applicable

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

• Evaluate survey data for accuracy and logical consistency

• Work alongside teammates and clinical personnel to resolve site issues and risks

• Ensure effective site contact and follow-up strategies while escalating non-compliance when necessary

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

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

• Contribute to global feasibility processes and best practices

• Train new staff in processes and systems

• Utilize local insights to identify and cultivate new sites

⛳️ Requirements

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

• Bachelor's degree is preferred

• Previous experience of 0 to 1 year is comparable

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

• Capability to work effectively in a team or independently

• Strong organizational skills and keen attention to detail

• Ability to analyze project-specific data and systems

• Flexibility to adjust workload priorities as needed

• Familiarity with applicable 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

• Competence in MS Office (Word, Excel, and PowerPoint)

• Ability to learn and become proficient in clinical trial database systems

• Capability to complete the organization’s clinical training program

• Effective oral and written communication skills

• Good judgment and decision-making abilities

• Ability to accurately follow project work instructions

• Strong negotiation skills

• Ability to manage risks and appropriately escalate them

• Occasional travel may be required

• Occasional driving to site locations

🏝️ Benefits

• Fully remote work arrangement

• Standard Monday–Friday work schedule