Clinical Trial Coordinator II

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

📋 Description

• Coordinate, manage, and finalize assigned trial activities according to the task matrix.

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

• Complete assigned tasks punctually, within budget, and maintaining high-quality standards.

• Communicate project risks to project leads and the line manager.

• Process documents sent to the client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members.

• Review and monitor local regulatory documents.

• Analyze and reconcile study metrics and findings reports.

• Assist in clarifying and resolving site documentation findings.

• Maintain vendor trackers.

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

• Support the preparation of study-specific translation materials and ensure translation quality control.

• Provide technical and administrative project support in collaboration with internal departments and team members.

• Stay updated with SOPs, client directives, and relevant regulatory guidelines.

• Maintain accurate and current trial status information in databases.

• Develop and nurture relationships with client local affiliates where applicable.

• Champion the inclusion of Strategic Collaboration sites.

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

• Train new personnel in processes and systems.

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

• Provide support for Activate, eTMF, and risk-based monitoring activities.

• Transmit documents to clients and centralized IRB/IEC.

• Attend kick-off meetings and take notes when required.

• Schedule and organize client/internal meetings and prepare meeting minutes.

• Collaborate with internal departments to align site start-up activities with the site activation critical path.

• Assist with regulatory compliance review packages and submissions.

• Obtain site-selection documents directly from sites when necessary.

• Develop site lists and maintain contact details for investigators and site staff.

• Complete Site Interest Plans in CTMS and document site communications and survey responses.

• Review survey data for logical, complete, and relevant responses.

• Collaborate with team members to meet project deadlines and address site issues and risks.

• Ensure effective site contact and follow-up plans while escalating non-compliance issues.

• Serve as a local expert on site capacity and experience, supporting local site tiering.

• Conduct phone interviews with physicians and site personnel to gather protocol-level insights.

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

• Contribute to global strategic feasibility processes and best practices.

⛳️ Requirements

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

• Prior experience providing the knowledge, skills, and abilities to perform the job, equivalent to at least 2 years.

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

• Ability to work independently or collaboratively within a team environment.

• Strong organizational skills and meticulous 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 and adaptability to changing project timelines.

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

• Excellent English language and grammar skills, along with proficient local language skills as required.

• Good presentation skills.

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

• Ability to learn and master clinical trial database systems and relevant software.

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

• Effective oral and written communication skills, including communication with medical personnel.

• Good negotiation skills.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Basic organizational and planning skills.

• Basic understanding of local health systems.

• Working knowledge of GCP and applicable SOPs.

• Ability to work effectively in a matrix environment.

• Strong relationship-building skills.

• Independent thinking capabilities.

• Ability to manage risk and perform appropriate risk escalation.

• Occasional travel to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.