Clinical Trial Coordinator

About the Role

Join a leading global team that supports pharmaceutical and biotechnology companies worldwide in conducting clinical trials. As a Clinical Trial Coordinator, you will provide essential administrative and technical assistance to clinical project teams, helping ensure efficient site activations, compliance with regulatory standards, and smooth trial operations. You will engage with investigators and site staff, conduct feasibility assessments, and help maintain excellent documentation and communication throughout study processes.

Key Responsibilities

• Manage and complete assigned clinical trial activities as outlined in project task matrices.
• Conduct thorough reviews of departmental, internal, country, and investigator files, documenting findings accurately in relevant systems.
• Deliver administrative support for site activation, including timely document processing, (e)TMF reviews, mass communications, and report distribution.
• Track and review local regulatory documentation and maintain vendor and study trackers.
• Coordinate preparation and distribution of Investigator Site Files (ISF), Pharmacy binders, study supplies, and translation materials.
• Support training and onboarding of new staff and contribute to process improvement initiatives.
• Maintain up-to-date knowledge of SOPs, regulatory guidelines, and client directives applicable to clinical trial activities.
• Develop and nurture relationships with client affiliates and external sites, including conducting on-site feasibility visits where applicable.
• Support data analysis of study metrics and resolve findings related to site documentation.
• Assist with regulatory compliance package preparation and support regulatory submissions as needed.
• Organize and facilitate meetings, including note-taking and scheduling with clients and internal teams.
• Lead local site identification and tiering activities, including phone interviews to assess site suitability and investigator capacity.
• Collaborate with global and local teams to ensure alignment of site activation processes and trial timelines.

Qualifications and Experience

• High school diploma or equivalent required; Bachelor's degree preferred.
• Minimum two years’ experience in a similar role or equivalent combination of education, training, and related experience.

Skills and Attributes

• Ability to work independently and collaboratively within team environments.
• Exceptional organizational skills and meticulous attention to detail.
• Analytical proficiency in reviewing project data and clinical trial systems.
• Strong customer service orientation and communication skills, including excellent English proficiency and local language capabilities.
• Competent computer skills, including MS Office and clinical trial database systems.
• Knowledge of GCP, regulatory guidelines, and relevant SOPs.
• Positive attitude, flexibility, adaptability, and strong interpersonal skills.
• Effective negotiation and presentation skills.
• Basic understanding of medical terminology and health systems.

Working Conditions

• Primarily office-based with exposure to standard office equipment.
• Occasional travel to clinical site locations may be required.
• Standard Monday to Friday work schedule.