Clinical Trial Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed.

What You’ll Do:

• Based on the assigned role (Central or Local), coordinates, oversees, and performs responsibilities for assigned activities in accordance with the task matrix.
• Provides system support (e.g., Power BI dashboards, Fieldglass, GSK access systems) and ensures all system databases are accurate and up to date.
• Reviews, analyzes, and reconciles global and country-level metrics and findings reports, and supports clarification and resolution of identified discrepancies.
• Maintains current knowledge of applicable SOPs, client SOPs and directives, and relevant regulatory guidelines related to the services provided.
• May support the scheduling and coordination of FSP Clinical Operations internal meetings.
• Based on the assigned role (Central or Local), coordinates, oversees, and performs responsibilities for assigned activities in accordance with the task matrix.
• Provides system support (e.g., Power BI dashboards, Fieldglass, GSK access systems) and ensures all system databases are accurate and up to date.
• Reviews, analyzes, and reconciles global and country-level metrics and findings reports, and supports clarification and resolution of identified discrepancies.
• Maintains current knowledge of applicable SOPs, client SOPs and directives, and relevant regulatory guidelines related to the services provided.
• May support the scheduling and coordination of FSP Clinical Operations internal meetings.
• May support the maintenance and oversight of designated documentation and systems, including but not limited to distribution lists, FSP Clinical Operations organizational charts, system access management, and FSP source documentation.
• Provides administrative and operational support to the FSP Clinical Operations team, including expense report reconciliation and billing report support.
• Documents all task-related communications, contact attempts, and follow-up activities in real time

Education and Experience Requirements:
• Bachelor's degree
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

Fresh graduates are open to apply
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete the organizations clinical training program
• Self-motivated, positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Good interpersonal skills
• Essential judgment and decision-making skills
• Capable of accurately following project work instructions
• Good negotiation skills
• Independent thinker
• Ability to manage risk and perform risk escalation appropriately

Working Conditions and Environment:
• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.