FSP Clinical Trial Coordinator

NCBioImpact; North Carolina; On-site; USD 65,000 - 78,000; Full time

Job summary

NCBioImpact in North Carolina is seeking a Clinical Trial Coordinator to support the project team and ensure audit readiness by reviewing files per SOP and guidance documents. You’ll provide administrative support for site activation and help craft the critical path for rapid activations, using local knowledge and sponsor directives for feasibility and site tiering input.

As a buddy during onboarding, you may train new staff and collaborate with external sites to maintain high-quality trial

Qualifications

• High School Diploma or GED or related qualification with at least 1 year of relevant experience.
• Bachelor's degree in a related field with 0+ years of experience.

Responsibilities

• Ensure timely availability of trial materials and documentation for setup and execution.
• Manage TMF/ISF, including setup, filing, and archiving readiness.
• Manage clinical systems for accurate reporting and access management.
• Coordinate with suppliers on site supplies, logistics, and import/export compliance.
• Support site activities such as confidentiality agreements and feasibility questionnaires.
• Assist in site initiation readiness.
• Maintain tracking tools for operational oversight.
• Coordinate site documentation for timely site qualification and progression.

Skills

Administrative skills

Document management

Organizational skills

Multitasking

Communication skills

MS Office

ICH/GCP knowledge

Education

High School Diploma or GED

Bachelor's degree in related field

Job description

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 biotech's, 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

• Ensure timely availability of trial materials and respective documentation for setup and execution of clinical trials.
• Manage TMF and ISF, including proper setup, ongoing filing, and completeness prior to archiving.
• Manage clinical systems, ensuring accurate reporting, data completeness, and access management.
• Coordinate with suppliers to ensure site supplies, logistics, and import/export compliance.
• Support site activities (e.g., confidentiality agreements, feasibility questionnaires, system forms).
• Assist in site initiation readiness.
• Maintain tracking tools for operational oversight
• Coordinate site documentation to support timely site qualification and progression

Knowledge, Skills and Abilities

• Highly developed administrative skills, excellent document management and organizational skills
• Capable of managing multiple assignments and able to work independently
• Good understanding of project related priorities
• Strong verbal and written communication skills (cultural-sensitive, clear and transparent)
• Strong MS-Office skills (Excel, Word, Power Point, Outlook etc.)
• Knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP), Good Documentation Practice and local regulatory regulations

Education and Experience Requirements

• A minimum of a High School Diploma or equivalent education (i.e., GED), relevant formal academic/vocational qualification, and at least one (1) year of relevant experience; or
• Bachelor's degree in a related field with 0+ years of experience.