Clinical Operations Administrative Support
Durham, North Carolina, United States · Tempo pieno
Sii il primo a candidarti
- Esperienza
- 1+ anni
- Stipendio
- —
- Aperture
- 1
- Pubblicato
- 2 ore fa
- Modalità di lavoro
- In ufficio
- Istruzione
- College or university science degree or equivalent
- Riprendere
- È necessario candidarsi
Dove lavorerai
Descrizione del lavoro
About the Company
Founded in 1995, the company is a dynamic global organization employing over 3,000 dedicated professionals. Committed to advancing medical science, it focuses on improving lives by facilitating the development of new medications worldwide.
Job Overview
As a member of the Clinical Operations team, you will provide essential administrative and operational assistance to ensure the smooth execution of global clinical trials. Your role supports project teams by managing study documentation, coordinating communications, and aiding clinical sites throughout the trial process. This position offers a great foundation for a career in clinical research.
Key Responsibilities
- Exchange project-specific information and documentation with internal departments, clinical sites, and external vendors.
- Update and maintain data in study-specific and corporate tracking systems.
- Assist with submissions and notifications to regulatory and ethics committees.
- Organize and support internal team meetings, including drafting agendas and taking minutes under supervision.
- Coordinate site payments and support Investigator Meetings preparation, execution, and follow-up.
- Handle tasks related to clinical supplies such as ordering, receiving, storing, distributing, returning, recalling, and reconciling inventory as directed.
- Support preparation and follow-up activities for Trial Master File (TMF) and system audits and inspections.
- Maintain and periodically review trial documents in the TMF at site and country levels under supervision.
- Prepare, distribute, and update Investigator Site Files (ISF) and related checklists under supervision.
- Assist in translating study documents and managing safety information flow with investigative sites under guidance.
- Perform other tasks as assigned within the department.
Qualifications and Skills
- Possession of a college or university degree in science or an equivalent blend of education and experience such as a minimum of one year in a corporate or academic environment with relevant administrative and technical competencies.
- Exceptional organizational abilities with strong attention to detail.
- Capability to juggle multiple tasks effectively in a fast-moving environment.
- Strong written and verbal communication skills.
- Proficiency using Microsoft Office suite.
Additional Information
This role is with a company that values its employees and emphasizes a people-centric culture and career growth. Note that the employer does not sponsor work visas, and candidates requiring visa sponsorship now or in the future will not be considered.