Clinical Operations Administrative Support

PSI CRO; Durham (NC); On-site; USD 42,000 - 64,000; Full time

Job summary

PSI CRO is seeking a Clinical Operations Administrative Support to back our global clinical trials team from our Durham, NC office. The role provides essential administrative and operational support to project teams, ensuring efficient studies, accurate documentation, and timely site support throughout the trial lifecycle.

Under supervision, you will assist with meetings, site payments, TMF processes, and collaboration across departments, vendors, and sites.

Qualifications

• College or university science degree or equivalent.
• Equivalency defined as a minimum of 1 year experience in corporate or academic environment with administrative experience and technical skills gained.
• Strong organizational skills with exceptional attention to detail.
• Ability to manage multiple priorities and work effectively in a fast-paced environment.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications.

Responsibilities

• Exchanges project-specific information and documents with other departments, sites and vendors.
• Maintains information in study-specific and corporate tracking systems.
• Supports regulatory submissions and notifications.
• Assists with organization of internal team meetings.
• Coordinates site payments within the project team under supervision.
• Prepares agendas for, and minutes of, internal team meetings under supervision.
• Assists with Investigator Meetings preparation, conduct and follow-up under supervision.
• Assists with clinical supplies ordering, receipt, storage, distribution, return/recall and reconciliation at PSI warehouse or as defined by the project team.
• Assists with TMF and systems audits and inspections preparation and follow-up.
• Maintains TMF files and ISF on site and country levels under supervision.
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists.

Skills

Organizational skills

Attention to detail

Communication skills

Multitasking

Microsoft Office proficiency

Education

College or university science degree

Tools

Microsoft Office

Job description

We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.

Join our Clinical Operations team and help support the successful delivery of global clinical trials. As a Clinical Operations Administrative Support (COAS) you will provide administrative and operational support to clinical trial project teams, helping ensure studies are conducted efficiently, documentation is maintained accurately, and clinical sites receive the support they need throughout the trial lifecycle. This is an excellent opportunity for someone looking to build a career in clinical research.

• Exchanges project-specific information and documents with other PSI departments, sites and vendors
• Maintains information in study-specific and corporate tracking systems
• Supports regulatory and ethics committee submissions and notifications
• Assists with organization of internal team meetings
• Under supervision, coordinates sites payments within the project team
• Under supervision, prepares draft agendas for, and minutes of, internal team meetings
• Under supervision, assists with preparation, conduct and follow-up of Investigator Meetings
• Assists with clinical supplies order, receipt, inventory storage, distribution, return/recall and reconciliation at either PSI warehouse or as defined by the project team
• Assists with preparation for and follow-up on TMF and systems audits and inspections
• Under supervision maintains, performs regular periodic checks of, and files study related documents in the TMF on a site and country level
• Under supervision prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Assists with translations of study-specific documents
• Under supervision, assists with safety information flow with investigative sites
• Other departmental assignments, as necessary

• College or university science degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.
  • Equivalency is defined as a minimum of 1 year experience in corporate or academic environment where administrative experience and technical skills have been gained.
• Strong organizational skills with exceptional attention to detail.
• Ability to manage multiple priorities and work effectively in a fast-paced environment.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future