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 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

The Project Coordination Associate supervises and coordinates trial administrative support, management of trial records, site management, and communication with the investigator sites, the sponsor, trial vendors, and members of the project team. This function operates at a regional or global trial level.

Responsibilities Include:

• Ensures planning, implementation, and management of trials in compliance with industry regulations, ICH-GCP, essential trial records and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)
• Ensures consistency of Clinical Operations processes in the assigned trials across the trial regions
• Organizes the exchange of trial-specific information and records with sites, sponsors, and vendors
• Participates in and follows up on regulatory and ethics committee submissions and notifications
• Tracks the financial and contractual tasks within the project team
• Supervises the preparation for and follow-up on site audits and inspections
• Organizes, participates in and prepares reports of project meetings
• Organizes, attends, and follows up on Investigator Meetings
• Conducts on-the-job coaching of Site Management Associates and Clinical Operations Administrative Support staff
• Coordinates and monitors compliance of trial-specific trainings of the project team
• Supervises site and trial handovers between Site Management Associates Project Coordination Associate
• Maintains and oversees the regular TMF quality checks for completeness and accuracy
• Prepares for and follows up on system audits and inspections
• Supervises the preparation, distribution, and update of ISFs and ISF checklists
• Supervises the translation process for trial records on a regional and global level
• Maintains and reviews trial-specific and corporate tracking management systems
• Supervises the timely update of trial-specific and corporate tracking management systems done by the project team
• Coordinates clinical supplies order, receipt, inventory, storage, distribution, return/recall, and reconciliation, and maintains accurate records of thereof
• Drafts and tracks project plans
• Initiates and supervises the trial-specific IP-REDs review process
• Supervises performance of Site Management Associates
• Performs other assigned trial coordination tasks as delegated by the Project Manage

Qualifications

• College or university degree in Life Sciences or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.
• Minimum four years of CRO and/or relevant clinical research experience required
• Must be in a commutable distance to the office in Durham, NC
• Strong communication and presentation skills
• Attention to detail and organizational skills are critical
• Ability to work in a team setting as well as independently as needed
• Proficient in using Microsoft Office tools

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then this 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