Project Coordination Associate

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

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

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

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.