Project Coordination Associate

Company DescriptionWe 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.Job DescriptionThe 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 regionsOrganizes the exchange of trial-specific information and records with sites, sponsors, and vendorsParticipates in and follows up on regulatory and ethics committee submissions and notificationsTracks the financial and contractual tasks within the project teamSupervises the preparation for and follow-up on site audits and inspectionsOrganizes, participates in and prepares reports of project meetingsOrganizes, attends, and follows up on Investigator MeetingsConducts on-the-job coaching of Site Management Associates and Clinical Operations Administrative Support staffCoordinates and monitors compliance of trial-specific trainings of the project teamSupervises site and trial handovers between Site Management Associates Project Coordination AssociateMaintains and oversees the regular TMF quality checks for completeness and accuracyPrepares for and follows up on system audits and inspectionsSupervises the preparation, distribution, and update of ISFs and ISF checklistsSupervises the translation process for trial records on a regional and global levelMaintains and reviews trial-specific and corporate tracking management systemsSupervises the timely update of trial-specific and corporate tracking management systems done by the project teamCoordinates clinical supplies order, receipt, inventory, storage, distribution, return/recall, and reconciliation, and maintains accurate records of thereofDrafts and tracks project plansInitiates and supervises the trial-specific IP-REDs review processSupervises performance of Site Management AssociatesPerforms other assigned trial coordination tasks as delegated by the Project ManageQualificationsCollege 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 requiredMust be in a commutable distance to the office in Durham, NCStrong communication and presentation skillsAttention to detail and organizational skills are criticalAbility to work in a team setting as well as independently as neededProficient in using Microsoft Office toolsAdditional InformationIf 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 futureSummaryType: Full-timeFunction: Information TechnologyExperience level: AssociateIndustry: Pharmaceuticals