Clinical Trials Unit Project Manager 1, 2, or 3 at Louisiana State University in LSU

Job description

About Us: At the forefront of medical discovery as it relates to understanding the causes of obesity, diabetes, cardiovascular disease, cancer and dementia, Pennington Biomedical Research Center is a campus of Louisiana State University and conducts basic, clinical and population research. The Center includes Basic Science, Clinical Research, and Population and Public Health, enabling both focused research and translational science. Research at Pennington Biomedical is supported broadly by multiple NIH Research Centers , and includes approximately 65 faculty and 20 postdoctoral fellows who comprise a network of 44 laboratories and 13 highly specialized core service facilities. Pennington Biomedical is located within state-of-the-art research facilities on a 222-acre campus in Baton Rouge, Louisiana. All Job Postings will close at 12:01a.m. CST (1:01a.m. EST) on the specified Closing Date (if designated). If you close the browser or exit your application prior to submitting, the application progress will be saved as a draft. You will be able to access and complete the application through “My Draft Applications” located on your Candidate Home page. Job Posting Title: Clinical Trials Unit Project Manager 1, 2, or 3 Position Type: Professional / Unclassified Department: LSUPBRC Cores - CTU - Project Management Office (Melissa Lingle (00002335) (Inherited)) Work Location: LSU - Pennington Biomedical Pay Grade: Professional Job Description: Pennington Biomedical Research Center , a world-renowned academic research institute of Louisiana State University, is seeking a Project Manager in the Clinical Trials Unit. Major Responsibilities Coordinate the planning, implementation, and day-to-day operations of assigned clinical trials, including timelines, milestones, priorities, workflows, and study deliverables. Coordinate regulatory and study start-up activities, including preparation and submission of required regulatory documents, study materials, amendments, and continuing reviews. Manage study activities throughout the research lifecycle, including participant recruitment and screening, enrollment, study visits, follow-up, data and document collection, and study closeout. Coordinate and monitor project team activities to ensure compliance with study protocols, Good Clinical Practice (GCP), applicable regulations, institutional policies, and sponsor requirements. Collaborate with Principal Investigators and study leadership to develop and implement study plans, protocols, training plans, recruitment strategies, inclusion/exclusion criteria, and participant targets. Monitor study progress, recruitment, enrollment, participant retention, regulatory milestones, and other key performance indicators; identify barriers and facilitate timely resolution of issues. Coordinate communication among Principal Investigators, research staff, sponsors, monitors, regulatory personnel, clinical partners, and other stakeholders. Maintain accurate and timely study documentation, records, data, and tracking systems in accordance with protocol, regulatory, institutional, and sponsor requirements. Coordinate study team meetings, training, and orientation activities and provide guidance to project team members regarding study procedures, protocols, and research requirements. Identify and implement opportunities to improve clinical research processes, workflows, communication, and study operations. Promote collaboration, accountability, and effective teamwork across multidisciplinary clinical research teams. Perform other duties related to clinical research operations as assigned. *As part of a career progression group, this vacancy may be filled as a Project Manager 1, 2, or 3 depending on the level of experience of the selected applicant. Complexity differences: Project Manager 1: Coordinates assigned studies with established procedures and guidance; manages routine/less complex projects. Project Manager 2: Independently manages moderately complex studies a