Clinical Trials Unit Project Manager 1, 2, or 3

Louisiana State University

4d•Onsite

About The Position

Pennington Biomedical Research Center, a world-renowned academic research institute of Louisiana State University, is seeking a Project Manager in the Clinical Trials Unit. 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.

Requirements

Bachelor's degree in clinical research, health sciences, life sciences, public health, nursing, healthcare administration, business, or a related field.
Two years of experience in clinical research, clinical trial coordination, healthcare research, or a related field.
Experience coordinating research projects, clinical studies, or multidisciplinary activities.
Working knowledge of Good Clinical Practice (GCP), clinical research regulations, and applicable institutional requirements.
Four years of experience in clinical research, clinical trial coordination, healthcare research, or a related field, including at least two years of project or clinical trial management experience.
Demonstrated experience independently coordinating clinical trials or research projects from study start-up through closeout.
Demonstrated knowledge and application of Good Clinical Practice (GCP), clinical research regulations, and institutional requirements.
Experience coordinating multidisciplinary project teams and managing competing priorities, timelines, and study deliverables.
Six years of experience in clinical research, clinical trial coordination, healthcare research, or a related field, including at least four years of project or clinical trial management experience.
Demonstrated experience independently managing complex clinical trials or multiple concurrent research projects from study start-up through closeout.
Advanced knowledge and demonstrated application of Good Clinical Practice (GCP), clinical research regulations, and institutional requirements.
Demonstrated experience leading multidisciplinary project teams, managing complex timelines and competing priorities, resolving operational issues, and coordinating with investigators and internal and external stakeholders.

Nice To Haves

A letter of application/cover letter is recommended but not required.

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.