Full-Time

Director of Research Projects

Deadline 10/14/26
Louisiana State University

Louisiana State University

Public research university in Baton Rouge, LA

No salary listed

No H1B Sponsorship

Baton Rouge, LA, USA

In Person

Bachelor's, Master's

Category
Biology & Biotech (1)
Required Skills
FDA Regulations
Quality Assurance (QA)
Biostatistics
Risk Management

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Requirements
  • A bachelor's degree in a health-related field is required, although relevant experience may substitute for the degree.
  • Three years of clinical research experience with supervisory and clinical project management experience are required, including clinical trial budgeting, protocol and consent development, regulatory submissions, study implementation, and oversight of data collection and quality assurance.
  • Strong knowledge of International Council for Harmonisation Good Clinical Practice, Food and Drug Administration and European Medicines Agency regulatory requirements, and clinical trial methodology is required.
  • Proficiency in clinical trial management systems, electronic data capture, electronic trial master files, and Microsoft Project or equivalent tools is required.
  • Candidates must have valid U.S. work authorization at the time of hire and maintain it throughout employment.
  • Candidates must complete required pre-employment screenings and a satisfactory background check.
Responsibilities
  • Lead and coordinate cross-functional project teams across clinical operations, data management, biostatistics, safety, regulatory, and medical writing.
  • Facilitate cross-functional team meetings and ensure documentation of decisions and action items.
  • Direct reports as Project Manager or Project Director.
  • Serve as the primary institute contact for internal and external stakeholders and compile data from research teams to provide regular project updates.
  • Lead the planning, initiation, and execution of clinical trials from study start-up through closeout.
  • Develop detailed project timelines, milestones, and resource allocation plans.
  • Oversee site feasibility, selection, initiation, monitoring, and closeout.
  • Work with clinical monitors, sponsors, and study teams to ensure high-quality site engagement and performance.
  • Ensure compliance with International Council for Harmonisation Good Clinical Practice, Food and Drug Administration and European Medicines Agency regulations, and internal standard operating procedures.
  • Identify risks, develop and implement mitigation strategies, and lead issue resolution efforts.
  • Support audit and inspection readiness activities.
  • Develop clinical trial budgets for funding submissions and ensure adherence to project scope, budget, and deliverables.
  • Oversee the selection, management, and performance of equipment and supply acquisition, maintenance, contract research organizations, laboratories, imaging providers, and other study-specific vendors.
  • Review and approve third-party invoices and ensure adherence to contractual terms.
  • Interface with the finance office to ensure that resource allocation for research projects remains within the institute's funding scope.
Desired Qualifications
  • A master's degree in a health-related field is preferred.
  • Ten years of experience managing complex, multi-site and/or multi-disciplinary studies is preferred.
  • Experience managing vendors, collaborators, sites, and cross-functional teams is preferred.
Louisiana State University

Louisiana State University

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Louisiana State University (LSU) is a public flagship research university in Baton Rouge, Louisiana. Its academic mission encompasses undergraduate and graduate instruction, research, and public service.

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