Clinical Research Operations Lead

Penn State University; United States; Hybrid; USD 60,000 - 86,000; Full time

Benefits offered by this job

75% tuition discount

Medical, dental, and vision coverage

Robust retirement plans

Job summary

Penn State University is seeking an experienced program administrator to oversee research projects within a department, coordinating workflows with research teams, external partners, and stakeholders. The role includes budget management, data collection planning, and timely submission of grants and compliance documents.

The position requires a Bachelor's degree and at least 3 years of relevant experience, with potential for funding-based continuation. Remote/hybrid work is not guaranteed.

Qualifications

• Bachelor's degree required.
• 3+ years of relevant experience; or an equivalent combination of education and experience accepted.

Responsibilities

• Provide operational oversight for research projects and activities within a department, including oversight of project timelines and deliverables, coordination of workflows between research teams, external organizations, and stakeholders, budget management, facilitation of data collection and management plans, preparation and submission of grants, proposals, and compliance documents, records management and documentation of studies, and ensuring program compliance with government regulations, university policies, and institutional review board requirements.
• Coordinate workflows between research teams, external organizations, and stakeholders.
• Manage budgets and financial transactions for the project.
• Facilitate data collection and management plans.
• Prepare and submit grants, proposals, and compliance documents.
• Manage records and documentation of studies.
• Ensure program compliance with government regulations, university policies, and institutional review board requirements.
• Develop operating procedures and workflow processes to ensure project scope and direction stays on schedule.
• Monitor project progress and deliverables; generate reports and deliver presentations to stakeholders.
• Coordinate meetings, trainings, and presentations between participants, research teams, sponsors, and internal or external organizations; create agendas and conduct training sessions.
• Develop recruitment and data collection plans including methods, tools, goals, and evaluation procedures.
• Coordinate and create documentation for projects, including operating procedures, data collection forms, templates, clinical trial submissions, and manuals.
• Author, review, and submit regulatory compliance documents and maintain communications with internal and external entities (IRB, ORA, NIH, Clinical Trials Office and HRPP); maintain relationships with governmental or regulatory agencies, research organizations, and central University offices.
• Direct the process for reviewing and approving new clinical trials.
• Identify, communicate, and resolve project issues; recommend and implement solutions.
• Manage and track budgets and resources to assure efforts align with project/study guidelines.
• Process financial transactions in support of the project including travel, p-card, transfers, and budget realignments.
• Track and document personnel and project certifications, training completion, and compliance records.
• Coordinate award administrative tasks; assist researchers with proposal preparation and submissions.
• May supervise staff members, including hiring, development, and performance management.

Skills

Project coordination

Education

Bachelor's Degree

Job description

Penn State University is seeking an experienced program administrator to oversee research projects within a department, coordinating workflows with research teams, external partners, and stakeholders. The role includes budget management, data collection planning, and timely submission of grants and compliance documents.

The position requires a Bachelor's degree and at least 3 years of relevant experience, with potential for funding-based continuation. Remote/hybrid work is not guaranteed.