Clinical Research Manager

About the role

The Tass Lab at Stanford University is seeking a Clinical Research Manager to lead and oversee our pioneering research in Parkinson’s disease. This role involves partnering with faculty to translate research visions into clinical realities, managing staff, adhering to regulatory standards, and ensuring efficient fiscal and operational management.

Responsibilities

• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with clinical trials.
• Serve as the strategic backbone of our studies by empowering clinical staff, navigating regulatory excellence, and ensuring fiscal and operational management.
• Educate research staff on established policies, processes, and procedures.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Develop consent forms for approval by Human Subjects Panel.
• Carefully coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
• Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies.
• Submit Investigational New Drug applications to the FDA as required.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• Monitor Institutional Review Board submissions, and respond to requests and questions.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• Make recommendations for a variety of options within a trial; track physician compliance.
• Assist with analysis of data and preparation of manuscripts and scientific presentations.

Qualifications

• Education & Experience (Required): Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
• Knowledge, Skills And Abilities (Required): Excellent interpersonal skills. Proficiency in Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology. Demonstrated managerial experience.
• Certifications & Licenses: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Physical Requirements

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

Working Conditions

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.

Stanford University is an Equal Opportunity Employer