Clinical Research Manager

Stanford University • Stanford, CA

112d • $124,521 - $153,615

About The Position

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University's School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education. The Department of Anesthesiology, Perioperative, and Pain Medicine is seeking a Clinical Research Manager to provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. We are looking for an enthusiastic and energetic individual to join in the management of a highly collaborative research effort. Topically, the core research aim focuses on elucidating the neuroscience underlying individual differences in nociceptive processing, the biology behind the influence of biopsychosocial factors, and how this may lead to differential risk of pain amongst our surgical patients. Research activities include employing validated questionnaires and quantitative sensory testing tools for the accurate measurement of an individual's psychosocial and psychophysical phenotype. Other studies are aimed at validating empiric methods to prospectively identify individuals at highest risk of pain persistence and problematic opioid use after surgery. We conduct longitudinal, perioperative observational and interventional studies in surgical and chronic pain patients. Interventions range from testing pharmacologic analgesics and regional anesthetic, to employing non-pharmacologic behavioral approaches. Other projects in the quantitative sensory testing lab investigate how pain may be modulated by non-opioid analgesic techniques (regional anesthesia, yoga-based exercise, distraction, music, CBT, and open-label placebo). Research involves interacting with operative and chronic pain patients and healthy volunteers, and working within clinical systems to implement self-reported psychosocial assessment, and perform quantitative sensory testing at the bedside or in the lab. Proficiency at analysis of data, manuscript preparation, and grant writing is valued. Because this research involves engaging with the PI and multiple collaborators both in and out of our department, professionalism, humor, problem-solving, and a pioneering spirit are appreciated. Strong communication skills, and a balance between independence and team spirit is essential. Applicants should hold a bachelors or masters in Neuroscience, Psychology or other biomedical discipline, some exposure to basic statistical analyses, and possess a strong work ethic, and writing and literature review skills.

Requirements

• 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.
• 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.

Nice To Haves

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Responsibilities

• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials.
• Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
• Supervise the implementation of and adherence to study protocols.
• 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.
• 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.
• Provide leadership and expertise in identifying and completing research grants.
• Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
• Lead or chair committees or task forces to address and resolve significant issues.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• Analyze trends in recruitment and assure there is a limited number of competing trials.
• 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.

Benefits

• Career development programs
• Competitive pay that reflects market trends
• Comprehensive rewards package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Bachelor's degree