Career Center

Neuromuscular Clinical Research Manager/Evaluator
School of Medicine, Stanford, California, United States

Schedule: Full-time
Job Code: 4926
Employee Status: Regular
Grade: J
Requisition ID: 92119

Neuromuscular Clinical Research Manager/Evaluator

Stanford University is seeking a Neuromuscular Clinical Research Manager to provide leadership and oversight of one of the nation's largest and most preeminent Neuromuscular Research Programs. The Stanford Neuromuscular Program is looking for a clinical research manager/evaluator with the training and experience necessary to measure quantitatively muscle strength and motor function in pediatric and adult subjects with genetically and clinically defined chronic neuromuscular disorders. Current natural history and treatment trials utilize detailed state-of-the-art measures of musculoskeletal and neuromuscular function that necessitating that successful applicants demonstrate excellence in training and professional experience in the precise assessment, measurement and longitudinal monitoring of chronic neuromuscular disorders including muscular dystrophies, motor neuron disorders and inherited neuropathies.

Responsibilities will include quantitative force and functional assessment of neuromuscular subjects involved in clinical trials. The clinical research manager/evaluator will be expected to utilize various force-assessment methods, as well as performing functional analyses, goniometric assessment of relevant joint function, and assessment of subject symptoms to ascertain the role of pain and fatigue in performance limitations. The evaluator will be expected to accurately retain data from these evaluations in the division database, and analyze them to determine disease trends.

Requirements of successful applicants include completion of clinical training as a physical therapist and must have/ or obtain active California license to practice within 6 months of hire. At least five years of work related experience or the equivalent combination of education, training and experience with a minimum of two years of experience in clinical or clinical research assessment of neuromuscular patients. The clinical evaluator will also interface with patient groups to determine eligibility for recruitment into active trials. An understanding of neuromuscular disorder pathophysiology, and a history of neuromuscular disorder laboratory research, will be of value to help interface with neuromuscular basic and translational investigators. Other requirements include, 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 and demonstrated managerial experience.

Duties include to:

• Work with the Neuromuscular Clinical Research Medical Director, to hire, orient, train, oversee and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials, including Clinical Research Coordinators, Level 2; Clinical Research Coordinators, Level 1; Assistant Clinical Research Coordinators - also termed Neuromuscular Clinical Research Facilitators.
• Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
• Supervise implementation of protocols 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.
• Oversee NM Clinical Research Unit 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.
• Be aware of and responsive to institutional clinical research facilities and resources as well as institutional regulatory units
• 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.
• Oversee and assist with analysis of data, statistical evaluation and preparation of results for manuscripts and scientific presentations.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Completion of clinical training as a physical therapist and five years of work related experience or the equivalent combination of education, training and experience.
• At least two years of experience in clinical or clinical research assessment of neuromuscular patients.
• Experience interfacing with study participants and groups to assist with recruitment for active studies
• An understanding of neuromuscular disorder pathophysiology, and a history of neuromuscular disorder laboratory research
• Ability to interface with neuromuscular basic and translational investigators
• 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.
• Demonstrated managerial experience.
• Organizational skills for written reports and for scheduling complex events with multiple participants.
• Education in a biological or medical field beyond the undergraduate level.
• Experience with neurodegenerative or neuromuscular disorders to a level that facilitates learning about the varied disorders studied in the Neuromuscular Division.
• Experience working with children and adult subjects who are affected by various physical and mental disabilities, preferably those that occur with neuromuscular disorders.
• Experience working in an academic medical center in performance of clinical research.

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.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

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.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy



To be considered for this position please visit our web site and apply on line at the following link: https://apptrkr.com/2767112

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.







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