H-1B Visa Clinical Research Manager Jobs

INTRODUCTION

Stanford University 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.

DUTIES INCLUDE:

• 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.

• Other duties may also be assigned.

DESIRED QUALIFICATIONS:

• Direct intervention and/or testing experience with children and families with autism and other neurodevelopmental disorders.
• Proficiency in developing and utilizing databases within RedCap.
• Proficiency in use of electronic medical record systems.
• Experience collaborating in multidisciplinary, patient-centered clinical care, research, and community-based team settings.
• Training in administration and scoring of developmental, cognitive, and autism diagnostic measures.
• Experience in large-scale event planning and management of professional training program logistics, including financial tracking and on-site execution, within academic and healthcare settings.

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.

COMPENSATION

• The expected pay range for this position is $124,521 – $153,615 per annum.

Stanford University provides pay ranges representing its good faith estimate of the salary the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package.

The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

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