Clinical Research Operations Manager

Job description



Clinical Research Operations Manager

Stanford University

Job Number:
86755

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The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our vision is to transform human health through innovative clinical research.



We are seeking an experienced clinical research operations manager to provide leadership and oversight of multiple, complex new projects involving cardiovascular medicine, infectious diseases and digital health. For example, the CROM will lead the operations for a new research center to improve outcomes for patients with atrial fibrillation. She or he will oversee the management of a $5M, innovative project conducted in partnership with multiple sites. Additional projects include a decentralized clinical trial with a major multinational biopharmaceutical, and a digital health Coordinating Center project.



The CROM will also help forge and strengthen new partnerships with senior leaders at Valley Care Hospital in Pleasanton. Several new COVID-19 studies are launching at this location with Stanford PIs.



The successful applicant will have the ability to supervise multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.



At SCCR, we strive to find team members who are passionate about their work, are creative and want to deliver results. We place a high priority on equipping our team members to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team members to have a healthy balance between work commitments and life outside of work, and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research in a rapidly growing academic research organization, we encourage you to apply!



Please visit our website to learn more about what we do and our core values.


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.

* - The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.




DESIRED QUALIFICATIONS:
  • Superb communication skills in speaking and writing
  • Proven track record in personnel/team management and team building
  • Ability to multi-task


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 ob jects 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.


WHY STANFORD IS FOR YOU:


Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
  • Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
  • A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
  • A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
  • Discovery and fun. Stroll through historic sculptures, trails, and museums.
  • Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

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.
Additional Information
  • Schedule: Full-time
  • Job Code: 4926
  • Employee Status: Regular
  • Grade: J
  • Requisition ID: 86755


Job:

Location: School of Medicine, Stanford, California, United States
Schedule:
Classification Level:

To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu

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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Job No:
Posted: 9/1/2020
Application Due: 9/1/2032
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