Clinical Research Manager

Company: Stanford University
Location: Stanford
Posted on: November 18, 2023

Job Description:

The Department of Dermatology (Dermatology Operations) within Stanford University, is a dynamic and innovative Department dedicated to excellence in research, medical education, and clinical care. Our Department is driven by over 70 faculty members and a cadre of staff who are the pillar of strength in the Department's ongoing efforts into the prevention and treatment of various dermatologic diseases, conditions & disorders.

We are seeking a Clinical Research Manager (CRM) who is passionate about clinical research and project management. The CRM will report to the Associate Director, Clinical Research Operations and work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Program Managers, and Associates in support of dermatology patients. The Clinical Research Manager will provide leadership and oversight of studies conducted by several affinity groups within the Department. The Clinical Research Manager will manage clinical research operations, relationships with other affinity groups and staff, study quality management, personnel management and career skill development, regulatory compliance, and fiscal oversight. The CRM will also assist with building automated clinical research workflows and solutions within the Department. 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.

Our Department strives 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!

Note the position will be based on the Stanford Redwood City (SRWC) campus and is hybrid (working on-site and working from home) subject to operational needs.

Dermatology Clinical Research is a growing team that's dedicated to supporting translational medicine and contributing to Stanford Medicine's mission. We invite you to join our team!


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:

Experience developing reports and dashboards.
Experience with Smartsheet.
Experience with Notion.


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.

The expected pay range for this position is $108,000 to $136,000 per annum/hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. 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 (https://cardinalatwork.stanford.edu/benefits-rewards) 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.

Keywords: Stanford University, San Francisco , Clinical Research Manager, Healthcare , Stanford, California