Clinical Research Manager 1

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.

Stanford University is one of the world's most renowned universities. Sitting in the heart of the San Francisco Bay Area among the valley's most progressive companies.

The Department of Pathology at Stanford School of Medicine, one of its founding departments, stands as a leader among its peers nationwide. Our preeminent faculty spans from emerging leaders to highly accomplished physicians and scientists, including a Nobel laureate and members of the National Academy. Our mission is to improve the diagnosis, treatment, and basic understanding of the human disease. This is done through discovery (research), education, and clinical care.

You will be working with an unparalleled leading-edge community of faculty and staff that are fundamentally changing the world of health care. You will have the opportunity to influence and drive change with your innovative ideas, the ability to make a difference and participate in human advancements. Our culture is fast-paced, energetic, and growing all of the time.

We offer a variety of benefits beyond traditional medical, dental, retirement, and savings options:

• Events and program for children, sports camps, tuition options
• World-class intellectual stimulation through learning and development classes, workshops, and onsite conferences from leading-edge speakers and faculty
• Work/life and family-friendly policies and reimbursement
• Participation in Stanford's social responsibility and sustainable programs for a better world

A vibrant university culture that values the uniqueness of each individual

We are seeking candidates who are progressive thinkers, see challenges as simply problems to solve, and have the spirit and energy to change the world.

About the Department of Pathology:

Comprised of extraordinary faculty and staff, our mission is to improve the ability to diagnose, treat and understand the origin and manifestation of human disease, and to care for those who have or are at risk to develop disease. We accomplish this through our clinical services (in all fields of anatomic and clinical pathology, including molecular and genomic pathology, histocompatibility testing and transfusion medicine) and be research (which includes basic, translational and clinical research into the origins and manifestations of disease, including efforts to improve disease prediction and prevention as part of the goal of achieving precision medicine and health), and also by educating future leaders in pathology and related fields. Everything we do is to achieve the goals of providing the highest quality of clinical services to the patients for whom we passionately care, to advance our ability to understand, diagnose, monitor and ultimately to cure disease or to prevent or delay its occurrence, and to provide outstanding education and career development opportunities to those who share these goals.

For more information about the department visit: http://pathology.stanford.edu/

About the Sean N. Parker Center:

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is an interdisciplinary center dedicated to advancing treatments and understanding the underlying immune mechanisms that drive allergic disease. Our work focuses on how immune system dysfunction leads to allergic reactions, with the goal of developing lasting, evidence-based therapies and safer, more effective treatments for both children and adults.

As a global leader in allergy research, the Center collaborates with researchers worldwide through an interlinked network of satellite centers that share data and support innovative clinical trials. Our team includes leading scientists, physician scientists, and specialists across immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, genetics, and related disciplines.

Through laboratory and computational research, clinical trials, and community outreach, we work to translate scientific discovery into meaningful improvements in patient care. While our primary focus is allergy and asthma, our research has broader implications for a range of immune related conditions, including eczema, food allergies, eosinophilic disorders, drug allergies, gastrointestinal diseases, toxic stress, vaccine response, menopause, and aging. By combining rigorous science with a patient centered approach, the Center aims to improve lives locally and globally.

About the Position:

The Clinical Research Manager provides leadership and oversight of research administration activities supporting the conduct of complex clinical trials. This role is responsible for hiring, orienting, training, and evaluating staff, monitoring staffing levels, and ensuring appropriate coverage across teams of study coordinators. The manager supervises implementation of and adherence to study protocols and educates research staff on established policies, processes, and procedures. Responsibilities include developing effective participant recruitment and retention strategies for long term clinical trials, analyzing recruitment trends, minimizing competing studies, and tracking physician compliance. The manager develops informed consent documents and coordinates protocol submissions, renewals, revisions, and annual reports to the Institutional Review Board and other regulatory bodies, including CSTA and the FDA, and submits Investigational New Drug applications as required.

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:

• Five years of clinical research experience in an academic health center, pharmaceutical, biotechnology, or CRO industry or
• equivalent.
• Three years of experience as a research manager or equivalent formal supervision duties.
• Clinical Research Certificate (ACRP, SOCRA, CROP).
• Ensures work is done on time in a high-quality manner
• Knowledge of clinical pharmacology and pathophysiology, and food allergy research.
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities
• Experience managing cross-functional teams or work groups as well as direct reports.
• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
• Strong regulatory knowledge and ability to perform monitoring of CRFs and GCP. This position must know IRB
• regulations and how to perform IRB submissions. Working knowledge of FDA procedures as applicable, and ICH-GCP and
• relevant SOPs.
• Disciplined work approach with the ability to function independently, take initiative and effectively problems solve issues.
• Customer service oriented both internally and externally with strong organizational, interpersonal and communication skills
• Bilingual in Spanish

Certifications & Licenses:

• Society of Clinical Research Associates or Association of Clinical Research Professionals or Stanford Clinical Research Operations Program certification is preferred.
• Phlebotomy 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.

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 fluids, 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.
• Due to the nature of the work, this position will be hybrid

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Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver''s License.

• Ability to drive day or night.

• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

Core Duties:

• 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.

• May lead or chair committees or task forces to address and resolve significant issues resulting from research activities.

• 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 ensure 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.

Minimum Education:

Bachelor's degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master''s degree preferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy 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.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

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

Core Duties:

• 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.

• May lead or chair committees or task forces to address and resolve significant issues resulting from research activities.

• 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 ensure 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.

Minimum Education:

Bachelor's degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master''s degree preferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy 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.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

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