Stanford was founded almost 150 years ago on a bedrock of societal purpose. Our mission is to contribute to the world by educating students for lives of leadership and contribution with integrity; advancing fundamental knowledge and cultivating creativity; leading in pioneering research for effective clinical therapies; and accelerating solutions and amplifying their impact.
Post : Clinical Research Manager
Job Description
• 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.
• Incumbent will be responsible for Allergy and Asthma research and assist with some COVID19 specific research, will manage a complex group and manage many levels of training. This is an on-site management position at Stanford clinics and hospitals (Stanford and Mountain View, CA locations).
Candidate Profile
• 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, GCP and GMP. 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.
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.
Additional Information
Pay range for this position is USD 120,411 to USD 143,265 per annum
Requisition ID : 105073
Job Code : 4926
Qualification : Bachelor’s degree
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th November 2024
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