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 reta... more details
The Childhood Research Obesity Prevention Lab under the Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition (Pediatric GI) within 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.
The selected candidate must have the ability to implement, organize and perform oversights of all aspects of clinical studies combined with knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments). S/he will lead the team of clinical researchers and clinical research coordinators in conducting the research studies in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients. Previous clinical research management experience is required.Previous clinical trial experience at Stanford and/or LPCH is highly desirable.
The Pediatric GI Division has approximately 40 pediatric gastroenterologists with nationally recognized expertise through their research, teaching, and clinical programs which attracts leading candidates to their fellowship program.We have a mission of healing children with digestive disease through innovation. Our Pediatric GI Specialty provides comprehensive GI care to children throughout our region. We lead global destination programs that deliver highly specialized care and train the next generation of pediatric gastroenterologists, and inspire hope through innovation.Our high quality, collaborative care is driven by cutting-edge research and active partnerships between doctors, nurses, and staff throughout the Stanford Medicine Children’s Health network, scientists at Stanford University, and patientfamilies.Together, we are changing the lives of children today and shaping care for tomorrow.
The Department of Pediatrics is a dynamic, stimulating place to work and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.
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
All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.
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. The pay range for this position working in the California Bay area is $107,000.00 to $136,000.00.
DESIRED QUALIFICATIONS:
Excellent oral and written communication skills
Experience with managing clinical data in a research setting
Proficiency in using computers, software, and web-based applications in a previous administrative setting
Experience training, mentoring, and/or supervising others on topics related to clinical research conduct and management
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.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.