Senior Clinical Research Program Manager job at reputed company in reputed company, CA

Title: Sr. Clinical Research Program Manager Location: reputed company reputed company Job reputed company: 2 year fixed term The Childhood Research Obesity Prevention Lab under the Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition (Pediatric GI) reputed company reputed company is seeking a Senior Clinical Research Manager to reputed company leadership and reputed company of reputed company large or multiple small clinical research reputed company. Supervise multiple clinical research staff, leads, managers. Manage clinical research operations, including reputed company management, personnel management, regulatory compliance, and fiscal reputed company. Mentor Clinical Research Managers. The selected candidate must have the ability to implement, organize and reputed company oversights of reputed company aspects of reputed company, multi-site, multi-level clinical studies combined with knowledge of good clinical reputed company (GCP) and health care economics including insurance billing, research-reputed company financial and budgetary processes (tracking study costs and sponsor payments). S/he will reputed company reputed company of clinical research managers and clinical research coordinators in conducting the research studies in reputed company 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 reputed company care and improve performance in the clinical care of patients. Previous clinical research management experience is required. Previous clinical trial experience at reputed company and/or LPCH is highly desirable. Previous experience with health services research reputed company to conduct patient-centered, community-based clinical trials using quantitative, qualitative, and implementation science reputed company is preferred. Duties include: Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials in patient-centered and community-based partnerships. Monitor reputed company reputed company and identify adequate coverage for workload across teams of study coordinators. Supervise development, implementation, and adherence in relation to study protocols and operating procedures. reputed company research staff on established policies, processes, and procedures. reputed company and monitor strategies for promoting/reputed company research participants and retaining participants in long-term clinical trials. reputed company development of consent forms for approval by reputed company Subjects Panel for investigator-initiated multi-site clinical research trials including behavioral and reputed company needs interventions in partnership with patients, clinical sites, and community organizations. Coordinate new protocol submissions, renewals, and revisions to Institutional Review reputed company for multiple studies. Complete annual reports to Institutional Review reputed company, 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; reputed company leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review reputed company submissions, and respond to requests and questions. reputed company leadership and expertise in identifying and completing research grants. reputed company financial resources, as needed, create reputed company budgets for research protocols, assure financial accountability, and serve as primary reputed company between sponsor, department reputed company, and Research Management Group. reputed company or chair committees or task forces to address and resolve significant issues. Engage in high-level reputed company and networking opportunities, representing the research program to a reputed company of reputed company audiences. Analyze trends in recruitment and assure there is a limited number of competing trials. reputed company recommendations for a reputed company of reputed company reputed company a trial; reputed company physician compliance. Assist with analysis of data and preparation of manuscripts and scientific presentations. reputed company members of the Department of Pediatrics are reputed company in reputed company learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to reputed company aspects of our work. The Department reputed company and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at reputed company reputed company. reputed company 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 reputed company for this position working in the California Bay area is $139,909.00 to $165,398.00 annually. DESIRED QUALIFICATIONS: Excellent oral and written communication skills Exceptional attention to detail Experience with pediatric behavioral, nutrition, and/or community-based participatory research Experience with managing multi-site randomized clinical trials Experience training, mentoring, and supervising others on topics reputed company to clinical research conduct, management, and regulatory requirements Experience auditing clinical research reputed company Training and experience in project management approaches EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in reputed company 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. Excellent diplomacy skills Proficiency in reputed company Office and database applications, and EHRs (i.e., reputed company, reputed company). Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review reputed company requirements, and Good Clinical Practices. Knowledge of medical terminology. Minimum of three years of demonstrated managerial experience. Demonstrated disease knowledge / study design experience of studies under purview. 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, reputed company above shoulders, reputed company 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, reputed company reputed company, 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 reputed company reasonable accommodation to any employee with a disability who requires accommodation to reputed company the essential functions of his or her job. Additional PHYSICAL REQUIREMENTS: (remove if none) WORKING CONDITIONS: May be exposed to blood borne pathogens. May be required to work non-reputed company, extended or weekend hours in support of research or project work. Additional Information Schedule: Full-time Job reputed company: 4905 Employee Status: Regular Grade: K Department URL: http://pediatrics.reputed company.edu/ reputed company: 108001 Work Arrangement : Hybrid Eligible Apply tot his job Apply To this Job