Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
- This role involves managing clinical research operations and staff at Arizona Arthritis & Rheumatology Associates.
- Serve as a first line manager to research coordinators and assistants
- Conduct training and mentorship of new clinical research staff
- Assign tasks and studies to ensure workloads are balanced among coordinators and assistants
- Utilize Clinical Trial Management System weekly to ensure productivity goals are met
- Monitor electronic source data capture system reports to ensure data and query goals are met
- Meet with employees monthly to review metrics and conduct weekly huddles with the team
- Manage operations at the clinical sites and facilitate all medical staff’s participation in research
- Implement Clinical Trial Agreements & Budgets and ensure model fiscal operations
- Assist with qualifying and onboarding vendors and staff for clinical services as required per study
- Approve and order supplies and equipment as needed from sponsors and vendors
- Ensure clinical research staff have the skills and resources necessary for success
- Ensure clinical sites have the medical equipment and resources necessary for success
- Ensure clinical sites are engaging in recruitment activities and meeting patient enrollment goals
- Facilitate operational changes using professional and positive motivation
- Ensure compliance with research protocols, handbook policies, standard operating procedures, ICH-GCP Standards, FDA regulations, and medical laws
- Implement solutions for compliance
- Perform quality assurance and complete corrective action and prevention assessment plans
- Conduct Pre-Study Visits and Site Initiation Visits for new clinical trials
- Serve as an escalation point for all clinical trials and the first point of contact for site staff members
- Provide ongoing support, needs assessment, and issue resolution to clinical sites and staff on an ongoing basis
- Escalate issues to Director of Clinical Research when needed
- Communicate with physicians, vendors, sponsors, and CROs to address and resolve issues
- Collaborate with fellow Regional Research Managers to ensure a consistent and coordinated department and management style across all sites nationally
- Meet with administrative staff regularly to ensure all research operations are running smoothly
- Perform duties for coordinators and managers when there is a lapse in coverage
- Qualifications
- Bachelor’s degree in Biomedical Science, Physiology, Nursing, Medicine, Clinical Research, or a related field
- Two years’ relevant experience
- Strong experience with clinical research and relevant clinical indications
- Knowledge of specific state and federal regulations governing clinical research and privacy
- Strong verbal and written communication skills
- Strong knowledge of medical procedures and clinical terminology
- Strong knowledge of ICH-GCP guidelines
- Up to 20% domestic travel required
- Requirements
- Salary ranging $109,678.00/yr. to $112,000.00/yr.
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