[Hiring] Regional Clinical Research Manager @ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES PC
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.
Apply Now
Apply Now
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.
Apply Now
Apply Now