Regional Clinical Research Manager
About The Position
Telework permitted, Arizona Arthritis & Rheumatology Associates, P.C. (Phoenix, AZ) seeks a Regional Clinical Research Manager to 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, and 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, and escalate 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; and perform duties for coordinators and managers when there is a lapse in coverage.
Requirements
- 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
Responsibilities
- 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, and 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, and escalate 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
