Regional Clinical Research Manager

Description

Title: Regional Clinical Research Manager

Location: 4550 East Bell Road, Suite 170, Phoenix, AZ 85032

Description:

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. 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; and up to 20% domestic travel required. Salary ranging $109,678.00/yr. to $112,000.00/yr.