Clinical Research Regional Manager

ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES PC•Rockville, MD

6d•Hybrid

About The Position

Arizona Arthritis & Rheumatology Associates, P.C. is the largest private Rheumatology practice in the United States, with over 60 providers, 15 sites, and over 350 employees. The practice is recognized for excellence in medicine and pioneering new treatments, supported by its Research department. They are seeking an ambitious, friendly, positive, and compassionate Clinical Research Coordinator to join their team. The Regional Research Manager reports to the Director of Clinical Research and is responsible for the clinical research staff and daily operations at each assigned medical clinic (research site).

Requirements

Bachelor’s Degree, or equivalent
2 years’ experience as clinical research coordinator
Subject Matter expert in clinical research and relevant clinical indications
Understands specific state and federal regulations governing medicine and privacy
Possess strong leadership & organizational skills
Excellent verbal and written communication skills
Willing and able to travel to all regional offices daily

Nice To Haves

Management experience and/or formal training
Clinical Research Certification (CRCC/CCRP)

Responsibilities

Travel daily to research sites to provide support and complete job responsibilities
Serve as the first-line manager (direct, supervise, and evaluate) for research coordinators and assistants
Conduct training and mentorship of new clinical research staff, ensuring their success
Assign tasks and studies to ensure workloads are balanced among recruitment staff
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
Perform HR responsibilities including interviews, reviews, reprimands, and terminations
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, 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 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
Participate in continuing education to remain a subject matter expert on all research protocols, medical indications, company policies, standard operating procedures, ICH-GCP regulations, FDA 21 CFR, IRB Guidelines, and all applicable local and federal medical laws