Clinical Research Operations Manager Jobs in Reston, VA

Description

Arizona Arthritis & Rheumatology Associates, P.C. is the largest private Rheumatology practice in the United States. The practice has over 60 providers, 15 sites and over 350 employees providing assessment and treatments for our rheumatology patients. Our providers work together to keep patients healthy, and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.

We are an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability.

Our vision is to provide the best Rheumatology care, anywhere and, to balance sustainable operation with the highest possible level of patient care.

We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Coordinator to join our team.

The Regional Research Manager reports to the Director of Clinical Research and is responsible for the clinical research staff & daily operations at each assigned medical clinic (research site).

RESPONSIBILITIES

• Travel daily to research sites to provide support and complete job responsibilities listed below
• First line manager (direct, supervise, and evaluate) to 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 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

Learn more about AARA on our website at http://azarthritis.com

Requirements

QUALIFICATIONS

• 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
• Management experience and/or formal training preferred but not required
• Clinical Research Certification (CRCC/CCRP) preferred but not required