Clinical Research Regional Manager
LONE STAR ARTHRITIS AND RHEUMATOLOGY ASSOCIATES
Behavioral Health Market Context
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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
- •4 more items(s)
Responsibilities
- •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)
- •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
- •24 more items(s)
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