Clinical Research Regional Manager

JOB DESCRIPTION:                        Regional Clinical Research Manager

LOCATION:                                     Central US / Texas

POSITION DESCRIPTION:             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

·       Perform Clinical Research Coordinator role, as needed

·       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 other regional 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

Qualifications:

·       Bachelor’s Degree, or equivalent

·       At least 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