Clinical Research Manager

Description

POSITION DESCRIPTION: The Research Manager reports to the Operations Manager and is responsible for the clinical research staff & daily operations at each office.

RESPONSIBILITIES:  

• Travels daily to managing clinical research sites, as needed
• Manage and supervise all study coordinators and research assistants
• Ensure workloads are balanced among coordinators and assistants in each office
• Assign studies and tasks to coordinators and assistants
• Ensure all site responsibilities and goals are met, including monthly productivity goals for staff 
• Monitor recruitment efforts and ensure enrollment goals are met in each office. 
• Meet with each staff member monthly for a one-on-one meeting 
• Perform HR responsibilities including interviews, 90 day and annual reviews, reprimands, and terminations for clinical staff
• Ensure the research clinical staff have the skills and resources necessary for success
• Perform quality assurance and complete corrective action and prevention assessment plans.
• Monitor compliance with protocols, policies, standard operating procedures, ICH-GCP Standards, local and FDA regulations and implement solutions to increase compliance as needed
• Ensure company SOPs and Handbook are followed by research staff and affiliates at all times, including all training and regulatory obligations
• Maintain professional and positive work environment for all offices
• Available as an expert resource on all clinical trials and related questions to all staff members
• Provide ongoing support, needs assessment, and issue resolution to sites and staff on an ongoing basis, and will escalate to Operations Manager if needed
• Performs coordinating functions when there is any lapse in coverage at the offices
• May coordinate a limited number of clinical trials 
• Participates in the training and mentorship of new staff
• Participate in Pre-Study Visits and Site Initiation Visits as needed
• Meet with administrative staff and department managers regularly to ensure all research operations are running smoothly
• Communicates with clinic staff, vendors, sponsors and CROs as needed to address and resolve outstanding issues
• Participate in ongoing education to remain knowledgeable on all protocols at the institution, staff handbook, standard operating procedures, ICH-GCP regulations, FDA 21 CFR, IRB Guidelines, and all applicable local and federal Laws

Requirements

Qualifications:

• Bachelor’s Degree or Equivalent
• 4 years’ experience in clinical research, including roles as clinical research cooridnator
• Clinical Research Certification (CRCC/CCRP)
• Subject Matter Expert in clinical research and clinical indications
• Must have in-depth knowledge of medical and clinical terminology
• Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations regarding clinical research
• Understands specific state and federal regulations governing medicine and clinical research
• Possess strong leadership & organizational skills
• Ability to develop and maintain strong professional relationships with all providers and research subjects
• Excellent verbal and written communication skills 
• Ability to lift 20 pounds
• Willing and able to travel to all offices weekly, including out of state
• Management experience and/or formal training preferred