The Director of Research will be responsible for the development, implementation and regulation of research services to meet the needs of both internal and external customers.

Equal Opportunity Employer/Veterans/Disabled

ESSENTIAL DUTIES & RESPONSIBILITIES

• Responsible for the development, management, and oversight of all research studies with the Semmes Murphey physicians, external healthcare physicians and providers, and sponsors
• Recruits, trains and manages the clinical research team to ensure it is comprised of qualified and appropriately trained individuals; monitors staffing levels and identifies adequate coverage for trial workload across teams of study coordinators
• Conducts education and training of coordinators, physicians, and all research staff regarding ICH, GCP, CFR’s and SOPs related to research
• Serves as subject matter expert for regulatory, ethical, and methodological questions and issues from staff, coordinators, and researchers; coordinates the education of the research team and provide one-on-one coaching as needed to investigators
• Audits operations to ensure compliance with all applicable regulations; provides leadership in identifying and implementing corrective actions/processes
• Determines effective strategies for recruiting research participants and retaining participants in long-term clinical trials; analyzes trends in recruitment and assures there is a limited number of competing trials; makes recommendations for a variety of options within a trial; and tracks physician compliance
• Collaborates with the Foundation Director to facilitate approval of studies through the Board, negotiate budgets, maintain legal documentation, and submit quarterly reports
• Completes documents for initial submission and ongoing review to the Institutional Review Board (IRB): assists with protocol development activities, completes required application forms, create and/or supporting documents that meet SMF, Sponsor, and regulatory bodies’ requirements, and responds to all reviewing/approval bodies’ requests
• Coordinates Critical Document Collection to facilitate the timely opening and maintenance of new and ongoing trials at the site: communicates and collaborates with research team to identify and resolve any regulatory issues; facilitates collection of site training documents from study initiation visits as well as coordinating and collecting ongoing amendment training documents

REQUIREMENTS

• Bachelor’s degree in Science, Nursing, or related field
• Eight (8) years’ experience in the clinical research industry
• Previous supervisory/managerial experience
• SOCRA/ACRP/RAC certification preferred
• Advanced degree in related field preferred

KNOWLEDGE, SKILLS & ABILITIES

• Advanced working knowledge of the clinical trial process and ICH-GCP guidelines and strong knowledge in medical terminology
• Highly proficient in Microsoft Office (Excel, Outlook, Word), Electronic Medical Records (EMR) and medical practice software
• Effective communication, both oral and written, with the ability to speak clearly and persuasively in positive and negative situations
• Excellent organizational skills with attention to detail
• Excellent interpersonal skills with the ability to tactfully interact with all levels of the organization
• High level of confidentiality and discretion
• Ability to manage various responsibilities with multiple deadlines and competing demands Ability to make frequent judgments and respond to both routine and escalated problems
• Can identify ways to streamline processes and improve efficiency without sacrificing quality and accuracy
• Must be able to travel locally and 10 percent or less out of state

PHYSICAL REQUIREMENTS:

These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential l functions of this position. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of the job. While performing these responsibilities the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers to handle or feel and to manipulate keys on a keyboard. The employee is often required to stand, walk, reach with arms and hands, and to stoop. The employee must occasionally lift and/or move up to 10 pounds. Visual and auditory capacity for frequent use of computer and telephone is required.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work area is fully equipped, well lit and ventilated. The noise level in the work environment is usually low to moderate. Interaction with others is frequent.