Research Program Director

University of Arkansas for Medical Sciences•Little Rock, AR

About The Position

The Research Program Director provides project management, risk management, and day-to-day coordination of multiple complex clinical research projects. The person in this position collaborates with leadership and support personnel in the Translational Research Institute (TRI) and the Department of Biomedical Informatics (DBMI) to create and document processes and procedures for data security and clinical trial operations in a formal quality management system, manages cross-functional teams and monitors the progress and performance of all aspects of assigned projects, including interactions with federal program offices and other sponsor representatives. A key component of the position is ensuring adherence to federal, state, and institutional regulations and providing multidisciplinary project management for internal staff, including Clinical Site Managers, Financial and IRB Administrators, Clinical Informatics and Data Management, Biomedical Informatics, Science Writers, Professional Development, and External Communications. The position requires a high degree of strategic and critical thinking, verbal and written communication, and information organization. The position works in a fast-paced environment with multiple priorities and deadlines. Candidates should have experience in clinical trial management and quality systems development. Strong technical writing skills, the ability to understand compliance requirements, excellent verbal communication skills, and knowledge of clinical information technology systems are needed. This position reports directly to the Chair of the Department of Biomedical Informatics.

Requirements

Bachelor's degree in biomedical informatics, business, finance, law, information quality, or related field, plus five (5) years of experience in biomedical informatics, research administration, compliance administration, or finance, or Master’s degree in biomedical informatics, business, finance, law, information quality, or related field, plus three (3) years of experience in biomedical informatics, research administration, compliance administration, or finance, required.
Supervisory experience is required.
Strong technical writing skills.
Ability to understand compliance requirements.
Excellent verbal communication skills.
Knowledge of clinical information technology systems is needed.

Nice To Haves

Working knowledge of NIST 800-171 risk assessment and 21CFR Part 11 compliance.
Special preference is given to candidates with a clinical research quality manager certification or similar certifications.

Responsibilities

Documents all regulatory issues, creates Corrective Action/Preventive Action plans.
Trains new internal staff in team operations.
Develops and provides training to investigators and research staff.
Ensures effective and efficient workflow and adherence to quality standards for staff/program, and self.
Leads multidisciplinary teams in the successful planning and execution of multiple clinical research projects.
Builds external relationships and works collaboratively with a variety of federal and institutional collaborators to develop and monitor policies and procedures.
Provides project management for multiple complex clinical research projects from protocol development to closeout.
Requires thorough knowledge of Federal Regulations and Good Clinical Practice.
Develops and adapts complex project reports and other appropriate tools needed for project oversight.
Manages external vendors for negotiation and provision of products/services.
Develops and provides overall training to investigators and research staff.
Ensures effective and efficient workflow and adherence to quality standards for staff/program, and self.
Works closely with Senior Leadership and the Department Chair to develop and execute strategic plans.
Demonstrates a high level of integrity, emotional intelligence, and innovative thinking, and actively contributes to the success of the institution.
Ensures federal and institutional compliance for research and clinical trial projects via risk management assessments.
Oversees data quality assurance activities, including documentation review, deviation management, and self-audits.
Ensures the integrity of data through data validation and quality control processes.
Manages documentation, including standard operating procedures, work instructions, procedures, and policies.
Performs other duties as assigned.