Assistant Director, Regional Research Operations

About the role

The Assistant Director of Regional Research Operations provides operational leadership for the expansion, standardization, and ongoing execution of oncology clinical research across regional practice locations. This role develops and implements standardized processes, oversees research education and competency programs, supports regulatory compliance, and collaborates with investigators and departmental leadership to ensure high-quality, compliant clinical trial conduct throughout the research network.

Responsibilities

• Lead the operational expansion of clinical research into the CARTI regional oncology practice locations, developing scalable operational workflows that promote consistent research practices across the CARTI regional research program.
• Collaborate with clinical, pharmacy, laboratory, imaging, and administrative leadership to establish regional site readiness and maintain research infrastructure in the regional research program.
• Lead internal quality assurance activities, audits, CAPA development, and inspection readiness initiatives for the regional research program.
• Monitor CARTI regional research performance metrics and support standardized execution of clinical trials throughout the regional research program.
• Design, implement, and maintain a comprehensive onboarding curriculum for new regional research personnel.
• Develop and implement competency-based education programs for research staff.
• Collaborate with Sponsor and CRO teams to ensure operational consistency from study startup through closeout, including identification of operational boundaries and solution development.
• Ensure regional research program operations align with ICH E6(R3) Good Clinical Practice, FDA regulations, EMA regulations, sponsor requirements, and institutional policies.
• Conduct operational reviews and process audits to ensure compliance and identify opportunities for improvement.
• Promote collaboration between regional research program and the central research office and participate in strategic planning for departmental growth and expansion.
• Support workforce development, including recruitment, hiring, mentoring, and succession planning for regional research team members.
• Identify opportunities to increase research participation within underserved and rural communities.
• Participates in required training and education programs.
• Represents the department and investigators at local, regional, and national meetings.
• Serve as the co-chair of the Regional Research Subcommittee of the CARTI Scientific Steering Committee (CSSC).
• Participate in Investigator Meetings, departmental committees, and strategic planning sessions.
• Assist with the creation of community outreach program.
• Assist with the creation of the research patient navigation program.
• Collaborate with leadership on feasibility assessments for regional research activation.
• Assist with preparation for sponsor audits, FDA inspections, and accreditation activities.
• Travel to other CARTI cancer centers and Clinics outside of Little Rock as required.
• Other duties as assigned in support of departmental objectives.

Qualifications

• Bachelor's degree in health sciences, business, or related field; Master's degree (MPH, MS, MHA, MBA) with clinical/research foundation preferred.
• Certified Clinical Research Professional (CCRP) certification within 12 months of exam eligibility.
• Valid Arkansas Driver's license.
• Minimum five (5) years of clinical research experience, including two (2) years of leadership experience.
• Demonstrate strong knowledge of oncology clinical research operations.
• Expertise in FDA regulations and ICH Good Clinical Practice (GCP).
• Experience in developing SOPs and operational workflows.
• Adult education and curriculum skills.
• Leadership and mentoring abilities.
• Excellent organizational and project management skills.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities across geographically dispersed sites.
• Experience with change management and process improvement.
• Collaborative leadership style with a commitment to quality and continuous improvement.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, or schedule form.
• Must interact and communicate both verbally and in written form.
• Must interact and exchange information regarding patients with physicians and other departmental personnel, and outside agencies on a frequent basis while respecting the confidentiality of patient information.

Supervisory responsibility

Yes

Physical demands

• While performing the duties of this job, the employee is regularly required to talk or hear.
• The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.

Work environment

• This position involves potential exposure to infectious diseases. Team members are offered appropriate vaccinations and safety training.
• This position is a Safety Sensitive Position and cannot be filled by a candidate who is a current user of medical marijuana. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.

This response is AI-generated, for reference only.