Research Operations Lead — Clinical Trials & Compliance

Highlands Oncology Group; Springdale (AR); On-site; USD 90,000 - 120,000; Full time

Job summary

Highlands Oncology Group in Springdale, AR, is seeking a Research Operations Manager to lead regulatory, business, and informatics teams within the Clinical Trials Office. You will oversee study start-up activities, feasibility, regulatory submissions, contracts, budgets, and system configuration to ensure timely, compliant activation of clinical studies.

The role emphasizes process standardization, performance metrics, staff development, and cross-functional collaboration while adhering to GCP,

Qualifications

• Graduate from an accredited institution of higher education.
• Proficient with research regulations and industry standards.
• Proficient in computer skills including EMR and Microsoft Office.
• Strong knowledge of medical terminology.
• Maintain continuing education hours as required.
• Maintain all licenses, certifications, and qualifications current as required.

Responsibilities

• Provide leadership and oversight of regulatory, business, and informatics teams.
• Direct study start-up activities from feasibility through site activation.
• Maintain complete study life-cycle oversight, from start-up to close-out.
• Ensure timely completion of regulatory approvals, contracts, budgets, and system setup.
• Oversee study activation timelines and implement process improvements to enhance efficiency.
• Improve research department & management efficiency.
• Manage departmental staffing, workload distribution, and resource planning.
• Review investigator initiated and student trials.
• Act on and reduce audit findings and deviations.
• Improve internal quality metrics.
• Recruit, develop, and evaluate research operations personnel.
• Track and report key operational and study start-up metrics to leadership.
• Identify internal process improvement.
• Write and revise standard operating procedures and working practices.
• Review clinical staff documents and procedures.
• Attend inter-department meetings to identify synergy.
• Resolve operational barriers impacting study activation, regulatory compliance, or sponsor expectations.
• Develop and mentor staff while fostering a culture of accountability, collaboration, and continuous improvement.
• Maintain and update study documentation in accordance with policies and regulations.
• Communicate effectively with investigators, site staff, and sponsors to provide support, guidance, and training as needed.
• Assist in the preparation and conduct of regulatory inspections, audits, and study meetings.
• Stay current with industry trends, regulations, and best practices to contribute to continuous improvement within the organization.
• Prepare and present operational reports, study start-up metrics, and make strategic recommendations to senior leadership.

Skills

Regulatory knowledge

EMR proficiency

MS Office

Medical terminology

Continuing education

Licenses & certifications

Education

Bachelor’s Degree or higher with 5+ years research and oncology experience

CCRP, CCRC, CCRA, or equivalent

Tools

EMR systems

Microsoft Office

Job description

Highlands Oncology Group in Springdale, AR, is seeking a Research Operations Manager to lead regulatory, business, and informatics teams within the Clinical Trials Office. You will oversee study start-up activities, feasibility, regulatory submissions, contracts, budgets, and system configuration to ensure timely, compliant activation of clinical studies.

The role emphasizes process standardization, performance metrics, staff development, and cross-functional collaboration while adhering to GCP,