Alcanza Clinical Research · 7 hours ago
Clinical Research Operations Manager
Charlottesville, VA
Full-time
Onsite
Mid, Senior Level
2+ years expAlcanza Clinical Research is a growing multi-site, multi-phase clinical research company with a strong presence across various therapeutic areas. The Clinical Research Operations Manager is responsible for leading the operational performance of the clinical research staff, ensuring compliance with guidelines, and enhancing study performance through collaboration and oversight.
Clinical TrialsHealth CareMedical
Responsibilities
Overall team management and leadership support with a focus on driving study performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance
Collaborating with other departments (Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality) to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors
Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency)
Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables (timeline, quality and budget)
Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study
Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures
Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level
Overseeing people management activities including timecards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and employment meetings
Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations
Collaborating with investigators to ensure patient safety and meeting client goals and timelines
Employing strategic thinking and problem-solving skills to propose and implement risk mitigations
Participating and presenting in management or site meetings
Perform all other duties as required or assigned
Qualification
Required
Bachelor's degree and a minimum of 2 years of clinical research experience, or an equivalent combination of education and experience, is required
2+ years' experience as a clinical research coordinator (CRC) is required
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm)
Must possess strong organizational, time management, problem solving, and project management skills to meet project deadlines
Well-developed written and verbal communication skills
Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers
Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities
Must be professional, respectful of others, self-motivated, and have a strong work ethic
Must possess a high degree of integrity and dependability
Ability to work under minimal supervision, identify problems and implement solutions
Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines
Preferred
1+ years of management experience in clinical research is highly preferred
Bi-lingual (English / Spanish) proficiency is a plus
Benefits
Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
Company
Alcanza Clinical Research
Alcanza Clinical Research provides health education and clinical research options.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Casey Orvin
Chief Commercial Officer (CCO)
James Clark
Chief Medical Officer
Recent News
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2026-01-06
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2025-10-16
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