Clinical Operations Lead: Multi-Site Trials & Compliance

Accel Research Sites; Orlando (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k plan with safe harbor match

Job summary

Alcanza is a growing multi-site clinical research firm seeking a Clinical Research Operations Manager to lead on-site operational performance for ICH/GCP/FDA compliant trials. The role oversees staff, site activities, and data quality to meet sponsor expectations and timelines.

You will collaborate with departments like BD, Recruitment, Finance, and Quality to drive study milestones, manage resources, and implement risk mitigation strategies while ensuring patient safety and protocol adherence.

Qualifications

• Bachelor's degree and at least 2 years of clinical research experience.
• 2+ years' experience as a clinical research coordinator (CRC) is required.
• 1+ years of management experience in clinical research is highly preferred.
• Bi-lingual (English / Spanish) proficiency is a plus.

Responsibilities

• Overall team management and leadership support with a focus on study performance.
• Collaborate with Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality to meet milestones.
• Review performance dashboards to oversee site and patient activities and ensure timely execution.
• Oversee resourcing allocations, site assignments, and staff performance to meet deliverables.
• Assist with trainings on SOPs, CRF completion, and timelines for the study.
• Ensure adherence to GCP, FDA regulations, and company policies.
• Oversee site staff compliance and develop corrective action plans as needed.
• Manage timecards, hiring, performance appraisals, and staff development.
• Identify risks to delivery, escalate to management, and support risk mitigation.

Skills

Organizational skills

Time management

Project management

Communication skills

HIPAA compliance

Multitasking

Interpersonal skills

Bilingual English/Spanish

Education

Bachelor's degree

2+ years clinical research experience

CRC experience

Management experience preferred

Bilingual English/Spanish

Tools

EHR systems

MS Office

Job description

Alcanza is a growing multi-site clinical research firm seeking a Clinical Research Operations Manager to lead on-site operational performance for ICH/GCP/FDA compliant trials. The role oversees staff, site activities, and data quality to meet sponsor expectations and timelines.

You will collaborate with departments like BD, Recruitment, Finance, and Quality to drive study milestones, manage resources, and implement risk mitigation strategies while ensuring patient safety and protocol adherence.