Clinical Research Operations Manager

About the Role

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations across AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX, and Puerto Rico. We specialize in Phase I-IV studies across several therapeutic areas, including vaccine, neurology, dermatology, psychiatry, and general medicine. As the Manager, Clinical Operations, you will lead the operational performance of the clinical research staff, ensuring execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA regulations, and company policies.

Responsibilities

• Provide overall team management and leadership with a focus on driving study performance, enhancing efficiencies, patient safety, and protocol/GCP/regulatory compliance.
• Collaborate with departments such as Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality to coordinate delivery expectations, meet study milestones (e.g., site activation and enrollment targets), adhere to budgets, and deliver quality data to sponsors.
• Review performance dashboards and clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and verify timely execution of operational aspects (required visits/calls, duration, and frequency).
• Oversee resourcing allocations, site assignments, and study team members' output to ensure study deliverables remain on track, identify risks, and escalate issues affecting timeline, quality, or budget.
• Assist with initial and ongoing trainings on protocol specifics, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans, guidelines, and study timelines.
• Ensure adherence to SOPs, GCP, FDA regulations, and company policies.
• Oversee site staff assigned to studies, routinely assess study-specific process and training compliance, CMP compliance, and identify emerging risks; develop and support corrective action plans as needed.
• Manage people-related activities, including timecards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching, and employment meetings.
• Proactively manage assigned site staff, identify and resolve issues, and ensure successful site operations.
• Collaborate with investigators to ensure patient safety and meet client goals and timelines.
• Employ strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participate and present in management or site meetings.
• Perform all other duties as required or assigned.

Requirements

• Bachelor’s degree and a minimum of 2 years of clinical research experience, or an equivalent combination of education and experience.
• 2+ years of experience as a clinical research coordinator (CRC).
• 1+ years of management experience in clinical research (highly preferred).
• Bi-lingual (English/Spanish) proficiency is a plus.

Skills

• Proficiency with Microsoft applications, email, electronic health records, web applications, and typing (40+ wpm).
• Strong organizational, time management, problem-solving, and project management skills to meet deadlines.
• Well-developed written and verbal communication skills.
• Strong interpersonal and listening skills; ability to work independently and collaboratively with coworkers, subjects, managers, and external customers.
• Ability to handle multiple tasks, adapt to changing workloads and priorities.
• Professional, respectful, self-motivated, and possessing a strong work ethic.
• High degree of integrity and dependability.
• Ability to work under minimal supervision, identify problems, and implement solutions.
• Ability to handle highly sensitive information confidentially and in compliance with HIPAA guidelines.

Benefits

Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following the date of hire. Benefits include:

• Medical, dental, and vision insurance.
• Life insurance and short/long-term disability insurance.
• Health savings accounts.
• Supplemental insurances.
• 401k plan with a safe harbor match.