Clinical Research Site Manager

Alcanza Clinical Research, LLC; Fredericksburg (VA); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Health Savings Account (HSA)

401(k) with safe harbor match

Job summary

Alcanza Clinical Research, LLC in Fredericksburg, VA, is seeking a Clinical Site Manager to oversee site operations, ensure protocol compliance, patient safety, and on-site visits within ICH/GCP guidelines. You will lead study teams, manage resources, track milestones, and partner with investigators to meet timelines and sponsor expectations.

Bi-lingual not required. This role requires an Associate’s degree and 3+ years in clinical research; leadership experience is preferred.

Qualifications

• Associate’s degree required with clinical research experience.
• 3+ years in clinical research; management experience preferred.
• Bi-lingual English/Spanish a plus.

Responsibilities

• Oversee site operations, ensuring protocol and GCP compliance.
• Provide on-site oversight of visits, documentation, and follow-up.
• Lead study teams, manage resources, and monitor milestones.
• Collaborate with investigators to meet timelines and sponsor goals.
• Manage staff performance, training, and regulatory adherence.
• Escalate risks and implement corrective actions when needed.
• Ensure data integrity across dashboards and trial systems.

Skills

Project leadership

Site management

Regulatory compliance

Documentation control

Communication

Problem solving

Time management

HIPAA awareness

Bi-lingual English/Spanish

Education

Associate’s degree

Tools

Microsoft Office

Electronic health records (EHR)

Clinical trial management systems

Job description

Key Responsibilities

Department: Operations

Location: Fredericksburg Clinical Research

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

The Clinical Site Manager is responsible for overseeing performance of the research site activities. Provides on-site oversight to help ensure execution and coordination of clinical research activities visits, documentation and follow up actions according to ICH/FDA guidelines, GCP, and company SOPs, policies and procedures.

Key Responsibilities

Essential Job Duties:

• Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance;
• Collaborating with manager to support delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors;
• 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);
• 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);
• 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 termination meetings.
• Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations;
• 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;
• Collaborating with investigators to ensure patient safety and meeting client goals and timelines;
• Employing 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.

Skills, Knowledge And Expertise

Minimum Qualifications: An Associate’s degree and a minimum of 3 years of clinical research experience, or an equivalent combination of education and experience, is required. One or more years of management experience is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus.

Required Skills

• 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 and problem solving skills.
• 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.

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 date of hire.
• 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.