Clinical Research Site Manager

Summary

The Site Manager for Vaccine Studies is responsible for initiating, leading, and coordinating clinical vaccine research projects, overseeing clinical data, and ensuring compliance with study protocols, regulatory requirements, and overall clinical objectives.

Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Oversee vaccine study operations to ensure procedures (including patient visits) adhere to IRB-approved protocols, sponsor instructions, company policies, state and federal regulations, Good Clinical Practices (GCPs), and ICH/FDA guidance documents.
• Drive the achievement of monthly site visit goals by championing accountability and setting clear expectations for the team.
• Direct and supervise patient identification, screening, scheduling, randomization, and enrollment in vaccine studies, including research and pre-research activities.
• Oversee or perform direct patient care activities, including obtaining informed consent, conducting physical assessments, administering vaccines, drawing blood, handling biological specimens, and performing ECGs or other related procedures.
• Lead Quality Control activities, manage day-to-day operations, and oversee staffing for the assigned vaccine research center.
• Maintain effective and ongoing communication with sponsors, research staff, investigators, and other stakeholders, including scheduling and coordination as needed.
• Serve as the main point of contact for joint venture practices and vendors to establish and maintain relationships.
• Ensure accurate and timely data entry into electronic data capture (EDC) systems and maintain compliance with ALCOA-C principles.
• Supervise study initiation, start-up, and close-out activities in collaboration with Start-Up teams and Directors.
• Investigate, track, and report Adverse Events (AEs), Serious Adverse Events (SAEs), and protocol deviations in line with sponsor requirements.
• Support internal and external audits, implementing corrective and preventive actions as needed.
• Effectively manage, coach, and mentor research center staff, conducting performance reviews and encouraging professional development.

Qualifications

Required:

• High school diploma or equivalent.
• Minimum of 2 years of experience in industry-sponsored clinical research, preferably in vaccine studies.
• Demonstrated leadership skills with the ability to manage and mentor a team.
• Proficiency in electronic medical record (EMR) systems, electronic data capture (EDC) systems, and medical terminology.
• Strong venipuncture skills, with experience in biological sample collection and vaccine administration.
• Knowledge of regulatory requirements, including GCP, FDA, and ICH guidelines.
• Experience with patient care procedures, such as obtaining informed consent, conducting physical assessments, and administering medications.

Preferred:

• Bachelor’s degree in a related field (e.g., healthcare, clinical research, or life sciences).
• Certification in clinical research (e.g., CCRP, CCRA) or healthcare-related credentials (e.g., RN, Phlebotomist, CNA).
• Previous experience managing vaccine clinical trials and working with diverse populations.
• Familiarity with ECGs, FibroScans, or other relevant diagnostic equipment.
• Strong communication, adaptability, and financial management skills.

Supervisory Responsibility:

The Site Manager supervises research center staff, ensuring compliance with clinical research protocols and fostering professional growth within the team.

Position Type and Expected Hours of Work:

Full-time, 40-hour on-site position, with flexibility based on patient appointments. Deviations from regular hours require supervisor approval.

Work Authorization/Security Clearance: Legal authorization to work in the U.S. is required.

Type: Direct Hire