Senior Clinical Research Site Manager

Description

We are seeking an experienced and motivated Clinical Research Site Manager to oversee and coordinate clinical trial activities across a network of clinical sites throughout the country. This role supports the clinical research goals of a leading Clinical Trials Coordinating Center, ensuring trial compliance, managing site performance, and driving successful study completion.

In this role, you will work closely with clinical and data entry teams at various centers, ensuring compliance with trial protocols and regulations, while maintaining open lines of communication with teams and stakeholders. This is an exciting opportunity to be a key player in the success of multi-site clinical trials.

Key Responsibilities

• Collaborate with clinical teams for trial activation, ensuring early communication and alignment.
• Lead and accelerate trial start-up processes, ensuring subject enrollment meets monthly targets across all clinical sites.
• Evaluate site feasibility, assess resource availability, and provide ongoing support for successful trial performance.
• Manage regulatory compliance, including submissions to IRBs, sponsors, and ethics committees, assisting with necessary documentation.
• Supervise investigational product compliance, monitor safety reporting, and ensure contracting and regulatory adherence.
• Conduct regular teleconferences and manage training sessions, providing mentorship and guidance.
• Address recruitment challenges, developing customized plans to meet site-specific goals.
• Foster relationships with site investigators and clinical teams, assigning tasks and reviewing performance.
• Execute project management processes to ensure adherence to budget, timeline, and quality standards.
• Conduct self-audits and site performance audits, recommending operational improvements.
• Serve as a liaison between project stakeholders and leadership, facilitating meetings and documenting project deliverables.
• Stay updated with the latest clinical research technologies, embracing innovations to improve trial efficiency.
  
  

Qualifications

• Bachelor's Degree in a related field is required.
• Minimum of 5 years of experience in clinical research management.
• Strong leadership and project management skills, capable of managing multiple sites and coordinating complex trials.
• Proficient in Microsoft Office Suite and experience with tools like SharePoint and electronic data capture software.
• Excellent communication and organizational skills, with the ability to prioritize tasks and meet deadlines.
  
  

Preferred Skills

• Experience with formal project management methodologies.
• Knowledge of clinical trial designs and regulatory requirements (GCP/ICH, IRBs, and compliance).
• Previous experience in a higher education or research environment.
• Familiarity with REDCap or similar web-based data collection applications.
  
  

Position Details

• Full-time, Remote (Monday - Friday, 8:30 AM - 5:00 PM)
• Competitive salary range: \(55,800 - \)97,600 annually, based on experience.
  
  

If you’re passionate about clinical research and have a strong background in managing multi-site trials, we encourage you to apply and join our team in advancing groundbreaking research.

Employment Type: Full-Time