Clinical Research Manager 182825

2 weeks ago

Fort Lauderdale, Florida, United States Medix™ Full time

We are looking to add a Site Manager to our growing team. This person would be responsible for overseeing 2 sites focused on Medical Device and Therapeutic clinical trials. This is a full time onsite role with lots of room for growth, fantastic benefits and the opportunity to join a large national organization that is changing the future of therapeutics.

Job Description

A Site Manager in clinical research plays a crucial role in overseeing and managing clinical trial sites within a specific geographic area. Their responsibility spans from site selection to ensuring that clinical studies are conducted in compliance with regulatory standards and study protocols.

Responsibilities:

  • Oversee and monitor the day-to-day operations of clinical trial sites in the region.
  • Ensure that the sites adhere to protocol requirements, Good Clinical Practice (GCP), and regulatory guidelines.
  • Provide support to sites during the initiation, monitoring, and close-out phases of the trial.
  • Track and assess site performance, including enrollment rates, data quality, and adherence to study timelines.
  • Troubleshoot issues related to recruitment, protocol deviations, and site performance.
  • Provide feedback to the site team and implement corrective actions when necessary.
  • Serve as the primary point of contact between the sponsor or Clinical Research Organization (CRO) and the clinical trial sites.
  • Foster strong relationships with site staff, investigators, and other stakeholders.
  • Conduct regular site visits and virtual meetings to ensure smooth communication and site support.
  • Train site personnel on clinical trial protocols, data collection processes, and compliance procedures.
  • Provide ongoing support to site staff to resolve operational issues or concerns.
  • Ensure the timely submission of regulatory documents, including Institutional Review Board (IRB) submissions, informed consent forms, and other required paperwork.
  • Ensure that essential study documentation is maintained accurately and in accordance with GCP and regulatory guidelines.
  • Conduct routine site monitoring visits and assessments, ensuring sites are operating within protocol requirements.
  • Prepare and submit regular progress reports to the Clinical Operations team or sponsor.
  • Assist in resolving any issues that arise during monitoring visits and recommend solutions.
  • Identify potential risks related to site management and proactively address issues to minimize study delays.
  • Ensure that corrective actions are implemented at sites as needed.

Qualifications

  • Education: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Experience: Minimum of 3-5 years of experience in clinical research, particularly in site management or clinical operations.
  • Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred.
  • Skills:
  • Strong understanding of clinical trial protocols, GCP, ICH guidelines, and regulatory requirements.
  • Excellent communication, interpersonal, and organizational skills.
  • Ability to manage multiple sites and tasks simultaneously.
  • Ability to work independently with minimal supervision.
  • Strong problem-solving and troubleshooting abilities.

Preferred Qualifications:

  • Experience in managing multi-site clinical trials
  • Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) tools.

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