Clinical Research Associate

2 weeks ago

Carlsbad, United States Surf Search Full time

Join our client's team as a remote Clinical Research Associate to help drive their clinical trials. Participate actively in the planning and execution phases of clinical studies for an innovative company in the cardiovascular electrophysiology space, which is conducting clinical trials for an exciting new system for Atrial Fibrillation treatment. Conduct both onsite and remote monitoring visits to ensure study integrity.

Qualifications of the Clinical Research Associate:

  • Bachelor's degree or equivalent in a technical or clinical discipline (e.g., engineering, biology/life sciences).
  • Minimum of 1 year of experience in clinical study data monitoring.
  • Experience in cardiovascular medical device, preferably in electrophysiology.
  • Familiarity with pivotal IDE trials and bimo audits is preferred.
  • Strong communication, interpersonal, analytical, and organizational skills.
  • Ability to meet deadlines and effectively communicate with stakeholders at all levels.

Responsibilities of the Clinical Research Associate:

  • Collaborate effectively with internal and external stakeholders, including employees, customers, contractors, vendors, and study sites.
  • Evaluate and select suitable clinical sites for study participation.
  • Coordinate startup, maintenance, and closeout activities at assigned clinical study sites in collaboration with field staff and in-house personnel.
  • Review and ensure completeness of informed consent documents and assist sites with IRB submissions.
  • Develop training materials and provide support for both internal and external clinical professionals to ensure protocol compliance.
  • Facilitate direct communication with study sites to enhance enrollment, data quality, and timely capture.
  • Analyze study data and regulatory documents for accuracy, supporting data query resolution.
  • Serve as a liaison between clinical study management, site personnel, and study participants to address protocol-related issues.
  • Assist in the development of monitoring plans and conduct both remote and onsite visits to ensure patient safety and data integrity.
  • Document site visits and support resolution of findings from monitoring visits and audits.
  • Maintain clinical monitoring tracking tools and contribute to process improvement initiatives.
  • Update and manage internal clinical study information and document systems.
  • Collect and maintain communication records to support study activation and execution.
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors including candidate's geographical location, education, relevant work experience, and years of experience. ccupational Category: Medical Scientists

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