We are seeking a meticulous Clinical Research Associate to join our team. The ideal candidate will have prior clinical research experience. If you are detail-oriented and passionate about maintaining high standards, we would like to hear from you!

SKILLS AND SPECIFICATIONS:

• Knowledge of specialized medical and scientific terminology.
• Excellent people and interpersonal skills.
• Excellent written and verbal communication skills.
• Discretion and maintain patient/participant confidentiality.
• Experience or training as a quality specialist or similar role preferred.
• Knowledge and understanding of Clinical Trials and ICH-GCP guidelines are preferred.
• Knowledge of tools, methods, and concepts of quality control and assurance.
• Skill in maintaining/reviewing records.
• Accuracy, thoroughness, and attention to detail.
• Good communication skills, both verbal and written.
• Excellent teamwork skills.
• Basic computer skills, including management of email, internet, Microsoft Office (word/PowerPoint/excel), and databases for clinical research.
  This position offers a competitive salary commensurate with experience and qualifications. Join us in ensuring top-notch quality standards are met within our organization.
  Job Type: Full-time
  Pay: From $40,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience:

• clinical research: 1 year (Required)

Work Location: In perso

• Protect the well-being of research participants and comply with all regulatory guidelines and protocols as outlined in the research protocol and in accordance with federal, state and institutional policies.
• Collaborate with investigators and statistical consultants, epidemiologists, research associates, regulatory staff, clinical research coordinators (CRC) and other relevant personnel in the execution of clinical research.
• Collaborate with other departments to address quality issues and drive continuous improvement initiatives.
• Submit reports, documentation and ensure all research protocol guidelines are followed.
• Participate in research meetings and assist in coordination of specific meetings as required by the sponsor, the organization, the research compliance office and the leadership team.
• Perform routine monitoring and quality audits of clinical trial documentation to identify areas of improvement.
• Maintain documentation and records related to quality assurance processes.
• Review regulatory documents and subject data prior to monitoring visits to ensure action items completion.
• Ensure proper correction of any queries or quality issues noted in research data.
• Assist in preparing and implementing quality assurance standard policies and procedures (SOPs).
• Document quality assurance activities and create reports.
• Create checklists, calendars, manuals, notes, and other site documents as required.