**Job Description**
This position involves comprehensive support for clinical trials and research operations, focusing on regulatory documentation, clinical trial coordination, data management, and administrative support. Responsibilities include preparing IRB and FDA documentation, coordinating subject enrollment and visits, managing study data, ensuring compliance with regulations, and providing general departmental assistance.
**Skills & Abilities**
• Computer proficiency and ability to navigate multiple software applications
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work in a complex environment
• Ability to work independently, as a part of a team and with changing priorities
• Excellent communication (written and verbal) and interpersonal skills
**Qualifications**
Required Degree(s):
• BA/BS degree
**Experience**
Experience Required:
• At least two years of relevant experience with a BA/BS degree, or a combination of education and relevant work experience equaling at least six years.
Other:
• Relevant and direct experience in clinical research, including data management and adherence to clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials, and Good Clinical Practice guidelines.
• Preferred: Previous experience with Ophthalmology specialty.
• Preferred: Experience in both adult and pediatric studies.
• Preferred: Relevant and direct experience with regulatory requirements, including study monitoring, Institutional Review Board submissions, Investigation New Drug (IND), and/or Investigational Device (IDE) submissions.
• Preferred: Experience with Epic or other electronic medical record system.
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