In-House Clinical Research Associate I

• Ensure quality of data submitted from study sites and assure timely submission of data
• Ensure appropriate reporting and follow-up for all safety events by site personnel
• Ensure completeness and compile regulatory and ethical submission documentation, including IRB approval, informed consent, and lab certification
• Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF)
• Perform feasibility studies and site identification activities for potential sites as requested
• Collaborate remotely with clinical operations colleagues, sponsors, and site personnel

• Excellent interpersonal, oral, and written communication skills
• Ability to contribute to a team remotely
• Strong customer focus and ability to interact professionally with a sponsor contact
• Proficiency in Microsoft Office, CTMS, and EDC Systems
• Four-year college curriculum with a major concentration in life science preferred but not required
• Two-year college curriculum or equivalent education/training and one year experience with clinical research or other relevant experience
• Proficiency in English, Romanian, and one other language: German, French, Italian, Spanish, or Polish

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law