Clinical Research Associate

Summary

Join Vitalief, an innovative healthcare consulting company, as a Clinical Research Coordinator. Contribute to advancing scientific discoveries and impacting patients' lives. Enjoy a PEOPLE FIRST culture prioritizing personal and professional growth. This fully benefited, 100% remote position (NY, NJ, CT, or PA residency required) offers a competitive salary, 20 PTO days, 9 paid holidays, company-paid life insurance, short/long-term disability, a 401k plan, and robust healthcare options. The role involves overseeing clinical research operations, implementing quality control, training staff, and managing international collaborations. International travel (up to 30%) is required.

Requirements

• Bachelor’s Degree plus two (2) years of scientific/clinical research experience OR Master’s Degree plus one (1) year of scientific/clinical research experience
• Experience overseeing administering protocols and translating protocols into operational implementation and conduct at the foreign and domestic sites
• Experience Implementing and monitoring quality control SOPs and conducting periodic monitoring visits working with investigators at the sites to develop and implement protocols
• Confident in ability to train junior research assistants in study document preparation and study-start-up procedures to develop the skills necessary to perform the required functions
• Ability to travel 6 weeks yearly – consisting of two to three 2-week trips to either South America, Africa, Europe, and/or Asia
• Strong relationship building and interpersonal skills
• Effective oral and written communication skills
• Excellent organizational skills and attention to detail
• Computer literacy with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access and PowerPoint

Responsibilities

• Perform various research operations for specific assigned observational clinical studies
• Implement and monitor quality control SOPs and conduct periodic monitoring visits working with investigators at the sites to develop and implement protocols
• Assist in the establishment of standard operating procedures and manuals of operations for clinical studies
• Assist with the instructing and training of student research assistants and temporary research assistants in study document preparation and study-start-up procedures to develop the skills necessary to perform the required functions. Assist in training local site clinicians on study protocols
• Oversee and administer protocols and translate protocols into operational implementation and conduct at the foreign and domestic sites
• Assure timely responses to study inquiries and schedule regular “monitoring” visits
• Oversee quality assurance/quality control activities with on-site staff and investigators
• Assists faculty in developing study patient consent forms & applications to the IRB. Responsible for reporting protocol changes to the IRB
• Provide specialized protocol, procedure and application (REDCap, FreezerPro specimen tracking) training to international site study team (investigators and staff)

Preferred Qualifications

Infectious disease experience

Benefits

• 20 PTO (Paid Time Off) days plus 9 paid Holidays annually
• Company paid life insurance and short / long term disability coverage
• 401K retirement program
• Robust healthcare plans