Clinical Research Associate

WHY VITALIEF?
Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials.  As a result, we are seeking a talented and enthusiastic Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives. 
 
Reasons to work for Vitalief:

• You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
• Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
• We give everyone a seat at the table – we encourage innovation.
• Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
• Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.

Salary Range:  From $65,000 to $73,000  (depending on level of experience)  
                                                         
Work Location:  Newark, NJ.  This job is 100% remote – however candidates MUST reside either in NY, NJ, CT or PA to be considered for this position!  Ability to travel internationally up to 30% - to South America, Africa or Europe, two to three times per year.

Responsibilities:  

• Under the direction of the Principal Investigator(s), Data and Operations Management Director and Associate Director, and other leadership within the Infectious Diseases department, this resource will perform various research operations for specific assigned observational clinical studies (meaning patients are NOT being treated in a clinical trial).
• 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.  Site locations include, but are not limited to: North America, Peru, Brazil, Moldova, Uganda, Kenya, South Africa, India, Vietnam, Indonesia, China, and the Philippines.
• 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).

Required Skills:

• Bachelor’s Degree plus two (2) years of scientific/clinical research experience OR Master’s Degree plus two (1) years 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.   
• Infectious disease experience is a plus (not a requirement).
• 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.

PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. Ability to travel internationally up to 30% - to South America, Africa or Europe, two to three times per year.
 

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