A clinical research organization is seeking a Regulatory Affairs Assistant to join their growing team! This role is an on-site role in Westbury, NY, with an annual salary of $55,000-$65,000.

Qualifications: 

• Experience in managing Electronic Medical Records
• Proficient in SharePoint and Microsoft Office Suite
• Background in regulatory affairs or pharmaceutical industry preferred
• Bachelor’s Degree in health-related field preferred

Responsibilities:

• Maintain patient research charts (digital and hard copy).
• Create new patient research charts (digital and hard copy).
• Prepare documentation for review by Sponsor/CRO during monitoring visits and quality checks.
• Complete uploads of patient scans to imaging platforms (Clario, Ambra, Caylx, QMS, URG) and answer associated queries.
• Request medical records when needed.
• Handle and pack investigational product and supplemental drug for delivery to treatment sites.
• Achieve understanding of schedule of assessments for each protocol.
• Handle outreach and scheduling for CRA/Principal Investigator calls with Sponsors/CROs and vendors.
• Maintain CRA calendar, provide a month-at-glance print-out to team, keep team apprised of scheduling conflicts.
• Manage off-site storage, package / box records by study, complete requisition forms.
• Maintain company Sharepoint, upload updated protocols, informed consents, pharmacy manuals.

Benefits:

• Medical/Dental/Vision
• Company-matched 401(k)
• PTO

Ascendo is a certified minority owned staffing firm, and we welcome and celebrate diversity. Ascendo is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, parental status, military service or any other characteristic protected by federal, state or local law.

Contact information

Colby Neumann