Benefits:

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Vision insurance

Clinical research facility is seeking the services of a full-time Regulatory Assistant. Applicants must be adept with computers and diligent, with the ability to multi-task while still having a strong attention to detail, and proficient in the use of Microsoft Office (Word, Excel, PowerPoint, etc).

OBJECTIVE: To assist in the maintenance of accurate and essential documents to ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA), local Institutional Review Board (IRB), pharmaceutical sponsors, and any other regulatory agencies. Work closely with Regulatory Coordinators as well as investigators, clinical trial coordinators, and other research staff to assure that all regulatory documents for the research studies are met and up-to-date, including but not limited to IRB submissions/approvals, study-specific regulatory documents, and staff certifications and CVs.

· Assist Regulatory Coordinator(s) in maintaining accurate and complete essential documents as required by the FDA, IRB, Sponsor and any other Regulatory agencies.

· Prepare and file IND Safety reports

· Obtain study staff signatures on Investigator Agreements and study logs as needed.

· Complete study specific logs as needed.

· File study specific correspondence, newsletters, and approvals in Investigator Site Files (ISF) in preparation for monitoring visits.

· File updated CVs and licensure as needed.

· Regulatory data entry in applicable CTMS databases, including ICF, protocol, and amendment updates.

· Maintain electronic ICF tracker within CTMS.

· Verify all subject ICF entries and file into site SD and CTMS

· Monitor site study workbooks to ensure timely completion of worksheets and logs, and ensure tasks and checklists are performed by assigned staff

· Assist RC to monitor investigator and rater certifications to ensure timely submission of REQs, training completion, and rater tracker updates via SSM and other sources.

· Assist RC to monitor CRC study vendor trackers and ensure timely completion of logs

· Assist with administrative set up and study closure of trials

· Update and maintain master site staff certifications binder.

· Make copies/scans of regulatory documents as requested.

· Set up and turn over monitoring rooms before and after each monitoring visit.

Requirements:

• Bachelor’s Degree preferred
• Proficiency in Word, Excel, and Adobe Acrobat
• Excellent organizational and administrative skills and a superior attention to quality and detail
• Excellent time management skills and written and verbal communication skills with a variety of individuals
• Ability to work independently as well as in a team environment
• Proven ability to multi-task and prioritize duties of varying skill levels, and to focus on and adapt to changing priorities
• Energetic, positive, flexible, and team-oriented
• Must be articulate, proactive, responsive to deadlines, detail-oriented, and able to prioritize multiple tasks

Full-time (FT) applicants only / 40 hrs/wk required on-site. Hours are Mon - Fri, 8:30 - 5:00 pm Compensation: $20/hr Position immediately available