Regulatory Program Coordinator

Job Summary

The Regulatory Program Coordinator will assist in the coordination of active Phase I-IV clinical trials and interact with study sponsors, PI's, and research clinical staff in the Lewis Katz School of Medicine's Thoracic Medicine & Surgery department. This is a grant-funded position.

Benefits

• Full medical, dental, vision coverage
• Paid time off
• 11 Paid Holidays
• Tuition remission
• A generous retirement plan
• and so much more!

Required Education and Experience

• Bachelor's degree
• At least three years of experience in research and/or regulatory compliance in a research or clinical setting

Responsibilities

• Maintain oversight of all regulatory compliance monitoring including internal and external progress reports
• Prepare and process all regulatory documentation through the IRB including new submissions, continuing reviews, amendments, adverse events and reportable events
• Organize and maintain all regulatory affairs documentation/files
• Support compliance and quality assurance activities
• Participate in site visits, monitoring, audit and close out visits
• Participate in study team meetings, other required group meetings, and ongoing protocol training/compliance meetings
• Assist in the development of investigator-initiated protocols, assists with IND applications and annual reports
• Assist with regulatory compliance guidance oversight of investigator initiated multi-center trials
• Train research personnel on consent process/forms and the regulatory processes and regulatory documents
• Perform other duties as assigned

Required Skills and Abilities

• Demonstrated knowledge and understanding of complex federal regulations, ethical issues, institutional policies, and other federal agency requirements governing human subjects research
• Demonstrated knowledge of quality assurance or auditing functions
• Demonstrated computer skills, and proficiency with MS Word, MS PowerPoint, MS Access or similar software programs
• Excellent interpersonal and customer service skills, along with the ability to effectively collaborate with a diverse constituent population
• Excellent verbal and written communication skills, including training skills
• Demonstrated organizational and time management skills, along with the ability to work under tight deadlines
• Demonstrated ability to be detail-oriented
• Demonstrated ability to work independently and as part of a team
• Maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subjects research
• Ability to travel to off-site locations that may not be accessible via public transportation

Preferred Experience

• Biomedical human research experience preferred

Compliance Statement

In the performance of their functions as detailed in the position description, employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.