Regulatory Program Coordinator

Temple University • Philadelphia, PA

5d • $50,000 - $55,000 • Onsite

About The Position

Temple University’s Lewis Katz School of Medicine’s Pulm/Critical Care/SleepMed Department is searching for a Regulatory Program Coordinator to join our team! This position will be on-site and is grant funded. The Regulatory Program Coordinator, under the supervision of the Regulatory Manager, participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI’s, and research clinical staff in the Lewis Katz School of Medicine’s Thoracic Medicine & Surgery department.

Requirements

• Bachelor’s degree and at least three years of experience in research and/or regulatory compliance in a research or clinical setting.
• 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.
• Must 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.

Nice To Haves

• An equivalent combination of education and experience may be considered.
• Experience with biomedical human research is preferred.

Responsibilities

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

Benefits

• Full medical, dental, vision coverage
• Paid time off
• 11 Paid Holidays
• Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE
• A generous retirement plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level