Research Contractors

Benefits

Qualifications

• •Regular, Full Time (30 Hours or More), Permanent Employment Job Requirements and Properties
• •Bachelor's Degree Experience
• •Bachelors degree in Healthcare Management or Healthcare Administration and 24 months of employment experience as Compliance Manager
• •24 months as a Compliance Manager must include knowledge of local and state laws, legal codes, precedents, government regulations, executive orders, and agency rules
• •Knowledge of regulatory compliance applicable to biomedical and clinical research
• •This includes the U.S. Food and Drug Administration (FDA) regulations governing clinical trials, informed consent, and investigational products
• •Must possess knowledge of regulatory compliance of Institutional Review Board (IRB) regulations and human subject protection
• •Demonstrable ability in Good Clinical Practice guidelines and compliance, conflict-of-interest disclosures, and research integrity standards
• •5 more items(s)

Responsibilities

• •Coordinate and monitor sponsored research accounts in accordance with study protocols and institutional guidelines
• •Ensure adherence to clinical trial billing practices and regulatory requirements, including federal, state, sponsor-specific, and institutional policies
• •Communicate sponsor guidelines, study protocols, and regulatory expectations to the research sta, and administrators to ensure proper conduct according to the contract language and budget
• •Track and evaluate expenditures and budget activity related to sponsored clinical research to ensure alignment with study budgets, funding agency requirements, and applicable regulations
• •Prepare and submit interim and final financial reports, in coordination with Research Institute administrators and sponsors, ensuring accuracy and timeliness
• •Promote effective research management practice by providing guidance and training to the team
• •Perform additional administrative and coordination duties related to the planning, implementation, and compliance of clinical research projects, as assigned
• •4 more items(s)