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Clinical Research Coordinator IV (Project Manager) - Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania

Created 06/11/2021
Reference 9252856
Category Research
Job type Full Time
Country United States
State Pennsylvania
City Philadelphia
Zip 19019
Salary Competitive
The Clinical Research Coordinator IV trains research staff, supervises staff and oversees clinical trials from start-up to close-out. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, and oversees research operation in department, and provides expert consulting at an institutional level.
  • Manages all Investigator-lead multi-site trials by developing and implementing processes for document management and IRB submission tracking (i.e. continuing reviews and amendments) for multi-center trials as well as have protocol status knowledge.
  • Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc.
  • Provides direct supervision of the research staff which includes conducting on-going training, reviewing workloads, completing annual evaluations, etc.
  • Oversees documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Identifies issues, recommends changes, writes new standard operating procedures (SOPs) or update existing SOPs with the goal of enhancing regulatory compliance.


Qualifications

Minimum of bachelor's degree. Minimum of five years of clinical research experience; or Master's degree and a minimum of three year of clinical research experience.

Closing Statement

Jefferson Health delivers state of the art healthcare services to patients throughout the Delaware Valley and southern New Jersey. Jefferson (Philadelphia University + Thomas Jefferson University) provides more than 8,400 students from nearly 40 states and 40 countries with 21st century professional education. Combined, we have over 30,000 employees.

Jefferson Health, with 14 hospitals (seven are Magnet designated by the ANCC for nursing excellence) and 40+ outpatient and urgent care locations, offers a broad range of primary and complex, highly specialized care that touches the lives of more than four million patients annually. U.S. News & World Report has ranked Thomas Jefferson University Hospital among the nation's best in eight specialties. Jefferson Health also includes the NCI designated Sidney Kimmel Cancer Center; it is one of only 70 such centers in the nation.

Thomas Jefferson University has ten colleges and three schools that offer more than 160 undergraduate and graduate programs. Our University is dedicated to inter-professional and transdisciplinary approaches to learning that offer a vibrant and expandable platform for professional education. Through this unique model, we are preparing our students for current and yet to be imagined careers.

As an employer, Jefferson maintains a commitment to provide equal access to employment. Jefferson values diversity and encourages applications from women, members of minority groups, LGBTQ individuals, disabled individuals, and veterans.
Employer Abington Hospital - Jefferson Health

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