Required Education:
Bachelor's degree
If any degree major/training is required, please specify the type. (NOTE: Concentration and minors are not equivalent to a major)
Healthcare related fields (e.g. Clinical Research, Health Administration, Public Health or Nursing)
Required Experience
7 years
If any experience is required, please specify what kind of experience:
Clinical Research experience of which three years must include progressively responsible management/supervisory experience.
If yes, what is the required licensure/certification?
Required Computer Applications:
Microsoft Excel, Microsoft Word, Microsoft Outlook
Required Other Computer Applications:
Required Additional Knowledge, Skills and Abilities:
Exceptional communication skills for collaborating with Principal Investigators (PIs), sponsors and multidisciplinary teams.
Prior experience in quality assurance, auditing or regulatory affairs within clinical trials environment.
Preferred Education:
Master's degree
If any degree/training is preferred, please specify the type:
Healthcare related fields (e.g. Clinical Research, Health Administration, Public Health or Nursing
If yes, what is the preferred licensure/certification?:
Nursing
Current certification through SOCRA (CCRP) or ACRP (CCRC/CCRA)
Preferred Computer Applications:
Preferred Other Computer Applications:
Oncore, EPIC
Preferred Additional Knowledge, Skills and Abilities:
Deep knowledge of FDA (21 CRF Part 11), ICH/GCP, and HIPPA Regulations
Familiarity with NCI Data Safety and Monitoring Committee (DSMC) requirements.
Exceptional communication skills for collaboration with PI’s, sponsors, multidisciplinary teams.
String analytical skills with the ability to synthesize complex data into actionable leadership reports.
High Degree of professional independence.
Excellent interpersonal and organizational skills.
Excellent writing, editing, and proofreading skills.
Ability to take initiative and demonstrate strong commitment to duties.
Ability to think critically and to compile and analyze data.
Ability to analyze problems, implement solutions and multi-task.
Ability to work within a deadline-driven structure.
Ability to demonstrate leadership in change management.
Strong proficiency in MS Office (Word, Excel. Outlook, Power Point)
Proficiency in Oncore
Prior clinical research experience at an NCI-designated cancer center or other NIH-funded research center