Quality Assurance Specialist

vor 4 Wochen


Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Georgetown University in Qatar Vollzeit
Job Title: Quality Control Coordinator I

Georgetown University's Lombardi Comprehensive Cancer Center seeks a Quality Control Coordinator I to interface with various faculty and staff in the development and maintenance of a cancer clinical research quality control program.

Key Responsibilities:
  • Perform various study and staff level assessments to ensure adherence to Lombardi CTO and Georgetown University Medical Center (GUMC) Standard Operating Procedures (SOPs) and continued adherence to federal, state and other regulatory standards, requirements and guidelines.
  • Assist with assessing staff competency, evaluating protocol compliance and promoting successful internal and external audits of LCCC cancer clinical research studies.
  • Work closely with the Lombardi CTO Administrative Director and Management Team as well as their Team Members (Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians, IIT Coordinators) to complete duties as assigned.
Work Interactions:

The Quality Control Coordinator I works very closely with the Georgetown Office of Research Quality Assurance team members, LCCC Consortium Quality Control Team Members, and Disease Group Members (Principal Investigators, Physicians, Clinicians). S/he interacts with external department clinicians and staff (Infusion Nurses, Oncology Pharmacists, hospital staff), along with clinical trial sponsors, auditors, and study monitors.

Requirements and Qualifications:
  • Bachelor's Degree with the ability to perform light travel.
  • Up to two (2) years of oncology clinical trials experience and Knowledge and/or experience with NCI CCSG expectations preferred.
  • Working knowledge of regulations governing clinical research conduct and skill in applying, applicable clinical research regulatory requirements (I Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines).
  • Strong understanding of medical and research terminology and experience working in oncology therapeutic research.
  • Strong leadership, mentoring, and training skills, as well as strong organizational and problem-solving skills.
  • Strong communication and interpersonal skills, including proficient use of the English language.
  • Effective presentation skills with the ability to effectively manage competing priorities and deliver high-quality results within defined timelines.
  • Proficient with technology applications including MS Office.
  • Ability to establish and maintain effective working relationships with supervisors, peers, and customers of the unit.
  • SOCRA or ACRP certification preferred.
Work Mode Designation:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$44, $73,406.80

Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.



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