Quality Assurance Specialist
Quality Assurance Specialist
Job Number: 75852
Stanford Cancer Institute's Quality Assurance Program reporting under the Clinical Research Oversight Group (CROG) operates in accordance within the established National Cancer Institute (NCI) guidelines for its designated Cancer Centers; overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements. There are more than 250 clinical trials open to accrual at any time within the Cancer Institute. More than one-third of these trials are Investigator-initiated (also referred to as investigator-sponsored or investigator-authored) trials. The remainder are NCI sponsored cooperative group trials and industry-sponsored trials. All of this is part of the cancer center's mission to combat cancer, a disease that profoundly affects our society.
We are looking to fill two Quality Assurance Specialist positions at this time. Each Quality Assurance Specialist is responsible to ensure that investigator-initiated and cooperative group trials are reviewed regularly for participant eligibility, regulatory compliance, and safety issues; that adverse reactions are reported in compliance with local and government regulations, and as appropriate are reviewed by the Data and Safety Monitoring Committee; that data collected on these trials is accurate, reliable, verifiable, and reproducible; and contributes to ensuring that all SCI trials remain in compliance with all institutional and federal regulations. The Quality Assurance Specialist's efforts will contribute to improving the quality and efficiencies of conducting clinical trials in compliance with regulatory, documentation, and eligibility requirements.
- Coordinate the Quality Assurance Program: To include but not limited to ensuring that patients are appropriately consented and registered, overseeing patient compliance to the study protocol, ensuring the confidentiality, security, and accuracy of data, and reviewing physician documentation to assure that dictation meets study requirements.
- Independently perform extensive quality assurance review of study documents, case report forms, and data across multiple complex studies of different therapeutic areas and phases and report findings to management and research team.
- Conduct investigational pharmacy monitoring, review drug or device accountability, tracking records, and clinical research pharmacy processes. Verify that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed.
- Act as a key contact and subject matter expert for answering queries related to internal SOPs, GCP guidelines, and current regulations.
- Works cooperatively with clinical research staff and investigators to address concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance.
- Author monitoring reports, status reports, and other communications. Develop and disseminate written communications, such as guidelines and standard operating procedures, as well as educational presentation materials.
- Ensure that clinical trials are initiated, documented and reported in compliance with internal SOPs, GCP guidelines, and current applicable regulatory regulations.
- Participates in meetings, FDA audit preparation activities, and special projects as needed.
- Help to create and maintain a quality education and training program for Clinical Research Coordinators.
- Establish and maintain an organizational and operational structure for tracking a large amount of information.
- Apply knowledge of federal, state and local regulations regarding the conduct of clinical trials, the informed consent process, and the protection of human research subjects.
- Provide guidance to Investigators to help ensure that the additional responsibilities of holding an IND/IDE are being met.
- Prior experience as a CRA, monitor or auditor.
- Sound knowledge of federal, state, and local regulations regarding the conduct of clinical trials, the informed consent process, and protection of human subjects.
- Experience as a user of Microsoft Office products is required, as is familiarity with database usage and reporting tools.
- Ability to prioritize, employ a high level of accuracy, communication, and interpersonal skills; demonstrated ability to coordinate multiple assignments and to work independently with minimal supervision.
- This position requires superior follow-up skills while exercising diplomacy and tact, in working with faculty, coordinators, and staff.
- Knowledge of oncology and clinical research conduct desired.
- Experience developing and delivering training.
- Certification through a professional organization such as Regulatory Affairs Professional Society (RAPS) or The Society of Clinical Research Associates (SOCRA) preferred.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated ability to prioritize own work and multi-task.
- Demonstrated excellent organizational skills.
- Demonstrated ability to take initiative and ownership of projects.
- Ability to communicate effectively both orally and in writing.
- Ability to routinely and independently exercise sound judgment in making decisions.
- Demonstrated experience working independently and as part of a team.
- Relevant subject matter knowledge.
- Ability to direct the work of others, for jobs requiring supervision.
- Constantly perform desk-based computer tasks.
- Frequently stand/walk, sitting, grasp lightly/fine manipulation.
- Occasionally use a telephone.
- Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
Occasional evening and weekend hours.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu
Location: School of Medicine
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.