Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

QA Specialist, Clinical Research

QA Specialist, Clinical Research

Job ID 
10632
Type 
Regular Full-Time
Company 
Seattle Cancer Care Alliance
Location 
US-WA-Seattle

More information about this job

Overview

Seattle Cancer Care Alliance brings together the leading research teams and cancer specialists of Fred Hutch, Seattle Children's and UW Medicine. One extraordinary group whose sole mission is the pursuit of better, longer, richer lives for our patients.

 

Seattle Cancer Care Alliance is ranked among the top ten cancer hospitals in the nation by U.S. News & World Report. Our care combines powerful science with devoted collaboration.

 

Above all, we exist to move patients forward, past boundaries and toward hope.

 

 

The Research Integration Quality Assurance (QA) Specialist coordinates and manages QA activities associated with industry sponsored, investigator initiated and NCTN clinical research studies that include, but are not limited to, the review of all trial-related activities and documents to assure compliance with the protocol plan, internal policies, standard operating procedures (SOPs), good clinical practices (GCPs) and all other relevant regulations. The QA Specialist will work closely with Research Integration (RI) leadership and staff, sponsors and Principal Investigators to address compliance challenges and issues. In this position, the incumbent will be responsible for developing and implementing a comprehensive quality assurance program in the context of clinical trials management. He/she will build a culture of excellence and compliance with the goal of achieving an audit ready operation at all times.  

 

The incumbent performs all duties in a manner that promotes the mission, values, and philosophy of the Seattle Cancer Care Alliance. In all aspects, he/she serves as a role model for the values and mission of the organization.

Responsibilities

  • Responsible for the completion of internal quality assurance audits and monitoring activities for Cancer Consortium clinical trials conducted or supported by RI at all participating sites including:
    • Reviewing research protocols and subject and/or study logs to assess study requirements for participants
    • Review patient eligibility for registration into trials to ensure compliance with protocol
    • Reviewing consent forms to assess whether proper guidelines were followed for subject consent
    • Reviewing source documents to assess whether study visits occurred within protocol-defined study windows; reviews source documents to determine whether protocol-required or recommended procedures were completed during study visits
    • Reviewing whether Adverse Events and Serious Adverse Events were thoroughly and accurately reported according to regulatory requirements
    • Reviewing materials provided to study participants to assess for compliance to Human Subjects regulations
  • Assists with the development and implementation of audit plans aimed at monitoring the compliance of Cancer Consortium trials to applicable regulations, policies, and procedures.
  • Contributes to the development and maintenance of tracking tools to log audit results including areas of non-compliance and informing what areas of improvement are needed for discussion with management and utilizes research audit tools that assess the quality indicators.
  • Coordinates post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts. Reports deficiencies to Managers and other appropriate personnel.
  • Maintains accurate records of findings of analysis of compliance; contributes in the preparation and implementation of corrective action plans; audits response timelines and escalation plans; communicates expectations in a collaborative environment.
  • Participates in and helps facilitate audits conducted by external agencies (i.e., FDA inspections)
  • Reviews outcomes from monitoring visits and assures that action items have been addressed by tracking non-compliance events.
  • Develops, implements and maintains policies, systems and standard operating procedures which support RI’s conduct of Cancer Consortium clinical trials.
  • Conducts and/or participates in audit wrap-up meetings and study initiation visits.
  • Defines Program and Center compliance and quality metrics, performs qualitative and quantitative data analyses and reports findings to senior management
  • May be involved in identifying and developing continuous improvement efforts.       This includes identifying opportunities for improvement, problem prioritization, and assisting in the creation of performance improvement plans for non-compliant audits and/or reports
  • Assists research staff in maintaining FDA compliance.
  • Develops protocol training/education materials as well as protocol implementation materials to assure high level on compliance with the protocol plan.
  • Additional responsibilities as assigned.

Principal duties and Functions:

  • Work collaboratively with the Research Integration Administration, Consortium Investigators, external sponsors and the FHCRC Clinical Research Support Office to develop and implement quality assurance plans in support of clinical trials offered to SCCA Community and SCCA Network Member sites to establish both short and long-term objectives.
  • Assist with the development and implementation of quality assurance assessment materials (e.g. audit plans) aimed at monitoring compliance to trial enrollments with regard to the protocol plan, applicable regulations, policies, and procedures.
  • Conduct internal monitoring activities for active trials at all participating sites including, but not limited to, the review of case report forms, study files, study protocols, and internal processes.
  • Report and follow-up on audit findings and corrective actions as applicable to assure that clinical trials research processes, procedures and activities are in compliance with industry standards, GCPs and other current Regulations and Guidance.
  • Identify areas of deficiency in quality and report those to managers and other appropriate personnel.
  • Support RI leadership in assessment of new trials and ensure trials are implemented in accordance with the protocol plan.

STANDARDS OF PERFORMANCE:

Each of these are considered an essential function:

  • Actively support and incorporates the Seattle Cancer Care Alliance (SCCA) mission and core values into daily activities.
  • Maintain confidentiality of all information related to patients, medical staff, employees, and as appropriate, other information.
  • Demonstrate service, excellence and positive interpersonal relations in dealing with others, including co-workers, colleagues, managers and medical staff throughout the Consortium and at Network member sites so that productivity and positive relations are maximized.
  • Develop individual objectives consistent with the goals of SCCA Research Integration Program and report on individual objectives on a regular basis.

Qualifications

Education

Bachelor’s degree in a health related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent professional experience.

 

Experience

 

A minimum of 5 years relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination function required.

 

Knowledge, Skills, and Abilities

 

  • Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations for research administration
  • Strong understanding of clinical research conduct, knowledge of both current standard and novel investigational therapies in multiple therapeutic areas across phase I, II & III oncology trials.
  • Proven ability to implement, trouble-shoot, and conduct clinical trials.
  • Experience developing protocol training/education materials as well as protocol implementation materials to assure high level on compliance with the protocol plan.
  • Experience reviewing/verifying the timely and accurate submission of clinical trial data, reporting findings and proposing quality improvements.
  • ACRP or SoCRA certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research) preferred.
  • Strong interpersonal skills and ability to interface with institutional faculty, administrators, industry sponsors and regulatory agencies.
  • Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline driven environment.
  • Ability to identify areas or operational weakness and work with clinical research leadership to propose and implement improvement initiatives.
  • Effective communication skills including difficult conversation and presentation skills.
  • Strong organizational and planning skills, attention to detail, and ability to solve complex problems as well as handle multiple projects/problems simultaneously.
  • Strong knowledge of medical and clinical research terminology.
  • Significant computer experience and competency including intermediate to advance skills in Microsoft Office programs (Outlook, Word, Excel, Access, PowerPoint and Visio), and ability and openness to learn and become proficient with new software and web interfaces quickly.

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.