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Kadlec Research Quality Assurance Specialist KC *$1,000 Sign-On Bonus* in Kennewick, Washington

Description:

Kadlec Clinic has an exciting opportunity for a Research Quality Assurance Specialist KC to join our growing Research located in Kennewick!

$1,000 Sign-On Bonus for eligible external candidates who meet all conditions for payment - this is in addition to the fantastic benefits and compensation package offered by Providence that begin on your first day of employment.

Shift Details : Full-time,1.0,Day-shift

Qualifications:

Minimum Requirements:

  • Bachelor's Degree in Science, healthcare, or other related field. Or equivalent educ/experience

  • Significant experience in research coordination or regulatory work may be substituted for educational requirements

Preferred Qualifications:

  • ACRP, SoCRA or HCCA certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research)

  • 3 years of relevant experience in research quality assurance, regulatory affairs, or clinical research/study coordination function

  • Reviewing/verifying the timely and accurate submission of clinical trial data, reporting findings and proposing quality improvements

  • Significant education in the field of clinical research, regulatory affairs or compliance can be substituted for experience

Duties include, but are not limited to, the following:

The Quality Assurance (QA) Specialist coordinates and manages QA activities associated with industry sponsored, and investigator initiated clinical research studies that include, but are not limited to, the review of all trial-related activities and documents to assure compliance with the investigational plan, internal policies/processes, standard operating procedures (SOPs), Code of Federal Regulations (CFRs), Good Clinical Practices (GCPs) and all other relevant guidance and regulations. The QA Specialist will work closely with research leadership, staff, sponsors and investigators to address compliance challenges and issues. In this position, the incumbent will be responsible for working with research leadership to develop and implement 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.

  • Demonstrate and sustain compliance with Kadlec Caregiver Expectations Standard of Excellence and Code of Conduct

  • Understand, embrace, and instill the Kadlec Clinic Guiding Principles

  • Responsible for the completion of internal quality assurance audits and monitoring activities for clinical trials conducted or supported by Kadlec Regional Medical Center (KRMC)

  • Review research protocols and subject and/or study logs to assess study requirements for participants

  • Review patient eligibility for enrollment into trials to ensure compliance with protocol

  • Review consent forms to assess whether proper guidelines were followed for Human Subject consent

  • Review source documents and case report forms to assess whether study visits occurred within protocol-defined study windows; reviews source documents and case report forms to determine whether protocol-required or recommended procedures were completed during study visits

  • Review whether Adverse Events and Serious Adverse Events were thoroughly and accurately reported according to regulatory requirements

  • Review materials provided to study participants to assess for compliance to Human Subjects regulations

  • Contribute to the development and maintenance of tracking tools to log audit results including areas of non-compliance or deviations and informing what areas of improvement are needed for discussion with management

  • Coordinate post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts. Reports deficiencies to the Research Manager and other appropriate personnel

  • Maintain accurate record 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

  • Participate in and helps facilitate audits conducted by external agencies (i.e., Sponsor, FDA inspections)

  • Review outcomes from monitoring visit and track non-compliance events

  • In coordination with department management helps develop, implement and maintain policies/procedures, systems and standard operating procedures which support conduct of clinical trials at KRMC

  • Conduct and/or participate in audit wrap-up meetings

  • 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

  • Work collaboratively with the Research Manager, Investigators, and external sponsors to develop and implement quality assurance plans in support of clinical trials

  • 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

  • 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 the Research Manager and other appropriate personnel

  • Oversee KRMC research personnel Human Subjects Protection, Good Clinical Practice and Conflict of Interest in Research training to verify compliance with current regulations and institutional policy

  • Function as a mentor to research staff and a primary resource for guidance related to regulatory compliance

  • Oversee the National Cancer Institute (NCI) regulatory compliance and the National Clinical Trials Network (NCTN) consortium partnership

  • Oversee KRMC’s Federal Wide Assurance (FWA) and ensures that changes be reported within the federally specified time frames.

  • Function as the Responsible Conduct of Research Coordinator in scientific misconduct in research allegations for KRMC and carries out institutional investigations in conjunction with Providence St. Joseph Health Risk and Integrity Services per KRMC’s Research Misconduct policy (699.69.00)

  • Attend the Research Committee meeting to provide guidance related to research compliance

  • 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, sponsors and medical staff so that productivity and positive relations are maximized

We offer comprehensive, best-in-class benefits to our caregivers. For more information, visit

https://kadlec.jobs/benefits-information/

Our Mission

Provide safe compassionate care. We promise to answer the call of every person we serve; to know them, care for them and ease their way. We are committed to safety, compassion, respect, integrity, stewardship, excellence and collaboration.

About Us

Located in sunny Tri-Cities, WA, Kadlec is the largest non-profit healthcare provider in the region. Kadlec is the premier choice for customer service excellence, providing compassionate healthcare by combining cutting-edge technology and innovation with evidence-based, patient-focused care. Kadlec does not unlawfully discriminate on the basis of race, sex, sexual orientation, age, color, religion, national origin, genetic information, marital status, veteran status, disability status, or any other characteristic protected by Federal, State, or Local Law. EOE. To learn more, click here: https://kadlec.jobs/about-us/

Schedule: Full-time

Shift: Day

Job Category: Quality/Risk/Safety (Non-Clinical)

Location: Washington-Kennewick

Req ID: 328529

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