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Providence Health & Services Clinical Research Associate I in Anchorage, Alaska

Description:

Providence is calling a Clinical Research Associate I (Research Support Services, Day Shift, 0.7 FTE) to Providence Alaska Medical Center in Anchorage, Alaska. We are a community of caregivers delivering every day on our Mission to provide compassionate care that is accessible for all - especially those who are poor and vulnerable.

In this position you will:

  • Maintains current knowledge of available trials and evaluates patient’s information for appropriateness of enrollment to these specific trials. Collaborates with research nurses, physicians, and other care givers to identify appropriate study candidates. Checks eligibility. Registers protocol patients in appropriate statistical centers. Documents according to regulatory trials.

  • Assists research nurse with (and when appropriate) consenting study participants to clinical trials. Assures ongoing informed consent process and patient advocacy during the trial according to guidelines per federal Office Protection of Human Subjects. Registers protocol patients in appropriate statistical centers. Documents according to regulatory and departmental standards.

  • Complies with all applicable regulatory bodies such as FDA, OHRP, Medicare and OIG related to research studies and subjects. Prepares and submits study specific regulatory documents to IRB as well as prepares and submits annual, quarterly, and other intermittent reviews to IRB. Monitors all study group data sources for updates and changes; initiates timely communication and revisions as appropriate. Updates protocol binder with study amendments, revisions and closures.

  • Coordinates implementation of protocol treatment and follow-up. Coordinates diagnostic, surgical and other procedures or physical exams specific to the study. Collects, records, submits and manages data. Obtains and submits reports to study groups (may include pathology reports, operative reports, radiographs, radiation oncology reports and other specialty reports). Obtains data from physicians as needed. Maintains data confidentiality. Monitors and maintains investigational agent accountability according to protocol guidelines. Records and reports any toxicities experiences by study participants per protocol, federal and IRB guidelines. Coordinates tumor and other specimen collection and submission specific to study adhering to applicable shipping federal guidelines. Answers queries where applicable.

  • Evaluates protocol study forms completeness, accuracy and compliance to protocol. Seeks assistance and clarification from Research Nurse. Performs consistency check, error edits, and monitors timeliness of data submission as assigned.

  • Assists research team with administrative support as required.

  • Collobrates with Research Compliance Coordinator on research billing.

  • Assures ongoing compliance with all IRB and department policies for regulatory documentation of research processes.

  • Maintains confidentiality standards for all potential and enrolled patients. Complies with federal HIPAA regulations.

  • Completes initial and annual Competency Plan for assigned job and department.

Qualifications:

Required qualifications for this position include:

  • Human Research Subject Protection Course, Good Clinical Practice and Conflict of Interest courses required within 3 months of employment

  • Certified Clinical Research Professional (CCRP) or Certified Research Associate (CRA) preferred within 3 years of hire or when eligible to sit for exam

  • Human Research Subject Protection, Good Clinical Practice, and Conflict of Interest Courses required within 3 months of employment

  • 2 years administrative, data management or directly related experience

  • Experience managing complex data

  • Knowledge of Medical Terminology

Preferred qualifications for this position include:

  • Associate's Degree

  • 1 year experience in health care field

  • Experience in Health Information Services

  • Experience building and managing data bases

  • Knowledge of medical records

  • Competent in use of office software to include Word, Excel, Access, Outlook, EPIC and Powerpoint

About Providence Alaska Medical Center

Providence Health & Services Alaska is among nation’s best employers for healthy lifestyles! The National Business Group on Health, a non-profit association of large U.S. employers, has honored Providence Alaska for its commitment and dedication to promoting a healthy workplace and encouraging our caregivers (employees) and families to support and maintain healthy lifestyles. Mountain-Pacific Quality Health has awarded Providence Alaska Medical Center with its Quality Achievement Award for high-quality care in the areas of heart attack, heart failure, pneumonia and surgical infection prevention. This is the highest honor awarded by Mountain-Pacific.

As the state’s largest hospital, Providence Alaska Medical Center provides full-service, comprehensive care to all Alaskans, a role unmatched by any other in the state. Within our community, you will find top notch ski resorts, kayaking, and wildlife. Enjoying the outdoors is just one of many reasons to live in and explore Alaska!

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

https://www.providenceiscalling.jobs/rewards-benefits/

Our Mission

As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.

About Us

Providence is a comprehensive not-for-profit network of hospitals, care centers, health plans, physicians, clinics, home health care and services continuing a more than 100-year tradition of serving the poor and vulnerable. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.

Schedule: Part-time

Shift: Day

Job Category: Research

Location: Alaska-Anchorage

Req ID: 299748

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