Billings Clinic
You’ll want to join Billings Clinic for our outstanding quality of care, exciting environment, interesting cases from a vast geography, advanced technology and educational opportunities. We are in the top 1% of hospitals internationally for receiving Magnet® Recognition consecutively since 2006.
And you’ll want to stay at Billings Clinic for the amazing teamwork, caring atmosphere, and a culture that values kindness, safety and courage. This is an incredible place to learn and grow. Billings, Montana, is a friendly, college community in the Rocky Mountains with great schools and abundant family activities. Amazing outdoor recreation is just minutes from home. Four seasons of sunshine!
You can make a difference here.
About Us
Billings Clinic is a community-owned, not-for-profit, Physician-led health system based in Billings with more than 4,700 employees, including over 550 physicians and non-physician providers. Our integrated organization consists of a multi-specialty group practice and a 304-bed hospital.Learn more (https://www.billingsclinic.com/about-us/) about Billings Clinic (our organization, history, mission, leadership and regional locations) and how we are recognized nationally for our exceptional quality.
Your Benefits
We provide a comprehensive and competitive benefits package to all full- and part-time employees (minimum of 20 hours/week), including Medical, Dental, Vision, 403(b) Retirement Plan with employer matching, Defined Contribution Pension Plan, Paid Time Off, employee wellness program, and much more.Click here (https://www.billingsclinic.com/careers/employee-benefits/) for more information ordownload the Employee Benefits Guide (https://ncstoragemlbillings.blob.core.windows.net/public/2021%20Billings%20Clinic%20Staff%20Benefits%20Guide.pdf) .
Magnet: Commitment to Nursing Excellence
Billings Clinic is proud to be recognized for nursing excellence as a Magnet®-designated organization, joining only 97 other organizations worldwide that have achieved this honor four times. The re-designation process happens every four years. Click here (https://www.billingsclinic.com/campaign-landing-pages/magnet/) to learn more!
Pre-Employment Requirements
All new employees must complete several pre-employment requirements prior to starting. Click here (https://billingsclinic.csod.com/ats/careersite/search.aspx?site=15&c=billingsclinic) to learn more!
Clinical Research Specialist (1.0 FTE)
Billings Clinic (Cancer Center)
req10639
Shift: Day
Employment Status: Full-Time (.75 or greater)
Hours per Pay Period: 1.00 = 80 hours every two weeks (Non-Exempt)
Starting Wage DOE: $17.15 - 21.44
The incumbent in this position is responsible for managing and coordinating record keeping systems and establishing internal procedures relative to a variety of research studies within one of the research areas of Billings Clinic (i.e., Research Center, Neurology, Cardiology, Oncology, etc.). Responsible to ensure internal procedures comply with the standards established by the sponsoring agency. Performs data verification and validation to ensure the highest levels of accuracy and compliance with the different standards set by each of the sponsoring agencies. Researches discrepancies in data collected and coordinates with nursing staff for clarification and resolution.
Essential Job Functions
• Supports and models behaviors consistent with the mission and philosophy of Billings Clinic and department/service.
• Attends training sessions held by the sponsoring agencies to develop an understanding and knowledge level of the scope of the study, protocols, testing procedures, data documentation standards, scheduling events, patient visits, and testing requirements, time frame deadlines, etc.
• Develops internal procedures, record keeping systems, and forms specific to each study to ensure compliance with the standards established by the sponsoring pharmaceutical company. Determines what each study participant will need at each visit, and what is to be completed at each visit. Utilizes a variety of computer programs and information systems to create documents and retrieve information necessary for each clinical trial.
• Assists with education and training of staff who will be participating in the study to ensure they have a thorough knowledge and understanding of the internal procedures and forms to be utilized during the study or for changes or addendums received during the course of the study. Identifies problems relating to data documentation and reports issues to RN study coordinator.
• Establishes and maintains individual medical record files for each study participant, tracking required authorizations for study participation, demographic information, medical history, laboratory results, diagnostic imaging/x-ray results, and on-going visit information. Tracks participants who are active, inactive, and off study and may also establish and maintain screening logs of all applicants who apply to be a study participant.
• Receives data and documentation information on each visit by a study participant. Data is scrutinized carefully to ensure accuracy and consistency in accordance with standards established by the sponsoring agency. Data is reviewed to identify new or significant events in the study participant’s condition, medications being taken, or abnormal test results. Reviews documentation for appropriate physician verification. Codes events into appropriate protocol categories for reporting purposes. Monitors data to ensure study participants are at the appropriate visit sequence and are receiving treatment/visits in accordance with the appropriate time frames which have been established.
• Documents, tracks, formats and reports information as required, ensuring high levels of accuracy, attention to detail, and meets time deadlines and requirements.
• Coordinates with nursing staff and/or physicians to resolve discrepancies in data and information provided.
• Participates in and provides support for periodic internal audits from sponsors and/or FDA. May prepare a variety of periodic reports for the sponsoring agency.
• Assists and provides support to the pharmaceutical drug company monitors hired by the pharmaceutical drug companies who come onsite to review the study progress, perform source data reviews and checks, and clarify source data which is questionable or not in compliance with study requirements/standards. Information approved by the monitors is forwarded to the pharmaceutical drug company sponsor for inclusion in the study database.
• Acts as the primary contact for questions and inquiries relating to the study data from Billings Clinic staff and/or the sponsoring agency.
• Assists with the preparation and submission of regulatory documents and maintenance of regulatory files as needed.
• Utilizes performance improvement principles to assess and improve quality.
• Identifies needs and sets goals for own growth and development; meets all mandatory organizational and departmental requirements.
• Maintains competency in all organizational, departmental and outside agency environmental, employee or patient safety standards relevant to job performance.
• Performs other duties as assigned or needed to meet the needs of the department/organization.
Minimum Qualifications
Education
•High school graduate
Experience
•Two (2) years health care related experience
Other Minimum Qualifications
•Basic knowledge of Microsoft Office programs, anatomy, physiology, pharmacology, medical terminology and transcription
•Basic knowledge and understanding of Billings Clinic information systems
•Basic knowledge of Institutional Review Board, Food & Drug Administration, and pharmaceutical regulations and standards as they relate to clinical drug research studies
Billings Clinic is Montana’s largest health system serving Montana, Wyoming and the western Dakotas. A not-for-profit organization led by a physician CEO, the health system is governed by a board of community members, nurses and physicians. Billings Clinic includes an integrated multi-specialty group practice, tertiary care hospital and trauma center, based in Billings, Montana. Learn more atwww.billingsclinic.com/aboutus (https://www.billingsclinic.com/about-us/)
Billings Clinic is committed to being an inclusive and welcoming employer, that strives to be kind, safe, and courageous in all we do. As an equal opportunity employer, our policies and processes are designed to achieve fair and equitable treatment of all employees and job applicants. All employees and job applicants will be provided the same treatment in all aspects of the employment relationship, regardless of race, color, religion, sex, gender identity, sexual orientation, pregnancy, marital status, national origin, age, genetic information, military status, and/or disability. To ensure we provide an accessible candidate experience for prospective employees, please let us know if you need any accommodations during the recruitment process.
And you’ll want to stay at Billings Clinic for the amazing teamwork, caring atmosphere, and a culture that values kindness, safety and courage. This is an incredible place to learn and grow. Billings, Montana, is a friendly, college community in the Rocky Mountains with great schools and abundant family activities. Amazing outdoor recreation is just minutes from home. Four seasons of sunshine!
You can make a difference here.
About Us
Billings Clinic is a community-owned, not-for-profit, Physician-led health system based in Billings with more than 4,700 employees, including over 550 physicians and non-physician providers. Our integrated organization consists of a multi-specialty group practice and a 304-bed hospital.Learn more (https://www.billingsclinic.com/about-us/) about Billings Clinic (our organization, history, mission, leadership and regional locations) and how we are recognized nationally for our exceptional quality.
Your Benefits
We provide a comprehensive and competitive benefits package to all full- and part-time employees (minimum of 20 hours/week), including Medical, Dental, Vision, 403(b) Retirement Plan with employer matching, Defined Contribution Pension Plan, Paid Time Off, employee wellness program, and much more.Click here (https://www.billingsclinic.com/careers/employee-benefits/) for more information ordownload the Employee Benefits Guide (https://ncstoragemlbillings.blob.core.windows.net/public/2021%20Billings%20Clinic%20Staff%20Benefits%20Guide.pdf) .
Magnet: Commitment to Nursing Excellence
Billings Clinic is proud to be recognized for nursing excellence as a Magnet®-designated organization, joining only 97 other organizations worldwide that have achieved this honor four times. The re-designation process happens every four years. Click here (https://www.billingsclinic.com/campaign-landing-pages/magnet/) to learn more!
Pre-Employment Requirements
All new employees must complete several pre-employment requirements prior to starting. Click here (https://billingsclinic.csod.com/ats/careersite/search.aspx?site=15&c=billingsclinic) to learn more!
Clinical Research Specialist (1.0 FTE)
Billings Clinic (Cancer Center)
req10639
Shift: Day
Employment Status: Full-Time (.75 or greater)
Hours per Pay Period: 1.00 = 80 hours every two weeks (Non-Exempt)
Starting Wage DOE: $17.15 - 21.44
The incumbent in this position is responsible for managing and coordinating record keeping systems and establishing internal procedures relative to a variety of research studies within one of the research areas of Billings Clinic (i.e., Research Center, Neurology, Cardiology, Oncology, etc.). Responsible to ensure internal procedures comply with the standards established by the sponsoring agency. Performs data verification and validation to ensure the highest levels of accuracy and compliance with the different standards set by each of the sponsoring agencies. Researches discrepancies in data collected and coordinates with nursing staff for clarification and resolution.
Essential Job Functions
• Supports and models behaviors consistent with the mission and philosophy of Billings Clinic and department/service.
• Attends training sessions held by the sponsoring agencies to develop an understanding and knowledge level of the scope of the study, protocols, testing procedures, data documentation standards, scheduling events, patient visits, and testing requirements, time frame deadlines, etc.
• Develops internal procedures, record keeping systems, and forms specific to each study to ensure compliance with the standards established by the sponsoring pharmaceutical company. Determines what each study participant will need at each visit, and what is to be completed at each visit. Utilizes a variety of computer programs and information systems to create documents and retrieve information necessary for each clinical trial.
• Assists with education and training of staff who will be participating in the study to ensure they have a thorough knowledge and understanding of the internal procedures and forms to be utilized during the study or for changes or addendums received during the course of the study. Identifies problems relating to data documentation and reports issues to RN study coordinator.
• Establishes and maintains individual medical record files for each study participant, tracking required authorizations for study participation, demographic information, medical history, laboratory results, diagnostic imaging/x-ray results, and on-going visit information. Tracks participants who are active, inactive, and off study and may also establish and maintain screening logs of all applicants who apply to be a study participant.
• Receives data and documentation information on each visit by a study participant. Data is scrutinized carefully to ensure accuracy and consistency in accordance with standards established by the sponsoring agency. Data is reviewed to identify new or significant events in the study participant’s condition, medications being taken, or abnormal test results. Reviews documentation for appropriate physician verification. Codes events into appropriate protocol categories for reporting purposes. Monitors data to ensure study participants are at the appropriate visit sequence and are receiving treatment/visits in accordance with the appropriate time frames which have been established.
• Documents, tracks, formats and reports information as required, ensuring high levels of accuracy, attention to detail, and meets time deadlines and requirements.
• Coordinates with nursing staff and/or physicians to resolve discrepancies in data and information provided.
• Participates in and provides support for periodic internal audits from sponsors and/or FDA. May prepare a variety of periodic reports for the sponsoring agency.
• Assists and provides support to the pharmaceutical drug company monitors hired by the pharmaceutical drug companies who come onsite to review the study progress, perform source data reviews and checks, and clarify source data which is questionable or not in compliance with study requirements/standards. Information approved by the monitors is forwarded to the pharmaceutical drug company sponsor for inclusion in the study database.
• Acts as the primary contact for questions and inquiries relating to the study data from Billings Clinic staff and/or the sponsoring agency.
• Assists with the preparation and submission of regulatory documents and maintenance of regulatory files as needed.
• Utilizes performance improvement principles to assess and improve quality.
• Identifies needs and sets goals for own growth and development; meets all mandatory organizational and departmental requirements.
• Maintains competency in all organizational, departmental and outside agency environmental, employee or patient safety standards relevant to job performance.
• Performs other duties as assigned or needed to meet the needs of the department/organization.
Minimum Qualifications
Education
•High school graduate
Experience
•Two (2) years health care related experience
Other Minimum Qualifications
•Basic knowledge of Microsoft Office programs, anatomy, physiology, pharmacology, medical terminology and transcription
•Basic knowledge and understanding of Billings Clinic information systems
•Basic knowledge of Institutional Review Board, Food & Drug Administration, and pharmaceutical regulations and standards as they relate to clinical drug research studies
Billings Clinic is Montana’s largest health system serving Montana, Wyoming and the western Dakotas. A not-for-profit organization led by a physician CEO, the health system is governed by a board of community members, nurses and physicians. Billings Clinic includes an integrated multi-specialty group practice, tertiary care hospital and trauma center, based in Billings, Montana. Learn more atwww.billingsclinic.com/aboutus (https://www.billingsclinic.com/about-us/)
Billings Clinic is committed to being an inclusive and welcoming employer, that strives to be kind, safe, and courageous in all we do. As an equal opportunity employer, our policies and processes are designed to achieve fair and equitable treatment of all employees and job applicants. All employees and job applicants will be provided the same treatment in all aspects of the employment relationship, regardless of race, color, religion, sex, gender identity, sexual orientation, pregnancy, marital status, national origin, age, genetic information, military status, and/or disability. To ensure we provide an accessible candidate experience for prospective employees, please let us know if you need any accommodations during the recruitment process.