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Billings Clinic Clinical Research Specialist in Billings, Montana

Clinical Research Specialist



Shift: Day

Employment Status: Full-Time (.75 or greater)

Hours per Week: 1.00 = 80 hours

Starting Wage DOE: $12.70 - $15.49

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 in Cancer Research. 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 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 tho rough 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 event s 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 ph armaceutical 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 standard s relevant to job performance.
• Performs other duties as assigned or needed to meet the needs of the department/organization.

Minimum Qualifications:

High school graduate or equivalent

Two (2) years health care related experience (i.e., Clinical Research Specialist, Certified Nursing Assistant, Medical Assistant, Phlebotomist, Transcriptionist, Medical Record Clerk or Coder, Unit Clerk, etc.)

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

Billings Clinic is committed to the principles of Equal Employment Opportunity. All policies and processes are designed toward achieving fair and equitable treatment of all employees and job applicants. Employees are encouraged to discuss any concerns they have in this regard with their immediate supervisor and/or the Vice President People Resources. All employees and job applicants will be provided the same treatment in all aspects of the employment relationship, regardless of race, color, creed, religion, national origin, gender, gender identity, sexual orientation, age, marital status, genetic information or disability.