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Billings Clinic Clinical Research Specialist in Billings, Montana

Clinical Research Specialist CANCER RESEARCH Non-Exempt req996 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.