S
Clinical Research Coordinator
Sanford Health
10 hours ago
Contract
On-site
Sioux Falls, South Dakota, United States
Registered Nurse
Sanford Health, the largest rural health system in the United States, is
dedicated to transforming the health care experience and providing access to
world-class health care in America’s heartland.
Work Shift:
8 Hours - Day Shifts (United States of America)
Scheduled Weekly Hours:
40
Compensation:
Salary Range: $24.00 - $38.50
Union Position:
No
Department Details
In this position you'll gain experience in clinical research and work with a
variety of neurology and vascular trials. This role requires educating patients,
physicians, nurses, and other staff about the research process. It also involves
organizing all aspects of clinical trials, including outreach, interviewing,
scheduling, and coordinating tests and procedures
Summary
Provides an opportunity to learn daily and contribute to treatments of the
future. Enthusiasm for learning required, along with participation in educating
patients, physicians, nurses and other personnel about the research process.
Job Description
Organize complex components of various clinical trials, including the
coordination of study-required testing and procedures, as well as
investigational treatment for a variety of conditions and symptoms. Participate
in listing and clarifying questions and concerns with the investigator and
sponsor regarding enrollment goals, sponsor expectations and study procedures.
Schedule and coordinate pre-study site visits. Monitor enrollment goals and
modify recruitment plan as necessary. Maintain patient screening/enrollment logs
and appropriately update sponsors, contract research organizations (CROs) and/or
senior medical officers (SMOs). Assure the completion of all screening,
eligibility and enrollment procedures. Conduct interviews to assess subject
ability and willingness to follow and complete study procedures and visits.
Follow randomization procedures per protocol. Schedule subjects for follow-up
visits. Review diaries and questionnaires completed by subjects. Ensure
appropriate specimen collection, batching and shipping as required. Collect
source documents for sponsor or audit review. Assess subject compliance with the
test article and follow-up visits. Abstract data from medical records, clinic,
consultation and referral notes for preparation of study forms and flow sheets.
Review inclusion/exclusion criteria to assure subject eligibility, and review
with physician investigator for final sign-off. Review and verify required
source documents in subject medical records to confirm study eligibility. Review
study protocol, informed consent form and follow-up procedures with potential
study subjects. Prepare case report forms for sponsor or audit review.
Responsible for insurance pre-authorization for study participation, as
applicable by study. Close collaboration with physician investigators required
to ensure safe and compliant investigational treatment or intervention and
follow-up per the established research protocol. Document and maintain all
study-related procedures, processes and events by planning and design of new
forms/source document tools to use in protocol implementation. Document protocol
deviations and exemptions. Obtain and review original source documents as
needed. Record accurate and timely data onto case report forms. Maintain source
documentation for all case report entries, as applicable. Key in data for
electronic submission, if applicable. Correct and edit case report form entries
as appropriate. Resolve data queries. Ensure drug/device accountability by
completing appropriate documentations per individual protocols. Schedule and
participate in sponsor monitoring visits and audits to ensure compliance with
regulatory requirements governing clinical research. Meet with monitors/auditors
during routine visits to discuss case report form completion, query resolution
and other protocol-related issues. Occasional local travel between sites and
student supervision may be required.
Qualifications
Bachelor's degree in biology, microbiology or related field. May consider
graduates of an accredited school of practical nursing as a Licensed Practical
Nurse (LPN) dependent on facility and department needs.
Minimum three years of clinical or clinical research experience or six to eight
years of relevant work experience required.
If a Licensed Practical Nurse (LPN), currently holds an unencumbered LPN license
with state nursing board and/or possess multi-state licensure privileges.
Obtains and subsequently maintains required department specific competencies and
certifications.
Sanford is an EEO/AA Employer M/F/Disability/Vet.
If you are an individual with a disability and would like to request an
accommodation for help with your online application, please call 1-877-949-5678
or send an email to talent@sanfordhealth.org.
dedicated to transforming the health care experience and providing access to
world-class health care in America’s heartland.
Work Shift:
8 Hours - Day Shifts (United States of America)
Scheduled Weekly Hours:
40
Compensation:
Salary Range: $24.00 - $38.50
Union Position:
No
Department Details
In this position you'll gain experience in clinical research and work with a
variety of neurology and vascular trials. This role requires educating patients,
physicians, nurses, and other staff about the research process. It also involves
organizing all aspects of clinical trials, including outreach, interviewing,
scheduling, and coordinating tests and procedures
Summary
Provides an opportunity to learn daily and contribute to treatments of the
future. Enthusiasm for learning required, along with participation in educating
patients, physicians, nurses and other personnel about the research process.
Job Description
Organize complex components of various clinical trials, including the
coordination of study-required testing and procedures, as well as
investigational treatment for a variety of conditions and symptoms. Participate
in listing and clarifying questions and concerns with the investigator and
sponsor regarding enrollment goals, sponsor expectations and study procedures.
Schedule and coordinate pre-study site visits. Monitor enrollment goals and
modify recruitment plan as necessary. Maintain patient screening/enrollment logs
and appropriately update sponsors, contract research organizations (CROs) and/or
senior medical officers (SMOs). Assure the completion of all screening,
eligibility and enrollment procedures. Conduct interviews to assess subject
ability and willingness to follow and complete study procedures and visits.
Follow randomization procedures per protocol. Schedule subjects for follow-up
visits. Review diaries and questionnaires completed by subjects. Ensure
appropriate specimen collection, batching and shipping as required. Collect
source documents for sponsor or audit review. Assess subject compliance with the
test article and follow-up visits. Abstract data from medical records, clinic,
consultation and referral notes for preparation of study forms and flow sheets.
Review inclusion/exclusion criteria to assure subject eligibility, and review
with physician investigator for final sign-off. Review and verify required
source documents in subject medical records to confirm study eligibility. Review
study protocol, informed consent form and follow-up procedures with potential
study subjects. Prepare case report forms for sponsor or audit review.
Responsible for insurance pre-authorization for study participation, as
applicable by study. Close collaboration with physician investigators required
to ensure safe and compliant investigational treatment or intervention and
follow-up per the established research protocol. Document and maintain all
study-related procedures, processes and events by planning and design of new
forms/source document tools to use in protocol implementation. Document protocol
deviations and exemptions. Obtain and review original source documents as
needed. Record accurate and timely data onto case report forms. Maintain source
documentation for all case report entries, as applicable. Key in data for
electronic submission, if applicable. Correct and edit case report form entries
as appropriate. Resolve data queries. Ensure drug/device accountability by
completing appropriate documentations per individual protocols. Schedule and
participate in sponsor monitoring visits and audits to ensure compliance with
regulatory requirements governing clinical research. Meet with monitors/auditors
during routine visits to discuss case report form completion, query resolution
and other protocol-related issues. Occasional local travel between sites and
student supervision may be required.
Qualifications
Bachelor's degree in biology, microbiology or related field. May consider
graduates of an accredited school of practical nursing as a Licensed Practical
Nurse (LPN) dependent on facility and department needs.
Minimum three years of clinical or clinical research experience or six to eight
years of relevant work experience required.
If a Licensed Practical Nurse (LPN), currently holds an unencumbered LPN license
with state nursing board and/or possess multi-state licensure privileges.
Obtains and subsequently maintains required department specific competencies and
certifications.
Sanford is an EEO/AA Employer M/F/Disability/Vet.
If you are an individual with a disability and would like to request an
accommodation for help with your online application, please call 1-877-949-5678
or send an email to talent@sanfordhealth.org.