Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. We’re proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.
Work Shift:
8 Hours - Varied Shifts (United States of America)Scheduled Weekly Hours:
40Salary Range: $24.00 - $38.50Union Position:
NoDepartment Details
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.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 1-877-673-0854 or send an email to [email protected].
Sanford Health, one of the largest health systems in the United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered in Sioux Falls, South Dakota, the organization includes 46 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and 10 countries.
We’re excited to be on a journey of tremendous growth and are always looking for talented team members to join our Sanford family. With a commitment to diversity and inclusion, our organization strives to continually build on the diverse talents, experiences and beliefs of our employees, as well as the patients and communities we serve.