Senior Clinical Research Specialist
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.
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Facility: Van Demark Building
Location: Sioux Falls, SD
Address: 1210 W 18th St, Sioux Falls, SD 57104, USA
Shift: 8 Hours - Day Shifts
Job Schedule: Full time
Weekly Hours: 40.00
An advanced research position that involves a balance of clinical patient contact, research study coordination, grant, protocol and manuscript development (if applicable), qualitative or quantitative data collection or analysis and management of study data. May spend up to 30 percent of the time providing basic project management assistance to the project management team. Organize complex components of various research projects and clinical trials, including coordination of study required testing and procedures. Also responsible for applicable insurance pre-authorization for study participation. Requires close collaboration with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol.
May assist in the preparation and submission Institutional Review Board (IRB) documents. Obtains and properly documents informed consent forms from research subjects prior to any study-related procedure.
Assures appropriate disposal of sensitive documents. Provides timely notification of Serious Adverse events to the sponsor or delegated representative and the IRB. Prepares for and participates in FDA inspections as needed.
Obtain and review inclusion/exclusion criteria and source documents to confirm study eligibility. Prepare case report forms and collect source documents for sponsor or audit review. Ensure drug/device accountability by completing appropriate documentation. Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets.
Follows screening, eligibility and enrollment procedures and maintains patient screening/enrollment logs. Follows randomization procedures, schedules subjects, reviews questionnaires completed by subject. Ensures appropriate specimen collection, processing and shipment. Review and document protocol requirements, compliance, deviations and exemptions.
Contact subjects for follow-up visits and new information. Listens to, respects, and seeks to accommodate cultural, religious and psychosocial requests within patient and organizational safety guidelines.
Enthusiasm for learning and participation in educating patients, physicians, nurses and other personnel to the research process required.
Occasional local travel between sites may be required.
Internal Clinical Research applicants only please.
Graduate from a nationally accredited nursing program preferred, including, but not limited to, Commission on Collegiate Nursing Education (CCNE), Accreditation Commission for Education in Nursing (ACEN), and National League for Nursing Commission for Nursing Education Accreditation (NLN CNEA).
Currently holds an unencumbered RN license with the State Board of Nursing where the practice of nursing is occurring and/or possess multistate licensure if in a Nurse Licensure Compact (NLC) state. Obtains and subsequently maintains required department specific competencies and certifications. Society of Clinical Research Associates, Inc. (SoCRA) or the Association of Clinical Research Professionals (ACRP) certification desired.
Sanford Health offers an attractive benefits package for qualifying full-time and part-time employees. Depending on eligibility, a variety of benefits include health insurance, dental insurance, vision insurance, life insurance, a 401(k) retirement plan, work/life balance benefits, sick leave and paid time off. To review your benefit eligibility, visit https://sanfordhealth.jobs/benefits .
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@example.com .
Sanford Health has a Drug Free Workplace Policy. An accepted offer will require a drug screen and pre-employment background screening as a condition of employment.
Job Function: Research
Req Number: R-33140