Clinical Research Coordinator

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: Day (United States of America) Scheduled Weekly Hours: 40 Compensation: Salary Range: $24.00 - $38.50 Union Position: No Department Details This position offers opportunities for learning about biobehavioral research. It requires enthusiasm for learning and involvement in educating patients about the research process. The role involves organizing complex aspects of research studies and ensuring data gathered is accurate. 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 View phone number on click.appcast.io or send an email to View email address on click.appcast.io. The Sanford organization owns and manages multiple distinct brands, including Sanford Health, Marshfield Clinic, and Good Samaritan, as well as Lewis Drug, Sanford Health Equip, Solutions by Sanford, Great Shots, and Blue Rock Bar & Grill. 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. Headquartered in Sioux Falls, South Dakota, the organization has 53,000 employees and serves over 2 million patients and nearly 425,000 health plan members across the upper Midwest including South Dakota, North Dakota, Minnesota, Wyoming, Iowa, Wisconsin and the Upper Peninsula of Michigan. The integrated nonprofit health system includes a network of 56 hospitals, 288 clinic locations, 147 senior care communities, 4,000 physicians and advanced practice providers and nearly 1,500 active clinical trials and studies. The organization’s transformational virtual care initiative brings patients closer to care with access to 78 specialties. Learn more about Sanford Health’s commitment to shaping the future of rural health care across the lifespan at sanfordhealth.org or Sanford Health News. Good Samaritan, one of the nation’s largest nonprofit providers of senior care and services, is committed to transforming the aging experience through innovation, compassion and personalized care. As part of Sanford Health, an integrated nonprofit health system headquartered in Sioux Falls, South Dakota, Good Samaritan serves 10,000 seniors and offers access to a full continuum of care, including 94 rehabilitation and skilled nursing centers, 56 assisted living and memory care facilities, 44 independent living locations and 37 home health and hospice agencies. The senior care provider delivers services across the upper Midwest, with 70% of residents living in rural communities. Learn more about Good Samaritan’s mission and commitment to delivering high quality senior care in rural America at good-sam.com.