Clinical Research Coordinator

Sanford Health is one of the largest and fastestgrowing notforprofit health systems in the United States. Were proud to offer many development and advancement opportunities to our nearly 50000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.

Work Shift:

8 Hours Day Shifts (United States of America)

Scheduled Weekly Hours:

40

Salary Range: $24.00 $38.50

Union Position:

No

Department Details

This position offers opportunities for learning about clinical research trials. It requires enthusiasm for learning and involvement in educating patients physicians nurses and other staff about the research process. The role involves organizing complex aspects of clinical trials including coordinating necessary tests procedures and investigational treatments for various conditions and symptoms.

A Bachelors degree in biology microbiology or related field is required.

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 studyrequired 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 prestudy 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 followup 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 followup 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 signoff. Review and verify required source documents in subject medical records to confirm study eligibility. Review study protocol informed consent form and followup procedures with potential study subjects. Prepare case report forms for sponsor or audit review.

Responsible for insurance preauthorization for study participation as applicable by study. Close collaboration with physician investigators required to ensure safe and compliant investigational treatment or intervention and followup per the established research protocol.

Document and maintain all studyrelated 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 protocolrelated issues.

Occasional local travel between sites and student supervision may be required.

Qualifications

Bachelors 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 multistate licensure privileges. Obtains and subsequently maintains required department specific competencies and certifications.

Sanford is an EEO/AA Employer M/F/Disability/Vet.

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