Sanford Health Clinical Research RN - Infectious Disease Trial in Fargo, North Dakota

Job Title: Clinical Research RN | Infectious Disease Trial | Fargo

City: Fargo

State: North Dakota

Department : FARGO INFECTIOUS DISEASE TRIAL

Job Schedule: Full Time

Shift: Days

Hours Per Shift: 8 hr

JOB SUMMARY

The Clinical Research Specialist - Registered Nurse (CRS-RN) is an advanced nursing position that involves a balance of clinical patient contact, research study coordination, and management of study data. This nurse must have the ability to organize complex components of various clinical trials, including ordering of study required testing, and scheduling of study required procedures. In addition, the CRS-RN is responsible for insurance pre-authorization for study participation, as applicable by study. This position requries close collaboration with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol. Critical thinking, self motivation and direction, as well as autonomy are critical to the daily tasks that are carried out in partnership with the physician investigators and other members of the research team. Clinical skills that may be required include, but are not limited to: patient assessment for adverse events and assistance with, or completion of, study related procedures as detailed in the research protocol (ex: injections, phlebotomy, or infusions), within the applicable state scope of practice. This position is an opportunity to learn daily and contribute to treatments of the future. Enthusiasm for learning is required as is participation in educating patients, physicians, nurses, and other personnel to the research process.

POSITION RESPONSIBILITIES

Uses appropriate nursing assessment skills to evaluate patient condition in response to study intervention. Will collect and integrate data regarding patient’s condition for review by the physician investigator. Participates in listing and clarifying questions and concerns with the

investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures. Reviews inclusion/exclusion criteria to assure subject eligibility, and reviews with physician investigator for final sign-off Reviews and verifies required source documents in subject’s medical record to confirm study eligibility. Reviews study protocol, informed consent form, and follow-up procedures with potential study subjects. Prepares case report forms for sponsor or audit review. Collects source documents for sponsor or audit review. Assesses subject compliance with the test article and follow-up visits. Abstracts data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets.

Attends and participates in investigator meetings. Schedules and coordinates pre-study site visits. Monitors enrollment goals and modifies

recruitment plan as necessary. Maintains patient screening/enrollment logs and appropriately updates sponsors, CROs and/or SMOs. Assures that all screening, eligibility and enrollment procedures are performed. Conducts interviews to assess the subject’s ability and willingness to follow and complete study procedures and visits. Follows randomization procedures as per protocol. Works closely with Pharmacy to dispense study article and provide subject education as appropriate. Schedules subjects for follow-up visits. Reviews diaries and questionnaires completed by subject. Ensures appropriate specimen collection, batching and shipping as required. Documents and maintains all study-related

procedures, processes and events by planning and design of new forms/source document tools to be used in protocol implementation. Documents protocol deviations and exemptions. Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results) as needed. Records accurate and timely data onto case report forms. Maintains source documentation for all case report entries, as applicable. Keys in data for electronic submission, if applicable. Corrects and edits case report form entries as appropriate. Resolves data queries. Ensures drug/device accountability by completing appropriate documentation per individual protocols. Maintains files of all study-related documentation. Participates in monitoring visits and audits by scheduling sponsor monitoring visits to ensure compliance with regulatory requirements governing clinical research. Meets with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues.

Communicates effectively with subjects, research team, IRB and sponsor and sponsor’s delegated representatives. Reviews protocol requirements and collaborates with ancillary departments (e.g., clinic nursing, infusion nursing, pharmacy, radiology, pathology, nurse navigators, dieticians, and laboratory personnel) to ensure subject safety and protocol compliance.

Establishes a mechanism to contact subjects for follow-up visits and new information.

QUALIFICATIONS

Currently licensed with the applicable State Nursing Board and/or possess multistate licensure privileges as required by position. Pertinent clinical skills and/or competencies must be maintained. Graduate from American Association of Colleges of nursing or National League for Nursing accredited college of nursing. Current South Dakota and/or North Dakota RN license required or multi-state licensure privileges. Three years nursing experience required.

About Sanford Health:

At Sanford Health, we are dedicated to the work of health and healing. Every day, we show that commitment by delivering the highest quality of care to the communities we serve. We are leaders in health care and strive to provide patients across the region with convenient access to expert medical care, leading-edge technologies and world-class facilities.

In addition to strong clinical care, we are also committed to research, education and community growth. We engage in medical research to not only discover innovative ways to provide care, but also cures for common diseases. We continuously seek new ways to achieve our vision of improving the human condition here in your community, across the region and around the world.

The entire team at Sanford Health recognizes the value of healthy families and communities. We continue to gain momentum and expand our reach. Together, we can make a positive difference now, and in the future.

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 1-877-243-1372 or send an email to talent@sanfordhealth.org .

In compliance with federal law requiring employers to verify new employees' U.S. employment eligibility, Sanford participates in E-Verify. To learn more click here for English Version at https://e-verify.uscis.gov/emp/media/resourcesContents/EverifyPosterEnglish.pdf or here for Spanish Version at https://e-verify.uscis.gov/emp/media/resourcesContents/EverifyPosterSpanish.pdf .

City: Fargo

State: North Dakota

Job Function: Research

Job Schedule: Full Time

Shift: Days

Req Number: req8514