Clinical Research Nurse

Indiana University
Published
October 9, 2019
Location
Indianapolis, IN
Category
Job Type

Description

Department

GASTROENTEROLOGY (IN-GAST-IUINA)

Department Information

Tired of working long shifts with an overwhelming patient load? Come work at Indiana University: School of Medicine where you can make a difference in medicine, working with a smaller number of patients and having work/life balance. Our nurses build long-lasting, mutually beneficial relationships with their patients, physicians, and research staff alike. They are always striving to find the best care which best fit the individual needs of the patient.

The IU Division of Gastroenterology & Hepatology has a distinguished tradition of excellence in patient care and innovation in research and education. Consistently ranked among the top 15 units nationally by US News and World Report, we are one of the largest divisions in the country with enormous breadth to our clinical and research expertise.

Job Summary

This position is posted as a Clinical Research Nurse but may be filled as a Certified Clinical Research Nurse, depending on the candidate’s qualifications. Although they will be similar, the duties and responsibilities may differ if filled at the lower rank. Please see the Required Qualifications section below for the qualifications listed for each level.

Initiate, conduct, complete, and report clinical studies/trials. Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.

Clinical Research Nurse:

  • Solicit industry-sponsored trials through contacts and professional organizations. Access and extract information for protocol development for investigator-initiated trials. Summarize literature review for study hypothesis.
  • Participate in protocol development or review of risk assessment. Evaluate the protocol, study design and risk to subject population. Determine staff, facility, and equipment availability, and assess study population/availability. Liaison with health-care professionals/providers to determine best recruitment practices for study.
  • Review, critically evaluate and comment on study contracts/agreement. Schedule and/or coordinate pre-study site visits of sponsor/s. Prepare and submit Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepare regulatory documents for sponsor.
  • Develop advertising and other information materials for recruitment. Identify and schedule screening procedures and review results. Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria.
  • Extract data from source documents. Order and receive drug/device supplies. Dispense drug/device supplies (calculate dosage as needed). Maintain files of drug/device dispensation, compliance and return.
  • Ensure proper collection, processing, shipment of specimens, and documentation. Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings. Complete Case Report Forms (CRF) or database entries. Audit for accuracy and correct CRFs. Resolve sponsor queries. Provide/create source documentation tools for subjects’ charts/records. Review incoming subject adverse event (SAE) information and assist PI in making submission determination of SAEs. Maintain follow-up to determine resolution of adverse event. Capture and record adverse events data. Compose adverse event reports for oversight agencies.
  • Compose and submit continuing review/amendments/close out information. Schedule and prepare for monitor visits. Prepare and respond to Sponsor or FDA audits. Audit documents and pertinent files and prepare for storage. Archive documents for study per sponsor/government/institutional requirements. Evaluate team effort at site. Document “drop outs” (e.g., causes, contact efforts).

Certified Clinical Research Nurse:

Duties include the responsibilities listed at the Clinical Research Nurse I level, in addition to:

  • Participate in preparation and negotiation of study budget. Reconcile study budget accounts with Business Manager.
  • Schedule study-related meetings and training sessions. Provide instruction to study team for specific study assignments. Educate staff regarding scientific aspects of study. Train ancillary staff regarding clinical trial.
  • Design recruitment strategies. Monitor enrollment goals and modify recruitment strategy as needed. Recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study. Contact outside health-care providers to obtain follow-up information. Communicate with subjects to obtain follow-up information. Develop and implement teaching tools for subjects and families. Serve as an advocate for the subjects and their family.
  • Prepare and organize space for study related equipment and supplies. Develop worksheet for “Standard of Care” versus study specific procedures. Monitor study team compliance with required study procedures and GCP standards. Record and document protocol deviations. Communicate with PI and sub-investigators about changes in the trial.
  • Determine appointments per protocol. Schedule subjects for appointments. Perform subject interviews and assessments at study visits for data required by protocol. Assess and ensure subject safety throughout participation in trial. Conduct study-related non-medical/behavioral assessments/interventions. Conduct study procedures/interventions (appropriate licensure may apply).

Required Qualifications

Clinical Research Nurse I:

Bachelor’s degree in nursing and one year of clinical nursing experience; OR Associate’s degree in nursing and three years of clinical nursing experience; OR LPN/diploma in nursing and four years of nursing experience.

Current RN/LPN licensure.

Ability to effectively communicate and exchange information.

Certified Clinical Research Nurse:

Bachelor’s degree in nursing and two years of clinical research experience; OR Associate’s degree in nursing and two years of clinical nursing experience and two years of clinical research experience; OR LPN/Diploma in nursing and three years of clinical nursing experience and three years of clinical research experience.

Current RN/LPN licensure. Clinical Research Certification (ARCP or SOCRA).

Ability to effectively communicate and exchange information.

Preferred Qualifications

Clinical Research Certification (ARCP or SOCRA) for Clinical Research Nurse I. Clinical Liver or clinical research experience. Hepatology and/or research experience.

Work Location

Indianapolis, Indiana

Job Classification

Salary Plan: PAE

Salary Grade: HE

FLSA: Exempt

Job Function: Health Services

Posting Disclaimer

This posting is scheduled to close at 12:01am EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but it will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.

Equal Employment Opportunity

Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University’s Notice of Non-Discrimination here which includes contact information.

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at [Click Here to Email Your Resumé] or by visiting IUPD.

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