Clinical Research Nurse

2 weeks ago


Fort Wayne, United States DeKalb Health Full time

Join Our Team: If you are passionate about clinical research and providing top-tier patient care while ensuring regulatory compliance, we encourage you to apply for the Clinical Research Nurse position and become an integral part of advancing healthcare research.

Position Overview: We are seeking a dedicated and detail-oriented Clinical Research Nurse to join our team under the mentorship of a Certified Clinical Research Nurse. In this role, you will plan, coordinate, and deliver exceptional nursing care for clinical research patients in accordance with physician orders, clinical protocols, and regulatory guidelines. You will also be responsible for coordinating clinical research trials, ensuring regulatory compliance, staff education, and maintaining efficient operations at the Parkview Research Center (PRC).

This position plays a critical role in ensuring compliance with government and industry regulations, including FDA, HHS, International Conference on Harmonisation Guidelines (ICH), and Good Clinical Practice Guidelines (GCP).

Key Responsibilities:

* Provide excellent nursing care to clinical research patients, following physician orders and research protocols.
* Coordinate and manage clinical research trials, including participant recruitment, scheduling, and study implementation.
* Ensure compliance with regulatory guidelines such as FDA, HHS, ICH, and GCP.
* Maintain accurate and up-to-date clinical documentation and patient records.
* Collaborate with research teams, physicians, and staff to support smooth study operations.
* Educate staff on trial protocols, procedures, and regulatory requirements.
* Support regulatory activities such as IRB submissions and FDA reporting.
* Assist with data collection, management, and reporting for clinical trials.
* Adhere to ethical guidelines and standards as outlined in the American Nurses Association (ANA) Code of Ethics, Indiana Nurse Practice Act, and ANA Standards of Clinical Practice.

Education & Experience:

* Education:
* Associate of Science in Nursing (ASN) required.
* Bachelor of Science in Nursing (BSN) preferred.


* Licensure/Certification:
* Valid Indiana Registered Nurse (RN) license.
* CPR certification required.
* Completion of CITI training within the first month of employment.
* Additional certifications may be required based on specialty area.


* Experience:
* Previous experience may be required based on the specific area of assignment.
* Experience in clinical research, clinical trials, or a related healthcare field is highly desirable.



Skills & Qualifications:

* Excellent verbal and written communication skills.
* Strong knowledge of basic computer functions, including Word, Excel, PowerPoint, and internet applications.
* Solid data management skills with high attention to detail.
* Ability to manage multiple tasks and prioritize in a fast-paced research environment.
* Knowledge of clinical research guidelines and regulations.
* Ability to travel or take on call duties as needed, depending on job assignment.
* Must be able to lift 50 pounds and assist with up to 100 pounds.



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