Clinical Nurse

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The Position

We advance science so that we all have more time with the people we love.

The Sensor Integration team in the Research and Development division at Roche Diagnostics is seeking a highly motivated and detail-oriented Clinical Study Nurse to play a vital role in our medical device development. This position offers an exciting opportunity to contribute to the advancement of innovative medical devices through the planning, execution, and management of clinical studies and wearable sensor characterization. 

The Clinical Study Nurse will work collaboratively with cross-functional teams, including chemists, engineers, and study managers, to ensure the safe and effective execution of development studies for our novel technologies. This role requires a Registered Nurse (RN) license in the state of Indiana (US) and demonstrated proficiency in blood sampling via capillary phlebotomy and in administering peripheral intravenous lines.

• You will assist in study coordination via the planning, initiation, and execution of early-stage feasibility clinical studies for investigational medical devices, adhering to study protocols, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements.

• You will participate in patient management by recruiting, screening (biometrics, inclusion/exclusion criteria), enrolling, consenting, and following up with study participants, ensuring their safety and well-being throughout the study and following all regulations and guidelines.

• You will accurately and meticulously collect, document, and manage clinical data in electronic data capture (EDC) systems and case report forms (CRFs).

• You are certified to independently perform venipuncture for IV lines for the collection of blood samples for laboratory analysis, adhering to safety and quality standards.

• You will identify, document, and report adverse events and serious adverse events in a timely and accurate manner, following study protocols and regulatory guidelines.

• You will work with our R&D testing team to perform routine bench testing and sensor characterization outside of the clinical studies

• You will guide members of cross-functional teams on study topics

• You will look for potential for improvement in established processes and try to implement this on a study-by-study basis
   

Who you are:

(Required)

• You have a bachelor's or master's degree in Nursing or related fields from an accredited academic institution

• You are a licensed Registered Nurse (RN) in the state of Indiana, US; you are experienced and fully certified/licensed to perform phlebotomy in Indiana

• You have a demonstrated level of 3+ years in blood sampling via capillary phlebotomy

• You have a demonstrated level of 3+ years experience administering peripheral intravenous lines.

• You have 3+ years of professional experience in nursing or clinical trials, enabling you to work independently within the scope of study protocols

• You have 2+ years of experience working in a matrixed organization
   

Preferred:

• You have a level of proficiency in a variety of documentation systems (e.g. eCRF and EDC systems). 

• You have demonstrated experience exploring new approaches and topics; ability to troubleshoot and have the ability to maintain direct and indirect exchanges with partners relevant to clinical studies, such as regulatory authorities, notified bodies, and ethics committees.

• You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated important relationships both inside an organization and externally. Has proven abilities to influence internal partners and stakeholders; seamlessly collaborates with colleagues/other parts of the organization. 
   

This position is based on-site in Indianapolis, Indiana. It is not a hybrid positi