Clinical Research Nurse

IMMUNOEe Research Centers (Veros Health), a Nexus HR Company

As a representative of IMMUNOe Research Centers, you are expected to maintain a neat and professional appearance, demonstrate commitment to serve at all times, uphold guidelines as set forth in the employee handbook and maintain patient confidentiality at all times. 

Duties and Responsibilities:

The IMMUNOe Research Nurse or Nurse Practitioner is involved in medical and case management of study participants in clinical trials including performing physical exams, (if allowed by study protocol) administration of Investigational Products, assessment of study IP compliance and response to therapy, study specific assessments, (if allowed by protocol), review and assessment of subject medical and concomitant medication records for accuracy and completeness, review of laboratory and study procedure reports, review and assessment of Adverse Events and Serious Adverse Events and may perform the Informed Consent Process. Between subject visits, the RN or NP will review IMMUNOe medical office visits as well as contact subjects via telephone for any new medications, AEs/SAEs. The RN or NP may also perform venipuncture, phlebotomy, vital signs, ECGs, PFTs, and will train less experienced research staff in clinical skills such as phlebotomy, venipuncture, vital signs, ECG and PFT as needed. Participation in the Quality Management Plan/Reviews will also be expected.

Works under the supervision of the Principal Investigator and will report weekly to the PI with written documentation of all subjects reviewed, review of lab or study procedure reports (obtaining co-signatures and dates), review of AEs and/or SAEs and any issues with subject continuity of care.

ESSENTIAL FUNCTIONS:

• Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol
• Perform medical procedures within the scope of license including infusions, vitals, phlebotomy, ECGs, injections, etc.
• Organize, facilitate, and implement research activities across multiple studies of different therapeutic areas and phases
• Develops an understanding of, and completion of training in ICH/GCP guidelines, HIPAA, Standard Operating Procedures, IATA, and technical skills trainings. Other trainings may be required
• Develops an understanding of the Investigator and Site responsibilities in regard to FDA, DHHS, and OHRP regulations
• Develops an understanding of the Drug Development Process (IND to NDA and IDE to PMA, if applicable, and Phase I to Phase IV)
• Develops an understanding of the elements of the Informed Consent Form regarding the Declaration of Helsinki and the various aspects of the informed consent process
• Possess a basic knowledge of Institutional Review Boards Regulations and their role in clinical trials
• Completes study visits and oversight including but not limited to:

oObtain and ensure that the informed consent process has occurred properly prior to any research related procedures being performed

oReview medical records and inclusion/exclusion criteria with assistance of the Principal Investigator, and other Sub-Investigators

oPerform safety assessments including venipuncture, vital signs, ECG, etc. as needed

oSource Documentation completion

oMaintain and document adequate follow-up with study subjects, physicians and sponsors

oCollaborate with clinical staff to ensure procedures required by the clinical protocol are performed and documented

• Recognizes and defines safety events (serious adverse events and adverse events) and promptly notifies appropriate parties, with assistance
• Prepares, attends and participates in site initiation meetings, as well as interim monitoring and closeout visits
• Attends sponsor Investigator / Coordinator meetings as needed for assigned protocols
• Participates in peer review of data quality
• Adheres to employee policies and procedures per the IMMUNOe handbook
• Required to follow all protocol guidelines and standard procedures for all areas of research.

EQUIPMENT USED:

Including but not limited to various models of infusion pumps, sphygmomanometer, ECG machine, pulmonary function equipment, various laboratory equipment

PHYSICAL/MENTAL DEMANDS:

1. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
2. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
3. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
4. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. 

Qualifications:

• Graduate of an accredited school of nursing at least 1 year of experience as a registered nurse or recent graduate with prior experience with allergy, immunology, and research.
• Current RN Licensure by the CO state board of Nursing, in good standing
• Knowledge of CO licensed, non-certified, home health agency regulations
• Strong written and verbal communication skills
• Proficiency with MS Office
• CRNI certification a plus

• Clinical skills of phlebotomy, basic laboratory testing, intravenous infusion and ECG are required
• Expected to possess and maintain current CPR, (BLS or ACLS) training.
• Strict attention to detail
• Exceptional organization skills
• Strong written and communication skills
• Ability to manage multiple studies simultaneously
• Basic computer skills
• Honesty and integrity 
• High level of professionalism
• Ability to work effectively as part of a high-performance work team
• A thorough understanding of regulatory requirements including ICH/GCP guidelines, FDA, DHHS, and OHRP regulations