Job Description

Full-time, 40 hours/week

Monday-Friday 8am-4:30pm

Hybrid remote (requires 6-12 days/month onsite Akron)

Summary: This position will support our Pulmonary and Cystic Fibrosis areas.

The Clinical Research Nurse I (CRN I), under the supervision of the Principal Investigator (PI) and Clinical Research Support Team Supervisor ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Akron Children's Hospital policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. In addition, the clinical trial nurse also acts as the study coordinator for studies.

Responsibilities:

1. Ensures compliance with each study's protocol by providing thorough review and documentation at each subject study visit.
2. Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.
3. Performs medical tests, including but not limited to, vital signs, venipuncture, lab collection, lab processing, specimen shipping, electrocardiograms, and additional tasks delegated by the PI.
4. Administers investigational medications and performs patient assessment during clinic visits to determine presence of side effects; notifies PI of findings/issues.
5. Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, investigational product drug accountability and disease treatment.
6. Recruit and enroll subjects into clinical trials through Rebecca D. Considine Research Institute, ensuring effective subject enrollment, development and utilization of study case records, accurate data collection, documentation, and organization, and exemplifying competence within the parameters of the clinical research nurse role according to local and federal regulations and guidelines.
7. Coordinate study activities with colleagues within Akron Children's Hospital system and sponsors and executes study protocols in accordance with governmental and institutional policies.
8. Documents medical data in patient chart to capture protocol requirements. Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and Good Clinical Practices (GCP) guidelines.
9. Acts as Clinical Research Coordinator for studies.
10. Occasional travel to attend sponsor study training meetings (required).
11. Other duties as required.

Other information:

Technical Expertise:

1. Competent in the use of Microsoft Office, Outlook, Word and Excel, Electronic Health Systems, EPIC and databases utilized in research or have a willingness to learn and demonstrate proficiency within six months of hire.
2. Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures preferred.
3. Experience in blood drawing (via venipuncture, PICC line, central line and peripheral IV) and IV placement.
4. Knowledge of clinical trial protocols preferred.

Education and Experience:

1. Education: Graduate of an accredited school of nursing and currently licensed as a registered nurse in the state of Ohio. BSN preferred (for new employees hired into positions posted on or after July 1, 2013 - BSN required or must obtain within 5 years from date of hire, and evidence of ability to assume responsibility of the advanced Clinical Nurse role).
2. Certification: None
3. Years of experience: Minimum 1-year prior experience in pediatrics, adult medicine/or critical care experience in nursing is required. Knowledge of clinical research coordination and/or exposure to clinical research practices.
4. Basic Life Support (BLS) - Certification is required within 90 days of employment. Akron Children's will facilitate training.
5. Advanced Cardiovascular Life Support (ACLS) - Certification is required within 90 days of employment - Akron Children's will facilitate training.
6. Pediatric Advance Life Support t(PALS) - Certification is required within 90 days of employment - Akron Children's will facilitate training.
7. CITI Certification - Certification is required within 90 days of hire.
8. International Air Transport Association (IATA)/Dangerous Goods Shipping certification is required within 90 days of hire.
9. Competent in all areas of nursing and healthcare.
10. Competent in working with all levels within an organization is preferred.
11. Ability to work independently as well as in a team environment.

Full Time

FTE: 1.000000

Status: Fixed Hybrid

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