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:
Ensures compliance with each study's protocol by providing thorough review and documentation at each subject study visit.
Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.
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.
Administers investigational medications and performs patient assessment during clinic visits to determine presence of side effects; notifies PI of findings/issues.
Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, investigational product drug accountability and disease treatment.
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.
Coordinate study activities with colleagues within Akron Children's Hospital system and sponsors and executes study protocols in accordance with governmental and institutional policies.
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.
Acts as Clinical Research Coordinator for studies.
Occasional travel to attend sponsor study training meetings (required).
Other duties as required
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.
Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures preferred.
Experience in blood drawing (via venipuncture, PICC line, central line and peripheral IV) and IV placement.
Knowledge of clinical trial protocols preferred.
Other information:
Technical Expertise:
Education and Experience:
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).
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.
Certifications:
Basic Life Support (BLS) - Certification is required within 90 days of employment. Akron Children's will facilitate training.
Advanced Cardiovascular Life Support (ACLS) - Certification is required within 90 days of employment - Akron Children's will facilitate training.
Pediatric Advance Life Support t(PALS) - Certification is required within 90 days of employment - Akron Children's will facilitate training.
CITI Certification - Certification is required within 90 days of hire.
International Air Transport Association (IATA)/Dangerous Goods Shipping certification is required within 90 days of hire.
Competent in all areas of nursing and healthcare.
Competent in working with all levels within an organization is preferred.
Ability to work independently as well as in a team environment.
More Than a Job. It’s loving what you do - and why you do it. Akron Children’s Hospital is ranked among the best pediatric hospitals by U.S. News & World Report, but it’s our compassionate approach to treatment that sets us apart. It’s creating special high-fives. Thinking of new ways to spark a smile. Holding hands to offer comfort. And working to get a giggle that brightens a room. The minute you walk into Akron Children’s, you can sense that people here love what they do. From visits with the Doggie Brigade, to the balloons and smiles in the halls, the sights and sounds are all about one thing: the children. We are the largest pediatric healthcare system in Northern Ohio and one of the fastest growing in the country. Akron Children’s has two hospital campuses in Northeast Ohio: one in Akron and the other in Boardman in the Mahoning Valley. With two hospital campuses, regional health centers and more than 50 primary and specialty care locations throughout Ohio, we’re making it easier for today’s busy families - regardless of where they live - to find the high-quality care they need. No matter which of our locations you choose, you’ll see that when you give the most, you get more—...support, rewards and satisfaction. CAREER OPPORTUNITIES: It’s making the most of your days. Our passion is felt every day in the way people care at every level. Whether you are working with children face-to-face, or behind the scenes supporting the care and services we deliver, you impact futures. Visit us and see why it’s more than just a place to work. It’s a family. Apply today at careers.akronchildrens.org.