Clinical Research Coordinator, RN - RI Gene Therapy

at  Nationwide Childrens Hospital

THIS POSITION WORKS WITH ADULTS AND CHILDREN THAT HAVE NEUROMUSCULAR DISEASES. THE RESEARCH STUDIES ARE FOR SIGNIFICANT EXPERIMENTAL TREATMENTS SUCH AS POTENTIALLY LIFE-PROLONGING MEDICATIONS AND GENE THERAPIES. STUDIES ARE GENERALLY MULTI-YEAR STUDIES WHICH ALLOWS FOR BUILDING RELATIONSHIPS WITH FAMILIES THAT ARE PARTICIPATING IN THE TRIALS. THIS WORK IS VERY MEANINGFUL AND REALLY MAKES YOU FEEL YOU ARE MAKING A DIFFERENCE FOR MANY.

The Clinical Research Nurse I (CRN) primary responsibility is managing elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.
Why Nationwide Children’s Hospital?:
The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose.
Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.
We’re 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.
Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.
Nationwide Children’s Hospital. A Place to Be Proud.
Responsibilities:

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED MINIMUM QUALIFICATIONS:

1. Graduate of an approved school/college of nursing and licensed for practice as a registered nurse in the State of Ohio; BS/BSN preferred.
2. At least 1 year of nursing experience; preferably pediatrics, preferred

3. Understanding of medical terminology and clinical trials preferred.

4. Skills required:

• Working knowledge of PCs,word processing, and data management software
• Strong verbal, written, interpersonal communication
• Goal-oriented; self-directive
• Initiation, self-motivation, creativity, flexibility
• Organizational and detail oriented
• Ability to actively participate as a team player

MINIMUM PHYSICAL REQUIREMENTS: Note frequency as Constantly (67-100%), Frequently (34-66%) and Occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit. AGE(S) OF PATIENTS SERVED: Pediatric and select adult patients X Yes _ _No MINIMUM PHYSICAL REQUIREMENTS: Talking on phone/in person; frequently (34-100%) Sitting; frequently (34-100%) Standing/Walking; frequently (34-100%) Lifts objects weighing up to 25 pounds; occasionally (0-33%) Typing on keyboard; occasionally (0-33%)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.
EOE M/F/Disability/Ve

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:
a) Establishes a strong working knowledge of all governing regulations and policies relating to clinical research and the job in accordance with:
i) NCH ii) FDA iii) NIH iv) State of Ohio v) Any other applicable regulatory bodies
b) Conducts clinical studies as outlined in the study protocol; performing study procedures according to recognized skill level and certifications and licensure; and adheres to good clinical practice.
c) Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours. Obtain and maintain IATA certificate.
d) Collects and controls research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable) ). Ensures PHI is collected and maintained in a secure manner.
e) Assists in the recruitment plan, in cost estimation when applicable; manages screening documentation and recruitment logs, and completes recruitment summary at study termination.
f) Creates source documents that facilitate systematic, accurate, and comprehensive data collection forms.
g) Aid in protocol execution and management, record keeping; and conducts accurate and timely subject data collection, ensure all reports requiring medical interpretation are reviewed and signed off by an investigator in accordance with all applicable regulations.
h) Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I;
i) Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations;
j) Adheres to departmental quality control and administrative guidelines and processes
k) Ensures all institutional and regulatory requirements have been met to begin enrollment prior to screening first subject
l) Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria (prior to randomization for drug studies);
m) Verified that the subject and/or legal guardian has provided informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;
n) Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
o) Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training.
p) Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.
q) Schedules, prepares study data for, and attends monitor visits, audits, or other meetings as required for the study.
r) Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder in conjunction with the regulatory coordinator office.
s) Performs invasive procedures such as venipuncture, IV insertion and injections, per protocol, with patient safety and comfort in mind, and in compliance with NCH and state licensing standards.
t) Administers investigational medications per protocol and in compliance with NCH and state and federal requirements
u) Performs other duties and maintains flexible schedule as required by a protocol or unit needs
Qualifications: