Clinical Research Coordinator RN-Gene Therapy

Clinical Research Coordinator RN-Gene Therapy

Nationwide Children's Hospital | Columbus, OH, 43216, US
Salary Range:$43,000 – $55,000 Salary range estimated by Zippia

Posted 8 days ago

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Description

Overview

This is a full-time, working 40 hours per week, exempt role.

Minimium payrate: $32/hr

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

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:

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

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

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

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

Assists in the recruitment plan, in cost estimation when applicable; manages screening documentation and recruitment logs, and completes recruitment summary at study termination

Creates source documents that facilitate systematic, accurate, and comprehensive data collection forms

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

Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I

Enrollment of subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations

Adheres to departmental quality control and administrative guidelines and processes

Ensures all institutional and regulatory requirements have been met to begin enrollment prior to screening first subject

Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria (prior to randomization for drug studies

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

Alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination

Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training

Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF's are completed prior to monitoring visits

Schedules, prepares study data for, and attends monitor visits, audits, or other meetings as required for the study

Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder in conjunction with the regulatory coordinator office

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

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

EDUCATION:

Graduate of an approved school/college of nursing and licensed for practice as a registered nurse in the State of Ohio; BS/BSN preferred

At least 1 year of nursing experience; preferably pediatrics, preferred

Understanding of medical terminology and clinical trials preferred

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

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/Vet