Clinical Research Coordinator II, NE, Non-RN- Research GI

Nationwide Children's Hospital

Job Description

Clinical Research Coordinator II- Research GI

Full time Exempt: Main Campus; Mon-Fri 8 AM 5 PM

We are seeking a Clinical Research Coordinator II- The 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 can feel it. When you meet one of our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it, too. Welcome to Nationwide Childrens Hospital, where Passion Meets Purpose.

Here, Everyone Matters. Were 12,000 strong. And it takes every single one of us to improve the lives of the kids we care for, and the kids from around the world well never even meet. Kids who are living 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 Childrens badge what they do for a living. Theyll tell you its More Than a Job. Its a calling. Its 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 Childrens Hospital. A Place to Be Proud.

What Will You Be Doing?
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:
Conducts clinical studies as outlined in the study protocol; performing study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; adheres to good clinical practices.
Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications.
Collects and controls research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable)
Develops the recruitment plan and the in cost estimation; manages screening sheets and recruitment logs, and completes recruitment summary at study termination.
Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection
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
Obtains informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate
Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training.
Alerts the investigator or Team Leader when the subject?s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
Completes Case Report Forms (CRFs) as instructed by the sponsor/PI; ensures CRF?s are completed prior to monitoring visits.
Responsible for regulatory/IRB submission and issues after a study has been initiated; maintains regulatory binder.
Assists the principal investigator in protocol development, preparation of scientific publications and grant proposals.
Coaches and mentors faculty, research assistants, students, fellows, and other clinical research coordinators.
Works in collaboration with Team Leader on maintaining accountability over grant spending.
Performs other duties and maintains flexible schedule as required by a protocol or unit needs.
Participates in process improvement activities.
Maintains a positive attitude and contributes to team productivity. Cultivates a strong working relationship with GI staff (such as Registration, Clinic, and Procedure Room) to ensure a smooth integration of research activities into their daily routine.
Works on special projects under direction of GI Research Team Leader


What Are We Looking For?

To fulfill this role successfully, you must possess these minimum qualifications and experience:
Associates degree or equivalent work related experience; BA/BS preferred.
1 year experience in clinical research or health care field.
Understanding of medical terminology and clinical trials preferred.
CRA/CRC certification (or must obtain within two years)
Working knowledge of PCs and word processing and data management software
Verbal and written communication
Goal-oriented; self-directive
Initiation, motivation, creativity
Organizational and interpersonal
Ability to actively participate as a team player
Team Player

Your Benefits, Your Wellness:

As an employer, Nationwide Childrens recognizes the importance of the benefits we offer. We also recognize the importance of balancing your work and personal needs. Our benefits and Employee Wellness package is designed to:
Empower you to be a conscientious health care consumer through educational and wellness activities
Establish a work environment that promotes health and well-being
Support your financial protection and security in retirement

Most of our positions are benefits eligible from day 1.

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.