Clinical Research Coordinator II- Center for Perinatal Research
The Clinical Research Follow Up Coordinator primary responsibility is managing elements of clinical studies in order to meet all protocol obligations while following International Council on Harmonization of Technical Requirements/Good Clinical Practice(ICH/GCP) guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; Institutional Review Board, 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 Children’s Hospital, where Passion Meets Purpose.
Here, Everyone Matters. We’re 13,000 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 we’ll 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 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.
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: a) Conducts the Follow Up Portion of 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. b) Attends all Follow Up Appointments with research subjects at appropriate time points. Coordinates with families of subjects, administers questionnaires, compensates families, and coordinates the collection of all necessary data per study requirements. May include coordination of examiners, physicians, nurses and personnel to ensure all data collected is in line with all sponsor requirements. Such activities may be performed independently and may require evening and weekend hours. c) Collects and controls research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable). d) Assists in the Follow Up plan and the in cost estimation; manages screening sheets and recruitment logs, monitors windows in which Follow Up must take place and completes Follow Up Rates and Summary at study termination and regularly throughout study duration. e) 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, f) Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I. g) Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; h) Adheres to departmental quality control guidelines i) 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; j) Assists PI in education and certification (if necessary) of other study personnel with regards to study responsibilities and keeps written documentation of this training. k) Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. l) Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits. m) Development of IRB, IACUC and safety protocols, as necessary. Responsible for regulatory/IRB issues after a study has been initiated; assists in maintaining regulatory binder. n) Assists the principal investigator in the preparation of scientific publications and grant proposals. o) Coaches and mentors new clinical research coordinators. p) Performs other duties and maintains flexible schedule as required by a protocol or unit needs, including, but not limited to: after-hours coverage.
What Are We Looking For?
Your Benefits, Your Wellness:
As an employer, Nationwide Children’s 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:
Minimum Physical Requirements: