Clinical Research Coordinator II - RI Gene Therapy

Nationwide Children's Hospital•Columbus, OH

5d•Onsite

About The Position

Collecting bioinformatics and biological samples for translational benchtop laboratory research and future research within the Center for Gene Therapy, and for collaborators. About 60% of the time: Curating the participant folders based upon specific directions from the principal investigator; harmonizing data collection within the participant folders and database; validating data; working closely with investigators to prepare data for statistical analysis; and participating in the preparation of publications/presentations. About 40% of the time: Contact with participants for consenting or updating clinical records, working with the investigators to collect muscle and skin biopsies and blood draws, and delivering them to the designated laboratory for processing. Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities.

Requirements

Associate's degree or equivalent work-related experience, required.
Eighteen months experience in clinical research or health care field, required.
Understanding of medical terminology and clinical trials preferred.
Working knowledge of PCs and word processing and data management software.
Demonstrated analytical skills with accuracy and attention to detail.
Excellent verbal and written communication skills.
Goal-oriented and self-directive, ability to manage complex projects independently.
Strong organizational and interpersonal skills.
Ability to actively participate as a team player.

Nice To Haves

BA/BS, preferred.
CRA/CRC certification, preferred.

Responsibilities

Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies
Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success
Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; 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,
Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF’s) and ensures CRF’s are completed prior to monitor visits.
Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder.
Assists the principal investigator in the preparation of scientific publications and grant proposals.