Clinical Research Coordinator I - CRS Bird
The Clinical Research Coordinator I's 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.
Schedule: (Full time, Benefits Eligible)
Central Campus700 Children's DrColumbus, Ohio 43205United States
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:
Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate
Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination
Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable)
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.
Assists in the recruitment plan; completes screening sheets and recruitment logs
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;
Adheres to departmental quality control guidelines
Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF's are completed prior to monitoring visits.
Maintains regulatory binder and documents
Performs other duties and maintains flexible schedule as required by a protocol or unit needs.
KNOWLEDGE , SKILLS AND ABILITIES REQUIRED
Associates degree or equivalent work related experience; BA/BS preferred.
Understanding of medical terminology and clinical research preferred.
Ability to obtain CRA/CRC certification in timely manner.
Working knowledge of PCs and word processing and data management software
Verbal and written communication
Initiation, motivation, creativity
Organizational and interpersonal
Ability to actively participate as a team player
Mentoring/training of new CRC's
Minimum Physical Requirement:
Nationwide Children's Hospital