Clinical Research Coordinator II - RI Biobeh Fox

Nationwide Children's Hospital • Columbus, OH

109d

About The Position

Dr. Kristen Fox seeks a full-time Clinical Research Coordinator II (CRC II) to join her research program focused on preventing risky health behaviors (e.g., e-cigarette use) among adolescents with congenital heart disease. The CRC II will support an NIH-funded randomized clinical trial evaluating a mobile health intervention, and contribute to studies examining health behaviors, psychosocial functioning, and healthcare experiences in adolescents and young adults with congenital heart disease. Research methods include clinical trials, surveys, medical record reviews, and qualitative interviews. This position is grant-funded and is fully in-person. Flexibility to work some evenings/weekends for participant recruitment and data collection is required. The position is available immediately.

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; 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.

Benefits

• Diversity, Equity and Inclusion integrated into core values and practices.
• Collaborative Culture to deliver innovative care and foster new discoveries.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees