Clinical Research Coordinator I - RI Behav Trials Off

Nationwide Children's Hospital • Columbus, OH

7d • Onsite

About The Position

The Behavioral Trials Office (BTO) works with investigators and research teams to support our mission of providing efficient coordination of diverse behaviorally-focused clinical research, including behavioral intervention trials and observational research. Our work spans a variety of pediatric departments and developmental stages. Example projects that the BTO is involved in include: how pre- and post-natal exposure to air pollutants and early life stress impact reading and math learning difficulties in children ages 6-10, testing of a chatbot-based app to connect families with unmet social needs to community resources, and an intervention to support Medicaid-enrolled families with obesity improve cardiovascular health. Please submit a cover letter with your application. Job Description Summary: Manages 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.

Requirements

• Associate's Degree, or equivalent certification or experience, required.
• CNA, PCA, LPN, MA, or equivalent education or experience, required.
• Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification after hire, required.
• Understanding of medical terminology and clinical research 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
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

Nice To Haves

• Bachelor's Degree, preferred.
• Previous experience in clinical research or health care related field preferred.

Responsibilities

• 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.
• 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.
• 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.

Benefits

• Where Passion Meets Purpose.
• Diversity, Equity and Inclusion are integrated into our core values and practices.
• 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.
• More Than a Job. It’s a calling.
• A Place to Be Proud.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree