Clinical Research Coordinator I - CDC

10 Nationwide Children's Hospital; Columbus (OH); On-site; USD 60,000 - 75,000; Full time

Job summary

Nationwide Children’s Hospital seeks a Clinical Research Coordinator I to manage elements of a clinical study in alignment with ICH/GCP guidelines. You will oversee start-up, launch, day-to-day management, and study closure activities within the NCH Child Development Center.

The role involves recruiting and consenting participants, data collection, specimen handling, and coordinating visits with PI/sub-I, while maintaining regulatory binders and source documents.

Qualifications

• Associates degree required; BA/BS preferred.
• 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-directed; strong organizational and interpersonal skills.

Responsibilities

• Recruits, consents and enrolls subjects according to ICH/GCP regulations; acts as a patient/family advocate.
• Ensures subject meets inclusion/exclusion criteria; alerts PI if safety is jeopardized or protocol deviations occur.
• Collects and manages research data; maintains accurate data collection and lab procedures.
• Prepares and processes human specimens for research use.
• Collects blood, urine, and other samples per skill level/certifications.
• Performs CLIA-waived lab assessments; may require evening/weekend hours.
• Creates source documents to facilitate data collection and protocol management.
• Coordinates study visits with hospital services and PI/sub-I; ensures schedule adherence.
• Maintains regulatory binder and essential study documents.

Skills

Medical terminology

Clinical research

Data management software

Analytical skills

Verbal and written communication

Organizational skills

Team player

Attention to detail

Education

Associates degree

BA/BS preferred

STNA

PCA

LPN

MA

Tools

Microsoft Word

Microsoft Excel

Data management software

Word processing

Job description

Overview

This position will be housed within the NCH Child Development Center. The CRC will work on projects that focus on contributing to the field of neurodevelopmental conditions such as autism spectrum disorder and development delays. Studies and projects may focus on measurement or symptoms or behaviors, assessment of skills, intervention, preserving/promoting quality of life, or other areas of interest.

Job Description Summary

The Clinical Research Coordinator I 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.

Job Description

Essential Functions

• 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. Such activities may be performed independently and may require evening and weekend hours.
• 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.

Education Requirement

Associates degree, STNA, PCA, LPN, MA or equivalent work-related experience required. BA/BS preferred.

Licensure Requirement

(not specified)

Certifications

Ability to obtain CRA/CRC certification in a timely manner.

Skills

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.

Experience

Previous experience in clinical research or health care related field preferred.

Physical Requirements

OCCASIONALLY: Cold Temperatures, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel FREQUENTLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Sitting, Standing, Walking CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near Additional Physical Requirements performed but not listed above: (not specified)

Additional Information

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision.

EEO Statement

EOE M/F/Disability/Vet

Company Culture

The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose. Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We’re 15,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live 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.