Clinical Research Coordinator I - CDC

Nationwide Children's Hospital; Westerville (OH); On-site; USD 42,000 - 64,000; Full time

Job summary

Nationwide Children's Hospital seeks a Clinical Research Coordinator I to manage elements of clinical studies within the NCH Child Development Center. You will oversee start-up, launch, daily study activities and closure in line with ICH/GCP and SOPs.

You will recruit and enroll subjects, monitor safety, collect data, prepare CRFs and maintain regulatory binders, collaborating with PI and hospital services. Associates degree or equivalent required.

Qualifications

• Associates degree or equivalent required; BA/BS preferred.
• Understanding of medical terminology and clinical research.
• Excellent verbal and written communication and attention to detail.

Responsibilities

• Recruits, consents and enrolls subjects per ICH/GCP and IRB rules.
• Monitors participant safety and protocol adherence; notes deviations.
• Collects and manages study data; processes specimens as needed.
• Completes CRFs and maintains regulatory documents for the study.
• Coordinates subject visits with PI/sub-I and hospital services.

Skills

Medical terminology

Clinical research

Communication

Data management

Analytical skills

Team player

Organization

Education

Associate degree or equivalent

BA/BS preferred

STNA/PCA/LPN/MA experience considered

Tools

Word processing

Data management software

PCs

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.

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

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. EOE M/F/Disability/Vet