Clinical Research Coordinator I - CDC

Nationwide Children's Hospital Inc; Columbus (OH); On-site; USD 52,000 - 66,000; Full time

Job summary

Nationwide Children's Hospital Inc. is seeking a Clinical Research Coordinator I to manage elements of pediatric clinical studies in compliance with ICH/GCP and institutional SOPs.

The role includes start-up, conduct, and close-out activities, with emphasis on data integrity and patient safety. You will recruit and enroll participants, oversee data collection and specimen processing, coordinate visits, and ensure regulatory documentation is complete.

Qualifications

• Understanding of medical terminology and clinical research preferred.
• Excellent communication skills in verbal and written form.
• Strong organizational and interpersonal abilities.

Responsibilities

• Recruits, consents and enrolls subjects according to ICH/GCP and IRB requirements; acts as patient/family advocate.
• Ensures eligibility criteria are met and flags safety concerns or protocol deviations.
• Collects and manages study data; maintains accurate data collection and laboratory procedures.
• Prepares and processes human specimens; may perform CLIA waived tests.
• Schedules subject visits with PI/sub-I and other services; maintains regulatory binder.
• Completes Case Report Forms accurately and on time.
• Participates as a team member; adheres to SOPs and quality control guidelines.

Skills

Medical terminology

Clinical research understanding

Analytical skills

Verbal and written communication

Organizational skills

Team player

Education

Associates degree, STNA, PCA, LPN, MA or equivalent

BA/BS preferred

Job description

## Clinical Research Coordinator I - CDCApply: Main Campus, Columbus, OH: 187 West Schrock Rd, Westerville, OH: Full time: Posted Today: R-17924**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/kneelFREQUENTLY: 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, WalkingCONTINUOUSLY: 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) \"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\"