Clinical Research Coordinator II - RI Academic Affairs & Research Dev

Nationwide Children's Hospital; Columbus (OH); On-site; USD 43,000 - 58,000; Full time

Job summary

Nationwide Children's Hospital is seeking a Clinical Research Coordinator II to support their academic affairs and research development initiatives. In this role, you will manage clinical studies focused on youth mental health, recruit participants, and ensure adherence to protocols. Candidates should have a Bachelor's degree in a social science field and experience in clinical research or mental health settings. Strong communication, organization, and analytical skills are required.

Qualifications

• 18 months experience in clinical research or health care field required.
• Understanding of medical terminology and clinical trials preferred.
• Goal-oriented and self-directive with project management capability.

Responsibilities

• Conducts clinical studies and manages participant safety.
• Coordinates subject study visits and manages protocol data.
• Educates other study personnel regarding study-specific responsibilities.

Skills

Analytical Skills

Communication Skills

Attention to Detail

Organization

Customer Service

Education

Bachelor's degree in social science field

Associate's degree or equivalent work-related experience

Tools

Data Management Software

Word Processing Software

Job description

Clinical Research Coordinator II - RI Academic Affairs & Research Dev

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Overview

With supervision, the CRC will engage in the enrollment, recruitment, retention of research participants, and other tasks as needed. The CRC will conduct clinical interviews for children and adults, obtain mental health history, and review reported suicidal ideation/behavior to determine if further intervention is indicated. They will work on projects focused on youth mental health, including school-based programming. Travel to school research sites required. Bachelor’s degree in social science field and previous research experience or work in the mental health field preferred. Effective customer service, communication, organization, and attention to detail required.

Overview

With supervision, the CRC will engage in the enrollment, recruitment, retention of research participants, and other tasks as needed. The CRC will conduct clinical interviews for children and adults, obtain mental health history, and review reported suicidal ideation/behavior to determine if further intervention is indicated. They will work on projects focused on youth mental health, including school-based programming. Travel to school research sites required. Bachelor’s degree in social science field and previous research experience or work in the mental health field preferred. Effective customer service, communication, organization, and attention to detail required.

Typical hours: Mon-Fri 8a-4:30p, one late day/week 12p-8:30p. Hours subject to change dependent on project needs.

Job Description Summary

Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities.

Job Description

Essential Functions:

• 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; and 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.
  
  

Education Requirement

• Associate's degree or equivalent work-related experience, required.
• BA/BS, preferred.
  
  

Licensure Requirement

(not specified)

Certifications

CRA/CRC certification, preferred.

Skills

• 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.
  
  

Experience

Eighteen months experience in clinical research or health care field, required.

Physical Requirements

OCCASIONALLY: Cold Temperatures, Driving motor vehicles (work required) *additional testing may be required, 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)

"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"

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Hospitals and Health Care

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