Clinical Research Coordinator II

10 Nationwide Children's Hospital; Ross Hall (MT); On-site; USD 65,000 - 90,000; Full time

Job summary

Nationwide Children’s Hospital is seeking a Clinical Research Coordinator to manage elements of clinical studies, ensuring protocol adherence and subject safety under ICH/GCP guidelines. Responsibilities include recruitment, consenting, data collection, regulatory duties, and collaboration with the PI and study team.

Ideal candidates will have 18 months of clinical research or health care experience and strong communication, organizational, and data management skills.

Qualifications

• Eighteen months experience in clinical research or health care field.

Responsibilities

• Conducts clinical studies per protocol and ICH/GCP guidelines.
• Recruits, consents and enrolls subjects per regulations and IRB requirements.
• Coordinates subject visits with hospital services and the PI/sub-I.
• Maintains study data, CRFs, and regulatory binders.
• Educates study personnel on study-specific responsibilities and trainings.
• Alerts PI if subject safety is jeopardized or protocol deviations occur.
• Prepares scientific publications and grant proposals with PI.

Skills

Clinical research

Regulatory knowledge

Communication skills

Data management

Analytical skills

Education

Associate's degree or equivalent work-related experience

BA/BS, preferred

Job description

Overview

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.

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)

EOE M/F/Disability/Vet

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.