Clinical Research Coordinator I

Overview

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) "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" 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 are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission. 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.