Job Description
Clinical Research Coordinator II
Requisition ID
2024-49144
Category
Research
Overview
The Clinical Research Coordinator II is responsible for managing all of the 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. The CRC II also trains and mentors other CRC?s to ensure consistency in study management activities.
Why Nationwide Children's Hospital?
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 14,000 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.
Responsibilities
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Performs research activities as outlined in the protocol; obtains informed consent, conducts subject data collection, and conducts patient sample collection. Performs study protocol procedures according to recognized skill level and certifications; collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
2. Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management; documents required observations on source documents as required by the protocol.
3. Verifies that the subject meets inclusion/exclusion criteria; verified that the subject and/or legal guardian has provided informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
4. Responsible for regulatory/IRB issues after a study has been initiated by the study sponsor; maintains regulatory binder.
5. Assists the Clinical Operations Manager in the recruitment plan and the Contract/Budget manager in cost estimation; manages screening sheets and recruitment logs, and completes recruitment summary at study termination.
Qualifications
REPORTING RELATIONSHIPS:
PIs responsible for the individual studies and will also report to Dr. Vidu Garg,Director of Center for Cardiovascular and Pulmonary Research.
MINIMUM QUALIFICATIONS:
1. Minimum of 3 years research experience preferred, Bachelor's Degree required.
2. Willingness to become certified as a Clinical Research Coordinator when eligible.
3. Skills required:
* Computer competence; working knowledge of PCs, word processing and data management software * Verbal and written communication
* Goal-oriented; self motivated and self-directive
* Initiation, motivation and creativity
* Organization and interpersonal
* Able to actively participate as a team player
MINIMUM PHYSICAL REQUIREMENTS: (List the minimum physical requirements necessary to perform the essential functions of the position. Physical requirements may include lifting, carrying, pushing, pulling, standing, walking, sitting, climbing, balancing, stooping, kneeling, reaching, finger dexterity, talking, hearing, seeing, etc.
If possible, minimum physical requirements should be described in terms of the amount (e.g., weight ) and duration (e.g., occasionally = 0-33%, frequently = 34 - 66%, constantly = 67-100%) of specific physical effort required to perform the essential functions. For example: "Lifts objects weighing up to 30 pounds. - Constantly") Talking on phone/in person; frequently (0-25%) Sitting; frequently (34-100%) Standing/Walking; frequently (34-100%) Lifts objects weighing up to 25 pounds; occasionally (0-33%) Typing on keyboard (33-100%) The above list of duties is intended to describe the general nature and level of work performed by people assigned to this classification.
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