Clinical Research Coordinator - Pediatric Neonatology

SHIFT:

Day (United States of America)

Seeking Breakthrough Makers

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A Brief Overview
Under moderate supervision from study PI or other research study management staff, this role provides substantial coordination level support for all clinical research activities within the scope of clinical research protocols.

Seeking a clinical research coordinator (CRC) to support a translational research Bacterial Genome Sequencing project examining bacterial populations in infants and the NICU environment. The CRC will be expected to accomplish:

• Regulatory tasks: maintaining and updating IRB protocol including IRB amendments, continuing reviews, updates to consent forms etc.
• Patient recruitment/obtaining consent for obtaining skin, nasal, stool samples etc.
• Performance of environmental sampling
• Sample collection and sample organization (labeling samples, maintaining sample log, coordinating sample transfer with IDDL and microbiome center, etc), 
• May need to support technical tasks around sample processing and storage (should be willing to learn/help with centrifuging, plating etc if needed). 
• Data management of clinical, laboratory and microbiome data, simple data analytic tasks - should be comfortable with Excel, Redcap, etc, 
• Communicating, supporting and coordinating targeted infection prevention interventions with NICU nursing and environmental staff

What you will do

• Core responsibilities
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Under the supervision of PI Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials
• Must comply with federal, state, and sponsor policies
• For multi-site studies or collaborations, support communication and meeting scheduling across teams
• Related responsibilities
• Manage essential regulatory documents
• Register study on ClinicalTrials.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
• Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facilitate study close out activities as appropriate
• Coordinate research/project team meetings
• Collect, process and ship samples as applicable to the protocol
• Schedule subject visits and procedures
• Retain records/archive documents after study close out

Education Qualifications

• High School Diploma / GED - Required
• Bachelor's Degree - Preferred

Experience Qualifications

• At least two (2) years of clinical or research related experience - Required
• At least three (3) years of clinical or research related experience - Preferred

Skills and Abilities

• Basic knowledge of IRB and human subject protection
• Strong verbal and written communications skills
• Strong time management skills
• Abili