Clinical Research Coordinator II - Hill Lab

SHIFT:

Day (United States of America)

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A Brief Overview

Under minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols.

Duties involve managing the day-to-day activities of the research study under the guidance of PI or managing study staff.

The Hill Research Lab in the Division of Allergy and Immunology is seeking a Clinical Research Coordinator II with excellent communication skills and a warm disposition to assist in recruitment of research subjects to their human studies, which center on atopic diseases (ie. eosinophilic esophagitis, asthma, IgE food allergies) and irritable bowel syndrome.

The CRC II will screen, consent, and enroll research subjects on applicable IRB protocols and transport blood samples from the endoscopy suite, CHPS, or occasionally satellite locations to the Hill lab, the clinical immunology lab, and/or the BioRC SPTU lab. Occasionally, the CRC II will transport tissue samples from the operating room to the Hill lab. The CRC II will function independently in their role and is committed to a career in research.

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
• 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
• Must comply with federal, state, and sponsor policies
• Related responsibilities
• Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
• Register study on ClinicalTrial.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• 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 laboratory specimens
• Schedule subject visits and procedures
• Retain records/archive documents after study close out
• Additional Responsibilities may include
• Manage study finances including sponsor invoicing & resolving study subject billing issues
• Develop advertisement materials
• Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
• Organize and/or run study-related meetings locally or across teams (for multi-site projects)
• Support study team communications and outreach
• Provide training to junior staff on conduct of research studies
• Document investigational product (drug/device) accountability
• Self-monitor and self-audit responsibilities
• Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
• Maintain Clinical Trial.gov
• Develop Case Report Forms
• Assignments to include more complex studies
• Education Qualifications
• Bachelor's Degree - Required
• Master's Degree in a related field - Preferred
• Experience Qualifications
• At least two (2) years of clinical/research coordination experience - Required
• At least three (3) years of clinical/research coordination experience - Preferred
• Skills and Abilities
• Basic knowledge of IRB and human subject protection
• Excellent verbal and written communications skills
• Strong time management skills
• Ability to collaborate with stakeholders at all levels
• To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.
• EEO / VEVRAA Federal Contractor | Tobacco Statement