Clinical Research Coordinator II - Hematology

SHIFT:

Day (United States of America)

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A Brief Overview

The Children’s Hospital of Philadelphia, Division of Hematology, is hiring a full-time clinical research coordinator. The research coordinator will work with clinical studies involving thalassemia and other red blood cell disorders, as well as coordinate sample collection and processing for the Division of Hematology Biorepository. Specific research projects will be discussed at the time of interview.

This position involves regular interaction with patients in a clinical setting and the opportunity to build relationships with patients and their families. It may also include travel to hematology conferences, authorship and publishing opportunities. There is a component of basic wet lab work to process samples and run simple assays.

Opportunities are available to attend weekly Hematology Divisional Clinical Conference and weekly Department of Pediatrics Grand Rounds, which provide unique insight into a large tertiary pediatric hospital. Research staff are required to attend disease program weekly clinical meetings.

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