Clinical Research Coordinator II
Children's Hospital of Philadelphia • Philadelphia, PA2d • Onsite
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Clinical Research Coordinator II - D3b Data-Driven Discovery in Biomedicine
Children's Hospital of Philadelphia•Philadelphia, PA
•Onsite
About The Position
We are the Center for Data-Driven Discovery in Biomedicine (D3b: d3b.center), an ambitious and unique blend of experts in the field of pediatric brain tumor research. Our mission is to empower researchers to analyze biological and genomic data, so that they may discover insights that lead to cures or dramatically improved treatment options. We want creative problem solvers that are passionate about clinical research operations and biobanking operations, and are excited to learn whatever is needed to empower our mission. As a Clinical Research Coordinator in the center, you will participate in routine operational tasks involved in clinical research and biobanking by following operational protocols and will exercise discretion and judgement in execution of assigned tasks. The impact of your work will be far-reaching and life-changing for every child, every time, everywhere. 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.
Requirements
- Bachelor's Degree Required
- At least two (2) years of clinical/research coordination experience Required
- 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
Nice To Haves
- Master's Degree in a related field Preferred
- At least three (3) years of clinical/research coordination experience Preferred
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
- 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
- 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
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
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