Clinical Research Coordinator II - Center for Bone Health

The successful candidate will join the research team of Dr. David Weber in the Center for Bone Health (Division of Endocrinology and Diabetes) at The Children’s Hospital of Philadelphia. Dr. Weber’s research focuses on improving the clinical care of children with impaired bone health from genetic conditions or secondary to severe childhood disease. He is building a research team that will work on multiple bone health related projects including investigator initiated prospective observational studies in children with primary (such as osteogenesis imperfecta) and secondary osteoporosis (such as Duchenne muscular dystrophy or diabetes), industry sponsored observational and clinical trials in children with rare bone diseases, quality improvement projects within the Center for Bone Health, and epidemiologic studies utilizing local and multi-center clinical records databases.

The ideal candidate will have a Master’s Degree in Public Health, Epidemiology, Biostatistics or a related field. Prior research experience and in patient-oriented research is required. The applicant is expected to work comfortably as part of a research team and will work on multiple research studies at any given time. The successful applicant should have strong communication, writing, organizational, and analytical skills. Job responsibilities will include participation in grant writing, protocol development, study implementation, subject recruitment, conduct of study visits, study management, budget management, data analysis, and potentially contribution to manuscript writing.

Dr. Weber works closely with other physicians and researchers within the Center for Bone Health, Metabolism, Nutrition, and Physical Development Research Affinity Group, and The Center for Pediatric Clinical Effectiveness. The candidate will be integrated within these research networks which will allow for robust senior, peer, and near-peer mentoring  and provide opportunities for career advancement.

Job Responsibilities

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

• Manage essential regulatory documents
• Register study on ClinicalTrial.gov
• 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
• Facilitate study close out activities
• Coordinate research/project team meetings
• Collect, process and ship laboratory specimens
• Schedule subject visits and procedures
• Retain records/archive documents after study close out

Also may be responsible for any of the following:

• 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
• Document investigational product (drug/device) accountability
• Self-monitor and self-audit responsibilities
• Develop informed consent document
• Maintain Clinical Trial.gov 
• Develop Case Report Forms
• Assignments to include more complex studies

https://careers.chop.edu/job/Philadelphia-Clin-Research-Coordinator-II-Center-for-Bone-Health-PA-19146/768134800/?locale=en_US