Clinical Research Coordinator Ii - Clinical Futures And Policylab

SHIFT:
Day (United States of America)
Seeking Breakthrough Makers
Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.
At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.
CHOP's Commitment to Diversity, Equity, and Inclusion
CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.
We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.
A Brief Overview
The successful candidate will join the research team of Dr. Alexander Fiks, Dr. Brian Jenssen and Dr. Stephanie Mayne at Clinical Futures and PolicyLab at The Children's Hospital of Philadelphia.
Dr. Fiks conducts research in primary care settings locally and nationally to improve pediatric decision making and child health outcomes. His research addresses diverse topics related to primary care including smoking prevention and cessation, immunization, obesity prevention, ADHD/mental health, and medication safety/effectiveness. Dr. Fiks implements and evaluates health information technology based-interventions (e.g., clinical decision support, mHealth, text messaging) through clinical trials, conducts secondary data analyses of large electronic health record and other datasets, conducts cohort studies in primary care practice, and often employs mixed methods.
Dr. Jenssen's research involves the use of clinical decision support systems and population health management techniques to protect children from secondhand smoke exposure and tobacco use. Current efforts include helping parents quit smoking in clinical settings and clinical and policy research to protect adolescents and youth from e-cigarettes/vaping. More broadly, he focuses on leveraging health information technology to engineer and implement novel approaches and products to improve care for children and their parents.
Dr. Mayne is an epidemiologist whose research focuses on the impact of environmental factors, including home and neighborhood characteristics, on child health and well-being, with a particular focus on health behaviors related to future cardiovascular disease risk (e.g. sleep, diet). Her work applies innovative technologies such as GPS tracking and mobile health techniques, as well as GIS and geospatial analysis, to address these questions.
The open position will involve work in these and related areas with a particular focus on innovation in clinical care delivery. The candidate will also join the Possibilities Project, an initiative focused on transforming pediatric primary care to improve care delivery and child/family health and wellness.
The ideal candidate will have Master's Degree in a health-related field, experience in using Stata, SAS, R or equivalent biostatistical software and prior research experience. Experience in patient-oriented research and/or secondary data analysis are strongly preferred. Qualitative research and/or GIS skills are also highly valued in this position. The team values a growth mindset and shares a commitment to lifelong learning and fostering career development among team members.
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

• Bachelor's Degree Required
• Master's Degree in a related field Preferred

• At least two (2) years of clinical/research coordination experience Required
• At least three (3) years of clinical/research coordination experience Preferred

• Basic knowledge of IRB and human subject protection. (Required proficiency)
• Excellent verbal and written communications skills (Required proficiency)
• Strong time management skills (Required proficiency)
• Ability to collaborate with stakeholders at all levels (Required proficiency)