Dr. Alexander Fiks of The Center for Pediatric Clinical Effectiveness and PolicyLab at The Children’s Hospital of Philadelphia is seeking a clinical research coordinator to join his team.
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, asthma, 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, social social media) through clinical trials, conducts secondary data analyses of large electronic health records and other datasets, conducts cohort studies in primary care practice, and often employs mixed methods.
The applicant is expected to work comfortably as part of a research team. The successful applicant should have strong writing, organizational, and analytical skills. Job responsibilities will include participation in grant writing, protocol development, study implementation, study management, research participant recruitment, data analysis, oral presentation and manuscript presentation. A collaborative working style is required. The successful applicant will be responsible for leading specific projects.
Additional Job Responsibilities
- Adhere to an IRB approved protocol
- Participate in the informed consent process of study subjects
- Support the safety of clinical 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
- 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