Clinical Research Coordinator I - Profound Autism Research Study
About The Position
A Clinical Research Coordinator position is open as part of a new large-scale longitudinal project spanning multiple departments (Developmental Behavioral Pediatrics, Neurology, Genetics, Center for Autism Research) at the Children’s Hospital of Philadelphia. This project is focused on advancing scientific discovery and creating more therapeutic opportunities for profoundly autistic individuals ranging from birth to 18 years of age. The CRC will be actively involved in recruiting families from CHOP specialty care and primary care settings, working with families and study clinicians to conduct study visits, and managing study data. Additional responsibilities include screening potential research participants and clinical patients for enrollment; scheduling and completing participant visits and collecting biospecimen samples (visits may occur on CHOP main campus, at external satellite sites or in the community); consenting participants and research families for enrollment; performing routine email and phone follow-up with consented families who have outstanding study-related tasks. Successful applicants will be highly self-motivated and fast learners who enjoy working in bustling research and clinical environments.
Requirements
- High School Diploma / GED - Required
- At least two (2) years of clinical or research related experience - Required
- Basic knowledge of IRB and human subject protection
- Strong verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Bachelor's Degree - Preferred
- At least three (3) years of clinical or research related 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
- Under the supervision of PI 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, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- 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 as appropriate
- Facilitate study close out activities as appropriate
- Coordinate research/project team meetings
- Collect, process and ship samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
