Clinical Research Coordinator - Neonatology

Children’s Hospital of Philadelphia•Philadelphia, PA

About The Position

Seeking CRC II to join established and active neonatal clinical research team at CHOP Newborn Care at Pennsylvania Hospital. Pennsylvania Hospital is the nation’s oldest hospital, a teaching facility of the University of Pennsylvania, and the busiest labor and delivery service in Philadelphia (with approximately 5000 annual births). The CRC’s primary role will be to manage an NIH-funded, prospective cohort study to understand antimicrobial pharmacology in mothers and infants in the immediate perinatal period. In close collaboration with the PI, responsibilities will include screening, time-sensitive consents, coordination of biospecimen collection and processing, and maintenance of study data and records. 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