Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned; 

Develops source documents, parental permission and assent documents for submission to IRB. Coordinates IRB submissions for assigned studies, maintains regulatory documents during conduct of study; develops and utilizes study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies.

Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.

Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains study databases.

Participates in training nursing and ancillary study staff for study purposes; recruits, screens and enrolls sufficient number of study participants in conformance with protocol requirements.

Assists in identifying, reporting and following-up on Serious Adverse Events. 

Assists in the maintenance of study accountability records; prepares clinical specimens for shipment to central laboratories

Coordinates monitoring activities with Sponsor’s representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.

Requirements:

Bachelor’s degree required; effectively uses Microsoft computer software; demonstrates ability to coordinate and establish priorities among diverse tasks; effectively communicates verbally and in writing

Must sit for ACRP Certification exam as soon as eligible.