The Clinical Research Coordinator II coordinates, implements and completes clinical research studies or clinical trials involving Morquio syndrome by assisting with IRB submissions, assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining study records, interfacing with study sponsors, participation in sponsor study monitoring visits.
Requirements:
Bachelor's degree in medical or science related field
Minimum of 2 years clinical research coordination experience
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing
Essential Functions:
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;
Understands and can conduct clinical research studies that require but not limited to, DSMB, Emergent Access, Conduct Investigator Initiated studies, Multi-site clinical trials, Research Team training manuals.
Achieves clinical research coordinator certification from ACRP or SOCRA.
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
Mentors new clinical research coordinators. 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 medication 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.
