Utilizes established methodologies to collect patient information for the research project(s); gathers and compiles data, statistics and other materials as needed. Inputs clinical and non-clinical data into the database and or case report forms. Extracts data for publications, or provides data collection from outside physicians offices. May perform library searches and retrieve reference materials from various sources; request articles from medical journals.
Ensures protocol compliance. Follows standard steps regarding eligibility criteria, follow-up process and documentation.
Compiles data and assists in consolidating and analyzing data for presentation to sponsoring and regulatory agencies. Reviews data with supervisor and then provides reports to all parties (e.g., data and safety monitoring committee, the principal investigator, sponsoring agency, etc.) on the progress of the study.
Recruits and the screens of potential patients/subjects for eligibility to the study.
Interacts with patient/subject and families in a courteous and professional manner. Collaborates with various personnel that may be involved in assisting with specific aspects in the study.
Demonstrate knowledge of policies and procedures of the host institution where the study is being conducted, including the regulatory requirements such as IRB and other approvals if necessary.
Acts as an internal auditor during quarterly internal audits for other studies, is aware of study regulatory status and keeps an up to date copy of regulatory documents.
Initiates and continues regular contact with patients; encourages visit reminders and compliance to research; ensures contact with patients and their families is courteous, effective, professional and cooperative.
Gathers, Properly Packages, Stores and Transfers Slides, Samples and Other Important Materials. Coordinates the shipment and transfer of varied types of materials among the various departments and labs.
May complete assessments on study subjects/patients per protocol (with proper training); continue to follow-through with items and patients as part of research study. May (if proper training has occurred) draw patients/subjects blood, perform EKG, and or take vital signs. May be required to travel to study initiation (that is, where sponsor teaches protocol to PI and CRC).