Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site
* Proactively develops and executes recruitment plans that meet and exceed enrollment goals
* Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
* Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
* Attends investigator meetings
* Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines
* Accurately collects study data via source documents/progress notes as required by the protocol
* Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol
* Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials
* Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events
* Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants
* Dispenses study medication at the direction of the Investigator
* Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits
* Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor
* Addresses all queries or data clarifications within the time period specified by the sponsor
* Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in a timely manner during these visits