Clinical Research Coordinator

Details for the position are as follows: Rate: $30-35 an hour Location: San Diego, CA 6 month contract to start with the possibility of extension or conversion depending on performance. Job Description: Conducts and coordinates tasks involved with the execution of the in-house clinical research projects in accordance with the clinical protocol, Clinical Affairs Donation Center SOPs/WIs, GCP guidelines and all applicable regulations governing the conduct of human subject research Maintains subject confidentiality and ensures PHI of all subjects are accurately and securely maintained in accordance to HIPAA privacy and security rules. Informs and updates subjects, and potential subjects, regarding study aspects and outcomes to be expected; ensures the proper tracking of study volunteers and documentation of all study procedures; ensures confidentiality in all aspects of clinical research.

Reviews and processes product complaints and adverse events as soon as they are reported. Contributes to the development and execution of informed consent documents, subject recruitment materials and supports the overall management of subject data and files. Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits of in-house activities Reviews and analyzes data and documents for accuracy and completeness.

Creates and processes data queries Provides laboratory supports the ARDx Sample Bank including receipt and storage of human specimens, cold-storage maintenance; equipment management, Clinical IP accountability and shipments; sample management and shipments. Under Clinical Trial Manager leadership, provides clinical monitoring and auditing support for Clinical Affairs' external studies / sites. Including site initiations, interim monitoring, closeout, and end of study audits.

Prepares and assembles materials for IRB submissions; ensures compliance in day to day management of site activities. Comfortable handling tissue that may include pathological Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships Required Skills: Must be a licensed phlebotomist, and able to collect blood samples from study participant. Must also be able to collect urine, oral fluid and other sample collections.

Must have direct patient / subject experience in a medical and or clinical setting 3. Must be organized and have strong written and verbal communication skills 4 Candidate must be able and willing to support San Diego and Carlsbad collection centers Candidate should have Clinical Research experience