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.
- 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
- 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