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 support for 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 samples.
• 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 participants.
• 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.
• Must be organized and have strong written and verbal communication skills.
• Candidate must be able and willing to support San Diego and Carlsbad collection centers.
• Candidate should have Clinical Research experience.