CRA - San Francisco

<p><br />At Medix we are extremely dedicated to our candidates, providing them with the best advice, support and direction during their job search.&nbsp;We work with all of our candidates personally to understand their skills and aspirations and best match them with opportunities that fit their goals. As we place contract, contract-to-hire and direct hire employment plans, we offer the flexibility to accommodate your schedule and needs.&nbsp;</p>

San Francisco, CA

Medix - Clinical Research

<h3>Launched in 2001, Medix was built on the principle of becoming a leading provider of workforce solutions for clients and candidates across the Healthcare, Scientific and Information Technology industries.&nbsp;As we grow and evolve, we recognize our differentiation lies not just in traditional staffing, but in true partnerships and collaboration on hiring solutions. We bring value to our talent by helping them identify their individual skills and aptitudes, matching them with opportunities to excel and creating communities where they can foster their skills and always have a trusted partner in their career.&nbsp;In supporting our clients, we understand that each organization and culture is unique, and we thrive in collaborating with our clients to provide innovative solutions to suit their specific needs.</h3>

keywords: relationships,teamwork,success,support,management,administration,communication,reporting,degree,experience,research,knowledge



Overview: <ul> <li>Key to the success of this effort will be the conduct of single- and multi-center clinical trials. Conduct early phase investigator-initiated trials as well as partner with biotech and pharmaceutical companies on industry-sponsored trials.</li> <li>The CRA is responsible for providing support to the Clinical Development management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites.</li> <li>This position will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.</li> <li>This person is able and willing to perform all duties or functions of subordinates.&nbsp;</li> </ul>
Responsibilities: <ul> <li>Performs general administrative functions such as clinical trial tracking, providing logistical support to one or more of the Clinical Development management teams, scheduling meetings and/or travel arrangements for clinical staff, requesting proposals/contracts from CROs, tracking and managing distribution of non-clinical supplies throughout the course of the&nbsp; &nbsp;study</li> <li>Tracks and maintains study information and reports on study progress</li> <li>Tracks and provides IRB/IEC submission documentation and other supplementary documentation&nbsp; as appropriate</li> <li>TMF Management: Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements</li> </ul>
Requirements: <ul> <li>A&nbsp; Bachelor degree&nbsp; is required</li> <li>2+ years of experience, or extended education in clinical research/drug development</li> <li>Familiar with concepts of clinical research and able to work effectively in a team &nbsp;environment</li> <li>Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/lCH guidelines, is required</li> <li></li> </ul>