To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02858

About our client Our client is a specialty drug development company based in San Francisco. They focus on reformulating old drugs that are already on the market. They improve drug candidates using modern technology of drug delivery or formulation. The company has an experienced CEO and board, an exciting product candidate and a team that is committed to the highest standards of integrity and to improving the lives of patients and their families. Position Location Senior Clinical Research Associate (Home-Based) USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Conduct study qualification, initiation, interim monitoring and closeout visits for the assigned clinical sites 2) Communicate with clinical sites to ensure adherence to protocol and regulatory guidelines as well as to maximize study enrollment and resolve problems 3) Complete clinical site monitoring according to established guidelines 4) Review Case Report Forms for clarity and consistency with source documents 5) Review and ensure maintenance of site regulatory files 6) Ensure that records of study test article inventory are maintained accurately 7) Complete and submit monitoring reports 8) Manage performance problems and provide re-training of clinical sites (as necessary) 9) Participate in client meetings (as necessary) 10) Maintain thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines 11) Provide leadership to the CRA Team 12) Participate in protocol reviewing and CRF development 13) Mentor new hires and junior CRA staff 14) Manage CROs Requirements 1) RN, BSN or Bachelor’s degree in Math, Science, or a related field (Master’s degree in a related field preferred) 2) 3 – 5 years of experience in clinical site monitoring with pharmaceutical trial experience 3) Good written and verbal communication skills with excellent organizational skills 4) Superb understanding of medical terminology 5) Self-motivated and flexible 6) Proficiency in Microsoft Word, PowerPoint and Excel 7) Willingness to travel – up to 50%