San Francisco, California | Contract
Duties: The successful candidate will have the skills necessary to thrive in a dynamic and growing company environment, as he/she assists Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Particularly important skills include flexibility; logical thinking; ability to prioritize day-to-day and critical tasks; willingness to adapt quickly to changing business conditions and learn new skills; interpersonal and team building skills.
Essential Duties & Responsibilities
May be responsible for independently managing the full scope of study conduct (start-up through database lock) and coordinating cross-functional efforts to achieve study objectives and goals; Assist/or drive managing defined aspects of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines; Perform the activities associated with the implementation, management, and monitoring of clinical trials, including monitoring report and Informed Consent Form review, as defined in the Monitoring Plan; Assist in the preparation of clinical study reports, annual reports, IND updates, etc; Work with Medical Monitor and to train investigators and investigative site staff and manage clinical supplies; Identify and communicate study issues that will impact budget, resources and timelines; Review and critique CRF for accuracy and completeness. Oversee data discrepancy management and assist with mapping as needed; Make recommendation on appropriate study vendor(s) to Director or CPM and independently manage vendor(s) to achieve project goals; Partner with business operations to ensure vendor agreements, change orders and site budgets meet clinical operations specifications; May be responsible for review of invoices for accuracy compared to work known to be performed by the vendor, may be done under the guidance of a senior clinical operations team member; Contribute to wider organizational goals; Other duties as assigned.
Skills: Core Competencies, Knowledge and Skill Requirements
Knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials; Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems; Must be self-motivating and be able to follow directions precisely, prioritize and manage a large volume of work, and show attention to detail; Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.
Communication & Interpersonal Skills
Excellent verbal and written communication skills; Ability to effectively collaborate in a dynamic environment; Must be able to write clearly and summarize information effectively.
Interacts with employees;
Site personnel (e.g., Principal Investigators, Study Coordinators); Manage study vendors, as needed.
Education: Education: BS/BA in Life Science or related discipline
Experience: 8+ years’ industry experience in drug development, including prior site monitoring experience. Previous line management experience or extensive mentorship experience. Licenses or Certifications: Clinical Research certification preferred, but not required.
DESIRED BACKGROUND AND EXPERIENCE
PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint);
Phase III Oncology or Urology experience preferred but not required; Global trial and CRO management experience is preferred.