SR. CLINICAL RESEARCH ASSOCIATE
Principia Biopharma is a clinical stage biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and inflammation. As such, we are comprised of a team of exceptionally talented scientists and business leaders. We are seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic and collaborative leader. The ideal candidate will contribute in a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department’s leadership and the willingness to grow in their responsibilities.
The Sr. CRA is responsible as the lead CRA on single or multiple center global clinical phase I to IV clinical studies to required quality standards.
• Extensive experience managing study sites, problem solving issues and providing resolution and performing clinical monitoring conducting pre-qualification, initiation, monitoring visits, and close-out visits and may perform co-monitoring visits with CRO personnel.
• Review monitoring reports for accuracy, completeness and conformance with CRO process and agreed upon study plan
• Designs and reviews study documents including, but not limited to, case report forms, site study procedure manuals and project tools, monitoring plans, tracking tools, and informed consent forms.
• Assists with design of clinical study protocols
• Maintain frequent contact with and work effectively with investigators and coordinators.
• Prepare and track required documentation from clinical sites and /or CRO.
• Provide guidance, clinical trial management expertise, and direction to contract CRAs in the field and in-house staff.
• Extensive experience with electronic EDC systems and EReview of clinical data and facilitates resolving clinical data and data management discrepancies with CRO and clinical sites
• Review clinical study reports for accuracy with tables, listings and figures and statistical analysis plan
• Assists with tracking CDAs, contracts and clinical timelines as well as appropriate performance metrics
• Extensive understanding and assurance of oversight and regulatory compliance of investigational sites with company SOPs, EMEA/FDA and ICH guidelines.
• Demonstrated experience in development of clinical documents in support of phase 1-4 clinical trials
• Experience in a lead CRA role leading clinical study efforts from start-up through close-out
• Demonstrated willingness to be hands-on and perform tasks within tight turnaround time
• Possessing excellent interpersonal and communication skills, with demonstrated leadership attributes
• Success working in a matrix environment
• Proficiency in and understanding of GCP, ICH, and EU regulations and guidelines
• Broad experience in data collection, monitoring, cleaning and analysis throughout Phase 1-4 clinical studies
• Proficiency in Microsoft Office (Word, Excel, Outlook), electronic TMF, and electronic clinical technologies
• Multi-task in a fast paced environment
• Build strong cooperative relationships with coworkers
• Write complex documentation without direct supervision
• Possess a high degree of attention to detail
• Previous employment at a pharmaceutical or biotech company or CRO preferred
• Bachelor’s Degree, Master’s Degree or higher in science, nursing, medical field, or business management. An Associate’s Degree/RN or equivalent with relevant years of experience is acceptable.
• A minimum of 5 years relevant experience with minimum 2 years in lead CRA role
• Superior written and spoken communication skills in English
• Ability to clearly communicate complex issues, observations and resolutions to management
• Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions
• Work on complex problems where the analysis of situations or data requires in-depth evaluation
• Work without close supervision both independently and as part of a team
• Proactively foresee and solve problems and commit to a high level of service
• Propose solutions and schedule all problem solving activities under indirect supervision in clear project plan with defined goals, decisions, and endpoints
Principia Biopharma, Inc. is an equal opportunity employer.