Seattle Biomedical Research Institute (Seattle BioMed) was founded in 1976 and is the largest non-profit research institute in the United States focused solely on researching the world's most devastating infectious diseases, including malaria, HIV/AIDS, and tuberculosis. Our research is designed to be the foundation for new vaccines, drugs, and diagnostics that can prevent the suffering and death of 14 million, who die each year from these diseases. Seattle BioMed is on the cutting edge of infectious disease discovery research and is moving its research to translation. Our scientists are conducting experimental immunization studies for malaria and are moving into human trials with malaria vaccine candidates that have proven highly effective in initial animal studies. Three years ago, Seattle BioMed began development of the Malaria Clinical Trials Center (MCTC) as an innovative facility to integrate basic science and clinical research, uniquely focused on discovering and developing new interventions that could contribute to malaria eradication.
We are seeking a Clinical Trials Manager who will report to the Medical Director, and will lead the MCTC operations initially focused on early phase trials in healthy volunteers. This is a key position that is being established at a critical time as we are expanding our clinical trials.
The Clinical Trial Manager is accountable for the overall day to day operations of the Malaria Clinical Trials Center, including trial start up, conduct, and close out activities for specific studies, clinical participant visits, and staff/department management. This role is responsible for development of trial plans including site monitoring strategies, risk mitigation strategies, trial budgets, and clinical supplies management.
Primary responsibilities include:
Working with Clinical Trials Investigators and Project Managers to plan for execution of clinical trials.
Collaborating with the study team, cross functional team members, and external partners to establish long term relationships and ensure day to day outcomes.
Oversight of study start up process, including budget development and negotiations, development of staffing plans, scientific review committee submissions, IRB submissions, and other relevant regulatory submissions.
Assisting with drafting of materials e.g. informed consent documents, draft source documents, patient instruction guides, and case report forms. May write protocols. Assist in the development of marketing and advertisement materials.
Serving as primary clinical representative in managing protocol execution, with oversight. Management and oversight of the daily operations of the research clinic, including management of clinic staff. Partnering with staff members to ensure participant visits for all trials are well supported.
Establishing study milestones and ensuring accurate tracking and reporting of study metrics.
Ongoing management of clinical trial budgets and financial reporting and projections.
Ensure trial adherence to GCP, ICH, FDA regulations as well as local regulations, Institute specific SOP’s, and HIPAA and participant confidentiality requirements.
Communicate effectively with internal and external partners regarding ongoing study status, timelines, and MCTC services.
Oversight and assisting faculty with data analysis.
Seattle BioMed is looking for someone with clinic operations and staff management experience, who also has strong business and project management skills. The ideal candidate will have 7+ years of clinical research experience plus an advanced degree in Life Sciences or a bachelor’s degree with equivalent relevant experience. So CRA or ACRP certification is a plus. Clinical degree (ARNP, PA, RN) preferred but not required. Knowledge of ICH/GCP guidelines and FDA regulations is desirable.
Seattle Biomedical Research Institute - 2 years ago