Senior Clinical Research Associate
This position works directly with the Clinical Trial Manager and Senior Medical Director to coordinate research and administrative strategies for the management of clinical trial research. Major responsibilities: Collaboration in development, organization, implementation and completion of clinical studies. May act as a mentor to junior personnel.
Essential Functions of the Position:
- Supervise collection of regulatory documents from clinical sites;
- Develop and procure study materials and distribute to sites;
- Assist in development and review of protocols;
- Manage the conduct of clinical studies, and the interaction with CROs and other outside vendors;
- Assess adequacy of clinical sites for study participation;
- Monitor clinical sites;
- Support tracking of study related timelines and budgets;
- Communicate with internal departments as needed, including attending program meetings and following up on action items;
- Plan, coordinate, prepare presentation materials and present information at Investigator meetings;
- Assist in development of departmental SOPs, personnel and training programs;
- Review study data and resolution of queries;
- Delegate work appropriately to other departmental personnel.
- Bachelor Degree in a scientific discipline, or commensurate experience within a scientific/medical field (medical technician, nursing, pharmacy, physician assistant);
- Minimum of 3 years of experience in clinical development/clinical trials in the pharmaceutical/biotechnology industry or CRO;
- Thorough knowledge of FDA regulations and ICH guidelines;
- Working knowledge of medical and scientific terminology;
- Able to travel as required by projects (< 50%);
- Demonstrated ability to handle multiple projects and meet timelines in a dynamic workplace environment;
- Demonstrated ability to work in a team environment;
- Excellent verbal and written communication skills;
- Excellent organizational skills;
- Excellent interpersonal skills;
- Attention to detail;
- PC skills including advanced MS Word, PowerPoint, and Excel;
- Experience with Documentum (a plus);
- CCRA certification (a plus).
Corus Pharma is a growing pharmaceutical company developing drugs to treat unmet needs in respiratory and infectious diseases. We are located in the heart of downtown Seattle, just one block from the historic Pike Place Market. We offer competitive compensation and health benefits, casual work environment, 401(k), stock options, and a health club subsidy.
For more information check out our website at www.coruspharma.com. Qualified candidates may apply directly at:
Corus Pharma, Inc.
Reference Job Code: 200410
Corus Pharma, Inc. is an Equal Opportunity Employer