Project Coordinator Job in Ellicott City, Maryland US
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. In a highly fragmented industry, we are one of a small group of organizations with the capability and expertise to conduct clinical trials and development projects on either a local or global basis. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated "full service" solution.
The successful candidate will be responsible for planning and coordinating assigned single service stand alone projects to ensure integration, coordination and consistency of processes throughout the project life-cycle.
- Ensure all budgetary requirements, study timeframes and targets are met for assigned projects.
- Provide project document management support to cross-functional teams by assisting in the administration, archive and tracking of essential documents of assigned projects.
- Assist in quality control audits of clinical study and project documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.)
- Set up, organize, track and maintain clinical study and project documentation both hardcopy and electronic (e.g. Main Study Files, CRFs, etc.) including document receipt and review, scanning and indexing, quality control, copying, filing, preparation for internal/external audits, final reconciliation and archival.
- Provide support to the Project Management Department and assistance to Project Manager(s) in completion of all required tasks to meet departmental and project goals as it relates to project document management requirements.
- Travel (approximately 10%) domestic and/or international.
- Minimum BA/BS in the life sciences, nursing or related field, a minimum of one year of field monitoring experience or relevant clinical experience.
- Minimum of one year experience in the administration of Clinical Trials in a CRO environment or equivalent and/or one year project management training and comprehensive understanding of project management principles and applications.
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
- Attention to detail, strong oral and written communication skills, customer service skills and advanced computer and computer application skills (Microsoft Office skills including Microsoft Project or similar scheduling tool).
Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive compensation and an exceptional benefits package that includes: Medical, Dental, and Vision Insurance, Flexible Spending Accounts, Short Term and Long Term Disability, Life and ADD Insurance, 401K Plan with matching contributions, a generous program of Vacation, Holidays and Personal Time Off and more.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.