Clinical Research Scientist Oncology Posted February 1, 2008 Seven years of experience

JOB DESCRIPTION: Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Clinical study report preparation Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc. Participate in Development Planning for assigned compounds. Oversee and challenges the adequacy of planning for study implementation In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety) Collaborates and supports operational activities as need be. Assist in establishing project budgets Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data. Participate and present at investigator meetings Participate in adhoc meetings  (e.g. marketing) Assist in document template design and SOP writing Participate on various corporate committees Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required Lead team meetings as required JOB REQUIREMENTS: Advanced Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), minimum 7 years experience in clinical research development or equivalent Minimum 2 yrs. experience in medical or technical writing Clinical monitoring experience preferred Excellent written and verbal communication skills and interpersonal skills.  Must be able to relate effectively to people at all levels of the organization. Extensive medical/scientific and clinical research knowledge Knowledge of Medical Terminology Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics Proficient at data interpretation Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions Experience in all aspects of the drug development process Knowledge of GCP and ICH Guidelines Experience in presenting at Investigator Meetings Detail-oriented, well-organized Limited travel required Ability to assimilate technical and scientific information quickly Clinical project management skills Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus Demonstrated ability to work as part of a team High level of interpersonal and communication skills (written and verbal)