Immediate Need for Clinical Research Scientist - Seattle WA

[shankar prasad]

Hi,

We have an immediate Need for  Clinical Research Scientist with cellular Therapy Oncology Experience.  Please reply back with your resume if you are comfortable moving forward to sha...@sourceconsult.net or call 508-417-8385.

Location: Seattle WA

Duration: 6+ Months

• Review of clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from clinical perspective.
• Conduct review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
• 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 presentations or 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 protocols regulatory submission documents, etc.
• Participate and/or lead team meetings as required.

Qualifications:

• Candidate must have experience working on clinical trials as a Clinical Research Scientist from a sponsor's perspective.
• Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development, Clinical Science capacity.
• Must have experience performing data review in HEMATOLOGY/ONCOLOGY indications (note, this position is different in scope from a CRA position or clinical operations).
• Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.
• Ability to function independently in data review to identify discrepancies in clinical trial data and to write queries from a medical perspective.
• Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings) would demonstrate the candidate's familiarity with the scope of work.
• Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative
• Ability to communicate medical or clinical information to a physician.
• Ability to understand clinical trial publications and disease state(s) under investigation.
• Degree in life sciences.

Regards,

Shankar

Source Consulting

508-417-8385

sha...@sourceconsult.net

[shankar prasad]