Hi,
Qualifications:
-- 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 shankar@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.
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