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Clinical Research Scientist
Ref No.: 19-09380
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Clinical Research Scientist in Summit, NJ with one of our top client.
 
Job Title: Clinical Research Scientist
Job Id: 19-09380
Location: Summit, NJ 07901
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • 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, andlaboratory 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 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 and/or Lead team meetings as required
Skills/Knowledge Required
  • 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 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; understanding of disease
  • Degree in life sciences
IN MANAGER's WORDS, the top 3 requirements are:
  • Clinical/Medical background and experience as a Clinical Research Scientist
  • Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development capacity
  • Must be able to function independently. 
Contact
Dayanand Barki
Direct: (732)-272-0326 | Email: dayanand.b@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com