Clinical Scientist

TSR Consulting Services provides best in class staffing solutions to clients nationwide, by staying true to our relentless focus of exceeding the highest professional IT service business standards. Today, as a NASDAQ company specializing in IT consulting and staff augmentation, TSR continues to expand and transform its services to meet and anticipate its client’s and candidate’s’ needs. For more than 53 years, TSR's has been a  leader in the industry because of our expertise and knowledge of the job market, our compassion and caring of our clients and consultants and our work environment of respect and inclusion. Your career is in good hands with TSR because at the end of the day, if YOU THRIVE, WE THRIVE.

Our client, a leading Pharmaceutical company is hiring a  Clinical Research Scientist on a  contracting basis.

Work Location: Summit NJ

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, 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 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.
  
   

Required skills:

 

• 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.