Scientist, Clinical Research - United States
Location: Summit, NJ
Duration: 6 Months
1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
4. Clinical study report preparation
5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
6. Review of clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from clinical perspective
7.Conduct review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
8. Participate and/or Lead team meetings as required
• Degree in life sciences
• Experience working on oncology or hematology clinical trials (multiple myeloma a plus), clinical monitoring experience preferred
• Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data. Ability 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
• Candidate should have direct experience working on clinical trials from a sponsor's perspective.
• at least two years in a CR&D capacity performing data review in oncology/hematology (note, this position is different in scope from a CRA position)
IN MANAGER's WORDS, the top 3 requirements are:
1. Clinical/Medical background
2. At least 2 years total years experience focused on Hematology/Oncology
3. Must be able to function independently in data cleaning (data analysis experience not needed)