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12 days old

Clinical Research Scientist

Kelly Services
Summit, NJ 07901
+ Job Title: Clinical Research Scientist

+ Location: Open to 100% Remote

+ Duration: 6+ months

+ Rate: $55-65/hr


**MUST HAVE:**

Experience as a Clinical Research Scientist (not laboratory or bench science!) in the pharmaceutical industry

Clinical/Medical background and solid experience performing data review within EDC systems and using tools like jReview, Spotfire, etc.

Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development capacity, experience in CAR T Cell Therapy , Lymphoma or Multiple Myeloma a PLUS.


**Job Description:**

1. Review of clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from clinical perspective

2. Conduct review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.

3. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.

4. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.

5. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).

6. Clinical study report preparation

7. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.

8. Participate and/or Lead team meetings as required


**Skills/Knowledge Required**

1. Candidate must have experience working on clinical trials as a Clinical Research Scientist from a sponsor's perspective in the pharmaceutical industry.

2. Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development, Clinical Science capacity

3. Must have experience performing data review in HEMATOLOGY/ONCOLOGY indications, CAR T Cell Therapy and/or Multiple Myeloma experience a plus (note, this position is different in scope from a CRA position or clinical operations)

4. Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.

5. Ability to function independently in data review to identify discrepancies in clinical trial data and to write queries from a medical perspective.

6. Familiarity with Medidata, RAVE, J-review, Spotfire or other clinical databases or other data review tools (patient profiles, listings) would demonstrate the candidate's familiarity with the scope of work.

7. Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative

8. Ability to communicate medical or clinical information to a physician.

9. Ability to understand clinical trial publications; understanding of disease

10. Degree in life sciences


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-06 Expires: 2021-10-07

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Clinical Research Scientist

Kelly Services
Summit, NJ 07901

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