Job Details

  • Title: Scientist, Clinical Research - NJ
  • Code: RCI-9881
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 10/16/2020
  • Duration: 6 Months
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  Job Description

Description:

 

Must be local to have the ability to go onsite when allowed

 

Responsibilities will include, but are not limited to, the following:

 

  • Assist the Clinical Research Scientist team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
  • Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
  • Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
  • Assist with Study Start up Activities and data base build
  • Participate or lead in Scientific meetings (ie Ad-Board, Steering Committee, Data Monitoring Committee)

 

Skills/Knowledge Required:

  • Minimum 6 yrs. experience in oncology/hematology clinical development
  • Excellent written and verbal communication skills and interpersonal skills.
  • Knowledge of clinical trial design, basic statistics, and data review tools
  • Proficient at data interpretation
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
  • Full understanding GCP and ICH Guidelines
  • Detail-oriented, well-organized
  • Ability to assimilate technical and scientific information quickly
  • Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave)
  • Demonstrated ability to work as part of a team
  • Hematology experience (plus).
  • Protocol authoring (preferred).
  • Data review and medical monitoring of data (required).

 

Qualifications:

  • Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field),
  • Minimum 5 years’ experience in clinical research development or equivalent

 

Strong collaboration with cross functional team members

  • Scheduling and facilitating protocol review meetings.
  • Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
  • Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
  • Participate in adhoc meetings
  • Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
  • Participate in Development Planning for assigned compounds.
  • Oversee and challenges the adequacy of planning for study implementation
  • In collaboration with the project physician, directs the planning and implementation of din programs to meet corporate and clinical research goals
    • - Assist Clinical Research Physician to make recommendations, take action and provide clinic research expertise related to projects
    • - Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
    • - Collaborates and supports operational activities as need be.
    • - Assist in establishing project budgets
    • - Assist with review of ongoing summary hematology/oncology data including: safety, prima efficacy variables, and laboratory data.
    • -Work directly into the clinical database to post and resolve queries with the sites.

KNOWLEDGE/SKILLS/ABILITIES MA's):

  • Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field),
  • Minimum 5 years’ experience in clinical research development or equivalent
  • Protocol writing experience is required.
  • Minimum 2 yrs experience in oncology/hematology clinical development
  • Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
  • Experience with electronic data bases (EDC, RAVE, JReview etc)
  • Knowledge of clinical trial design, basic statistics, and data review tools
  • Proficient at data interpretation
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
  • Full understanding GCP and ICH Guidelines
  • Detail-oriented, well-organized
  • Ability to assimilate technical and scientific information quickly
  • Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus),
  • Demonstrated ability to work as part of a team