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Principal Scientist
Ref No.: 18-02175
Location: Raritan, New Jersey
Start Date / End Date: 04/23/2018 to 10/18/2019
Education
Degree Type Major/Certification Required Preferred
Bachelor's Degree active
Master's degree active
PhD/MD

Job Description & Requirements
Job Type: Recruited Resource - Project-Based Temp Number of Positions: 1
System Location: - 6118 Created Date: 3/28/2018
Job Title: Principal Scientist
CWR Type: W-2 Reason: New Position

Qualifications:
CLINICAL RESEARCH SCIENTIST/TESTING. SEE ATTACHED JOB DESCRIPTION FOR DETAILS. 3 or more years of clinical laboratory or R&D experience preferred. Previous experience in clinical research or equivalent experience in project management preferred.

Responsibilities:
CLINICAL RESEARCH SCIENTIST/TESTING. SEE ATTACHED JOB DESCRIPTION FOR DETAILS.

Comments/Special Instructions
Per today's conference call, this requisition is replacing Job 2649. Please pay special attention to the attached Job Description. Candidates with significant US experience preferred.


Attached Documentation:
Position Description
Clinical Research Scientist/Testing

Under supervision of the Project Lead, plans and executes clinical studies of varying complexity in support of FDA 510k, PMA and BLA submissions and international registrations.

RESPONSIBILITIES:
  • Prepares/assists in preparation of clinical study protocols and related documents.
  • Works within US and international regulatory guidelines and GCP.
  • Designs clinical study forms and manages version control.
  • Conducts investigator site and vendor qualifications for participation in sample collection and IVD testing protocols.
  • Identifies and selects Principal Investigators and clinical study sites.
  • Assists in preparation of clinical study agreements and clinical site budgets.
  • Monitors site costs and coordinates site payments.
  • Develops site management and monitoring plans and participates in clinical study implementation.
  • Prepares training documents, regulatory documents, data collection tools and study materials.
  • Assists Data Management in the creation, updating and validation of clinical study databases based on project specific guidelines.
  • Assist Data Management in the review, cleaning and auditing of clinical data following SOPS and regulatory agency guidelines.
  • Trains Principal Investigators, study sites, CROs and vendors to assure GCP compliance and understanding.
  • Participates in clinical study execution and study materials management.
  • Reviews and monitors diagnostic testing data as received. Identifies, tracks and resolves data issues.
  • Conducts periodic onsite monitoring of clinical sites to ensure protocol adherence, data integrity and regulatory compliance.
  • Prepares/assists in preparation and maintenance of the trial master file.
  • Assist in the review of data summaries.
  • Assists in the preparation of clinical summaries and reports.

Qualifications

  • Bachelor or higher degree required in a Biological science (medical technology, clinical laboratory science, microbiology, infectious diseases, immunology, biochemistry, or closely related science).
  • Three or more years of clinical laboratory or R&D experience preferred. Previous experience in clinical research or equivalent experience in project management preferred.
  • Must be willing to periodically work with potentially biohazardous materials in an approved safe manner and to work in biohazardous environments, utilizing appropriate PPE.
  • Must be able to work both independently and within a cross-functional team environment.
  • Must be skilled in common computer programs, e.g., word processing, graphics, spreadsheets.

Travel up to 30% on an annual basis.
Work Location: 1001 US Highway 202 USRAR, Raritan, NJ 08869 United States
Start Date: 4/23/2018 Work Days:
Sun Mon Tue Wed Thu Fri Sat
End Date: 10/18/2019
Start Time: 8:00 AM Total Reg Hours: 40.00
End Time: 5:00 PM Overtime Required:
Lunch Time: 1 Hour