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Study Director

By July 7, 2022No Comments
Nobile Life Sciences Logo

 

Nobile Life Sciences LogoNoble Life Sciences (Noble) is an award-winning small but rapidly growing business. A preclinical contract research organization (CRO), providing services in the fields of preclinical drug, vaccine, and medical device development and testing. Services offered range from early product discovery to GLP-compliant studies for regulatory submissions. The company offers integrated preclinical drug development services including cellular and animal disease model design and development, non-GLP and GLP efficacy, toxicity, biodistribution, and product release studies in a broad range of animal species.  

You can learn more about our company and our values at www.noblelifesci.com 

What’s in it for you: 

Noble Life Sciences is a fast-growing company, with a lot of personal and professional growth opportunities. We pride ourselves on having close-knit people who are leaders in the life sciences industry. We recognize top talents and provide pathways to prosperity for those willing to put in the work by ensuring we actively promote from within. If you are looking to grow personally and professionally, this is a great opportunity for you. We offer; 

  • Competitive pay
  • PTO and holiday pay
  • Health, Dental, and Vision insurance
  • Health savings account
  • Life and disability insurance
  • Matching 401K
  • Tuition reimbursement program

In this role you will: 

  1. Overall responsibility for the conduct of the assigned study as well as the interpretation, analysis, documentation, and reporting of results.
  2. Conducting the study in accordance with GLP regulations, the protocol, and Noble Life Sciences (NLS) SOPs.
  3. Defining: staffing, supplies, equipment, and space requirements for the study and assuring those test systems are as specified in the protocol.
  4. Notifying testing facility management which animal rooms and personnel will be required for the study.
  5. Preparing the study protocol and getting signed approval from the sponsor, testing facility manager, and pertinent subcontractors.
  6. Defining and coordinating subcontractor support requirements.
  7. Preparing IACUC documentation and submitting it to the IACUC committee for approval.
  8. Coordinating with the sponsor to establish the start and end dates of the study.
  9. Preparing an event schedule, documenting all critical events to occur during the study, and having the facility management sign an agreement.
  10. Notifying the quality assurance unit of the GLP-compliant study receipt and providing a copy of the protocol and schedule.
  11. Obtaining a study number from the master schedule.
  12. Review Noble Life Sciences SOPs to assure the SOPs are adequate to perform the study. If required prepare study-specific operating procedures required by the protocol and get them approved by the appropriate parties.
  13. Preparing a list of SOPs to be used in the execution of the protocol and reviewing the SOP with the assigned staff.
  14. Determine that the study staff is familiar with the protocol and competent to execute it according to GLP requirements and NLS SOP.
  15. Ensuring that all instruments and instrument supplies required for the study are available, operable, and within their calibration dates.
  16. Assuring that food bedding, glassware, and animals are ordered and received prior to the start of the study.
  17. Assuring that any changes made to the protocol after study initiation are documented, approved by the sponsor, and study personnel are informed of the change.
  18. Review all study data frequently during the study for accuracy and protocol and SOP compliance.
  19. Cooperating with the quality assurance unit as requested to assure a GLP-compliant study.
  20. Providing assistance to the quality assurance unit, if requested, in the audit and approval of subcontractors.
  21. Assuring that any unforeseen circumstances that may affect the integrity of the study are documented when they occur and reported to the QAU and testing facility management and ensuring the appropriate corrective action is taken and documented.
  22. Preparing and signing the final report in accordance with GLP regulations, the protocol, and NLS SOPs.
  23. Obtaining the sponsor’s representative and facility management signature on the QA audited final report and submit a copy of the final report to the sponsor.
  24. Assuring that the signed final report, protocol, raw data, and study specimens, as required by the GLP regulations, are transferred to the archives during or at the close of the study.
  25. Reporting to the testing facility management.

This is for you if … 

  • You care deeply about documenting processes, and you are diligent.
  • You pay attention to details, and you are very organized.
  • We called your past classmates/co-workers/supervisors, and they had attested that you are a great team player.

Ideally, we’d like to see: 

  1. MS or Ph.D. in Biological Sciences, Biomedical Sciences, or related sciences.
  2. The following is a plus but not required –
  • Nucleic Acid Isolation (DNA/RNA)
  • Mammalian Cell Culture
  • PCR, qPCR
  • Immunostaining of blood and tissue cells for flow cytometry assays
  • Comfortably work on processing animal blood and tissue specimens

Equal employment opportunity 

At Noble Life Sciences, we are passionate about diversity, equity, and inclusion. Our mission is to provide pathways to prosperity for those willing to put in the work. As such, we pride ourselves in being an equal opportunity employer and encourage applications from diverse backgrounds to apply. 

Salary Range:  

DOE 

Position Type 

Full time 

Where you will be working … 

On-site

Physical Requirements 

The physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to sit, use hands to handle or feel, and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl. The employee may frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. The work environment may consist of moderate noise (i.e business office computers, phones, printers, and light traffic). The employee must have the ability to work in a small cubicle and the ability to sit at a computer terminal for an extended period. 

Disclaimer 

The above statements are intended to describe the general nature and level of work being performed by individuals assigned this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. 

*** As a condition of employment with Noble Life Sciences, you are required to provide proof that you are fully vaccinated for Covid-19 or qualify for an exemption. Accordingly, employment is conditioned on providing proof of vaccination or having an approved exemption prior to starting employment. Noble Life Sciences provides reasonable accommodations consistent with legal requirements *** 

Qualified candidates interested in this opportunity should submit their resumes to careers@noblelifesci.com 

Thank you for your interest! We really look forward to hearing from you.  

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