Job Summary

Serve as a scientist in the conduct of assigned nonclinical or clinical research studies of moderate to high complexity, to include study management, interpretation, and reporting of study data, and assuring the regulatory compliance of these projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

• Efficiently perform and document all procedures, materials, and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.).
• Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data.
• Independently execute the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues.
• Independently develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area. 
• Develop and maintain critical thinking, troubleshooting, and time management skills aligned with needs of operational areas.
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team. 
• Able to recognize method and/or data issues and communicate them to management to minimize study impact independently.
• Independently prepare summary of method development data. 
• Independently execute review and approval of data for final scientific/technical decisions within a single operational area.
• Full understanding of compliance expectations to independently respond to quality assurance audit observations in appropriate software. 
• Responsible for writing and preparing study plans/protocols/amendments/reports independently. 
• Independently participate in sponsor visits/tours. 
• Independently function as liaison, maintaining timely and frequent communication between CRL and sponsor/client/SD. 
• Independently ensure scientific integrity of studies. 
• Independently function as a Principal Investigator, Individual Scientist, and/or Study Director as assigned.
• Independently write, review, and approve deviations.
• Full understanding of regulatory and GLP requirements, industry standards, and company SOPs with the ability to mentor others within one operational area. 
• Independently manage a portfolio of projects, including method development and validation studies while ensuring timelines are met in a single operational area. 
• Provide support to staff members as required by operational areas, as needed. 
• Lead internal process improvements, presentations, and harmonization efforts.
• Attend scientific meetings, conferences, and training courses to enhance job and professional skills.
• Perform all other related duties as assigned.

The pay range for this position is 110-115K. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

• Education: Associate’s degree (A.A./A.S.) or equivalent from a two-year college, preferred. Bachelor's degree (B.A./B.S.) or equivalent in a scientific related discipline, recommended. Related Master's degree (M.A./M.S.) or Ph.D./D.V.M., strongly recommended.
• Experience:  Minimum of 11 to 14 years related experience in the contract research, academic, or pharmaceutical industry.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Other:  Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.

PHYSICAL DEMANDS:

• Must be able to lift, move, manipulate and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies.
• Must be able to perform procedures, standing or sitting, for long periods of time, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
• Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.
• Must be able to regularly provide information to and receive information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.
• Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• Move about inside the work area to access file cabinets, office machinery, etc.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT:

• General office and lab working conditions, the noise level in the work environment is usually quiet.
• While performing the duties of this job the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, and work with biohazards.
• The employee may occasionally be exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.
• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperature conditions.
• The noise level in the work environment ranges from low to moderate depending upon the task being performed.