SPARK SOLUTIONS WHAT YOU LOVE
We love being purpose-driven. We are eager to make significant contributions that directly improve quality of life. We love providing opportunities for our employees to grow and ensuring they maintain a good work/life balance. We celebrate all types of problem solving. We thrive when we act as a catalyst for change in all areas that we serve in their respective communities.WHAT YOU DO WELL
We are cultivating Birmingham's biotech scene with first-rate talent through cutting-edge science. We are great at translating research into innovation that impacts our world. We are smart, creative people always looking for a better way forward. We are excellent collaborators making our partnerships seamless. We are more boutique than our competition because of our deep expertise and agility.WHAT THE WORLD NEEDS
People need both academic and CRO (contract research organization) because they need more than basic lab-for-hire services. They need both the guidance and knowledge base to help move their projects forward and to find answers where they currently do not exist. More end users, specifically Alabamians, need to trust the research and innovations being made in biotech.
Come help Southern Research "Move Science" as aSCIENTIST 2 TOXICOLOGYGeneral Summary
The Scientist 2 serves as Study Director and Subject Matter Expert on commercial and government contracts. Individuals in this role will work independently on studies; compiling and evaluating data, assembling study files and reports. A Scientist 2 will have experience in in vivo studies and will be competent in the execution and monitoring of GLP regulations as applied to various projects as well as monitoring project work for timely completion, deliverable tracking, budget maintenance, and quality standards. Provides coverage for client-facing activities and communications. A Scientist 2 will work closely with assigned project team members and related management for studies. A Scientist 2 is fully trained in the position's key responsibilities as it applies to work areas and may require training on new processes as they arise. May provide training to others as necessary, to conduct similar project execution.Essential Duties & Responsibilities
- Drafts protocols, amendments, and departmental notifications for projects; formats documents for correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
- May create and maintain the study file (electronic) and/or study binders (hard copy).
- May create and maintain the ACUP and BPR as needed.
- Distributes study protocols, amendments, and departmental notifications; prepares/reviews data collection systems/forms as needed; schedules and conducts pre-study meetings.
- Ensures that the protocol and/or scope of work reflects the contract.
- Identifies and incorporates exceptions to GLP conduct into GLP study protocols as applicable (e.g., systems/processes that are not validated).
- Submits protocols, study records, and applicable data/reports to QA for review; manages and coordinates completion of audit responses.
- Completes review of Standard Operating Procedures (SOP) associated with study conduct and incorporates appropriate language into the protocol when necessary to provide detail on procedures not included.
- Reviews contract for use in execution of studies and proactively notifies Study Director or Project Manager of any issues.
- Sets up or requests the creation of Provantis study files for applicable studies.
- Performs review of Provantis study setups prior to providing Study Director approval for use.
- Knowledgeable of GLP procedures/regulations and application of those guides to either in vitro or in vivo studies.
- Works closely with the scheduling staff and department leadership to ensure project work is scheduled appropriately to meet customer timelines.
- Collaborates with project team members and related management to support study execution.
- Submits requisitions as necessary.
- Communicates and approves purchase requisitions as necessary.
- Provides coverage for client-facing activities.
- Performs/documents study inspections and presents findings as applicable.
- Prepares or reviews data for processing and reporting; ensures quality control is performed and corrections are made in accordance with deadlines.
- Reviews software programs, forms, and/or data for missing, inaccurate, or improbable results and for adherence to regulatory and/or client requirements; may aid in resolving data collection problems as needed.
- Assists in preparation of study report or contributing scientist reports.
- Assists in the training of others as applicable.
- Authors, updates, and/or reviews area-specific Standard Operating Procedures (SOP), ensuring that SOP reflect current practices.
- May be asked to serve as System Administrator, assist on validation teams, ad hoc committees, represent at internal meetings, or contact sponsors regarding study specific issues.
- Performs other duties as may be required by the supervisor or management.
Work Environment & Conditions
- PhD in life sciences discipline or Master's degree in life sciences with 6 years' prior experience or Bachelor's degree in life sciences with 10 year's prior experience.
- Ability to coordinate the work of others to meet project objectives and deadlines.
- Ability to interact with others in a cooperative, persuasive, and tactful manner.
- Ability to read, understand, retain, and apply knowledge of Good Laboratory Practices (GLP) and other study requirements.
- Demonstrated work experience in a GLP-compliant environment.
- Demonstrated proficiency with Provantis software and the ability to utilize additional specialty software applications as necessary.
- Proficient with software applications (Windows, Microsoft Word, Microsoft Project, Microsoft Excel, or other database software).
- Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
- Highly detail oriented; possesses good planning, organization, task efficiency, and time management skills.
- Ability to conduct and manage meetings/trainings effectively.
- Working knowledge of or the ability to learn and utilize specialty software applications (e.g., Edstrom, laboratory information management systems, etc.)
- Must be eligible to work in the United States without employer sponsorship.
This position is in a laboratory environment, including BSL-3, and requires the use of personal protective equipment (PPE) including (but not limited to):
- Eye protection (Safety glasses and/or full-face shield)
- Respirator (varies based on tasks and barrier requirements)
- Tyvek/scrub suits
- Nitrile (or equivalent) gloves (varies based on tasks)
- Hearing protection (varies based on tasks)
Immunizations are required for this position and are determined by the study/agent. Some examples include Tetanus, Hepatitis B, Smallpox, Polio, and Influenza. Physical Demands
This position requires the following physical abilities including (but not limited to):
- Performing work with utilizing a computer for extended periods of time.
- Sitting for extended periods of time without being able to leave the work area.
- Standing for extended periods of time without being able to leave the work area.