Scientist 1 - Infectious Disease Research
SCIENTIST 1 - INFECTIOUS DISEASE RESEARCH
General Summary
The Scientist 1 is responsible for providing study support for execution of project work in the CRO Services Division, usually under the direction of a study director or senior study director. The position functions as a subject matter expert within the organization. Individuals in this role will aid in the conduct of studies, compiling and evaluating data, and assembling study files. Individual may function independently as a study director with appropriate experience. In the role of study director, has oversight of the scientific elements of projects to ensure successful completion and/or implementation, land analyzes and reports results for publication or to sponsors. Provides instruction to other members of the project team; and collaborates with other senior members of the staff on projects/research.
Key Responsibilities
- Performs the role of Scientific Subject Matter Expert (SME) on commercial and government contracts.
- Aids senior study directors or serves independently as study director on studies for commercial and government sponsors.
- Drafts protocols, amendments, and departmental notification; formats documents for correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
- Ensures that the protocol and/or scope of work is consistent with the contract.
- Identifies and incorporates exceptions to Good Laboratory Practices (GLP) conduct into GLP study protocols as applicable (e.g. systems/processes that are not validated).
- May create and maintain the study file (electronic) and/or study binders (hard copy).
- Distributes study protocols, amendments, and departmental notifications; prepares/reviews data collection systems/forms as needed; schedules and assists with conduct of pre-study meetings.
- Submits protocols, study records, and applicable data/reports to QA for review; manages and coordinates completion of audit responses under the direction of the study director.
- Reviews Standard Operating Procedures (SOP’s) associated with study conduct and incorporates language into the protocol describing procedures or processes when necessary.
- Reviews contract for use in execution of studies and proactively notifies study director or project manager of any issues.
- Observes appropriate safety and study requirements by reading, understanding, and following SOP, GLP requirements and study protocols.
- Performs review of Provantis study setups prior to study director review and approval.
- Participates in all required training.
- Follows GLP Practices to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
- Manages studies within time and budget constraints.
- Performs other duties as may be required by supervisor.
Requirements/Minimum Qualifications
- Ph.D. or equivalent (e.g. DVM) in life sciences discipline, or MS with at least two (2) years relevant experience, or BS with at least five (5) years relevant experience.
- Knowledge and ability to use the fundamental concepts, practices, and procedures of the particular field of specialization.
- Knowledgeable in or able to master GLP procedures/regulations and application of those guides to studies.
- Experience with viral diseases such as influenza, COVID-19, Dengue and Zika
- Deep understanding and experience with viral in vitro assays such as TCID50, viral propagation in cell culture, HA, HAI, plaque assay, FRNT, PRNT, MNT assays.
- Immunogenicity and efficacy testing in Animal models such as mice, ferrets, hamsters, monkeys
- Assessment of viral shedding and viral load in different organs by TCID50 and qRT-PCR
- Presentation and statistical analysis of data
- Effective written and verbal communication skills including correct grammar, spelling, and punctuation. Ability to communicate with stakeholders at all levels internally and externally to the organization.
- Proficient with software applications (Windows, Microsoft Word, Project, Excel or other database software).
- Highly detail oriented; possesses good planning, organization, task efficiency, and time management skills.
- Working knowledge of or the ability to learn and utilize specialty software applications (e.g., Edstrom, Provantis, laboratory information management systems, etc.).
- Ability to work in A/BSL- 2 & 3 environments.
- In compliance with federal mandates, effective December 8, 2021; Southern Research will require that all newly hired employees show proof of full COVID vaccination or authorized exemption prior to their start date.
Work Environment & Conditions
This position works in office and laboratory environments 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)
This position may require the ability to meet all entry requirements, including medical and vaccination requirements for work in both an ABSL-2 and ABSL-3 laboratory environment. Immunizations are required for this position and are determined by the study/agent. Some examples include Tetanus, Hepatitis B, Smallpox, Polio, and Influenza.