Preclinical Research Specialist, Pulmonary Research

Preclinical Research Specialist, Pulmonary Research

General Summary

The Preclinical Research Specialist is responsible for providing study support for execution of project work in the CRO Services Division, under the direction of the Director of Translational Pulmonary Research. The position functions as a subject matter expert within the organization. Individuals in this role will aid in the conduct of studies by employing a broad knowledge of principles, practices and procedures in a particular field of translational pulmonary research, compiling and evaluating data, and assembling study files. Individuals may function independently as a study director for nonregulated studies with appropriate experience. In the role of study director, has oversight of the scientific elements of projects to ensure successful completion and/or implementation, and analyzes and reports results for publication or to sponsors. Provides training to other members of the project team; and collaborates with other senior members of the staff on projects/research.

Essential Duties & Responsibilities

• Performs the role of Scientific Subject Matter Expert (SME) on cystic fibrosis and non-cystic fibrosis commercial and government contracts.
• Aids study directors or may serve independently as study director on nonregulated studies for commercial and government sponsors.
• Works in collaboration with academic partners on the execution of cystic fibrosis grants.
• Drafts protocols, amendments, and departmental notification; formats documents for correct grammar, punctuation, consistency in format and style, and adherence Adato 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).
• Participates in all required GLP, BSL-3, and select agent training as required.
• 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 as required.
• 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.
• Contributions to grant proposals, participated in budgeting for external contracts, experimental plans in Service Agreements, and work on manuscripts for IND package and scientific journal publications as needed.
• Contribute to the development of research programs based on an understanding of the pathophysiology of disease and mechanism of action of biotherapeutics. 
• Contribute execution and interpretation of pulmonary in-vivo studies, for the evaluation and characterization of new biotherapeutics. 
• Coordinate day-to-day execution/oversight of internal/external research studies for multiple programs, ensuring performance, timeliness, and integrity of data.
• Utilize PET/CT for novel therapeutic validation.
• Perform a variety of in vitro/ex-vivo methods such as IHC, ISC, IF, ALI, and flow cytometry.
• Train and work closely with the scientific and in-vivo staff to ensure alignment with corporate/partnering needs. 
• Perform care and maintenance of laboratory equipment, following SOPs and procedures.
• Participates in all required training.
• Follows applicable regulatory standards to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
• Performs all work tasks following laboratory safety requirements including A/BSL-3 and select agent, if applicable.
• Performs other duties as may be required by supervisor.

Requirements/Minimum Qualifications

• BS with 3-5 years relevant experience, or AS with at least five (5) years relevant experience.
• Knowledge and ability to use the basic concepts, practices, and procedures of specialization.
• Prior experience in oversight of GMP regulations for administration of mRNA or gene therapy drugs to animal models
• 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.

Preferred Qualifications

• M.S in Biology or equivalent in life sciences discipline

Core Values

Cultivating human connection – putting people first.  We know that every individual makes a difference and that no one can do it alone.  We believe the world's most powerful resource is human potential.  We are an inclusive and courageous team where innovation and diversity of thought go hand in hand.  We understand that relationships move at the speed of trust.

Operating with precise execution – measuring what matters and owning results as a team.  We leverage data to drive decisions that advance science.  We recognize the importance of a stable foundation coupled with an agile mindset.  We hold ourselves accountable and take pride in our work.  We give and receive candid feedback as a gift that keeps us growing.

Harnessing relentless curiosity – our unstoppable, innovative force.  We are driven to ask sharp questions and push the boundaries of knowledge.  We use creativity and critical thinking as catalysts for finding solutions that change lives.  We learn by doing, consistently striving to improve our relationships, training, methodologies, questions, and results.

Stewarding a healthy community – implementing sustainable operations for a safe, engaging environment.  We don't compromise on safety and health for our employees, customers, or community.  We believe a healthy community begins with inclusive economic opportunities.  We respect the dignity of the patients we ultimately serve.  We are motivated to serve communities that are underserved and markets that are overlooked.

Job Specific Behaviors

Relationship Orientation – Develops positive relationships by making others feel their concerns and contributions are important.

Continuous Learning - Targets learning needs; seeks learning activities; maximizes learning; applies knowledge or skill; and takes risks in learning.

Operational / Technical Excellence - Ensures that work product (whether service or process) enables the organization to deliver on customer's expectations.

Effective Communication – Effectively communicates verbally and in writing. Creates a team environment in which information flows freely and decision making is based on a win-win philosophy.

Compliance – Applies an understanding of regulatory requirements, policies and practices to protect the interests of the organization.

Quality Orientation - Follows procedures, ensures high-quality outputs and takes action.

Attention to Detail – Utilizes established monitoring system, records data accurately and in a timely manner, and ensures accuracy of data.

Adaptability – Tries to understand changes; approaches change or newness positively; and adjusts behavior.

Tolerance for Stress, Ambiguity & Change – Demonstrates flexibility in applying different approaches to changing work demands.

Physical Demands

• Ability to perform work utilizing a computer for extended periods of time.
• Ability to sit for extended periods of time without being able to leave the work area.
• Ability to stand for extended periods of time without being able to leave the work area.
• As related to laboratory work (as applicable):

• Ability to stand for extended periods of time without being able to leave the work area.
• Ability to climb ladders and stairs in performing the work.
• Ability to walk for reasonable distances in performing the work.

Certifications, Licenses & Registrations

• None required.