Research Scientist, Study Director
Company: Altasciences
Location: Everett
Posted on: May 12, 2022
Job Description:
Altasciences is a forward-thinking, mid-size contract research
organization offering pharmaceutical and biotechnology companies a
proven, flexible approach to preclinical and clinical pharmacology
studies, including formulation, manufacturing and analytical
services. For over 25 years, Altasciences has been partnering with
sponsors to help support educated, faster, and more complete early
drug development decisions. Altasciences' integrated, full-service
solutions include preclinical safety testing, clinical pharmacology
and proof of concept, bioanalysis, program management, medical
writing, biostatistics, and data management, all customizable to
specific sponsor requirements. Altasciences helps sponsors get
better drugs to the people who need them, faster.
The Study Director, Research Scientist will have a passion for
preclinical research. The Preclinical Study Director represents the
single point of control for assigned studies and following
confirmation of appropriate education, training and experience.
Study Directors are responsible for the interpretation, analysis,
documentation, and reporting of study results for GLP and non-GLP
studies.
Responsibilities:
- Overall responsibility for the technical conduct of the study,
as well as for the interpretation, analysis, documentation and
reporting of results, and represents the single point of study
control
- Performs functions in accordance with G Ps and other applicable
regulations and/or guidances
- Consults with Sponsor, Study Directors and others during
protocol development to optimize protocol design to appropriately
address study objectives
- Works with the appropriate individuals to design and approve
the study protocol
- Responds to inquiries from clients and other relevant parties
regarding scientific aspects of studies. Actively participates in
client discussions regarding studies
- Coordinates the schedule and logistics of the study with
clients, sub-contractors, and relevant internal departments
- Confirms with management that study personnel have the training
and education to perform their assigned function
- Assures that current copies of approved protocol and amendments
are available to all study personnel and Sponsors
- Prepares the Project Review Form and obtains approval of the
study by the IACUC
- Monitors, tracks, and communicates study milestones throughout
departments
- Assures that all experimental data, including observations of
unanticipated responses of the test system, are accurately recorded
and verified
- Assures that unforeseen circumstances that may affect the
quality and integrity of the nonclinical laboratory study are noted
when they occur and that corrective action is taken and
documented
- Analyzes and interprets study data and prepares study
reports
- Assures that Sponsors are appropriately informed of ongoing
study activities and results and of any corrective actions
required
- Confirms that all raw data, documentation, protocol, specimens,
and study reports are transferred to the archives during or at the
close of the study
- Reviews, revises, and writes SOPs, as necessary
- Other duties may be assigned as neededQualifications:
- Masters or Doctoral Degree or equivalent degree in a relevant
scientific discipline. A Baccalaureate or equivalent degree and
relevant experience may substitute for the education requirements
for this position
- Three years' experience as a Study Director for in vivo studies
(including GLP) in a biopharmaceutical company or Contract Research
Organization (CRO)
- One to two years' experience in Toxicology a plus
- Intermediate to Advanced Computer Skills
- Ability to effectively communicate scientific data
interpretation and conclusions
- Ability to utilize and interpret appropriate mathematical and
statistical methods for analysis of scientific study data
- Ability to multi-task and maintain organization in a fast
paced, rapidly changing environment
- Strong planning and organizational skills
- Ability to work effectively and cooperatively in a team
environment under significant time pressure
- Demonstrated attention to detail and consistent ability to
operate with accuracy and quality
- Proven presentation and facilitation skills
- Must complete Study Director Training, training on applicable
procedures and SOPs
- Continuing scientific and/or professional education in areas of
scientific and regulatory expertiseAltasciences is an Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, or national
origin, and protected veteran status, or disability status.
Altasciences uses E-Verify to confirm the employment eligibility of
all newly hired employees. To learn more about E-Verify, including
your rights and responsibilities, please visit www.E-Verify.gov.
INDMP
Keywords: Altasciences, Everett , Research Scientist, Study Director, Executive , Everett, Washington
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