Position: Clinical Research Associate
Location: Philadelphia, PA
Essential Duties and Responsibilities:
·
Accountable for investigator site activities including, but not limited
to, site selection, initiation, management and timelines, study drug
delivery and management, specimen collection, and close-out activities.
·
Train investigator site personnel
·
Monitoring / co-monitoring as required
·
Interact with investigators and site staff
·
Assure trial and investigator site compliance with federal regulations,
protocol requirements, ICH/GCP practices and investigator integrity
·
Identify areas requiring follow-up and improvement at investigator sites
·
Retrieve and review regulatory documentation
·
Manage SAE reporting procedures
·
Maintain orderly and accurate files on clinical investigators and sites
·
Responsible for managing investigator site and vendor budget activities
·
Track investigator payments
·
Define, negotiate, and ensure execution of study-related agreements such
as clinical trial agreements, CROs, laboratory services, etc
·
Provide periodic internal reports, as requested, regarding study
activities
·
Assist in the development of protocols, informed consents, case report
forms, source notes and clinical reports
·
Assist with the development and resolution of data queries
·
Review of clinical trial data
·
Organize and assist with investigator meetings
·
Contribute to projects that support wider organization goals
Requirements:
Position: Quality Assurance Specialist II
Location: New Brunswick, NJ
Job Description:
The person will be working
in a QA team environment to accomplish the Regulatory /QA
objectives of the organization, monitor the performance of the quality
system and interact with research, manufacturing and QC departments to
assure cGMP compliance.
The person is familiar
with cGMP requirements of the biopharmaceutical industry and will be
working on a variety of tasks involving development compounds and
commercial products
Responsibilities:
-
Writing/reviewing/releasing
cGMP required documents, such as SOPs, validation protocols,
validation reports.
-
Assess supplier performance, including raw material suppliers as
well as manufacturing and testing contractors.
-
Review and release raw materials, intermediates and finished drug
products
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Investigate or review investigation reports for deviations
-
Conduct cGMP training, organize training for employees and document
completion.
-
Conduct audits, perform trend analysis, annual product reviews and
other assessments of quality performance internally as well as
suppliers
-
Review CAPAs and track them to completion
Qualifications:
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Bachelor degree in scientific discipline
-
2-5 yrs pharmaceutical experience
Position: Manufacturing Technician
Location: New Brunswick, NJ
Job Description and Responsibilities:
-
Perform unit operations in the manufacture of blood
derived alpha interferon and a synthetic RNA species.
-
Operations in the manufacture of the interferon
include but are not limited to cell isolation and culture, solution
formulation, sterile component preparation, cell harvesting, bulk
liquid concentration, preparative chromatography and related
operations.
-
Operations in the manufacture of the RNA include but
are not limited to RNA synthesis, extraction, precipitation,
diafiltration and freeze-drying.
-
Both processes require compliance to cGMPs.
Job Requirements:
-
A minimum of 2 years experience in a cGMP
manufacturing environment or a BS in life science, chemistry, or
related field is required.
-
Experience in at least some of the operations listed
above would be preferable.
-
Experience with bio-hazardous materials and/or
hazardous solvents is important.
-
Must be willing to work in a team environment.