Sr. Clinical Research Associate
Company: InCarda Therapeutics
Location: Newark
Posted on: June 24, 2022
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Job Description:
LOCAL CANDIDATES PREFERRED
Senior Clinical Research Associate (Sr CRA), independently or in
consultation with the Clinical Trial Manager should be able to
perform the following tasks: - - - - - - - -Demonstrate a solid
understanding of therapeutic indications and the study protocol(s)
assigned. - - - - - - - -Assist in project planning; timeline
preparation, preparation and review of study plans, including the
Clinical Monitoring Plan and review of eCRF
guidelines/specifications. - - - - - - - - -Provide vendor
management that may include EDC, IRT, Central Lab and specialty
vendors. - - - - - - - -Develop clinical documents including ICFs,
protocol support documents, Pharmacy Manuals, Lab Manuals, site
support documents, and source documents. - - - - - - - -Select
clinical Investigators appropriate to the therapeutic area and
phase of the study. - - - - - - - - -Assess potential study sites
to ensure the facility, staff and patient population are adequate
for study conduct. - - - - - - - - -Facilitate budget planning and
support site budget review, tracking and reconciling site related
invoices of planned vs. actual spend. - - - - - - - -Independently
manage study tracking, enrollment, site performance in
collaboration with CTM - - - - - - - -Assess/review/ensure CRO
monitoring quality, perform monitoring visits (PSV through
closeout) as needed, review Monitoring Visit Reports (MVRs) and MVR
metrics, attend SIVs and assist with site training, etc. - - - - -
- - - -Review essential documents for IP release, provide label
review, and preparation and coordination of IP supply - - - - - - -
-Perform TMF reviews for assigned study(ies) and support Clinical
Trial Assistant with the set up and management of the filing. - - -
- - - - - -Monitor study progress to assure compliance with
protocol requirements, FDA regulations and Good Clinical Practice
by conducting site visits independently or in conjunction with the
CRO. - - - - - - - - -Perform co-monitoring visits to evaluate
CRO's CRAs, site performance and review source documents at the
site to ensure compliance with the protocol. - - - - - - - -
-Ensure the timely, accurate and complete collection and submission
of study data. - - - - - - - - -Identify, address, and resolve
issues and problems as they might occur. - - - - - - - - -Ensure
collection of all data and remaining study supplies for return to
the InCarda/CRO as appropriate. - - - - - - - - -Ensure that
appropriate study documents are complete and properly filed. - - -
- - - - - -Help prepare the site for possible inspections by Health
Authorities. - - - - - - - - -Assist the InCarda/CRO in problem
solving and provide consultation on monitoring and study related
activities. - - - - - - - - -Demonstrate strong knowledge of Good
Clinical Practice/ICH Guidelines and other applicable regulatory
requirements. - - - - - - - -Work independently in a fast-paced
environment.This position may require up to 20% travel.Knowledge,
Skill and Competency Requirements: - - - - - - - -Excellent oral
and written communication skills, interpersonal relationship
skills, negotiating skills, knowledge of scientific method, GCPs
and regulations relating to clinical research. - - - - - - - -
-Must have a working knowledge of computer technology and its
application to the clinical environment. - - - - - - - - -Ability
to develop tools and processes that increase measured efficiencies
of the project. - - - - - - - - -Must be able to anticipate
obstacles and proactively develop solutions to achieve project
goals. - - - - - - - -Must have a general understanding of
functional issues and routine project goals from an organizational
perspective. - - - - - - - - -Ability to provide clear direction
and guidance to others. - - - - - - - - -Demonstrated ability to
lead by example and mentor others.
Keywords: InCarda Therapeutics, Newark , Sr. Clinical Research Associate, Healthcare , Newark, California
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