Clinical Research Associate 4/REMOTE (3300)
Company: Stefanini, Inc
Location: San Diego
Posted on: March 20, 2023
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Job Description:
Clinical Research Associate 4/REMOTE (3300)- Medical
Device/Pharma/Biotech- Raland Compliance Partners Career Portal
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Medical Device/Pharma/Biotech Clinical Research Associate 4/REMOTE
(3300) San Diego, -CA Posted: -2/7/2023 Job Description Job ID#:
186 Job Category: Medical Device/Pharma/Biotech Position Type:
Contractor Duration: 12 months Shift: 1
Job Title: Staff (Level 4) Clinical Research Associate Collaborates
with various departments on the design documentation testing and
implementation of clinical data studies. Develops systems for
organizing data to analyze identify and report trends. Analyzes the
interrelationships of data and defines logical aspects of data
sets. Prepares reports of clinical trial studies for internal
validation and cross validation studies. May evaluate and resolve
issues regarding contents of reports. Summary: Able to work under
minimal supervision to implement and monitor clinical studies at
participating study sites according to FDA"s Code of Federal
Regulations (CFR), Good Clinical Practices (GCP), and ICH
Guidelines. Assists Clinical Affairs management to plan and execute
the design and conduct of Client-sponsored (including
Sponsor-Investigator studies). Assists with overall study planning
and ensuring that all site visits, monitoring, data collection,
reports, and ancillary requirements are appropriately assigned and
executed to meet company deadlines, quality expectations, and
priorities. Learn to act as department representative/clinical
project leader on project teams. Works collaboratively with
company"s Biometrics, R&D and Regulatory Affairs groups to
compile study results, reports and/or tracking various study
documentation. Essential Duties and Responsibilities: * Partner
with Clinical Affairs management to develop and execute clinical
studies. * Communicate progress updates to Clinical Affairs
management and the various functional groups (R&D, Biostats,
Clinical Operations). * Write/reviews protocols, and study reports
in consultation of CRA personnel and/or study manager. * Develop
clinical study materials (including, but not limited to, source
documentation, CRFs, IRB submissions, training slides, etc.) under
direct supervision of study lead and/or study manager. * Maintain
thorough understanding of clinical regulations and standards
(including changing regulations). * Create and implement regular
process improvements. * Act as a study and/or site lead for
multiple sites/projects simultaneously. * Clearly demonstrate
understanding of clinical study management/prioritization. *
Conduct site initiation, monitoring, and close-out visits for
Sponsor-Investigator and Client-Sponsored studies. * Complete study
monitoring visits. * Assist with documenting initial and
re-qualification of new clinical sites for Client-Sponsored
studies. * Assist with developing monitoring plan and conventions
for Sponsor-Investigator and Client-Sponsored studies. * Act as
primary contact for Client-Sponsored clinical sites. * Act as lead
coordinator or monitor for Sponsor-Investigator studies. * Work on
projects and routinely creates, suggests, and/or implements regular
process improvements. * Work independently to manage all clinical
tasks and deliverables to meet clinical timeline * Provide training
to study staff and subjects at clinical sites. * Collaborate
effectively with peers and leadership across departments and can
professionally interact/build relationships with FDA, IRB, and key
opinion leaders. * Responsible for identifying and escalating
safety events for Sponsor-Investigator and Client-Sponsored
studies. * Responsible for identifying and escalating major
protocol deviations for Sponsor-Investigator and Dexcom-Sponsored
studies. * May assist with assessing trends for safety and protocol
deviations and communicating this to study team and study manager *
Maintain organization, preparation and ordering of supplies and
equipment required for clinical studies. * Process timely shipping
of clinical study supplies and equipment. * Assist with the
management of studies by coordinating daily operations including
methods, workflow and implementation of procedures. * Set-up IT
equipment for Sponsor-Investigator and Client-Sponsored sites. *
Complete testing of electronic data capturing systems. * Quality
control SME for study-related documents and be accountable for
their correct distribution. * Initiate distribution of all
regulatory documents and maintain for assigned clinical trials. *
Provide support to CRA personnel for preparing documentation,
reports, and presentations. * Coordinate study-related meetings, as
needed. * Perform scribe function during clinical meetings and
produce meeting minutes for management review. * Assists management
with departmental audits of clinical studies and procedures. *
Coordinate Sponsor-Investigator studies and complete all
study-related responsibilities. * Maintain tracking mechanism for
regulatory documents for any regulatory submission (FDA or other
regulatory body). * Prepare of key documents for trial site
submission to IRBs. * Assist in the creation and maintenance of
tracking mechanisms for all study-related documents, activities,
and projects through all phases of the study. * Draft
clinicaltrials.gov submissions. * This position assumes and
performs other duties as assigned. * Complete tasks under minimal
or no direct supervision. Experience and Education Requirements: *
Bachelor"s (BA or BS) degree in a STEM discipline, and at least 8
years of related experience. or Master"s degree in a STEM
discipline, and 5 years of related experience. * Current GCP (Good
Clinical Practice) Training. * Clinical Trial Management System
(CTMS) experience. * Manage multiple, diversified tasks
concurrently and to prioritize projects and tasks effectively. *
Monitoring clinical studies experience. Preferred Qualifications: *
Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP,
ACRP, RAPS). * Study coordinator experience. Travel Required: *
25-50%. * Local to San Diego, California or willing to relocate OR
may work remotely elsewhere, with approval. Functional Description:
* Requires specific expertise in an engineering and/or scientific
area(s) * Ability to contribute to and propel engineering and/or
scientific innovation in support of Company"s technology strategies
* Demonstrates successes in technical proficiency,
engineering/scientific creativity, and collaboration with others *
Recognized internally and externally as a technology leader *
Progression through the engineering levels requires increasing
expertise in breath and depth of technological areas * In some
instances, may require management skill, broad technical and
functional expertise, and business knowledge Functional/Business
Knowledge: * Possesses advanced knowledge of technical principles
and theories. Recommends solutions in support of functional
objectives tied to overall company objectives and strategies.
Scope: * Demonstrates significant technical expertise,
collaboration with others and independent thought. Anticipates
potential complex problems requiring an in-depth evaluation. *
Demonstrates strategic thinking and commercial/industry
understanding in functional projects. * Determines methods and
procedures on new assignments and may coordinate activities of
other colleagues Supervisory Responsibilities This job has no
supervisory responsibilities.
Language Skills: Ability to read, analyze, and interpret general
business correspondence and governmental regulations. Ability to
write basic reports, emails, and transcribe notes either orally or
handwritten Ability to effectively present information and respond
to questions from managers, clients, customers, and the general
public. Ability to effectively interact with international
customers and their local customs as needed. Writes/reviews
protocols, study reports, and other materials. Apply negotiation
skills, manage Dexcom-Sponsored partners and critical business
assets when needed. Physical Demands: The physical demands
described here are representative of those that must be met by an
employee to successfully perform the essential functions of this
job. Reasonable accommodations may be made to enable individuals
with disabilities to perform the essential functions. While
performing the duties of this job, the employee is regularly
required to sit; use hands to finger, handle, or feel; and talk or
hear. The employee frequently is required to reach with hands and
arms. The employee is occasionally required to stand; walk; and
stoop, kneel, crouch, or crawl. The employee must be able to lift
and/or move up to 20 pounds. Specific vision abilities required by
this job include close vision, color vision, peripheral vision, and
ability to adjust focus.
Work Environment: The work environment characteristics described
here are representative of those an employee encounters while
performing the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions. The noise level in the work
environment is usually moderate. The work environment may include
collaboration with and/or supervision by remote employees, so
excellent communication, independence, self-drive, and discipline
skills are required. Job Title: Staff (Level 4) Clinical Research
Associate Collaborates with various departments on the design
documentation testing and implementation of clinical data studies.
Develops systems for organizing data to analyze identify and report
trends. Analyzes the interrelationships of data and defines logical
aspects of data sets. Prepares reports of clinical trial studies
for internal validation and cross validation studies. May evaluate
and resolve issues regarding contents of reports. Summary: Able to
work under minimal supervision to implement and monitor clinical
studies at participating study sites according to FDA"s Code of
Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH
Guidelines. Assists Clinical Affairs management to plan and execute
the design and conduct of Client-sponsored (including
Sponsor-Investigator studies). Assists with overall study planning
and ensuring that all site visits, monitoring, data collection,
reports, and ancillary requirements are appropriately assigned and
executed to meet company deadlines, quality expectations, and
priorities. Learn to act as department representative/clinical
project leader on project teams. Works collaboratively with
company"s Biometrics, R&D and Regulatory Affairs groups to
compile study results, reports and/or tracking various study
documentation. Essential Duties and Responsibilities: * Partner
with Clinical Affairs management to develop and execute clinical
studies. * Communicate progress updates to Clinical Affairs
management and the various functional groups (R&D, Biostats,
Clinical Operations). * Write/reviews protocols, and study reports
in consultation of CRA personnel and/or study manager. * Develop
clinical study materials (including, but not limited to, source
documentation, CRFs, IRB submissions, training slides, etc.) under
direct supervision of study lead and/or study manager. * Maintain
thorough understanding of clinical regulations and standards
(including changing regulations). * Create and implement regular
process improvements. * Act as a study and/or site lead for
multiple sites/projects simultaneously. * Clearly demonstrate
understanding of clinical study management/prioritization. *
Conduct site initiation, monitoring, and close-out visits for
Sponsor-Investigator and Client-Sponsored studies. * Complete study
monitoring visits. * Assist with documenting initial and
re-qualification of new clinical sites for Client-Sponsored
studies. * Assist with developing monitoring plan and conventions
for Sponsor-Investigator and Client-Sponsored studies. * Act as
primary contact for Client-Sponsored clinical sites. * Act as lead
coordinator or monitor for Sponsor-Investigator studies. * Work on
projects and routinely creates, suggests, and/or implements regular
process improvements. * Work independently to manage all clinical
tasks and deliverables to meet clinical timeline * Provide training
to study staff and subjects at clinical sites. * Collaborate
effectively with peers and leadership across departments and can
professionally interact/build relationships with FDA, IRB, and key
opinion leaders. * Responsible for identifying and escalating
safety events for Sponsor-Investigator and Client-Sponsored
studies. * Responsible for identifying and escalating major
protocol deviations for Sponsor-Investigator and Dexcom-Sponsored
studies. * May assist with assessing trends for safety and protocol
deviations and communicating this to study team and study manager *
Maintain organization, preparation and ordering of supplies and
equipment required for clinical studies. * Process timely shipping
of clinical study supplies and equipment. * Assist with the
management of studies by coordinating daily operations including
methods, workflow and implementation of procedures. * Set-up IT
equipment for Sponsor-Investigator and Client-Sponsored sites. *
Complete testing of electronic data capturing systems. * Quality
control SME for study-related documents and be accountable for
their correct distribution. * Initiate distribution of all
regulatory documents and maintain for assigned clinical trials. *
Provide support to CRA personnel for preparing documentation,
reports, and presentations. * Coordinate study-related meetings, as
needed. * Perform scribe function during clinical meetings and
produce meeting minutes for management review. * Assists management
with departmental audits of clinical studies and procedures. *
Coordinate Sponsor-Investigator studies and complete all
study-related responsibilities. * Maintain tracking mechanism for
regulatory documents for any regulatory submission (FDA or other
regulatory body). * Prepare of key documents for trial site
submission to IRBs. * Assist in the creation and maintenance of
tracking mechanisms for all study-related documents, activities,
and projects through all phases of the study. * Draft
clinicaltrials.gov submissions. * This position assumes and
performs other duties as assigned. * Complete tasks under minimal
or no direct supervision. Experience and Education Requirements: *
Bachelor"s (BA or BS) degree in a STEM discipline, and at least 8
years of related experience. or Master"s degree in a STEM
discipline, and 5 years of related experience. * Current GCP (Good
Clinical Practice) Training. * Clinical Trial Management System
(CTMS) experience. * Manage multiple, diversified tasks
concurrently and to prioritize projects and tasks effectively. *
Monitoring clinical studies experience. Preferred Qualifications: *
Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP,
ACRP, RAPS). * Study coordinator experience. Travel Required: *
25-50%. * Local to San Diego, California or willing to relocate OR
may work remotely elsewhere, with approval. Functional Description:
* Requires specific expertise in an engineering and/or scientific
area(s) * Ability to contribute to and propel engineering and/or
scientific innovation in support of Company"s technology strategies
* Demonstrates successes in technical proficiency,
engineering/scientific creativity, and collaboration with others *
Recognized internally and externally as a technology leader *
Progression through the engineering levels requires increasing
expertise in breath and depth of technological areas * In some
instances, may require management skill, broad technical and
functional expertise, and business knowledge Functional/Business
Knowledge: * Possesses advanced knowledge of technical principles
and theories. Recommends solutions in support of functional
objectives tied to overall company objectives and strategies.
Scope: * Demonstrates significant technical expertise,
collaboration with others and independent thought. Anticipates
potential complex problems requiring an in-depth evaluation. *
Demonstrates strategic thinking and commercial/industry
understanding in functional projects. * Determines methods and
procedures on new assignments and may coordinate activities of
other colleagues Supervisory Responsibilities This job has no
supervisory responsibilities. Language Skills: Ability to read,
analyze, and interpret general business correspondence and
governmental regulations. Ability to write basic reports, emails,
and transcribe notes either orally or handwritten Ability to
effectively present information and respond to questions from
managers, clients, customers, and the general public. Ability to
effectively interact with international customers and their local
customs as needed. Writes/reviews protocols, study reports, and
other materials. Apply negotiation skills, manage Dexcom-Sponsored
partners and critical business assets when needed. Physical
Demands: The physical demands described here are representative of
those that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions. While performing the duties of this job, the
employee is regularly required to sit; use hands to finger, handle,
or feel; and talk or hear. The employee frequently is required to
reach with hands and arms. The employee is occasionally required to
stand; walk; and stoop, kneel, crouch, or crawl. The employee must
be able to lift and/or move up to 20 pounds. Specific vision
abilities required by this job include close vision, color vision,
peripheral vision, and ability to adjust focus. Work Environment:
The work environment characteristics described here are
representative of those an employee encounters while performing the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions. The noise level in the work environment is
usually moderate. The work environment may include collaboration
with and/or supervision by remote employees, so excellent
communication, independence, self-drive, and discipline skills are
required. Job Requirements
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