Principal Investigator
Company: Care Access
Location: Berkeley
Posted on: March 18, 2023
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Job Description:
What We DoCare Access is delivering the future of medicine
today! Care Access has a revolutionary model that breaks down
traditional barriers to clinical trials that limit participation
among physicians and patients to 3%. By removing this bottleneck,
Care Access is helping accelerate the approval and delivery of
critical and life-saving therapies.Who We AreWe care. Our people
are the engines behind our mission: to revolutionize access to
clinical trials for the benefit of patients everywhere. We care for
one another, find new ideas to accelerate medicine, and seed a
long-term impact for generations.Position OverviewThe Principal
Investigator is responsible for ensuring that all research team
members have appropriate education, training, and qualifications to
assume delegated study tests. Principal Investigator is responsible
for ensuring that the conduct of the study is compliant with
federal and industry guidance and regulations. Principal
Investigators manage Phase 1 - Phase 4 studies, with demonstrated
decision-making capabilities. They will also engage with the
sponsor's monitor to discuss findings and ensure timely correction
and documentation of any identified issues.The administrative
structure of investigational sites under the decentralized site
model requires a nontraditional approach. The Principal
Investigator will be responsible for the oversight of trial conduct
at one or more facilities where participants are located. Since the
facilities may not be in proximity, oversight will be provided in
accordance with a well laid out Decentralized Clinical Trials
Oversight Plan.What You'll Be Working OnDuties include but are not
limited to- Review the inclusion/exclusion criteria, endpoint
criteria, and investigational article use with the internal
research team.-Determine whether inclusion/exclusion criteria apply
to the study population.-Maintain protocol compliance on all
clinical trials/studies according to the International Conference
on Harmonization-Good Clinical -Practice (ICH-GCP), local
regulations, and study protocol.-Oversee IRB review of study and
ensure written IRB approval is obtained before initiating the study
or instituting any changes to the protocol as approved.-Assess
subject response to therapy, evaluate and address adverse
experiences-Meet regularly with the research team to discuss
subject participation and protocol progress.-Meet with study
assigned monitors at regular intervals-Train Sub-Investigators and
study staff members on protocol and protocol specific
procedures.-Provide medical support to Sub-Investigators and study
staff for protocol-related issues including protocol
clarifications, inclusion/exclusion determinations, and issues of
patient safety and/or eligibility.-Maintain essential documents and
records necessary for conduction of study.-Train on and implement
Care Access Standard Operating Procedures.-Review sponsor provided
safety reports.-Review and maintain accurate case report
forms.-Sign off electronic case books as required by the study
sponsor.-Provide clinical oversight and quality of the studies
virtually.-Ensure the medical well-being and safety of the study
participants, through the safe performance and execution of the
clinical trials/studies.-Participate and engage in driving delivery
of study targets, such as: participant recruitment, enrollment, and
retention.-Perform other duties as assigned.Physical and Travel
RequirementsThis role requires regular onsite work in Berkeley, CA.
Occasional planned travel may be required as part of the role with
less than 10% travel requirements.What You BringRole
Requirements:Knowledge, Skills, and
Abilities:Certifications/Licenses, Education, and Experience:-MD/DO
License in good standing.-Willing to obtain multi-state licensure
as needed-Board Certification in any of the following areas:
Internal Medicine, Cardiology, Gastroenterology, Dermatology,
Endocrinology-Prior research experience required-Possess a thorough
understanding of the requirements of clinical
protocols.Benefits-PTO/vacation days, sick days, holidays.-100%
paid medical, dental, and vision Insurance. 75% for dependents.-HSA
plan-Short-term disability, long-term disability, and life
Insurance.-Culture of growth and equality-401k retirement
planDiversity & InclusionWe serve patients and researchers from
diverse cultures and communities around the world. We are stronger
and better when we build a team representing the people we aim to
support. We maintain an inclusive culture where people from a broad
range of backgrounds feel valued and respected as they contribute
to our mission. We value diversity and believe that unique
contributions drive our success.At Care Access, every day, we are
advancing medical breakthroughs. We're uniting standard patient
care with cutting-edge treatments and research. Our work brings
life-changing therapies to those in need and paves the way for
newer and greater treatments to reach the world. We're proud to
advance these breakthroughs and work with the big players while
engaging with the bestphysicians and caring for patients.We are an
equal opportunity employer, and all qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity or expression,
pregnancy, age, national origin, disability status, genetic
information, protected veteran status, or any other characteristic
protected by law.Care Access is unable to sponsor work visas at
this time.
Keywords: Care Access, Berkeley , Principal Investigator, Other , Berkeley, California
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