Homebased/Remote-Senior Clinical Research Associate- Oncology
Company: Precision For Medicine
Location: San Jose
Posted on: June 25, 2022
Job Description:
Precision for Medicine is not your typical CRO. We are
passionate about cultivating our culture and are proud to share
extremely high CRA retention rates compared to industry averages.
CRAs join us, love their positioning to make a difference, and stay
because of the amazing people, reasonable travel and quality of
life carrying an average of one to two studies setting you up to be
a protocol expert. Most meaningfully - your voice will be heard. As
a smaller CRO, you will have influence and impact when it matters
most and support from direct line management.We invite you to learn
more about our growing organization serving our clients that are
researching groundbreaking cancer & rare disease therapies. We are
steadfast in ensuring our employees feel appreciated for the
contributions they make every single day. You will provide input
and have your ideas valued and nurtured, impacting positive
change.About You
- You are passionate about spending your professional time
working on finding new treatment options for patients and their
families suffering from cancer or rare diseases
- You are calm, thoughtful, and responsive when things don't go
as planned.
- You are well-prepared, whether it be for an investigator
meeting, site visit or project team update, always staying two
steps ahead of the game.
- You have an impeccable eye for detail; identifying potential
study risks and propose mitigation solutions.
- How we will keep you busy and support your growth:
- You will monitor and be responsible for the progress of
clinical studies at investigative sites and ensure that clinical
studies are conducted, recorded, and reported per protocol, SOPs,
ICH-GCP, and all applicable regulations and standards. You will
coordinate all necessary activities required to set up and monitor
a study (i.e., identify investigators; helping prepare regulatory
submissions, conducting pre-study and initiation visits, etc.).CRAs
handle appropriately sized clinical trials, and support Project
Managers with trials that are larger in scope. You will also have
the opportunity to train and mentor junior staff members. You will
interact directly with clients, initiate payments, and participate
in proposal activities, including development and client
presentations.QualificationsMinimum Required
- 4-year college degree or equivalent experience in a scientific
or healthcare discipline.
- CRA experience in either a CRO or pharmaceutical/biotech
industry or equivalent, relevant experience and/or demonstrated
competencies; 2+ years for CRA II and 3.5+ years for Sr. CRA,
including significant site management experience or equivalent
experience in clinical research.Other Required
- Excellent communication and organizational skills am essential.
An excellent teammate
- Evidence of a client focused approach
- Experience using computerized information systems, electronic
spreadsheets, word processing and electronic mail required
- Ability to travel overnight; up to 60% regional expected on
average & based on regional requirements. International travel as
needed
- Fluency in English and for non-English speaking countries the
local language of country where position based
- Select opportunities require Oncology experience preferably in
early phasesPreferred
- Graduate, postgraduate degree
- Monitoring in rare and complex therapeutic areas, monitoring
EDC trials and EHR records
- Biopharma or meaningful therapeutic area
- Relevant site start-up (feasibility, contract negotiations,
submissions) experience for the particular country
- Monitoring study sites, with supervision, according to protocol
monitoring guidelines, SOPs, GCP and ICH guidelines
- Resolving project related problems and prioritize workload to
meet deadlines with oversight from management. Mentorship of junior
CRAs in problem resolution
- Precision for Medicine is a precision medicine CRO. Precision's
uniquely integrated offering enables the science of precision
medicine by combining novel clinical trial designs,
industry-leading operational and medical experts, advanced
biomarker and data analytics solutions, and an unequivocal real
passion for rare diseases and oncology.
- CRA I level needs little to no practical experience however
transferable skills from health care or related industries a
plusPrecision for Medicine is a precision medicine CRO. Precision's
uniquely integrated offering enables the science of precision
medicine by combining novel clinical trial designs,
industry-leading operational and medical experts, advanced
biomarker and data analytics solutions, and an unequivocal real
passion for rare diseases and oncology.Precision medicine is
revolutionizing the attack on cancer-and we are passionate about
helping you harness its power. We strike tumors on a molecular
level using biomarkers to link specific mutations to specific
treatments. We combine deep science with deep data from advanced
technological platforms, then layer on specialized expertise in the
design and execution of targeted, adaptive clinical trials.
Ultimately, we deliver robust insights that inform real-time
decisions-and optimize the oncology development pathway.Any data
provided as a part of this application will be stored in accordance
with our Privacy Policy .Precision Medicine Group is an Equal
Opportunity Employer. Employment decisions are made without regard
to race, color, age, religion, sex, sexual orientation, gender
identity, national origin, disability, veteran status or other
characteristics protected by law. - 2020 Precision Medicine Group,
LLCIf you are an individual with a disability and require a
reasonable accommodation to complete any part of the application
process, or are limited in the ability or unable to access or use
this online application process and need an alternative method for
applying, you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
Keywords: Precision For Medicine, San Jose , Homebased/Remote-Senior Clinical Research Associate- Oncology, Healthcare , San Jose, California
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