Clinical Research Associate 2 / Sr. CRA 1 & 2 - Ophthalmology & Biopharm
Company: LabCorp
Location: Portland
Posted on: May 28, 2023
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Job Description:
Labcorp is Hiring CRAs!! Remote based anywhere in the US!
Ophthamology experience required! Regional travel!
Are you ready to redefine what's possible, and discover your
extraordinary potential at Labcorp? A career here provides the
unique chance to create a lasting impact and difference in our
patient's lives. Joining our team will offer you a rewarding
career, an opportunity to work in a high-energy & collaborative
work place, along with access to comprehensive benefits. Your work
will be meaningful, the patient outcomes are real, and the results
are lasting. With the support of exceptional people from across the
globe and an energized purpose, you'll be empowered to own your
career journey with mentoring, training and personalized
development planning.
Our mission is to help our clients bring the miracles of medicine
to market sooner
Join us for your next career move!!
Essential Job Duties:
Responsible for all aspects of study site monitoring including
routine monitoring and close-out of clinical sites, maintenance of
study files, conduct of pre-study and initiation visits; liaise
with vendors; and other duties, as assigned.
Responsible for all aspects of site management as prescribed in the
project plans
General On-Site Monitoring Responsibilities:
Ensure the study staff who will conduct the protocol have received
the proper materials and instructions to safely enter patients into
the study
Ensure the protection of study patients by verifying that informed
consent procedures and protocol requirements are adhered to
according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms
(CRFs) or other data collection tools by careful source document
review. Monitor data for missing or implausible data
Ensure the resources of the Sponsor and Labcorp are spent wisely by
performing the required monitoring tasks in an efficient manner,
according to SOPs and established guidelines, including managing
travel expenses in an economical fashion according to Labcorp
travel policy
Prepare accurate and timely trip reports
Manage small projects under direction of a Project Manager/Director
as assigned
Serve as lead monitor for a protocol or project and may assist in
establishing monitoring plans as assigned
Review progress of projects and initiate appropriate actions to
achieve target objectives
Organize and make presentations at Investigator Meetings
Report, write narratives and follow-up on serious adverse
experiences
Participate in the development of protocols and Case Report Forms
as assigned
Participate in writing clinical trial reports as assigned
Interact with internal work groups to evaluate needs, resources and
timelines
Act as contact for clinical trial supplies and other suppliers
(vendors) as assigned
Responsible for all aspects of registry management as prescribed in
the project plans
Undertake feasibility work when requested
Recruitment of potential investigators, preparation of EC
submissions, notifications to regulatory authorities, translation
of study-related documentation, organization of meetings and other
tasks as instructed by supervisor as assigned
Negotiate study budgets with potential investigators and assist the
Labcorp legal department with statements of agreements as
assigned
Complete process of Serious Adverse Event (SAE) reporting, process
production of reports, narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution
against established data review guidelines on Labcorp or client
data management systems as assigned by management
Assist with training, mentoring and development of new employees,
e.g. co-monitoring
Co-ordinate designated clinical projects as a Local Project
Coordinator (with supervision, if applicable), and may act as a
local client contact as assigned
Perform other duties as assigned by management
Required Experience:
University/college degree (life science preferred), or
certification in a related allied health profession from an
appropriately accredited institution (e.g., nursing certification,
medical or laboratory technology)
In lieu of the above requirement, candidates with three (3) or more
years of relevant clinical research experience in pharmaceutical or
CRO industries may be considered
Minimum Required:
Advanced site monitoring skills
Advanced study site management skills
Advanced registry administration skills
Ability to work with minimal supervision
Good planning and organization skills
Good computer skills with good working knowledge of a range of
computer packages
Advanced verbal and written communication skills
Ability to train and supervise junior staff
Ability to resolve project-related problems and prioritizes
workload for self and team
Ability to work within a project team
Works efficiently and effectively in a matrix environment
Valid Driver's License
Independent, onsite monitoring experience
Pay Range: CRA 2: $105-125K ; Sr. CRA 1: $115-132K ; Sr. CRA 2:
$120-145K
Benefits: All job offers will be---based on a candidate's skills
and prior relevant experience,
applicable---degrees/certifications,---as well as internal equity
and market data.---Regular, full-time or part-time employees
working 20 or more hours per week are eligible for comprehensive
benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K),
ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus
where applicable. For more detailed information, please click here
(https://cdn.phenompeople.com/CareerConnectResources/COVAGLOBAL/documents/Labcorp-Benefits-TheWayWeLive-1659629596356.pdf)
.
Labcorp is committed to diversity in the workplace and is an equal
opportunity employer (Minority/Female/Individual with
Disability/Veteran/Sexual Orientation/Gender Identity). Your
confidentiality and privacy are important to us.
As a leading global contract research organization (CRO) with a
passion for scientific rigor and decades of clinical development
experience, Fortrea provides pharmaceutical, biotechnology, and
medical device customers a wide range of clinical development,
patient access and technology solutions across more than 20
therapeutic areas. With over 19,000 staff conducting operations in
more than 90 countries, Fortrea is transforming drug and device
development for partners and patients across the globe.
Did you know?
Labcorp's Clinical Development and Commercialization Services
business is now Fortrea in connection with its planned spin-off
from Labcorp, which is expected in mid-2023. Fortrea's spin-off
from Labcorp is subject to satisfaction of certain customary
conditions. This spin-off will position both organizations for
accelerated growth and allow each to focus resources on distinct
strategic priorities, customer and employee needs and value
creation opportunities.---As a provider of phase I-IV clinical
trial management, regulatory guidance, patient access solutions and
market access consulting, Fortrea will partner with both emerging
and large pharmaceutical, biotechnology, device and diagnostic
companies to drive healthcare innovation and improve the lives of
patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who
are passionate about breaking down barriers faced by sponsors of
clinical trials, and who are committed to helping transform the
development process to get promising life-changing ideas and
therapies to patients faster. Join us as we cultivate a workspace
where all employees have the opportunity to grow and make impacts
on a global scale. For more information and questions related to
Fortrea, please visit www.fortrea.com .
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion
in the workforce and does not tolerate harassment or discrimination
of any kind. We make employment decisions based on the needs of our
business and the qualifications of the individual and do not
discriminate based upon race, religion, color, national origin,
gender (including pregnancy or other medical conditions/needs),
family or parental status, marital, civil union or domestic
partnership status, sexual orientation, gender identity, gender
expression, personal appearance, age, veteran status, disability,
genetic information, or any other legally protected characteristic.
We encourage all to apply.
For more information about how we collect and store your personal
data, please see our Privacy Statement
(https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .
Keywords: LabCorp, Portland , Clinical Research Associate 2 / Sr. CRA 1 & 2 - Ophthalmology & Biopharm, Healthcare , Portland, Oregon
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