Senior Clinical Research Associate I
Company: Labcorp Drug Development, Labcorp
Location: Bend
Posted on: January 25, 2023
Job Description:
Senior Clinical Research Associate I USA - West Coast Oncology
Experience RequiredWhy settle for one thing when you can have
everything? Labcorp Drug Development gives you the best two for one
opportunity for career growth. Who doesnt want twice the perks
working at one of the largest FSP CROsand partnering with one
sponsor with a dedicated therapeutic focus.Our Energizing Purpose,
Exceptional People and Extraordinary Potential combined with
collaborative and proactive teams offer a great place for you to
continue honing your therapeutic skills and growing and excelling
in new exciting research. Our reach is global extending to 60+
countries making us one of the largest FSP CROs. So, no matter
where you are located on the globe, we have an FSP opportunity for
you.We are seeking a Senior Clinical Research Associate I to be
responsible for all aspects of study site monitoring and management
including routine monitoring and close-out of clinical sites;
maintain study files; conduct pre-study and initiation visits;
liaise with vendors; and other duties, as assigned.Additional
Responsibilities include:
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report
Forms and clinical trial reports as assigned
- 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 Covance legal department with statements of agreements as
assigned
- Independently perform CRF review; query generation and
resolution against established data review guidelines on Covance or
client data management systems as assigned by management
- Travel, including air travel, may be required and is an
essential function of the job; prepare accurate and timely trip
reports; review progress of projects and initiate appropriate
actions to achieve target objectives
- Conduct, report, and follow-up on Monitor Quality Control
Visits (MQC) or Quality Control Visits (CQC) when
requestedRequirements:
- University or college degree, or certification in a related
allied health profession from an appropriately accredited
institution (e.g., nursing licensure). An equivalent amount of
experience can be substituted as appropriate
- Minimum of at least 2 years of onsite Clinical Monitoring
experience
- Advanced site monitoring; study site management; and registry
administration skills
- Ability to train and supervise junior staff; resolve project
related processes
- Thorough knowledge of ICH Guidelines and understanding of local
regulatory requirements
- Thorough knowledge of monitoring procedures; Basic
understanding of the drug accountability process
- Have a full understanding of the Serious Adverse Event (SAE)
reporting, process production of reports, narratives and follow up
of SAEs
- Good planning, organization and problem-solving abilities;
Ability to work with minimal supervision
- COVID-19 vaccination required
- Valid Driver's LicensePreferred Experience:
- At least 1 year of additional experience in a related field is
preferredPay Range: $95,000 -$115,000/yearBenefits: All job offers
will bebased on a candidates skills and prior relevant experience,
applicabledegrees/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.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.
Keywords: Labcorp Drug Development, Labcorp, Bend , Senior Clinical Research Associate I, Healthcare , Bend, Oregon
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