Sr. CRA - Diagnostics/IVD

Job Description

Job Description

Kelly® Science & Clinical is seeking a Sr. CRA for a fulltime, long-term contract position with a biotech company in California. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

The Sr. Clinical Research Associate is responsible for in the execution of clinical trials in addition to supporting the study site identification, monitoring plan, and implementation of all aspects of assigned clinical trials. Works with and may help guide a study team regarding all operational activities for new and/or on-going in vitro diagnostic clinical evaluations.

 

***Must have IVD monitoring experience clearly documented on resume or your application will be rejected.***

This position is part of the Clinical Affairs department and will be a Remote position located in the US. Our client's vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

Execute all activities related to a clinical study, including (but not limited to):

• Clinical site selection
• Site contract and budget negotiation
• Study initiation visits
• Interim monitoring visits
• Study close out visits
• Data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness.

Identify and suggest ways to resolve problems or issues at site associated with GCP or protocol compliance which could affect the integrity of the data or timely completion of the clinical study.

Prepare study documents for review by project lead. Documents my include but are not limited to:

• Training materials
• Case Report Forms
• Study procedure guidance document
• Protocol specific ICF
• Maintain a high level of familiarity with GCP and assigned protocols.

The essential requirements of the job include:

• Bachelor’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry and/or Human Physiology, or similar).
• Minimum of 5 to 8 years of experience with monitoring In Vitro Diagnostic (IVD) products.
• Experience in all aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.).
• Remain current on clinical trial regulatory requirements and guidelines (e.g. GCP, ICH, FDA, etc) with the ability to translate current regulatory requirements into clinical trial.
• Excellent oral and written communication skills. Ability to develop strong rapport with investigators and site staff.
• Ability to travel 30-60% (mostly for study startup and closeout
• Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics especially in the areas of oncology and/or infectious disease
• Experience with laboratory automation and biological databases (preferred)
• CCRA certification (preferred)

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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