26 days old

REMOTE Clinical Research Associate - CRA - IVD, Molecular Diagnostics

Kelly Services
Sunnyvale, CA 94086 Work Remotely
**Clinical Research Associate**

**Remote || Chicago, IL || Sunnyvale, CA**

**Contract, 12 months**

**JOB DESCRIPTION/POSITION SUMMARY:** The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of IVD clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various stages or phases in the life cycle of the product including alpha (early stage feasibility), beta and most importantly the clinical studies that validate the product.


Perform internal performance testing such as proficiency and system testing

Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products

Identify potential investigators, prepare site budgets and contract agreements

Collect, review and process regulatory documents and correspondence from participating trial sites

Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required.

Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution

Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits

Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem

Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance

Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives


Complete all assigned and required training satisfactorily and on time

For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.

**MINIMUM REQUIREMENTS: Education and Experience (in years):**

Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.

**Knowledge and skills:**

Ideally 3-4 years of experience with In Vitro Diagnostic (IVD) products

Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment

Excellent communication and team skills

Effective interpersonal skills

Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.

Experience in the handling and shipping of Bio hazardous specimens.

Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.

Knowledge of GCP & ICH guidelines and FDA regulations

Working knowledge of the diagnostic field and clinical trial material that is to be studied

30-50% travel required


Good understanding of medical terminology, human physiology and laboratory testing Knowledge of regulatory and clinical practices (GCP, ICH)

Experience with laboratory automation and biological databases

Previous hands-on experience in clinical research at either a diagnostic company/hospital or laboratory

Knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, and the current gold standard for the diagnosis of disease

Must be detailed oriented, with strong time management and organizational skills

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2021-09-20 Expires: 2021-10-21

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REMOTE Clinical Research Associate - CRA - IVD, Molecular Diagnostics

Kelly Services
Sunnyvale, CA 94086

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