Clinical Trial Associate (Hybrid)

　　Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a long-term contract opportunity for a Clinical Trial Associate with our client, a leader in the medical device industry in Rochester, New York.

　　Preferred Hybrid role - 2 days home 3 in office in Rochester

　　Possible REMOTE option eastern time zone candidates preferred

　　Until the end of the year likely to extend

　　$45 to 50 an hour

　　Monday through Friday standard business hours

　　Responsibilities:

　　Collaborates on and supports CTM on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form CRF development, IRB submissions, investigator agreements, informed consent form ICF development, site selection, Trial Master File structure and preparation, and communication with clinical trial sites regarding administrative documentation, support materials and training

　　Supports CTM and clinical operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures SOPs during all clinical investigations and post-market studies

　　Supports CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements

　　Assists in tracking study specific payments Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed

　　Collaborates on project teams, primarily with the Clinic, Research and Development, Advanced Development, Marketing, Regulatory and Quality/Compliance Supports CTM and clinical operations members with administrative documents related to all clinical study programs, TMFs, and study start up activities

　　Assists and supports CTM and clinical operations team in presentations of clinical information concerning specific projects

　　Works on projects of moderate-to-high degree of difficulty in which analysis of situation or appropriate judgment and flexibility is required and should be exercised

　　Qualifications Bachelor s degree in a health profession or science. Advanced degree a plus. At least 2 years of ongoing clinical trials experience.

　　Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.

　　Knowledge of medical terminology.

　　Ability to effectively work independently

　　Excellent verbal and written communication skills plus computer proficiency Word, Excel, Outlook .

　　Individuals must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally.

　　Ability to assist in identifying problems, collecting data, draw valid conclusions, and report on findings.

　　Possibly some limited travel

　　Physical Requirements While performing the duties of this job the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations.

　　What happens next

　　Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

　　Helping you discover what’s next in your career is what we’re all about,

　　#1

　　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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.