Sr Clinical Research Scientist/Medical Writer

2 days ago

Irvine, United States Kelly Full time
Job DescriptionSenior Clinical Research Scientist

Qualifications:

 

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  • A minimum of a Bachelor’s degree with at least 5 years of clinical research experience required
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  • Advance degree (Master’s degree, PhD, PharmD etc.) with 2-3 year of clinical or related research experience highly preferred
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  • A Life Science, Physical Science, Nursing, or Biological Science degree is preferred
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  • Ability to analyze and interpret scientific data and advanced writing/presentation skills are required, such as conducting literature reviews, and planning and drafting conference presentation and peer-reviewed journal articles
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  • Knowledge of Good Clinical Practices and ICJME/Good Publication Practices is required
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  • Gpp3, ISMPEE – highly preferred
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  • Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics related to healthcare market environment, and global clinical trial regulations is preferred
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  • Prior experience designing and executing clinical studies is highly desirable
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  • Project management skills with the ability to handle multiple projects is required
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  • Medical device experience is preferred
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  • Cardiovascular experience is a plus
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  • Relevant industry certifications preferred (ie, CCRA, RAC, CDE, CMPP, MWC)
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  • This position is located in Irvine, CA


Job Description:

This professional will report to Clinical Science and External Research (CSER) Leaders in the management of assigned clinical projects for the Cardiovascular Group to support the development of the evidence generation and dissemination strategy of assigned products, manage clinical studies, execute publication plans, and conduct literature reviews. S/he will manage activities with supervision consistent with level of experience. S/he will be responsible for providing support activities for clinical activities and other study-related tasks, as well as applicable department study-related procedures.

The Senior Clinical Research Scientist will or may be responsible for:


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  • Working with Global Strategic Marketing, Franchise Clinical Leaders, Biostatistics, Data Management, Medical Affairs, and other functions on: (i) planning and executing research collaborations with physicians, (ii) tracking study idea development and progress, and (iii) planning data dissemination via congress presentation and peer-reviewed publications
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  • Managing nonregulated studies (eg, Investigator initiated, Registries, Real-world evidence, Company -sponsored postmarket studies) and low complexity regulated studies (eg, Postapproval, Real-world evidence) including study budget assessment, fair market value appraisal, contract development and execution, and payments
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  • Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities, contractors/vendors, and Company personnel
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  • Developing study-related materials (eg, protocol, CRFs, CSR)
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  • Analyzing, interpreting, summarizing, and sharing appropriate interpretation of clinical evidence generated from research studies
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  • Leading study-related publication efforts including abstracts, congress presentations, and manuscripts, per clinical publication policy
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  • Collaborating with cross-functional team members to develop collaterals to disseminate research results among internal and external stakeholders
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  • Knowing, understanding, incorporating, and complying with all applicable laws and regulations relating to business activities, and Policies and Procedures
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  • Evaluating publication support requests and providing meaningful, consolidated comments during the publication development lifecycle
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  • Tracking assigned project budgets to ensure adherence to business plans
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  • Communicating progress towards planned timelines


Additional Skills Requirements:

 


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  • Effective time management, organizational and prioritization skills, and the ability to manage multiple tasks
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  • Strong project management skills with meticulous attention to detail and accuracy
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  • Professional verbal and written communication skills
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  • Proven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently, as needed
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  • Must be reliable, and flexible in adapting to shifting business needs while contributing to a multidisciplinary and fast-paced working environment
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  • Must be a highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of his/her contributions to the advancement of the collective CSER goals and objectives

Proficient in Microsoft Office

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\t\t\t\tAs 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.
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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 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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