Clinical Research Scientist

Employer
Kelly
Location
Durham, North Carolina
Posted
Apr 23, 2021
Closes
May 05, 2021
Ref
d490acdb0833
Sector
Science
Organization Type
Corporate
Kelly Services is currently seeking a Clinical Research Scientist to work a contract assignment of 12 months for one of our top clients. The role will mainly be remote work with occasional on-site travel to Durham, NC location when needed. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

Primary Responsibilities of the Clinical Research Scientist includes:

Guided in our work by a strong set of values and are resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods and thinking, and bring unexpected teams together. From scientists to sales, lab techs to legal, we are on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you are our kind of person.

The Clinical Research Scientist (CRS)/Senior (Sr) CRS will provide scientific and clinical input to all aspects of late stage product development. This includes but is not limited to the design, delivery, and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit, risk, and value of late stage development products in the Respiratory and Immunology (R&I) therapeutic area.

In this role, the CRS/Sr CRS provides input and has responsibilities and accountabilities in support of clinical studies and programs. The objectives of the CRS/Sr CRS will be set by the Group Director in agreement with the specific product Global Clinical Head(s). The role will have a special focus on late stage clinical trials within the R&I TA where the CRS/Sr CRS will work in close collaboration with the study team physician and other internal stakeholders with all aspects of scientific input, clinical data quality metrics, and safety evaluation.

You are a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance clinical drug development programs throughout the clinical development process leading to IND submissions and inspections. You will be expected to effectively collaborate with colleagues within Late R&I and early development groups. Other capabilities are to demonstrate clear and professional written and verbal communication, including presenting scientific designs and results to multidisciplinary teams and key stakeholders. You will work as a member of a diverse and motivated team of researchers spanning across multiple divisions and geographies within Biopharmaceuticals R&D. The CRS/Sr CRS works both independently and collaboratively within activities and contributes significantly to regulatory submissions, process improvement, and mentoring.

Key activities and leadership areas
• Provide scientific leadership in the innovative design, execution, and interpretation of clinical trials in one or more development programs
• Effectively collaborate with colleagues in other functions including Clinical Development, Patient Safety, Regulatory Affairs, Clinical Operations, Global and US Medical Affairs, and Early R&I
• Provide expert scientific input into the preparation of regulatory documents and interactions
• Provide expert scientific analysis and interpretation of data from ongoing studies and in the literature
• Lead development of quality metrics and data review plan for assigned studies
• Contribute to and support medical monitoring of trials
• Lead and participate in activities that ensure quality, consistency, and integration of clinical study related deliverables
• Ensure scientific input to TA standards
• Provide scientific evidence to support strategic decision making for R&D, clinical, marketing, medical affairs, and business development departments
• Present protocol, scientific results, and other key information to multidisciplinary teams and key stakeholders, including presenting at investigator meetings
• Develop and review protocols, clinical study reports, informed consent forms, investigator's brochures, electronic data capture forms, other key clinical development documents

Qualifications
• Scientific and clinical expertise related to the design and implementation of clinical trials and interpretation of trial results.
• Proven ability to work collaboratively in a cross-functional setting
• Experience, particularly Phase II and Phase III clinical development and experience with regulatory submissions, life cycle management, advisory boards, annual safety updates is ideal
• 5 or more years of relevant pharmaceutical industry experience (multi-country clinical trials) is required
• Availability to travel, including international, may be required

Education and Experience Requirement of the Clinical Research Scientist includes:

• Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with extensive experience from clinical development or medical affairs

Additional Information:
  • Contract assignment, duration 12 months.
  • Work schedule: full-time, first shift.

Kelly Temporary Employee Perks:
  • Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase-and the coverage is portable*
  • Service bonus plan and Holiday pay plan, if qualified
  • Weekly electronic pay options
  • Free online training campus available
  • Exclusive online employee community
  • Corporate discounts

Apply Now!

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:

Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3424847]

Thank you for your interest in the assignment.

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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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.
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