Clinical Research Leader Job Listing at Kelly Services in Irvine, CA (Job ID US3622836_BH9981745)

Description

JOB SUMMARY*
This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization. 

DUTIES & RESPONSIBILITIES*
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate client, procedures and guidelines, this position:

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for the <insert Operating Company>;
• Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures; 
• May serve as the primary contact for clinical trial sites (e.g. site management);
• Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision;
• Ensure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov)
• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Oversee the development and execution of Investigator agreements and trial payments;
• Responsible for clinical data review to prepare data for statistical analyses and publications;
• If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
• If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
• Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
• Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Track and manage assigned project budgets to ensure adherence to business plans; 
• Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;
• Develop a strong understanding of the pipeline, product portfolio and business needs;
• May serve as the clinical representative on a New Product Development team;
• May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
• Perform other duties assigned as needed;
• Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations.

EXPERIENCE AND EDUCATION*
Education

• Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience                 

• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
• Previous experience in clinical research or equivalent is required.
• Experience working well with cross-functional teams is required.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background a plus.
• Experience managing projects a plus.
• Medical device experience highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
Functional and Technical Competencies:

• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects;
• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral communication skills;
• Demonstrate competencies in the following area are required:
• Behave and lead in a professional and ethical manner
• Advanced technical writing skills
• Advanced project management skills with ability to handle multiple projects

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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