19 days old

Senior Clinical Research Specialist (Trial Manager)

Kelly Services
Irvine, CA 92604
**Sr Clinical Research Specialist**


Kelly is currently seeking a Senior Clinical Research Specialist for a long-term engagement at one of our Global clients. This role is remote but may have travel from 10 20% travel at requirements at times.

This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All KellyOCG employees receive annual performance reviews.


This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.


+ Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for the client.

+ 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)

+ Contribute towards development of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on from study initiation through posting of results and support publications as needed;

+ 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

+ Contribute to 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

+ Support project/study budget activities as assigned

+ Develop a strong understanding of the pipeline, product portfolio and business needs

+ Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures

+ Generally, manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations.


**Functional and Technical Competencies** **:**

+ Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations

+ Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations

+ Good presentation and technical writing skills

+ Good written and oral communication skills

**Leadership Competencies:**

Ability to lead small study teams to deliver critical milestones, as may be assigned.

Leadership required in alignment with the clients Leadership Imperatives:

+ **Connect** - Develop collaborative relationships with key internal and external stakeholders.

+ **Shape** - Make recommendations for and actively participate in departmental process improvement activities.

+ **Lead** - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

+ **Deliver** - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.



+ Minimum of a bachelors degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.


+ BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred

+ Previous experience in clinical research or equivalent is required.

+ Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

+ Clinical/medical background a plus.

+ Medical device experience highly preferred.

+ Ability to travel approximately 20% depending on the phase of the program.

**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: 2021-10-06 Expires: 2021-11-06

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Senior Clinical Research Specialist (Trial Manager)

Kelly Services
Irvine, CA 92604

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