Clinical Research Specialist

About the role

Kelly Science and Clinical FSP is seeking a Clinical Research Specialist for a 7 to 8 month contract opportunity with a Global Medical Device client in Irvine, CA. This role is full-time and offers full benefit options as part of the Kelly FSP (Functional Service Provider) division.

Responsibilities

• Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones under supervision
• Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with ICH-GCP, applicable legislation and Company Standard Operating Procedures
• May serve as the primary contact for clinical trial sites (e.g. site management)
• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
• Supports applicable trial registration (e.g. clinicaltrials.gov) from study initiation through posting of results and support publications as needed
• Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel
• Interfaces and collaborates with Clinical Research Associates (CRAs)
• Assists in overseeing and supports the development and execution of Investigator agreements and trial payments
• Assists in clinical data review to prepare data for statistical analyses and publications
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
• Assists in tracking assigned project budgets
• May perform other duties assigned as needed
• Is 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
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• Should develop a strong understanding of the pipeline, product portfolio and business needs
• Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations

Qualifications

• Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science
• BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred
• Previous experience in clinical research or equivalent is desired
• Relevant industry certifications preferred (CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, etc.)
• Clinical/medical background is a plus
• Medical device experience is a plus

Required knowledge, skills, and abilities

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations
• Proven track record in supporting clinical projects within clinical/surgical research setting, on time, and in compliance to SOPs and regulations
• Presentation and technical writing skills
• Written and oral English communication skills

Leadership competencies

• Connect: Develop collaborative relationships with key internal and external stakeholders
• Shape: 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

Location & travel

• Primary location is Irvine, CA. At management discretion, the position may be performed remotely
• Ability to travel approximately 20% depending on the phase of the program

External interactions

• Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated
• May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial