Join Kelly FSP as Clinical Research Specialist at our client site in Irvine, CA.
This is a Hybrid Position. Monday, Wednesday and every other Friday on site.
JOB SUMMARY
This 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.
DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position
Serve 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, for the under supervision
Participate in the 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);
Assist in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed
Coordination and execution of ordering, tracking, and managing investigational products and trial materials
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Assist in overseeing the development and execution of Investigator agreements and trial payments
Assist in 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
If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
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
Assist in tracking assigned project budgets
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
Performs other duties assigned as needed
Generally manages work with supervision, dependent on project complexity
Independent decision-making for simple situations but required guidance for complex situations.
Education • Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required. Experience • 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 (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…). • Clinical/medical background a plus. • Medical device experience a plus.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* Functional and Technical Competencies: • 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 communication skills. Leadership Competencies: Leadership required in alignment with Leadership Imperatives: • 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.
