Kelly is currently seeking an Sr. In-house CRA for a long-term engagement with one of our Global Medical Device clients. It is preferred that this person is located locally to Irvine, CA.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
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.
Support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones;
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 www.clinicaltrials.gov 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;
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;
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.
REQUIRED KNOWLEDGE AND SKILLS
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;
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