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Clinical Research Associate

Company: Kelly Services
Location: Irvine
Posted on: September 24, 2022

Job Description:

Clinical Research Associate II (CRA II) - Regional CRA JOB DESCRIPTION: REGIONAL CLINICAL RESEARCH ASSOCIATE The requirements listed below under the job title are representative of the knowledge, skills, and/or abilities required to perform the duties of this position. 1 QUALIFICATIONS: a Minimum education required for competent performance: BA/BS required b Minimum experience number of month/years and type of work experience beyond formal education required for competent performance: 2-5 years of independent field monitoring experience for clinical trials. Risk Based Monitoring experience required Ophthalmic medical device industry experience strongly preferred e.g. intraocular lens/cataract surgery studies with large device machines c Equipment usage and abilities needed: Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials. Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities. Ability to problem-solve. Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings desired. Proficiency with MS Word, Excel and PowerPoint required. Proficiency with electronic data capture and electronic Trial Master File. Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate. d Travel: 50 75 travel for site visits in California and Utah 2 JOB GOAL: Monitors and reports on the conduct of simple to complex clinical research studies required to enter new products into the marketplace or to expand product claims, in compliance with state and federal regulations, industry standards and corporate policies. Effectively manages multiple clinical sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials. 3 RESPONSIBILITIES: a Compliance with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations. b Serving as primary contact for investigative site communication for each assigned site. c Collaborating with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation. d Coordinating Institutional Review Board/ Ethics Committee IRB/EC approvals, as appropriate. e Training investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations. f Evaluating actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets. g Assessing case report forms CRFs for trends in safety, effectiveness, and adherence to protocol. h Performing on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include: i Ensuring that final CRFs are accurate and complete by verifying against source documentation, as assigned. j Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File and is accessible to investigative site personnel. k Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated. l Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner. m Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance n Monitoring overall progress of clinical trials by regularly atteiteon

Keywords: Kelly Services, Irvine , Clinical Research Associate, Healthcare , Irvine, California

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