Kelly Services Clinical Research Associate II (CRA II) in Santa Ana, California
Kelly Services OCG is currently seeking an In-House Clinical Research Associate II located in Santa Ana, California for one of our top clients for a long-term, up to 18 month contract assignment. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
This assignment is based in the client’s facility (some travel may be required) and and will provide clinical research support and assistance in overseeing the conduct of clinical trials.
Primary Responsibilities of the In-House Clinical Research Associate II includes:
Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (GCP) guidelines, and government regulations.
Evaluate, monitor, and document study results.
Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.
Monitor Clinical Research Organizations (CROs) and study management of multiple sites.
Document retrieval, archival, informed consent release forms, amendments, etc.
Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome.
Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.
Approximately 15% local on-site co-monitoring.
Education and Experience Requirement of the In-House Clinical Research Associate II includes :
Bachelor’s degree required
3-5 years combined experience with at least one of the following:
Medical device experience
In-house pharma CRA experience (strictly Regional CRA experience will be considered)
On-site monitoring experience is preferred but not required
Candidates transitioning directly from a Clinical Research Coordinator role will NOT be considered
Electronic Data Capture (EDC) experience required (non-discriminatory)
Excellent oral and written communication skills
Willingness to travel up to 25% (on an as-needed, not continuous basis) in Southeast US for occasional co-monitoring
Duration: up to a 1 year assignment
Work schedule: 40hr/week.
This assignment comes with enhanced benefits which include (*benefits to be received upon meeting eligibility requirements):
50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
Paid sick days and vacation days*
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning Center
Online application system
Never an applicant fee
This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.
Why Kelly ® ?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm