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1+ months

Sr Regional Clinical Research Associate

Kelly Services
Chicago, IL 60684
**Regional Clinical Research Monitor - Remote**


**(Ophthalmic device experience is a must with a good understanding of LASIK refractive procedures)**


Kelly is currently seeking a home based Regional CRA to support one of the largest pharma companies in the world. This role is offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise.



**Primary Job Function**


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.



**Core Job Responsibilities**




+ Compliance with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.

+ Serving as primary contact for investigative site communication for each assigned site.

+ Collaborating with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.

+ Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.

+ 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.

+ Evaluating actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.

+ Assessing case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol.

+ Performing on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include:

+ Ensuring that final CRFs are accurate and complete by verifying against source documentation, as assigned.

+ Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File and is accessible to investigative site personnel.

+ Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.

+ Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner.

+ Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance

+ Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.

+ Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.

+ Supporting study payment activities or accruals, as assigned.

+ Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.



**Minimum** **Education**



BA/BS required.



**Minimum** **Experience/Training Required**




+ **5+ years of independent field monitoring experience for clinical trials** .

+ **Risk Based Monitoring experience required.**

+ **Ophthalmic medical device industry experience required (intraocular lens (IOL) or lasik device studies that use major device machines to conduct surgery or assess conditions is a must). Must be able to understand the process of ophthalmic device and a good understanding of LASIK refractive procedures.**

+ 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.

+ Travel: Remote Risk Based monitoring at this time and possibly up to 50% travel in future




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS

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Posted: 2020-10-23 Expires: 2020-12-26

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Sr Regional Clinical Research Associate

Kelly Services
Chicago, IL 60684

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