Kelly Services Regional CRA/Site Manager in Santa Ana, California
Kelly Services’ Outsourcing & Consulting Group (OCG) is seeking a Regional CRA/Site Manager with ophthalmology (Lasik refractive/PRK) and medical device experience based in/near Orange County CA . This is an open-ended assignment and comes with enhanced benefits. Travel is approximately 75% and the customer does want the CRA/Site Manger to come into the office 1-3 days per week when not traveling. This position will oversee approximately 10 sites for one protocol and typically requires 1.5-2 days at each site which are located across the U.S.
The CRA/Site Manager interacts with internal and external personnel involved in clinical research, including investigators and investigative site personnel, and contributes to the successful planning and execution of assigned studies within budget and in conformance with global regulations and internal policies and procedures. This role is also accountable for performance and compliance of assigned investigative sites and works with relative autonomy and some supervision. Failure to achieve results or erroneous decisions or recommendations may cause delays in project schedules and may result in the allocation of additional resources.
As assigned CRA for investigative site(s) on a clinical trial, responsibilities include:
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 high 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 and 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 of 3 years of independent field monitoring experience for clinical trials
Ophthalmic monitoring experience and/or medical device monitoring experience
Intraocular Lens (IOL) experience required
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 preferred.
Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate.
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
This position comes with enhanced benefits which include:
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
*benefits to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at email@example.com.
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