Clinical Study Assistant - Kelly Services
Jacksonville, FL 32256
About the Job
Clinical Study Assistant
Hybrid - On-site in Jacksonville, FL every Monday and Wednesday
Pay: 60,000 - 66,000 a year
QUALIFICATIONS:
Minimum education required for competent performance:
- BA/BS or equivalent years of experience required.
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
- 0-2 years of clinical research experience
- Knowledge of ophthalmology highly desirable, but not required.
- Ability to problem-solve.
- Good communication via written, verbal and listening skills.
- Ability to report to corporate offices for routine, daily work.
- Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities.
- Ability to problem-solve.
- Proficiency with MSWord, Excel and PowerPoint.
Equipment usage and abilities needed:
- Medical Device industry experience is preferred.
- Knowledge of ophthalmology is preferred.
- Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials, is required.
- Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities is preferred.
- Ability to problem-solve is required.
- Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings is preferred.
- Proficiency with MS Word, Excel and PowerPoint is required.
- Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate is required.
JOB GOAL:
Provides administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs. Close collaboration with other members within Clinical R&D. Effectively manages multiple clinical study start activities to assure accurate and timely initiation for assigned clinical trials.
RESPONSIBILITIES:
- Serving as internal support for all members of assigned teams.
- Supporting investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation.
- Supporting establishment and maintenance of the electronic Trial Master Files(eTMF) for assigned clinical trials.
- Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
- Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, as requested by the Study Manager, Lead CRAs, CRA sand other clinical trial team members.
- Assist the study team with study startup procedures, including preparing site binders.
- Assisting assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials.
- Ensuring all equipment/supplies provided to investigative sites is appropriately tracked and reported to Study Manager and/or Lead CRA during study startup
- Assist with contracts and purchase orders. 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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Source : Kelly Services