
Description
Kelly Science & Clinical is excited to present a Clinical Research Coordinator position on behalf of one of our client's rapidly expanding their clinical research portfolio in Winter Park! Seeking individuals with clinical trial experience for at least 1 - 2 years.
The Clinical Research Coordinator I - is an entry-level position
What's expected of you:
- I will be expected to carry a slightly reduced study load and will be mentored by a more experienced CRC III during the ensuing months. - Over time, it is expected that the CRC I will demonstrate greater proficiency and productivity, a quality work product and develop the skills and capability to progress to the next CRC level CRC II.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
- Study Preparation: Learn to review and assess protocol including amendments for clarity, logistical feasibility, subject safety, and inconsistencies, etc.
- Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff
- Assist with planning and creation of appropriate recruitment materials
- Actively assist in development of recruitment plan and obtain listing of potential candidates to contact from database
- Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
- Participate in Investigator s meeting and/or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives Co-Create or review sponsor provided protocol specific source documents Review and determine facility, equipment and outsource vendor availability
- Ensure adequate supplies have arrived on site for protocol initiation lab kits, study medication, specialized equipment, IVRS/EDC access and passwords
- Work with mentor to ensure education of staff and/or sub-investigators is completed for required tasks
- Study Management: Learn to integrate new trial with existing trial load, delegate tasks as necessary, and prioritize activities with regard to protocol timelines
- Maintain organized files for blank source documents, patient charts, CRFs, and supplies
Job Description Clinical Research Coordinator I
- Work with mentor to actively handle Investigational Product accountability: receive inventory, dispense, monitor patient for compliance, and re-order study supplies as necessary.
- Document on accountability log and patient records.
- Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings
- Ensure trial activities are discussed in advance with covering personnel in case of vacation or sick leave
- Actively practice and maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
- Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the team in an ongoing fashion
- Develop and maintain effective relationships with study participants and the Research personnel
- Interact in a positive, professional manner with patients, sponsor representatives, offices/investigators, and the Research personnel
- Communicate clearly verbally and in writing Accept accountability for actions and learn to function independently
- Patient Coordination: Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
- Obtain informed consent per Research SOP and document process when revised ICF discussed with patients during the course of the trial Complete visit procedures
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.
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