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1+ months

Winter Park

Kelly Services
Winter Park, FL 32789
**Bilingual (Spanish) Clinical Research Coordinator I (CRC I) - REPORTS TO: Site Director Study Specific Principal Investigator Mentored by CRC III**


**JOB SUMMARY:**


The Clinical Research Coordinator I is an entry level position and is meant to fully integrate the new CRC in the Clinical Research process. Although basic responsibilities are similar to the more experienced CRCs, the CRC 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 meetings 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:**


+ Work with mentor to actively handle Investigational Product accountability: receive, inventory, dispense, monitor patient compliance, and re-order 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 Research personnel Interact in a positive, professional manner with patients, sponsor representatives, offices/investigators, and 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


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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 worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits 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** ****


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 (plus, did we mention we provide a ton of benefits ?). 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 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 Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-08-24 Expires: 2022-10-27

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Winter Park

Kelly Services
Winter Park, FL 32789

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