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28 days old

Clinical Research Assistant

Kelly Services
Fort Myers, FL 33906
Clinical Research Coordinator II


Fort Myers, FL


Full-Time


1st Shift


Monday-Friday, 8AM-5PM


Kelly Science & Clinical is looking for a Clinical Research Coordinator II to join a growing CRO studying metabolic diseases in Fort Myers, FL.


Responsibilities


+ Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities by following GCP, ICH, FDA Guidelines, and site SOPs.


+ Maintain CITI training.

+ Ensure scientific integrity of data and protect rights, safety, and well-being of patients enrolled in clinical trials.

+ Develop accurate source document materials and ensures compliance of all staff.

+ Provides accurately and timely data collection, documentation, and assists with EDC entry and queries.

+ Interfaces with research subjects to support efforts to determine eligibility and consenting of research subjects.


+ Ensures compliance with research protocols by providing ongoing QC audits, maintaining IP drug accountability, accurate records of correspondence with Sponsors and patients, and following protocol specific guidelines.

+ Monitors research subjects to ensure adherence to study protocol and reports deviations to the Sponsor and IRB as required.

+ Provides cross coverage for all studies as assigned by Chief Clinical Officer.

+ Collects and processes lab specimens, ECGs, vital signs, etc. as required per the study protocol.

+ Manages inventory of equipment and supplies related to study needs.


+ Schedules all subject visits and procedures consistent with the protocol requirements.

+ Reports SAEs and AEs in the timeframe required by the Sponsor and IRB and collaborates with the PI/SubI on assessing the AE relationship/causality.

+ Monitors laboratory and other imaging reports for any abnormalities that need to be addressed by the SubI/PI in a timely manner.

+ Meets with monitors during scheduled monitoring visits and close-out visits.

+ Reports all compliance issues to QC and Regulatory team


+ Attains credentialing certificate for CCRP or CCRC

+ Complies with all PTO guidelines including subject communication as needed

+ Maintain membership to site approved national accredited research society


Qualifications


+ Experience with the management of patients in clinical trials is required

+ Minimum of Associate Degree with 10 years of clinical research experience or Bachelors Degree with 5+ years of clinical research experience

+ Vast experience as CRC I

+ Bilingual in Spanish strongly preferred


**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** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-07-15 Expires: 2022-08-29

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Clinical Research Assistant

Kelly Services
Fort Myers, FL 33906

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