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Sr Clinical Research Coordinator IIIEvery day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We currently have exciting opportunities with an innovative patient research solutions based company that has been around and operating for over 100 years. This is a direct hire opportunity with growth potential based in the South Florida region. We are hiring a Sr CRC who is able to be on-site in Sarasota FL and can meet the following expectations:Job Duties: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 SOP’s.
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, ECG’s, 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 SAE’s and AE’s 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.
Attends weekly CRC meetings, SIV and IM meetings as required and attends end of day CRC Meetings for schedule planning.
Reports all compliance issues to QC and Regulatory team.
Attains credentialing certificate for CCRP or CCRC.
Complies with Covenant Research drug policy.
Collaborates and communicates with other team members as needed, i.e., recruitment, RA’s, interns, PI/SubI.
Maintain membership to site approved national accredited research society.
Position Minimum Qualifications:Minimum of BS degree required
10 years of clinical research experience; 5 years clinical research experience with a master’s degree. Will flex on years of experience if strong clinical trial coordination and leadership experience in the past. At least 5 years of CRC experience is required.
Experience with clinical trial coordination and exposure or hands on experience as a group and study leader manage projects and timelines
Must be a team player with great communication skills, organized, task oriented, and has great attention to detail.
Spanish speaking preferred but not required.
#P2You 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 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 ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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 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.
Vacancy expired!