Clinical Research Associate

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Job description

Clinical Research Associate (levels II and III):

Kelly® Science & Clinical is seeking Clinical Research Associate professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all. If you're passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.

The Clinical Research Associate II/III will be responsible for data collection and management for CCTRA clinical trials. This position must be able to organize complex projects, provide attention to detail, and communicate effectively. Works closely with CRA Team Lead and CRNs to manage the day-to-day operations and objectives in support of the assigned portfolio.

Responsibilities:

• Interprets institutional policies related to clinical trial data collection, management, and reporting to ensure departmental adherence.
• Represents the department and investigators at local, regional and national meetings.
• Facilitates effective communication among staff, PIs and other research/clinical professionals, senior leaders, and study sponsors.
• Serves as the general administrator and liaison for the PI, research subjects, human testing compliance, privacy/HIPAA compliance, other research and clinical professionals, and the granting or funding entity relative to the research protocol.
• Ensures strict adherence to all regulatory requirements such as the reporting of serious adverse events in the timeline required by the study sponsor and the Institutional Review Board.
• Prepares high-quality written documents; analyzes data and formulates conclusions.
• Participates in the development and maintenance of electronic infrastructure and clinical trial management suite.
• Advises the PI on administrative requirements necessary as required per protocol. Monitors protocol status and advises PI on requirements and deadlines.
• Manages the collection and transmission of samples, scheduling of clinical visits and tests, and the collection, processing, and reporting of data.
• Assists departmental faculty/PI in the development, preparation, and submission of research protocols and related documentation.
• Confers with PI and support staff to secure necessary documents for proposals.
• Assists in the screening, recruitment, selection, consenting, and enrollment of subjects.
• Assists with the development, implementation, maintenance, and evaluation of quality assurance plan for conduct of clinical trials, while working closely with sponsor representatives to address and respond to monitoring and auditing reports.

Minimum Qualifications:

Level II:

• Bachelor's degree plus three (3) years of general or clinical research experience with demonstrated study planning/development, study coordination/management and data collection OR a High School diploma/GED plus seven (7) years of general or clinical research experience with demonstrated experience/proficiency in relevant to oncology clinical trials.
• Travel for CRAs could be be 50% to 90%.

Level III:

• Bachelor's degree plus five (5) years of clinical research experience with demonstrated study planning/development, study coordination/management and data collection OR a High School diploma/GED plus nine (9) years of general or clinical research experience with demonstrated experience/proficiency in relevant to clinical trials.

• CRA Level III also requires CCRP, CCRC or equivalent professional certification.
• Flexible to travel and could be 50%-90%.

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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.

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 interests-it's 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.

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 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.

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