Kelly Science & Clinical is currently recruiting for a Clinical Research Coordinator for research site in the Georgetown, TX area. This role is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials.
Collaborates with physician in determining eligibility of patients for clinical trials.
Provides education to staff and patients.
Ensures site research quality by practicing in compliance with Company’s Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP), and applicable federal, state, and local regulations.
Supports and adheres to Company Code of Ethics Business Standards.
Screens potential patients for protocol eligibility.
Presents trial concepts and details to the patients, participates in the informed consent process and enrolls patients on protocol.
Coordinates patient care in compliance with protocol requirements.
May administer and/or dispense investigational product and provide patient teaching regarding administration.
Maintains investigational product accountability.
In collaboration with the investigator, reviews patients for changes in conditions, adverse events, concomitant medication use, and protocol compliance and thoroughly documents all findings.
Responsible for accurate and timely data collection, documentation, entry, and reporting.
Works with sponsor representatives during site initiation visits, interim monitoring visits, etc.
Participates in required training and education programs.
Responsible for education of clinic staff regarding clinical research.
Identifies quality and performance improvement opportunities and collaborates with staff in development of action plans to improve quality.
Works closely with Recruitment Director to identify appropriate patients for clinical trials
Responsible for local management of assigned research studies from start-up to study close-out
Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Associates degree in a clinical or scientific related discipline required, Bachelor’s degree preferred.
Minimum of two years’ experience in a clinical or scientific related discipline, preferably in clinical research.
SoCRA or ACRP certification preferred.
Must be knowledgeable of FDA Guidance in Clinical Research and ICH/GCP Guidelines.
Must have excellent written and verbal communication skills, a strong background in medical/clinical terminology and medications and be proficient in Microsoft Office applications.
Direct Hire; Great Benefits
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.