At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Research is highly specialized, regulated and require exceptional organizational skills.
This role requires coordinating multiple studies, all at different states, in their implementation.
Paperwork, data, participant information, and regulatory information all need to be entered, filed, and kept in order.
Requires adherence to all policies and procedures from Sponsors, IRB, FDA, GCP and other regulatory sources.
Provides leadership in the management and operation of clinical research to ensure patient safety, protocol compliance and data quality and reporting requirements.
Organize, participate, prepares, and submits documents needed for the initiation, monitoring, internal and external auditing and study close out visits.
Identifies and recruits patients for clinical trials through referrals, medical record screening, education, and direct communication with potential subjects.
Stays in direct communication with the PI, Co-I’s, managers and Sponsors regarding the status of the study.
Monitor and assess patient compliance.
Schedule and oversee subject visits, testing, procedures, and rectify billing to ensure study related activities versus standard of care bills and paid by Study grants versus Subject’s
Insurance as outlined in the study contract and protocol.
Collect, process, and ship specimens in accordance with shipping and transport of regulated biological materials (IATA) and local regulations.
Mentors study staff with less research experience.
Requires travel to outpatient sites and the Hospital.
Instruction and training of Clinical Research Coordinators 1-3.
Provides instruction and guidance to CRC Levels 1-3 to ensure compliance with FDA requirements.
Provides evaluation and recommendation to leadership in preparation for FDA Audit.
6-10 years' experience required.
Communication – Ability to communicate with patients, visitors and coworkers required.
Phlebotomy skills preferred.
Clinical experience, including but not limited to RN/LPN/MA required.
Dedication to patient – focused, family centered care (for jobs with patient/family contact) required.
Bachelor’s degree required.
May substitute required education degree with 10 plus years of research experience.
Current Research Coordinator Certification (CCRC or CCRP) required.
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