GENERAL OVERVIEW:
Plans, coordinates, and manages the activities associated with the initiation and completion of clinical trials, sponsored by internal, industry, foundation, and/or Federal funding sources. Maintains compliance with all regulatory bodies associated with human subject research.
ESSENTIAL RESPONSIBILITIES:
Interfaces between clinical staff, the Office of Sponsored Research, Research Administration, PIs, clinical research staff, and external entities to identify clinical research pipeline and completes protocol budgeting, feasibility, and initiation. (30%)Interfaces with clinical staff to identify patients eligible for clinical trials across one or multiple sites of service. Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (25%)Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure they are informed prior to obtaining written consent. Completes required follow-up and active patient monitoring per study protocol at one or multiple sites of service. (25%)Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies. (10%)Performs other duties as assigned or required. (10%)QUALIFICATIONS:
Minimum
Associate's degree, RN, or equivalent research experience.3-5 years’ related experience.Preferred
Bachelor’s Degree.Current research-related certification from accredited program such as The Association of Clinical Research Professional (ACRP), e.g. Certified Clinical Research Coordinator (CCRC), ACRP Certified Professional (ACRP-CP) or The Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professionals (CCRP).Driver's license may be required depending on facility requirements.Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.
Compliance Requirement: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.
As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy.
Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.
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