GENERAL OVERVIEW:
This job 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 with clinical staff to identify patients eligible for clinical trials. Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (30%) Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure that they are informed prior to obtaining written consent. Completes required follow-up and active patient monitoring per study protocol. (30%) Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies. (15%) 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. (15%) Performs other duties as assigned or required. (10%)QUALIFICATIONS:
Minimum
Associate's degree, RN, or equivalent research experience. 1-3 years’ related experience.Preferred
Bachelor’s Degree Experience in phlebotomy 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.
Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, age, religion, sex, national origin, sexual orientation/gender identity or any other category protected by applicable federal, state or local law. Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, age, religion, sex, national origin, sexual orientation/gender identity, protected veteran status or disability.
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