Company :Allegheny Health Network
Job Description :
Plans, coordinates, and manages activities associated with the initiation, conduction, and completion of multiple clinical trials sponsored by internal, industry, foundation, and federal funding sources. Maintains compliance with all regulatory bodies. Provides and develops educational opportunities for staff and monitors outcomes.
- Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies. (20%)
- Plan, coordinate, and manage all activities pertinent to the specific clinical trials, ensuring patient safety, Good Clinical Practices (GCPs), and compliance with the protocol and regulatory agencies. (20%)
- Communicate all relevant data, information to the PI, appropriate hospital personnel, the IRB, external sponsors, and the FDA (if applicable) to assure patient safety and compliance with institutional, local, state, and federal policies/procedures, regulations, guidelines, laws. (20%)
- Identify, evaluate, and resolve solutions to problems/issues associated with the research protocol to the PI, the external sponsor, and the appropriate regulatory agency (if needed) to assure patient safety, enrollment, and compliance with the GCPs and regulatory agencies. (10%)
- Educate patients and their families regarding the investigational study and the requirements of participation to assure that they are informed prior to obtaining written consent. Provide in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (10%)
- Participates in the development and implementation of departmental and hospital performance improvement activities. (10%)
- Communicates and coordinates patient care with patient, family, community health services, and interdisciplinary team. (5%)
- Ensures compliance with all regulatory agencies. (5%)
- Bachelor's degree in research or public health or degree/diploma in Nursing
- Requires excellent organizational skills, critical thinking skills, excellent computer skills, decisive judgment, and the ability to work independently with minimal supervision. Must be able to work in a dynamic and rapidly changing environment and take appropriate actions. The complexity is further defined by the need to adhere to and understand regulations related to human subject research.
- Prefer 5 years of experience relevant to area of research.
- Bachelor's Degree in Nursing
- Certified Clinical Research Coordinator (CCRC)
- Research coordination experience
- Quality Measure work strongly preferred
- Driver's license may be required depending upon 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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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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