Company :Allegheny Health Network
Job Description :
Assists with the planning, coordination, data management and regulatory 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.
This is a part time role working with the Pediatric Orthopedic Institute.
- Assists with the collection, maintenance, and storage of relevant clinical data including electronic data entry, case report forms, patient follow-up and regulatory binders in accordance with the study sponsor and all regulatory bodies. (30%)
- Assists with the planning and coordination of regulatory activities pertinent to clinical trial operations, including but not limited to: interfacing with local and central IRBs, assuring patient safety and organizational compliance with institutional, local, state and Federal policies/procedures, regulations, guidelines, and laws. (30%)
- Assists senior-level research coordinator staff with patient screening, education, consenting, monitoring, and evaluation for protocol accrual. (30%)
- Performs other duties as assigned or required. (10%)
- Associate's degree or equivalent research experience.
- 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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