duties and responsibilities may include the following. Other duties may be assigned. Regulatory
Responsibilities: Is responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures as well as other regulatory policies regarding human subject research. Reviews proposed protocols and determines appropriate regulatory agency for submission, provides direction and guidance regarding the procedures, required forms, and documentation necessary for compliance.
Maintains knowledge of site and sponsor specific requirements as well as ensuring compliance for all assigned studies both active and pending. Serves as a resource for the clinical staff; assist with review of source data and regulatory documents to address sponsor/auditor queries, conduct regulatory binder reviews to ensure they are complete and up-to-date.
Is responsible for understanding and promoting Human Subjects Protections, as defined by the federal Office for Human Research Protections (OHRP), within study sites for studies and trials; supporting the safety of research patients and participants; ensuring OHRP compliance by Primary Investigators, research teams, study staff, clinical staff and any other personnel assigned to or otherwise involved with the studies.
Identifies, initiates, and ensures completion of all training required for employment in the Clinical Trials Department: data logs; audio-video presentations; informational portals; and all institutional requirements and certifications. Work with intra-office staff to insure that the Clinical Trials Department remains in compliance with all government regulations.
Clinical Trials
Responsibilities: Assists Investigator(s) by helping to identify potential clinical trial patients for enrollment. Collaborates with Investigator(s) to ascertain eligibility of potential subject for study per protocol. Educate patient and families with respect to study participation, informed consent, potential side effects if applicable, insurance and financial considerations of study participation, follow up care and available support if needed.
Assists the Investigator with protocol entry, adherence to compliance, and other matters as needed. Is responsible for data submission, paper or digital, to the appropriate cooperative group of sponsor per protocol requirements. Other Responsibilities Demonstrates compliance with the Statement of Organizational Ethics and all policies related to the organization's Corporate Compliance Program as evidenced by attendance at applicable educational programs; consistently carrying out job responsibilities ethically and professionally; exhibiting ethical and professional workplace behavior and decision-making; and reporting any infractions using the appropriate chain of command and without fear of retribution.
Completes annual learning requirements, reviewing fire safety and Isolation precaution policies, applicable code reviews, disaster plan reviews, policies on handling hazardous and toxic substances, and risk management issues. Demonstrates an interest in patient safety education and participates proactively in identifying problems and incidents in the department and throughout the hospital which place any patient, visitor, or staff member at risk or injury.
Modifies work schedule to meet department goals and deadlines. Follows EMTALA, HIPAA, payer, and other regulations and standards. Observes hospital and department guidelines concerning dress and display of name badge, presenting an appearance appropriate to the work environment.
Adheres to department customer service standards. Readily identifies work that needs to be performed and completes it without needing to be told. Demonstrates a positive and friendly demeanor even in stressful situations to ensure a positive experience for all customers.
Communicates in a respectful, positive way with fellow colleagues. Assists in orienting new colleagues. We're glad you're here.
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If you're interested in exploring career opportunities within Halifax Health and unsure of where to start, upload your resume here. Our Recruiters will review and contact you if there is an opportunity that seems like a good match. Recognized as one of the 50 Top Cardiovascular Hospitals in the United States by IBM Watson Health, Halifax Health serves Volusia and Flagler counties, providing a continuum of health care services through a network of organizations including a tertiary hospital, two community hospitals, urgent care clinics, psychiatric services, a cancer treatment center with five outreach locations, the area's largest hospice, a center for inpatient rehabilitation, outpatient rehabilitation clinics, primary care walk-in clinics, a clinic specializing in women's health, a pediatric care community clinic, five pediatric medical practices, a home health care agency and an exclusive provider organization.
Halifax Health offers the area's only Level II Trauma Center, Thrombectomy-Capable Stroke Center (TSC), Center for Transplant Services, Pediatric Intensive Care Unit, Child and Adolescent Behavioral Services, complete Neurosurgical Services, OB Emergency Department and Level III Neonatal Intensive Care Unit that cares for babies born earlier than 28 weeks.
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This posting was published by Halifax Health on their own careers system and is shown here with a direct link to apply there. Employers: for corrections or removal, contact jobs@veritahire.com.