Oncology Research Coordinator Overview:

The Patient Navigator is responsible for coordinating the regulatory research services, advocate for the patient, and facilitates timely access to clinical trials through the cancer care research continuum.

Position Summary:

The Oncology Research Regulatory/Data Coordinator (RDC) is responsible for regulatory compliance and the submission of clinical trials conducted through our cancer treatment center. Under the guidance of regulatory personnel within the Clinical Trials department, the RDC will collaborate with physicians, nurses and other key personnel to ensure compliance with the regulations of study sponsors, the Halifax Oversight Committee, and Institutional Review Boards (IRB). Duties includes obtaining regulatory approval for new protocols; maintaining approval for existing protocols; tracking and documenting completion of protocol training; obtaining approval for protocol addenda and study renewal; maintaining protocol databases; and submitting and tracking all IRB documents. Regulatory compliance must be enforced throughout the Clinical Trials Department to ensure compliance with FDA regulations, Good Clinical Research Practice Guidelines as outlined by the World Health Organization, and requirements of the National Institute of Health. Although the primary focus will be on regulatory compliance, the RDC will also be responsible for assisting with the management of ongoing clinical trials and assisting with new trials. Examples of these responsibilities include assisting in identifying potential trial participants; explaining and obtaining Informed Consents; entering adult and geriatric patients into trials; collecting and submitting data into the research bases of trials sponsors; and assisting physician investigators and their designees in follow-up management of trials participants.

Minimum Job Qualifications Education/Licensure:

Minimum 2 years' experience in a clinical trial role, preferably working with oncology patients. Clinical Trial regulatory certification preferred CPR Training Yearly annual computer based learning modules (CBL's).

Experience:

Experience with databases and/or patient data; Experience with Microsoft Office suite, particularly Excel, Word; Ability to work independently, interact professionally, and utilize effective writing and organizational skills; Proficient time management skills and ability to manage multiple priorities; Demonstrated understanding of Good Clinical Practice is preferred; Professional clinical research and/or oncology certification (through SOCRA, ACRP, ONS, etc.) are preferred.

Physical Requirements:

Requires the ability to sit for prolonged periods. Lifting and carrying weights of up to 10 pounds from low to high levels is occasionally required and is an essential function of the position. Grasping, fingering and reaching are frequently required. Occasional walking, bending, kneeling, reaching overhead, and standing are also required. Requires periodic travel to off-site locations. Independent decision-making is required. Excellent communications skills are required. Close visual acuity to perform activities such as preparing and analyzing data; transcribing; viewing a computer terminal etc. is required. Hearing at normal speaking levels with or without correction is required.

Working Conditions :

Pleasant inside environment. Regular day shift with occasional schedule variation to meet department needs. Daily contact with patients, families, physicians, Clinical Trial department staff, Hospital and Center for Oncology staff. Attend various hospital based tumor boards and conferences. Frequent contact with various outside hospitals, physicians and office staff. Occasional contact with National Cancer Institute, Clinical Trials Support Unit, various cooperative groups and pharmaceutical sponsors and IRB's.

Special Equipment/Work Aids :

Computer at work station. Halifax Health and Center for Oncology computer systems, radiology and Microsoft programs. Multiple web based computer programs to meet the department needs such as: regulatory contacts (IRB's), Cooperative Groups research bases, Clinical Trials Support Unit (CTSU) and various pharmaceutical sponsors. Copy machine, telephone, fax machine utilized on the unit. Responsibilities and Standards Job 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. 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Oncology Research Coordinator