Oncology Research Coordinator

Oncology Research Coordinator

Requirements

• 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 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.

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.
• 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.

Preferred Qualifications

• Demonstrated understanding of Good Clinical Practice is preferred;
• Professional clinical research and/or oncology certification (through SOCRA, ACRP, ONS, etc.) are preferred.