Senior Clinical Research Coordinator - Oncology

Duties & Responsibilities

• Documentation/Data Collection
• Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities
• Utilizes and assists with training team members on electronic data capture systems, technologies, and software
• Scores tests, enters data, and completes required forms accurately and according to protocol
• Led the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies
• Identifies issues, recommends solutions
• Regulatory
• Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed
• Submits assigned studies for review and approval and provides status updates throughout the startup process
• Assists regulatory team with Institutional Review Board (IRB) preparation and submission
• Study Participation
• Screens, schedules, consents participants in a variety of clinical research programs and/or studies
• Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants
• Conducts difficult, sensitive conversations with patients/families
• Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention
• Affords assistance to participants with individual needs
• Collections information to determine feasibility, recruitment, and retention strategies
• Collections, prepares, processes, ships, and maintains inventory of research specimens
• Protocol
• Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs)
• Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols
• Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting requirements
• Serves as a resource regarding institutional and sponsor-specific reporting requirements
• Assists with the development of proposals or protocols
• Identifies and communicates related shortcomings
• Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level
• Human Subject Research Protection
• Maintains compliance with institutional requirements and policies
• Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research
• Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations
• Serves as a resource and trainer for issues related to professional guidelines and code of ethics
• Identifies and facilitates resolution of potential problems and risks to the participant, study and/or institution
• Team Coordination
• Leads team meetings
• Proactively includes others in decision making and escalates issues to leadership as necessary
• Provides significant contribution and influence upon research work, activities and/or productivity of study teams
• Leads a committee or task force under direction of a supervisor
• Leads scientific or programmatic presentations
• Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims
• Implements with leadership team on the operational elements needed for the conduct of clinical and translational programs and/or studies
• Quality Assurance
• Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data and assists management with resolution
• Recognizes and reports vulnerabilities related to security of physical and electronic data
• Assists with recognizing trends related to data quality and develops and implements retraining as appropriate
• Adheres to and oversees the development and assessment of quality assurance processes
• Identifies issues related to operational efficiency and shares results with team members and management
• Recognizes when data agreements or special regulatory requirements are necessary and acts as a resource and mentor to determine when special contracts are necessary and escalates to stakeholders
• Develops systems and/or frameworks for quality assurance processes in collaboration with leadership
• Budgets/Financials
• Participates in and provides oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing
• Comprehensive understanding of institutional process for the development of budgets
• Proactively identify gap deficits and escalating
• Mentoring/Coaching
• Provides oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design

Minimum Qualifications

• Degree: Bachelor’s degree in a related field is required.
• Experience- Required: Three (3) years of clinical, clinical support, and or clinical research related experience.
• Equivalency- Associates degree + 5 years experience above stated requirements may substitute for bachelor's degree.
• Preferred- Three (3) years experience working in Phase I-IV clinical oncology trials.
• Experience working with Children's Oncology Group