Clinical Research Coordinator-Per Diem-Research-Oncology

Job Objective:

Coordinates and implements clinical research activities.

Essential Responsibilities:

• Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
• Recruits, educates, consents, schedules, and completes follow-up with patients/subjects.
• Participates in the design, planning and conduct of clinical trials program and clinical research projects.
• Performs pre-investigation, initiation and periodic monitoring visits to assure that the protocol, obligations, responsibilities, and regulations are established and followed.
• Monitors subject records for quality, data integrity and compliance with regulations and organization’s standard operating procedures (SOP).
• Assists in writing and/or auditing clinical reports.
• Assists in developing protocols, case report forms, and informed consent documents.
• Works closely and acts as a liaison between sponsors, Contract Research Organization (CRO) sites and other department staff members.
• Manages the negotiation and monitoring of budgets and contracts; formulates study budgets utilizing the protocol, manuals, study plan and resource needs assessment for the study; develops and supports the development of tools and training to aid in the development of study budgets, coverage analysis, tracking of invoiceable term items and research billing.
• Performs clinical site activities (regulatory issues, patient accrual, patient scheduling and care coordination, data capture and monitoring, adverse events reporting).
• Develops sufficient service/ program / product / indication expertise to communicate directly with clinicians, staff, other departments, consultants and provide consultation/expert advice to leadership.
• Develops or contributes to the development of SOPs, best practices, tools, processes and training to enhance safety and compliance with federal, local and institutional regulations/guidelines.
• Manages tracking and reporting Serious Adverse Events (SAEs) and Adverse Events (AEs).
• Works with physicians and leadership to develop and implement client trials and research programs; carries out key activities in evaluating, initiating, operationalizing and conducting clinical trials.
• Works closely with physicians and staff to facilitate research and enrollment to research studies and clinical trials.
• Prepares and presents materials to Institutional Review Board (IRB); investigates and resolves problems and complaints; develops corrective and preventative action plans.
• Develops educational/promotional materials to educate patients on available programs and clinical trials; develops and maintains a formal mechanism to ensure that information about the availability of clinical trials is provided to patients.
• Works to accrue and monitor cases enrolled in program and clinical trials; reports to governing Committee.
• Coordinates performance improvement activities as they relate to clinical trials and research.
• Provides support to investigators and maintain screening, enrollment, compliance, statistics on program and trials. Involved in planning long or short term objectives that support research program.
• Develops and implements Education Program for the community, including materials and lectures.
• Performs other duties as assigned.

Essential Skils:

• Ability to demonstrate professionalism by acting with integrity, accountability, responsibility, and excellence while maintaining a professional appearance and fostering effective communication and collaboration
• Ability to identify challenges, analyze issues, and develop practical solutions while maintaining compliance with research protocols and patient safety requirements
• Knowledge of good clinical practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects
• Ability to effectively manage multiple priorities, timelines, and competing responsibilities while demonstrating leadership, critical thinking, diplomacy, conflict resolution, and negotiation skills
• Ability to maintain a high level of accuracy, recognize discrepancies, and identify potential issues before they impact study quality or operations
• Ability to take ownership of assigned work, maintain accountability for outcomes, and contribute to a culture of trust, collaboration, and shared success
• Ability to work independently, demonstrate initiative, and proactively identify, prioritize, and complete assigned responsibilities with minimal supervision
• Ability to collaborate with clinicians and stakeholders to make timely, informed decisions that support patient care and research objectives
• Ability to review, interpret, analyze, and communicate qualitative and quantitative data accurately and effectively
• Ability to communicate clinical research information clearly, accurately, and professionally to patients, physicians, sponsors, and multidisciplinary research teams