Clinical Research Coordinator-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.

Essential Skils:

• Ability to prioritize tasks and manage time efficiently to meet deadlines
• Written and verbal communication skills
• Ability to work independently and as a team member
• Understanding of relevant technologies and tools pertinent to the job role
• Ability to use Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and other relevant software applications
• Ability to collect, analyze and disseminate data
• 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 coordinate multiple projects
• Ability to create and maintain positive interpersonal relations with peers, staff, leaders and vendors