Clinical Research Coordinator Jobs

Description:

The clinical research coordinator manages the screening, enrollment, and maintenance of patients on clinical trials. Duties include assuring protocol compliance for all patients on trial, participation in consent process, ongoing assessments for changes in condition and adverse events, accurate and timely documentation/data entry, responsible for education and training of other staff and patients, understands the strategic and operational objectives of the research program, may performs high level financial work including budget oversight. Trains and promotes professional development of staff. Ensures site research quality by practicing in compliance with company Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Responsibilities:

• May work with SRL to determine study recruitment and enrollment goals
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations
• Responsible for compiling and reporting protocol activity, accrual data, and research financials to practice administration and physicians
• Disburses investigational drug and provide patient teaching regarding administration and other patient educational needs
• Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel
• Interacts with the monitors/auditors while on-site
• Responsible for review of consents to ensure proper execution of the informed consent process for study subjects
• Develops SOPs in collaboration with research and clinical teams
• May be responsible for the development of practice research budgets
• Working independently, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents and reports all findings to physician and care team
• Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials
• Leads efforts to find effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials Assists SRL in feasibility assessments and study selection
• Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials
• Participate in scheduling monitoring and auditing visits
• Works with clinic staff to solve complex issues around patient trial participation
• Due to expertise in subject matter, functions in a lead role as a resource for research staff
• Provide input in determining, and implementing improvements to policies/processes
• Coordinates patient care in compliance with protocol requirements
• Screens potential patients for protocol eligibility
• Oversees subject recruitment and study enrollment to meet goals
• Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting Provide clinical services as required including patient assessments
• Oversees the preparation of orders by physicians to assure that protocol compliance is maintained
• Maintains investigational drug accountability
• Conduct protocol-specific training for study personnel to include training of staff in preparation for study activities Review protocols and provide input on study activities in relation to areas of responsibility