Job Description
OVERVIEW:
Plans, coordinates, and manages activities associated with the initiation, conduction, and completion of multiple clinical trials sponsored by internal, industry, foundation, and federal funding sources. Maintains compliance with all regulatory bodies. Provides and develops educational opportunities for staff and monitors outcomes.
RESPONSIBILITIES:
• Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies.
• Plan, coordinate, and manage all activities pertinent to the specific clinical trials, ensuring patient safety, Good Clinical Practices (GCPs), and compliance with the protocol and regulatory agencies.
• Communicate all relevant data, information to the PI, appropriate hospital personnel, the IRB, external sponsors, and the FDA (if applicable) to assure patient safety and compliance with institutional, local, state, and federal policies/procedures, regulations, guidelines, laws.
• Identify, evaluate, and resolve solutions to problems/issues associated with the research protocol to the PI, the external sponsor, and the appropriate regulatory agency (if needed) to assure patient safety, enrollment, and compliance with the GCPs and regulatory agencies.
• Educate patients and their families regarding the investigational study and the requirements of participation to assure that they are informed prior to obtaining written consent.
• Provide in-service education to the appropriate hospital personnel in the departments involved with the investigational study.
• Participates in the development and implementation of departmental and hospital performance improvement activities.
• Communicates and coordinates patient care with patient, family, community health services, and interdisciplinary team.
• Ensures compliance with all regulatory agencies.
QUALIFICATIONS:
• Bachelor's degree in research or public health, or diploma in nursing, or relevant experience and/or education as determined by the company in lieu of bachelor's degree.
• Requires excellent organizational skills, critical thinking skills, excellent computer skills, decisive judgment, and the ability to work independently with minimal supervision.
• Must be able to work in a dynamic and rapidly changing environment and take appropriate actions. The complexity is further defined by the need to adhere to and understand regulations related to human subject research.
• 5 years of experience relevant to neuroscience area of research, strongly preferred.
• Quality Measure work, strongly preferred.
• Certified Clinical Research Coordinator (CCRC), preferred.
• Research coordination experience, preferred.
Plans, coordinates, and manages activities associated with the initiation, conduction, and completion of multiple clinical trials sponsored by internal, industry, foundation, and federal funding sources. Maintains compliance with all regulatory bodies. Provides and develops educational opportunities for staff and monitors outcomes.
RESPONSIBILITIES:
• Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies.
• Plan, coordinate, and manage all activities pertinent to the specific clinical trials, ensuring patient safety, Good Clinical Practices (GCPs), and compliance with the protocol and regulatory agencies.
• Communicate all relevant data, information to the PI, appropriate hospital personnel, the IRB, external sponsors, and the FDA (if applicable) to assure patient safety and compliance with institutional, local, state, and federal policies/procedures, regulations, guidelines, laws.
• Identify, evaluate, and resolve solutions to problems/issues associated with the research protocol to the PI, the external sponsor, and the appropriate regulatory agency (if needed) to assure patient safety, enrollment, and compliance with the GCPs and regulatory agencies.
• Educate patients and their families regarding the investigational study and the requirements of participation to assure that they are informed prior to obtaining written consent.
• Provide in-service education to the appropriate hospital personnel in the departments involved with the investigational study.
• Participates in the development and implementation of departmental and hospital performance improvement activities.
• Communicates and coordinates patient care with patient, family, community health services, and interdisciplinary team.
• Ensures compliance with all regulatory agencies.
QUALIFICATIONS:
• Bachelor's degree in research or public health, or diploma in nursing, or relevant experience and/or education as determined by the company in lieu of bachelor's degree.
• Requires excellent organizational skills, critical thinking skills, excellent computer skills, decisive judgment, and the ability to work independently with minimal supervision.
• Must be able to work in a dynamic and rapidly changing environment and take appropriate actions. The complexity is further defined by the need to adhere to and understand regulations related to human subject research.
• 5 years of experience relevant to neuroscience area of research, strongly preferred.
• Quality Measure work, strongly preferred.
• Certified Clinical Research Coordinator (CCRC), preferred.
• Research coordination experience, preferred.
Additional Details
Experience: 2-5 years