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Do you have a passion for helping human kind?

The Clinical Research Coordinator II will work with an interdisciplinary team of neurologists, neuropsychologists, and clinical researchers with expertise in Alzheimer’s disease and related dementias.

The Clinical Research Coordinator II works independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC II member is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents information at research staff meetings and may plan and coordinate strategies for increasing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.

Primary Duties and Responsibilities:

• Scheduling of research participants for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
• Schedules and participates in monitoring and auditing activities.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines.
• May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.
• Coordinates training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.

Department-Specific Duties and Responsibilities:

• Transportation of research medications.
• Performs research study related assessments and questionnaires.
• Assists with prescreening of research participants for various clinical trials.
• Attends research meetings and monthly conference calls with sponsors for study updates.
• Maintains organized paper and electronic research files.
• Performs all data collection and data entry tasks for department clinical trials.
• Assists with preparing manuscripts, letters, and other research documents as needed.
• Responds to sponsor’ inquiries regarding protocol start-up activities and recruitment.
• Performs literature reviews.

Education:

• High School Diploma/GED, required.
• Bachelor's degree in a Science, Sociology, or related field is preferred.

Licenses/Certifications:

• ACRP/SoCRA certification is preferred.

Experience:

• 2 years of clinical research experience, required.