Clinical Research Associate

Job Summary
We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team. In this role, you will be responsible for overseeing the conduct of clinical trials, ensuring compliance with regulatory standards, and maintaining high-quality data collection. Your expertise will help advance innovative medical research and bring new therapies to patients in need. This paid position offers an exciting opportunity to contribute to groundbreaking clinical development projects while working in a collaborative and fast-paced environment.

Responsibilities

• Monitor clinical trial sites to ensure adherence to protocol, Good Clinical Practice (GCP), and regulatory requirements, including FDA regulations and ICH GCP standards
• Review and verify clinical documentation, including informed consent forms, case report forms (CRFs), and source documents for accuracy and completeness
• Conduct patient monitoring visits to assess patient safety, collect vital signs, blood samples, and perform phlebotomy as needed
• Provide supervision and guidance to site staff, including training on study procedures and compliance management
• Manage data collection processes, ensuring timely entry into electronic data management systems (EDC) and EMR systems while maintaining data integrity
• Review laboratory results from clinical laboratories, ensuring proper documentation and compliance with protocol specifications
• Collaborate with cross-functional teams on clinical trials management, including site selection, initiation, monitoring, and close-out activities
• Ensure all trial activities are conducted in accordance with CDISC standards for data formatting and reporting

Qualifications

• Proven supervising experience in clinical research or related healthcare fields
• Strong knowledge of clinical trials management, medical terminology, and regulatory guidelines such as FDA regulations and ICH GCP certification
• Experience with clinical laboratory procedures, blood sampling, vital signs measurement, and patient monitoring techniques
• Familiarity with EMR systems, data management tools, statistical software, and CDISC standards for data analysis
• Excellent documentation review skills with attention to detail for source documents and regulatory compliance records
• Background in nursing or clinical laboratory work is highly desirable
• Knowledge of HIPAA regulations to ensure patient privacy and confidentiality is maintained at all times
• Ability to analyze complex data sets using analysis skills to support research objectives
• Strong communication skills for effective collaboration with site staff, sponsors, and regulatory bodies

Join us in advancing medical science by ensuring the highest standards of clinical research excellence. This role offers an engaging environment where your expertise directly impacts patient health outcomes while supporting your professional growth in the field of clinical development.

Pay: From $65.00 per hour

Benefits:

• Flexible schedule

Application Question(s):

• Do you have prior experience working on Alzheimer's or Dementia studies? If yes, how many years of experience do you have?

Education:

• Bachelor's (Required)

Location:

• Florida (Required)

Ability to Commute:

• Florida (Required)

Willingness to travel:

• 25% (Required)

Work Location: Remote

Salary : $65