Job Description

Woodlands Private Outpatient Medical Clinic has an immediate opening for a Clinical Research Assistant.

Responsibilities:

• Provide general support to research coordinators for the conduct of clinical trials.
• Assist with screening and recruiting study patients.
• Discuss trials, obtain informed consent, and enroll patients.
• Schedule patient appointments, tests, and procedures as required by the study protocol.
• Ensure accurate study records and maintain proper study documentation.
• Assist coordinators with entering data into the study database and electronic case report forms.
• Conduct all study activities in compliance with federal and institutional regulations.
• Blood drawing skills, EKG/ECG, and obtaining vital signs skills are preferred but not required if willing to learn.
• Order supplies and maintain the clinical trial lab supplies inventory.
• Conduct testing procedures required by the study protocol under the direction of the coordinators.
• Assist other research personnel with reports to regulatory agencies like the FDA, and the Data and Safety Review Committee.
• Maintain working knowledge of current protocols and internal SOPs.
• Assist with preparing for audits, inspections, and monitoring visits from regulatory agencies or sponsors.
• Assist with data collection and reporting of Adverse Events to appropriate regulatory agencies and sponsors.
• Attend continuing education and training opportunities relevant to job duties.

Requirements:

• Experience in biological lab processing, collection, shipping, and maintaining paperwork for blood and specimens according to procedures outlined in the study protocol.
• Bilingual is a plus.

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