Job Description

Job Description

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:

· Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients

· Participates in the informed consent process and enrolls patients on protocol.

· Coordinates patient care in compliance with protocol requirements.

· In collaboration with the physician, reviews patients for changes in condition, adverse events,

concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.

· Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.

· Maintains regulatory documents.

· Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.

· May oversee the preparation of orders by physicians to assure that protocol compliance is maintained.

· Communicates with physician regarding study requirements.

· Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards.

· Responsible for accurately maintaining and recording Investigational Product receipt from the Sponsor and its use.

· Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

· Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs guidelines

· Contribute to growth of company with future supervisory role

REQUIREMENTS:

· Great at customer service

· Self-motivated/starter

· Outgoing, excellent recruiting skills

· Phlebotomy experiences a MUST.

· CCRC certification a PLUS.

· Concrete background in medicine

· Thorough knowledge of medical research

· Excellent verbal and written communication skills

· Proficiency with computers, especially Microsoft office

· Knowledgeable about ICH Guidelines, GCPs, as well as FDA regulations

· Able to handle multiple protocols in various therapeutic areas

· Must be detailed oriented

· Must be willing to travel to various locations in Greater Houston

Education Experience

· Bachelors required, Master degree preferred.

· Minimum of three years in Clinical Research

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