What are the responsibilities and job description for the Medical Monitor position at tech-res?

Job Title

Medical Monitor

Location

Bethesda, MD 20817 US (Primary)

Category

Drug Safety

Job Type

Full-Time

Salary Range

120,000.00-150,000.00/YEAR

Education

Medical Doctor

Travel

None

Job Description

Ensures compliance with standard operating procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies
Develops guidelines and ensures the uniform and timely processing of adverse event reports
Acts as liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Develops and prepares reports for company management as well as external regulatory requirements
Provides medical evaluation of adverse event reports
Reviews experimental protocols and informed consent documents; prepares, reviews, and edits presentations regarding safety issues
Performs various tasks in support of clinical research including the reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary
Assists in gathering adverse event report information documentation
Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
Contributes to technical proposals and responses to technical questions
Maintains files of publications relating to safety
Suggests improvements to current procedures/processes
Leads/coordinates client requests/projects
Participates in the training and mentoring of staff.
Participates in Business Development activities

Job Requirements

Experience in clinical research and drug safety
Ability to analyze medical research data, review experimental protocols, and summarize safety data
Excellent oral, written, and computer skills

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

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