Medical Monitor

Who Are We?

Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

What is the Primary Objective of the Medical Monitor?

The primary objective for our Medical Monitor is to provide input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training.

Your Main Responsibilities and Duties Include:

• Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial.
• Reviewing and analyzing the eligibility of participants per inclusion/exclusion requirements of a clinical trial.
• Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting.
• Providing review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
• Ensuring activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations.
• Consulting with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments.
• Developing and/or reviewing operational, medical monitoring, and safety plans for studies.
• Leading and/or participating in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies.
• Generating safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
• Writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• 24/7 emergency coverage for safety-related matters

To Succeed in this Position:

• You must have a DO, MD or equivalent required with Board Certification in a medical specialty /subspecialty and a current California medical license.

• You have a minimum of 5 years direct experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.

• You are proficient with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

If you are smart and good at what you do, we welcome you to apply!