WHO ARE WE?

Founded in 1997 and built upon 27+ 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.

• You are responsible and accountable for multiple clinical trials and manage each project within defined timelines. You coordinate/execute of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
• You will facilitate investigational site budget negotiations.
• You will provide regular updates to TI staff, Sponsors, vendors and contract staff concerning status and progress of the trial.
• You will facilitate protocol development as needed.
• You are responsible for writing/approving clinical project deliverables such as scope definition documents, CRFs, source documents, monitoring tools, monitoring plans, close-out plans.
• You are responsible for ensuring the trial is “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). You ensure that any audit observations are addressed appropriately and in a timely manner.
• You are responsible for ensuring that project team members are compliant with TI SOPs and internal guidelines.
• You will assist with training and supervising CRAs.
• You will develop presentations, handouts and coordinate investigator meetings and make effective oral and written presentations.
• You will perform oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
• You are responsible for reviewing and approving all monitoring reports and correspondence with sites from CRAs.
• In regards to Data Management: You will perform SAP and DMP review, edit specifications review, and ensure query monitoring and resolution, review of data listings and clinical study report, as needed.