Who Are We?

Founded in 1997 and built upon 26+ 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 Clinical Project Manager?

You will provide project management and leadership to plan, prepare and execute high quality clinical trials. You will ensure that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.

To Succeed in this Position:

• You should have a Bachelor’s-level degree in science/health related field or a combination of education and industry experience. A Master’s degree is preferred.
• You should have 4 to 5 years of clinical research experience and/or at least 2-3 years of clinical project management specific experience at a CRO, as well as a thorough understanding of GCPs and FDA and ICH guidelines. Job title will be determined based on experience level of the candidate of choice.
• You should have excellent written and oral communication skills with the ability to manage multiple priorities with high attention to detail.
• Remote-based will be considered for the right candidate; however, San-Diego based in preferred.
• Although travel is typically very limited, you must have the willingness to travel up to 15%

Your Main Responsibilities and Duties Include:

• 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.

The most likely base pay range for this position is $110,000 - $145,000 per year. Several factors, such as experience, location, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.

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Candidates based in San Diego are preferred and would be required to be onsite per our company's hybrid schedule. Remote candidates will be considered but are required to come to the San Diego office upon hire, at year-end annual training and as needed. Will be discussed during interview process.

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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.

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

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PRIMARY OBJECTIVE OF THE POSITION:

The Senior Clinical Research Associate (CRA) will play a critical role in overseeing and managing clinical study sites, ensuring subject safety, and ensuring compliance with study protocols, timelines, and budgets. You will serve as a primary point of contact for clinical study sites, investigators, and cross-functional teams, ensuring all aspects of the clinical trial are executed with precision. Your contributions will be integral to the success of our clinical studies, driving on-time, within-budget regulatory submissions.

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‍EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific discipline, RN or BSN degree, 4-year Life Science degree or equivalent
• 3-5 years of clinical research monitoring experience.
• Strong knowledge of clinical research principles and regulatory requirements (GCP, FDA, ICH).
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and superior attention to detail.
• Superior critical thinking and problem solving skills
• Proficient with Microsoft Office and virtual meeting tools (Zoom, GoToMeeting).
• Strong proficiency in Microsoft Excel.
• Willingness to travel 60-80% of the time.
• Candidates based near a major metropolitan area, preferably in the Northeast or Central U.S. with easy access (typically ~1 hour distance) to an airport hub.

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In addition to managing site monitoring and data quality, you will mentor and support junior CRAs, contributing to their professional development while maintaining a strong focus on high-quality clinical trial management. You will be involved in the entire lifecycle of a clinical study, from site initiation and training to close-out procedures, audit preparation, and regulatory compliance. Your role will require a balance of collaboration with internal teams and external stakeholders, as well as the ability to problem-solve independently when challenges arise.

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MAJOR RESPONSIBILITIES AND DUTIES:

• Assess and initiate clinical study sites, providing protocol training and ensuring site readiness.
• Perform routine monitoring visits, ensuring subject safety and compliance with study protocols.
• Assess suitability of clinical sites for study readiness and ensure comprehensive training of site personnel.
• Verify data consistency in CRFs with source documents.
• Write monitoring visit reports and track test article accountability.
• Maintain regular communication with study site staff and investigators.
• Assist with developing study protocols, case report forms, and ensuring compliance with regulatory standards.
• Assist with site close-out procedures, audit preparation, final report preparation, and routine audit tasks.
• Mentor junior CRAs on monitoring procedures and study management.

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Salary and Benefits

• $100,000-$145,000 USD Annual. Range dependent upon experience.

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Equal Opportunity Employer

Therapeutics is an Equal Opportunity Employer. All employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, or age.

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*This job description is not inclusive of all activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.

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