Therapeutics, Inc. Senior Clinical Research Associate- Northeast
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. Learn more here:
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.
About the Role
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.
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.
Responsibilities:
- 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.
Qualifications:
- 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.
Location:
- We are seeking candidates based near a major metropolitan area, preferably in the Northeast with easy access (typically <1 hour distance) to an airport hub.
- This role requires 60-80% travel
Salary and Benefits
- $100,000-$145,000 USD Annual. Range dependent upon experience.
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.
*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.
Job Type: Full-time
Pay: $100,000.00 - $145,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Medical Specialty:
Work Location: In person
