About Tr1X
Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit www.tr1x.bio.
Position Summary
The Senior Clinical Trial Associate (Sr. CTA) supports clinical studies and the Clinical Operations department by managing various administrative tasks including generating agendas and minutes, maintaining study tracking, and conducting filing and quality reviews. The Sr. CTA participates in process improvement initiatives across the department. The Sr. CTA is instrumental in collaborating cross-functionally, working closely with study teams from vendors and CROs to achieve departmental and project goals. The Sr. CTA adheres to the Company's core values and complies with all applicable regulations, ICH-GCP guidelines, and SOPs. The Sr. CTA understands trial and study site management, vendor management, and has experience participating in the full cycle of studies from start-up to close-out.
Key Responsibilities
Provide general administrative support to the Clinical Operations departmentAssist in the production of presentations as needed for project, departmental, and/or business developmentAssist the Study Lead(s) with Sponsor oversight of CRO, including study-specific documentation review and QC, and reviews of ICFs, study plans, study reference manuals, eCRFs, etc.Assist with creation and maintenance of study metrics trackers, tools and reportsAssist in coordination and tracking of clinical trial samplesEnsure required study documents are submitted to the CRO-held eTMFAssist the Study CTM(s) with Sponsor oversight of CRO-held eTMFs, including periodic audit and findings resolutionAssist the Study CTM(s) in executing clinical monitoring oversightAssist in review/QC for study documents as assignedAssist the CTM(s) and clinical team with Investigator meeting coordination, activities preparation and generate meeting minutesContact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) when neededAttend internal and external team meetings/teleconferences and generate meeting agenda and minutes when neededTravel to clinical sites as needed.Perform other responsibilities as may be required based on business needs.
Required Qualifications & Experience
Bachelor's degree or an equivalent combination of education, training and/or experience.Minimum 3 years of related experience in pharmaceutical industry, clinical research organization (CRO), or related role;CRO experience preferredExperience working on Phase 1 and 2 studies; experience in global/international studies is a plusExperience and knowledge of ICH GCP, eTMF management and DIA TMF Reference ModelExcellence in task management and collaborationDemonstrated passion to succeed through professionalism and integrity in all actions and relationships with employees and other colleagues while maintaining a fun and collegial demeanor
Other Requirements
Legally authorized to work for any employer in the U.S.Must be willing to travel domestically to clinical sites as necessary (up to 15% time)Position is 100% on-site in San Diego
The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.
Working at Tr1X
At Tr1X, our team is united by a singular shared mission: to transform patients' lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.
Base Pay Range Anticipated: $95,000 - $115,000
Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.
Compensation and Benefits
Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.
Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at .
Notice to Employment Agencies
The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.