What are the responsibilities and job description for the Senior Clinical Research Associate position at Tr1X?
Job Description
Job Description
Tr1X ("Trix") is a biotechnology company focused on engineering cures for autoimmune and inflammatory diseases. The company develops cellular therapies with the potential to cure disease by inducing immune tolerance and restoring homeostasis.
Tr1X has a state-of-the-art technology platform that allows for the scalable generation of engineered living drugs to help patients suffering from debilitating diseases with high unmet medical need. More information can be found at www.tr1x.bio
JOB SUMMARY
The Senior Clinical Research Associate will support 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. This role, reporting to the Clinical Operations department's leadership, will also involve participating in process improvement initiatives across departments. The Sr. CRA will be instrumental in collaborating cross-functionally, working closely with study teams from vendors and CROs to achieve departmental and project goals. The Sr. CRA must adhere to the company's core values and comply with all applicable regulations, ICH-GCP guidelines, and SOPs. Strong candidates should understand trial and study site management, vendor management, and experience participating in the full cycle of studies from start-up to close-out.
KEY RESPONSIBILITIES :
- Provide general administrative support to the Clinical Operations Department
- Assist in the production of presentations as needed for project, departmental, and / or business development
- Assist 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 reports
- Assist in coordination and tracking of clinical trial samples
- Ensure required study documents are submitted to the CRO-held eTMF
- Assist the Study CTM(s) with Sponsor oversight of CRO-held eTMFs, including periodic audit and findings resolution
- Assist the Study CTM(s) in executing clinical monitoring oversight
- Assist in review / QC for study documents as assigned
- Assist the CTM(s) and clinical team with Investigator Meeting coordination, activities preparation and generate meeting minutes
- May contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc. when needed)
- Attend internal and external team meetings / teleconferences and generate meeting agenda and minutes when needed
QUALIFICATIONS :
ADDITIONAL REQUIREMENTS :
WE OFFER :
At Tr1X we believe that a diverse, open, and inclusive environment and culture is key to our success. Tr1X will not be influenced in recruitment, hiring, promotion or any other employment practices by race, color, citizenship status, national origin, ancestry, sex, sexual orientation, gender identity / expression, age, religion, physical or mental disability, medical or genetic condition, marital status, veteran status, or any other characteristics protected under applicable federal, state and local laws. Tr1X will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable laws.
Note to External Recruiters : Submission of unsolicited resumes prior to an agreement set in place will not create any implied obligation.
Salary : $75,000 - $95,000