Senior Clinical Research Associate - Tr1X : Job Details

JOB SUMMARYThe Senior Clinical Research Associatewill 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:

• Four-year Bachelor's Degree or equivalent international degree
• 2 or more years or experience in pharmaceutical industry, clinical research organization (CRO), or related role;CRO experience preferred
• Experience working on Phase 1 and 2 studies and global/international studies is advantageous
• Experience and knowledge of ICH GCP, eTMF management and DIA TMF Reference Model
• Excellence in task management and collaboration
• Proficient in English language (spoken and written)
• Demonstrated passion to succeed through professionalism and integrity in all actions and relationships with employees and other colleagues while maintaining a fun and collegial mentality

ADDITIONAL REQUIREMENTS:

• This position requires on-site presence five days a week at our San Diego, CA office
• You must be legally entitled to work for any employer in the US.

WE OFFER:

• Anticipated Base Salary Range: $75,000- $95,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law
• This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan
• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, and 401k employer contribution, regardless of employee contribution
• We also provide top-notch health insurance plans for employees (and their families) which include medical, dental, vision and basic life insurance and additional policies including , disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans
• A market leading FSA plan