Clinical Research Associate

Summary

Ansun Biopharma, Inc. is a clinical stage biopharmaceutical company developing drugs for unmet medical needs. The individual will be primarily responsible for quality for clinical activities, including but not limited to conducting clinical monitoring, study site management and designed clinical activities efficiently and ensuring compliance with SOPs, GCPs and ICH guidelines. The individual will co-work with the internal clinical operation team and deliver the timeline per company’s plan. He/she will be responsible for interactions with project manager and research team at the site.

Primary Responsibilities:

• Execute clinical monitoring, including pre-study visits, site initiation visits, interim monitoring visits, and close out visits in adherence with Good Clinical Practice (GCP) and write/revise the relevant reports
• Ensure sites are in compliance with study protocol, appropriate Standard Operating Procedures (SOPs), ICH/GCP regulations, and study-specific manuals
• Train investigator and study staff at site and ensure the procedures are performed per protocol
• Assist with third-party vendor training on protocols and practices
• Develop and maintain good working relationships with investigators and study staff
• Identify, select, and monitor performance of investigational sites for clinical studies
• Investigate queries, monitoring discrepancies
• Manage investigational product (IP) accountability and reconciliation process
• Perform clinical data review of data listings and summary tables, including query generation
• Assist- in planning and conducting investigator meetings
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team
• Review IP release packages
• TMF maintenance
• Assist in tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits
• Author, review and/or edit clinical study-related documents (e.g., informed consents, Investigator’s Brochures, study materials, essential documents, presentations, IND sections, and reports) as necessary
• Assist update clinical operations Standard Operating Procedures (SOPs)
• Assist Clinical Operations Team in negotiating and managing the budget and process the invoices
• Co-work with in-house project manager, clinical team, CMC team, non-clinical team, regulatory person and third-party vendor (such as central lab management) to support the company’s clinical trials
• Conduct medical monitoring, pharmacovigilance, regulatory, data management related to delegated clinical study
• Trouble-shoot site level challenges, processes, activities and risk pertaining to the conduct of clinical trials and keep timeline deliverables

Qualification / Education/ Experiences/ Skills:

Education/ Experience:

• Minimum BA/BS in scientific, life science, or related field with 2+ years CRA related experiences
• Sponsor-side clinical trial experience in the pharmaceutical industry is preferred
• A positive attitude with a fervor for learning and meeting timelines may be considered in lieu of clinical trial experience
• Late-stage clinical trial experience and working knowledge of US regulatory agency requirements, preferred
• Experience in respiratory diseases and oncology is preferred

Skills:

• Ability to motivate and collaborated with teams at other functional departments
• Excellent written, oral and presentation communication skills o Ability to work independently, take initiative, and meet company goals within timelines and budget o Able to work in a fast-paced environment with multiple competing tasks and demands, across time-zones
• Ability to communicate with vendors and keep a high quality of clinical study
• Strong knowledge of GCP and FDA regulations
• Proficient in Microsoft Office (excel, word, outlook, power point), electronic data capture (EDC) software (Medidata, Medrio and/or others) and other platform related to electronic Trial Master File (eTMF) and safety report

Benefits:

• Employee Incentive Stock Options
• Medical, Dental, & Vision Coverage
• Paid Vacation & Sick Time
• Life & Disability Insurances
• 401(k) Retirement plan
• Flexible Spending Account (FSA)

This is an onsite position, located at our San Diego, CA 92121 location. Must be local to the San Diego, CA area.

Annual Base Salary Range: $75,000.00 - $95,000.00

Ansun is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.