ADARx Pharmaceuticals - San Diego, CA

posted 6 days ago

Full-time - Entry Level
San Diego, CA
Professional, Scientific, and Technical Services

About the position

We are seeking a highly motivated and qualified individual to join our Clinical Department as an in-house CRA and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The in-house CRA (CRA) is responsible under supervision for supporting the administration and progress of clinical trial(s) on behalf of ADARx Pharmaceuticals. The CRA monitors the research procedures and ensures that research is always following the proper clinical trial protocol to obtain the correct data. The CRA also ensures that these processes are performed in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP).

Responsibilities

  • Assist with the identification and set up of the trial sites; ensuring each site has the trial materials, including the investigational product.
  • Responsible for study start-up activities and tracking study metrics (e.g. feasibility data, ICF review, regulatory document collection and review, and Trial Master File tracking).
  • Assure regulatory compliance of investigational sites with ADARx Pharmaceuticals SOPs, FDA regulations, and ICH guidelines.
  • Review and approve monitoring visit reports.
  • Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
  • Collect completed CRFs and other trial materials throughout and at the end of the study.
  • Maintain internal document management system and TMF ensuring important documents and communication filed timely and appropriately.
  • Assist and support data query process.
  • Verify internal data listings.
  • Generate reports or notes to files, and file/collate trial documentation and reports.
  • Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects.
  • Utilize clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS), including report generation.
  • Assist with preparing study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents.
  • Assist with coordination and be responsible for the design of study materials such as Case Report Forms (CRFs), patient diaries, study participation materials, and source documents.
  • Assist with protocol development and study report completion.
  • Assist with planning and participating in investigator meetings.
  • Assist with preparing training materials used to train site staff during the SIV and at other times to trial-specific industry standards.
  • May include monitoring the trial throughout its duration for specific tasks or activities.
  • Coordinate study supplies at all sites.
  • Assist with preparing final reports.
  • Archive study documentation and correspondence as appropriate.
  • Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
  • Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
  • Maintain all corporate standards for lab safety and hazardous material management.
  • Other duties as assigned.

Requirements

  • BA/BS in a health-related field or ADN.
  • Minimum 4 years of relevant clinical research experience.
  • Clinical research related monitoring or study coordinator experience.
  • Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
  • Proficiency working with Microsoft Office Suite Products.
  • Ability to travel (domestic/international) if necessary.

Nice-to-haves

  • Global clinical trial experience preferred.
  • Clinical research or life sciences degree preferred.

Benefits

  • Equity-based compensation
  • Performance-based bonuses
  • 401(k) with Company Match
  • Medical, Dental, Vision
  • Flexible Spending Account
  • Life Insurance
  • Employee Assistance Program
  • Employee Discounts
  • Gym Membership
  • Paid Vacation
  • Paid Holidays
  • Paid Sick, Jury Duty, Bereavement
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