(Sr) Clinical Research Associate (San Diego based)

Location
San Diego, CA
Salary
Base plus Bonus plus Options!
Posted
Apr 27, 2018
Required Education
Associate Degree
Position Type
Full time

Arena has multiple, potential “best-in-class” drugs with positive topline Phase 2 results. It’s an exciting time to join a dynamic and growing team and we’re looking for a (Sr) Clinical Research Associate (CRA) that will support the planning, design, execution, monitoring and reporting of the assigned clinical trials.

This role will support Arena’s clinical trials ensuring alignment of activities and timelines including, but not limited to essential document collection and review, investigative site recruitment & feasibility, compliance and data management and query resolution.

What you’ll dive into

  • Supports the Clinical Study Leader in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines
  • Supports investigative site recruitment and feasibility
  • Process essential regulatory and administrative documents; collection and review; maintenance and close-out of in-house site management activities
  • Ensure study activities are documented via confirmation and follow-up letters, trip reports, communication logs, and other required study documents
  • Creation of monitoring reports; assists in review and approval
  • Assists with investigators contracts, budgets and payments
  • Assist investigational product shipments and ensures supplies are appropriate per study and site
  • Participates in the review and development of CRFs; helps resolve data management and query issues with study sites and vendors
  • Reviews data to identify protocol deviations and risks to subject safety/data integrity
  • Evaluates execution of study protocol at the site level; manage overall performance of site and site staff and provides recommendations regarding site-specific actions or issues
  • Support and monitor all clinical activities to ensure delivery in accordance with expectations, trial protocol, ICH/GCP guidelines and applicable SOPs and regulations (local/US/international)
  • Verifies that the rights and well-being of human subjects are protected, and that the reported trial data are accurate, complete and verifiable from source documents
  • Ongoing interaction with cross-functional stakeholders and investigator site staff/vendor to monitor clinical trial activities, study issues, status updates and relay information to the clinical trial team and management
  • Performs other work-related duties as assigned or required

What we expect

  • Bachelor’s degree, preferred
  • 5+ years of relevant and progressive experience with clinical trials
  • Experience in all stages of drug development/pharma (study start-up, maintenance, database lock etc.)
  • Strong understanding of clinical trial processes, protocols and medical terminology
  • Strong experience utilizing CTMS, EDC, TMS and related software
  • Prior experience in management and monitoring of CRO and investigative sites, preferred
  • Experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability
  • Knowledge of ICH GCP, IRB/IEC and local regulatory authority drug research & development regulations
  • Motivated to work in a fast-paced, high accountability environment
  • Experience with bio-samples, storage of 3rd party data, preferred
  • Experience in Arena’s focused therapeutic areas, preferred
  • Travel up to 35%

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives

  • Opportunities to learn and contribute creative solutions

  • Comprehensive health insurance ($0 premium on select medical plans)

  • Matching 401k retirement plan

  • Paid time off and holidays including a Summer & Winter break

  • Company celebrations