In-House Clinical Research Associate

Arena Pharmaceuticals San Diego , CA 92140

Posted 3 months ago

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

The Clinical Research Associate (CRA) supports global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring and reporting of clinical trials. The IHCRA partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to, essential document collection and review; investigative site recruitment & feasibility; FDA/GCP/ICH and regulatory compliance; data management and query resolution; document and SOP review; study document/plan development and review; maintenance and close-out of in-house site management activities; and clinical operations support activities and tasks.

What you'll dive into

  • Supports the global and regional clinical trial managers and trial leaders in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines

  • Performs an array of assigned duties including investigative site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements

  • Assists in review and approval of monitoring reports

  • May conduct co-monitoring or observational visits at investigational sites

  • Assists with the preparation and finalization of investigators contracts, budgets and payments

  • Obtain, review (to ensure completeness, accuracy, and regulatory compliance), and process essential regulatory, administrative documents, and Informed Consent Forms (ICFs)

  • Works with Technical Operations and/or CTAs to Initiate investigational product shipments as needed and ensures that supplies are adequate/appropriate for assigned studies and sites

  • Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities

  • Supports the Regional Clinical Trial Manager in start-up and management and oversight of vendors including the review of specifications, charters and plans

  • Ongoing interaction with clinical operations team members and Investigator site staff to obtain and relay key study issues, status updates and other study information to the clinical trial team and management

  • Participates in development and improvement of department processes, best practices, and tools and templates related to clinical trial management and operations

  • Participates in the review and development of CRFs and CRF guidelines

  • Performs in-house review of CRF data for completeness and accuracy, and resolves data management/query issues with study sites and vendors as needed

  • Reviews data to identify protocol deviations and risks to subject safety/data integrity

  • Works with CTAs to obtain licensing for study tools and assessments

  • Evaluates execution of study protocol at the site level. Uses judgment and experience to evaluate overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the study team.

  • Work with assigned CTAs and CROs to ensure study activities are documented via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and the Study Monitoring Plan

  • Supports and monitors clinical trials to ensure sponsor and investigator obligations are met and in compliance with the currently approved protocol/amendment(s); applicable study procedures; applicable federal and local regulatory requirements; GCP; and company policy and procedures

  • Supports the oversight of all activities listed and ensures all duties/documents/protocols/etc. meet Arena's expectations, and delivers them in accordance with the sponsor expectations, trial protocol, ICH/GCP guidelines and applicable SOPs (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

  • 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.) and strong understanding of clinical trial processes, protocols and medical terminology

  • 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

  • Strong written and verbal communication and computer literacy (eg, Microsoft Word, Excel, Powerpoint, Outlook); strong experience utilizing CTMS, EDC, TMS and related software

  • 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 potentially up to 30%

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

  • Matching 401k retirement plan

  • Paid time off and holidays

  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.


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In-House Clinical Research Associate

Arena Pharmaceuticals