- 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 investigator 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; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements
- Assists in the 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, and 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
- 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 the 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 the execution of the study protocol at the site level. Uses judgment and experience to evaluate the overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately communicates/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 Longboard's expectations, and delivers them in accordance with the sponsor's 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
- Bachelor's degree, preferred
- 5+ years of relevant and progressive experience with clinical trials
- Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) and a 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, an investigational product, IP accountability
- Strong written and verbal communication and computer literacy (e.g., 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, and preferred
- Experience in Longboard's focused therapeutic areas, preferred
- Travel up to 35%
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
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Clinical Research Associate - San Diego, United States - Longboard Pharmaceuticals, Inc.
Description
Job Description
Job DescriptionJob Title: Clinical Research Associate (CRA or Senior CRA; In-House)Reporting To: Director, Clinical Line Management
Department: R&D: Clinical Operations
People Manager: No
FLSA Status: Exempt
Location: San Diego, CA
Schedule: Hybrid (2-3 days a week) out of San Diego office
Position Summary
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 In-House Clinical Research Associate 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.
Responsibilities include but may not be limited to:
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $130, $150, The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
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