Clinical Trial Associate

Job Title: Clinical Trial Associate

Location: Van Nuys, Los Angeles

Job Type: Full-Time

Overview: We are seeking a highly organized and detail-oriented Clinical Trial Associate to join our team. This is a great opportunity for clinical research professional to work on the Sponsor side and learn trials from another perspective. The ideal candidate will play a pivotal role in coordinating and managing clinical research studies at our sites, ensuring adherence to protocols, regulatory requirements, and ethical guidelines. This position is an in-house role, meaning the candidate will work directly with sites nationwide and be actively involved in the daily operations of clinical trials. Under the supervision of the Senior VP of Operations, the Clinical Trial Associate will be responsible for assisting with study coordination and recruitment at assigned sites, ensuring compliance with applicable protocol regulations and ethical guidelines.

This unique opportunity offers valuable experience within a tech-driven CRO. This position provides an excellent pathway for career advancement within the research industry, potentially leading to a Project Management role.

Key Responsibilities:

• Coordinate operational aspects of clinical research studies at assigned trial sites, including supporting site efforts in subject recruitment, enrollment, and retention.
• Prepare, submit, maintain, and monitor all required regulatory documentation, including IRB submissions, ICFs, and other essential documents, ensuring compliance with GCP, FDA regulations, and study protocols.
• Assist in the start-up of new studies, working directly with the sites to generate, distribute, and obtain required study documents.
• Set up and manage new clinical research studies within the Salesforce platform, ensuring timely and accurate data entry and scanned source documentation uploads.
• Communicate with sites to ensure ICFs, CRFs, and essential study documents are accurate, up-to-date, and submitted to RDI on timely basis.
• Coordinate requisitions with reference laboratories required for the study.
• Proactively identify and address potential issues that could impact study conduct or data quality.
• Communicate corrective and preventative actions (CAPAs) as needed.
• Assist CRAs in preparing study closeout by conducting TMF reviews and compiling closeout binders.
• Communicate regularly with Principal Investigators (PIs), study sponsors, and other research staff to ensure effective study management and address any study-related queries.
• Ensure proper documentation of adverse events (AEs) and serious adverse events (SAEs) according to protocol and regulatory requirements.
• Schedule and provide support for site initiation visits (SIVS), interim monitoring visits (IMVs), and close-out activities.
• Communicate with reference laboratories and imaging centers to ensure the timely and accurate execution of all required laboratory tests, imaging studies, and other diagnostic procedures for the clinical trial. This includes managing requisitions and coordinating scheduling logistics.
• Assist with training and mentoring new research staff as needed.
• Handle study-related queries from participants, research teams, and sponsors.
• Maintains study supplies and equipment in accordance with protocol.
• Process and complete subject reimbursements in a timely manner.
• Provide timely updates on study progress and address any issues that may arise.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, or a related field (or equivalent experience).
• Minimum of 2-3 years of experience as a Clinical Research Coordinator or Clinical Research Assistant (preferably in an in-house setting).
• Knowledge of ICH-GCP, GDP, FDA regulations, and other clinical trial regulations.
• Strong written/oral communication skills as well as strong organizational and multi-tasking skills.
• Ability to manage multiple tasks and priorities effectively.
• Proficient in Microsoft Office Suite, Adobe, and clinical trial management software (e.g., OnCore, Velos, Veeva).
• Ability to work independently and in a team environment.
• Must be sufficiently fluent in the English language to satisfactorily perform the essential functions of the position.

Preferred Skills:

• Certification in Clinical Research (CCRC, ACRP, or SOCRA).
• Experience with electronic data capture (EDC) systems.
• Familiarity with specific therapeutic areas (e.g., oncology, cardiology, etc.).
• Knowledge of various types of human subject clinical trials

Working Conditions:

• In-office work with no travel