Pangea Laboratory

Job Summary: Pangea Laboratory is looking for a highly motivated and detail-oriented Clinical Trial Assistant (CTA) with 3-5 years of experience in the biotech or in vitro diagnostics (IVD) industry. The CTA will support the planning, execution, and documentation of clinical studies in compliance with applicable regulations (IVDR, GCP, ISO 14155) and internal SOPs. Essential Duties and Responsibilities: * Support study start-up, maintenance, and close-out activities across multiple clinical trials. * Coordinate with CROs, clinical sites, and vendors to ensure timely delivery of study milestones. * Track and manage clinical supplies, shipments, and site communications. * Assist in the development and review of study-related documents (e.g., protocols, ICFs, CRFs, monitoring plans). * Support data collection and query resolution. * Participate in internal and external meetings, including meeting minutes and following up on action items. * Assist in the preparation of regulatory documents, ethics committee applications, and study start-up materials as needed. Education: Bachelor’s degree in life sciences, healthcare or related field. Experience: * 3–5 years of experience as a CTA in biotech, diagnostics, or medical device industry. * Familiarity with IVD clinical trials and regulatory frameworks (IVDR, ISO 14155, GCP). * Experience with TMF systems and clinical trial management systems (CTMS). * Strong understanding of clinical trial documentation and workflows. * Ability to work independently and collaboratively. * Detail-oriented with a proactive approach to problem-solving. * Strong organizational and communication skills. Preferred Skills: - Experience supporting Class C IVD studies under IVDR. - Knowledge of clinical utility and performance evaluation studies. - Prior involvement in post-market surveillance activities. - Proficient Excel, Word and PowerPoint skills. About us: Pangea Laboratory is a California-based diagnostics company founded in 2014. We focus on the precise, early detection of emerging diseases. Our mission is to have a positive impact on human life, by providing biomedical communities with reliable and high-quality testing services, delivering the data they need to diagnose and treat diseases in an effective and timely manner. Named a Top Workplace by the OC Register, Pangea Laboratory continues to be a place where employees feel engaged, connected, and energized about their work. If you are passionate about helping people in advancing science and working with awesome teams in a fast-growing company, we want to speak with you! Compensation: The estimated base compensation range for this position is $26 to $32 per hour at the time of posting. Actual compensation details will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. Pangea Laboratory also offers competitive benefits and perks including: - Medical, Dental, Vision, and Life Insurance Coverages - EAP Sessions - Vacation Time plus Company Holidays - Paid Sick Leave - Generous 401(K) with matching - Employee Referral Bonus - Complimentary fruit, snacks, and beverages - Complimentary catered lunches on Thursdays Equal Employment Opportunity Employer: Pangea Laboratory welcomes candidates of all backgrounds. These include sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender, gender identity, gender expression, physical & mental disability, medical condition, genetic information, military and veteran status, or any other protected status as defined by federal, state, or local law. Location: Onsite – Pangea HQ – 14762 Bentley Cir. Tustin, CA 92780 Disclaimer: At Pangea Laboratory, we take the integrity of our hiring process seriously. Please be aware of fraudulent recruitment activities that may use our name to deceive job seekers. We will never ask for payment, sensitive personal information, or financial details during the recruitment process. All legitimate communications will come from an official Pangea Laboratory or TriNet Hiring email address. If you are contacted by anyone claiming to represent us using a free email service (e.g., Gmail, Yahoo, Hotmail) or asking for payment, please treat this as fraudulent and report it immediately to [email protected] ( [email protected] )