Clinical Research Compliance Specialist

Job Description JOB LOCATION / SCHEDULE : Monday Friday / On-Site / San Diego, CA COMPANY OVERVIEW : At Alliance Clinical Network, were people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day. Summary : The Clinical Research Compliance Specialist supports clinical research studies by monitoring protocol and regulatory compliance, reviewing research data for accuracy, managing documentation and milestones, auditing essential documents, writing monitoring reports, and developing risk monitoring plans and study-related documents. Essential Duties and Responsibilities : Conduct SOP / GCP / Compliance Training with site coordinators. Ensure sites adhere to ACNs policies and procedures. Perform on-site and remote audits to evaluate compliance, human subject protection, and data integrity. Manage audit/inspection findings effectively and escalate significant issues to management. Coach and support CRCs and PIs based on audit findings. Monitor protocol and regulatory compliance across multiple treatment areas and research designs. Review source documentation for accuracy and completeness. Collaborate with offshore and onsite teams to address findings. Maintain confidentiality and compliance standards. Collect, review, and audit essential documents. Assist in developing study-specific risk monitoring plans. Communicate with study teams regarding trial activities. Serve as the main contact during audits and monitoring visits. Understand new and amended research protocols. Meet targets and deadlines efficiently. Apply analytical and problem-solving skills with attention to detail. Perform additional duties as needed to meet department goals. Qualification Requirements : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made for disabilities. Education and Experience : Associate degree in healthcare or related field preferred. Minimum two years of clinical research experience as a CRC or one year as a CRA. Proficiency in Microsoft Word, Excel, and Adobe Acrobat. Knowledge of medical and clinical trial terminology. Strong attention to detail and prioritization skills. Excellent communication skills. Special Skills, Knowledge, and Abilities : Ability to analyze data and adapt to changing priorities. Effective communicator, capable of relaying information clearly. Supportive of new initiatives and able to identify performance issues early. Collaborative in finding solutions aligned with departmental goals. Understanding of data management and study operations. Compliance with SOPs and GCP guidelines. Awareness of safety, ethical, and regulatory considerations. Certificates, Licenses, Registrations: Maintain GCP certification and relevant certifications. Travel Required :

5-10% Physical Demands and Working Conditions : Regularly required to stand, walk, sit, kneel, handle objects, and communicate. Occasionally lift up to 25 pounds. Must have specific vision abilities. Work environment requires adherence to safety regulations. Management reserves the right to reassign duties as needed. This description is not exhaustive and duties may change. BENEFITS : 401(k) Retirement Plan Medical, Dental, and Vision Insurance Paid Time Off (PTO) Floating Holidays And more! #J-18808-Ljbffr