Job Title: Clinical Research Coordinator IIJob Description We are seeking a detail-oriented and experienced Clinical Research Coordinator II to manage and oversee clinical trials in accordance with study protocols, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) Guidelines, and standard operating procedures (SOPs). The role involves implementing and coordinating clinical trials, managing subject recruitment, ensuring data integrity, and maintaining regulatory compliance. Responsibilities + Manage and oversee clinical trials according to study protocols, GCP, ICH Guidelines, and SOPs. + Implement and coordinate assigned clinical trials including start-up, vendor management, subject recruitment, and source development review. + Schedule subjects, provide protocol training, collect regulatory documents, and conduct visits. + Ensure data is entered in a timely manner and all queries are resolved. + Manage and report adverse events, serious adverse events, and deviations. + Implement new protocol amendments and provide close-out activities. + Develop, coordinate, and implement research and administrative strategies for managing protocols. + Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. + Apply good documentation practices for data collection, correction, and transfer to sponsor/CRO data capture systems. + Maintain confidentiality of patient protected health information and sponsor confidential information. + Verify and escalate patient safety concerns and ensure adverse events are reported as per protocol and SOPs. + Ensure staff are delegated and trained appropriately with proper documentation. + Create, collect, and submit regulatory documents to Sponsors and IRBs as required. + Evaluate potential subjects for clinical trial participation including pre-screens. + Create and execute recruitment strategies defined by the team. + Understand key timelines, endpoints, required vendors, and patient population for each protocol. + Understand product development life cycle and significance of protocol design. + Understand the disease process or condition under study. + Collaborate to develop Quality Control strategy for reviewing work and preparing for monitor visits. + Perform clinical duties such as drug preparation, administration, fibroscan, phlebotomy, ECG, and lab processing. Essential Skills + Bachelor’s degree and 2 years relevant experience in the life science industry OR Associate’s degree with 4 years relevant experience OR High School Graduate/technical degree with 6 years relevant experience AND 1 year Clinical Research Coordinator experience. + Experience in chart review, clinical research, EDC, and consent processes. + Proficiency in GCP and clinical trial management. + Skills in phlebotomy and clinical trial procedures. Additional Skills & Qualifications + Strong communication and interpersonal skills. + Excellent organizational and time management abilities. + Attention to detail and adherence to regulatory guidelines. + Proficiency in using data management systems. Work Environment This position is onsite and offers a comprehensive benefits package including medical, dental, vision, HSA, and FSA plans with employer contributions. The role includes a 401k plan with company match, paid time off starting at three weeks per year, 10 paid holidays, life insurance, short- and long-term disability benefits, and an employee assistance program. Additionally, site bonuses are paid twice annually to recognize individual contributions and team success. Pay and Benefits The pay range for this position is $70000.00 - $80000.00/yr. Health and Wellness Benefits Medical, dental, vision, HSA, and FSA plansEmployer contributions from 55-80% based on coverage levelCompany contributions to HSAs401k Eligibility and Company Match 100% match of the first 3% of contributions; 50% on the next 2% contributedImmediate eligibility and automatic enrollment at 5% contributionPaid Time Off and Company Holidays PTO starting at three weeks per year and growing with company tenure10 paid holidays each calendar yearLife Insurance and Employee Assistance Program 100% paid life Insurance policy (double annual salary)100% paid short- and long-term disability benefitsOptional insurance coverage for the employee and dependentsComplimentary emergency assistance planSite Incentive Bonus Plan Site bonuses are paid twice annuallyTies site team success to Velocity's successRecognition and reward for individual contributions Workplace Type This is a fully onsite position in North Hollywood,CA 91606. Application Deadline This position is anticipated to close on Mar 10, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.