Job Title: Clinical Research Coordinator II (Gardena)Job Description The Clinical Research Coordinator II conducts and manages multiple clinical trials from start-up through study close-out in accordance with the study protocol, GCP, and SOPs. This role involves implementing and coordinating clinical trials, managing vendor relationships, recruiting subjects, and ensuring all regulatory requirements are met. Responsibilities + Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and SOPs. + Implement and coordinate assigned clinical trials including start-up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, and ensuring data is entered in a timely manner. + Resolve all queries, manage and report adverse events, serious adverse events, and deviations, implement new protocol amendments, and provide all close-out activities. + Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols. + Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. + Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries. + Maintain confidentiality of patient protected health information, sponsor confidential information, and proprietary information. + Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and SOPs. + Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner. + Ensure staff are delegated and trained appropriately and documented. + Create, collect, and submit regulatory documents to sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements. + Evaluate potential subjects for participation in clinical trials including phone and in-person pre-screens. + Create and execute recruitment strategies defined by the team. + Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol. + Understand the product development life cycle and significance of protocol design including critical data points. + Understand the disease process or condition under study. + Collaborate to develop a Quality Control strategy for reviewing work on an ongoing basis and in preparation for monitor visits. + Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope. Essential Skills + Experience with clinical trials and research. + Proficiency in pre-screening patients and obtaining consent. + Bilingual capabilities. + Phlebotomy skills. + Clinical research experience. + Experience with electronic data capture (EDC) systems. Additional Skills & Qualifications + Bachelor’s degree and 2 years relevant experience in the life science industry OR + Associate’s degree with 4 years relevant experience in the life science industry OR + High School Graduate and/or technical degree with a minimum of 6 years relevant experience in the life science industry AND + 1 year Clinical Research Coordinator experience. Work Environment This position is onsite and offers private examination/consultation rooms, comfortable patient reception areas, facilities for extended-stay pharmacokinetic studies, parking, a nursing station, secure monitoring rooms or workstations with phone & high-speed internet access, multiple individual & secure workstations for research staff, a regulatory document processing area, and electronic data capture capabilities. The facility also includes secure record storage, a CLIA certified research laboratory or clinical laboratory with a CLIA waiver, ambient and refrigerated centrifuge, secured & temperature-controlled investigational product storage with pharmaceutical refrigerator & freezer, freezers equipped for laboratory specimens at -20 & -70 degrees Celsius, a backup generator/power source in the event of site power loss, and standard medical equipment, including ECG machines, digital and analog scales. Pay and Benefits The pay range for this position is $64400.00 - $72800.00 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 Gardena,CA. Application Deadline This position will be accepting applications until Jan 29, 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.