• Provide statistical support for CMC-related studies, including formulation development, stability studies, process validation, and analytical method validation. • Collaborate with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs, to develop and implement appropriate statistical strategies. • Design and analyze experiments using linear mixed models, particularly for stability and variability analyses. • Perform statistical modeling, data visualization, and simulations using R programming. • Experience with Bayesian methods preferred. • Ensure quality and compliance with internal standards and regulatory guidelines (e.g., FDA, EMA, ICH).

Title: Senior Clinical Research Coordinator - Hematology, Oncology Work Location: Santa Monica, CA, USA Onsite or Remote Flexible Hybrid Work Schedule Monday – Friday, 8:00am - 5:00pm Posted Date 06/25/2026 Salary Range: $82705.68 - 133068.24 Annually Employment Type 2 - Staff: Career Duration Indefinite Job # 31477 Primary Duties and Responsibilities Press space or enter keys to toggle section visibility The Senior Clinical Research Coordinator plays a critical role in the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The ideal candidate is an experienced professional or leader who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities. Recognize and perform necessary project management tasks and prioritizes work to reach scheduled goals. The Senior Clinical Research Coordinator is a technical leader responsible for ensuring the study protocol and procedures have been completed accurately, safely, and in a timely manner. This position may supervise and train others on projects as necessary. Work with PIs, departments, sponsors, institutions, and other entities as needed to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of studies. Annual salary range: $93,927.51 - $151,099.73. Job Qualifications Press space or enter keys to toggle section visibility Required: - Minimum of 4+ years of experience in a clinical research setting - Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team. - Ability to effectively communicate to and interact with patients in a compassionate and kind manner. - Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. - Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. - Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. - Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. - Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. - A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently. - Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. - Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner. - Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. - Ability to handle confidential information with judgement and discretion. - High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual. - Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc. - Strong knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. - Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. - Ability to think creatively to develop solutions affecting the full team. - Experience with FDA processes and procedures. - Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets. Preferred: - Bachelor’s Degree in related area and/or equivalent combination of education and experience. Advanced degree preferred As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. Current/former UC employees are subject to a personnel file review.

Title: Clinical Research Coordinator - Pediatrics Location: Los Angeles United States Salary Range: $36.37 - 58.52 Hourly Job #: 29178 Job Description: Primary Duties and Responsibilities Press space or enter keys to toggle section visibility The Clinical Research Coordinator will join a centralized clinical research team conducting clinical trials across multiple pediatric sub-specialties. Under the direction of the Clinical Research Supervisor, the Clinical Research Coordinator will manage and coordinate clinical trial activities. Responsibilities include, but are not limited to, participant recruitment, assessment of trial eligibility, enrollment, coordination of research visits, collection and management of participant source documents, regulatory submissions and file maintenance, data management, and specimen handling. The Clinical Research Coordinator is responsible for adhering to institutional and federal clinical research requirements and ensuring studies are conducted in accordance with study protocols and Good Clinical Practice. This role requires the ability to adapt to changing priorities and work flexible hours to meet research deadlines. Travel to other locations may be required. This position is primarily on-site at the UCLA Westwood campus. This is a limited position that may convert to career. Salary Range: $36.37 - $58.52 Hourly Job Qualifications Press space or enter keys to toggle section visibility Required: - Bachelor’s degree or 2+ years of previous study coordination or clinical research coordination experience - Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators, and administration and to work as a member of a team. - Ability to effectively communicate and interact with patients in a compassionate and kind manner. - Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. - Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. - Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. - Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. - Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. - A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently. - Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. - Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner. - Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. - High degree of concentration and focus on a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual. - Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc. Preferred: - Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer.

Title: Phase I Oncology Clinical Research Associate Job Id: 168580 Job Category: Job Location: Remote Job Description: Piper Companies is seeking a Phase I Oncology Clinical Research Associate to support early-phase oncology clinical trials within the biotechnology and pharmaceutical industry. The Phase I Oncology Clinical Research Associate role is ideal for a clinical research professional experienced with first-in-human and dose-escalation oncology studies. The Phase I Oncology Clinical Research Associate role is a remote opportunity and requires you to travel up to 8-10 days per month. Responsibilities of the Phase I Oncology Clinical Research Associate: - Monitor Phase I and first-in-human oncology trials in compliance with ICH-GCP and FDA regulations. - Conduct site initiation, monitoring, and close-out visits. - Ensure subject safety, data quality, and protocol adherence. - Review source documents, EDC data, and safety reports. - Collaborate with sites and internal clinical teams to resolve issues. Requirements of the Phase I Oncology Clinical Research Associate: - 3+ years of onsite monitoring as a CRA with a focus on Phase I or early-phase oncology. - Bachelors Degree is Required - Hands-on experience with dose-escalation and DLTs. - Strong knowledge of GCP, FDA regulations, and monitoring best practices. - Experience with oncology indications and EDC systems. - Ability to travel to research sites as required. Compensation for the Phase I Oncology Clinical Research Associate: - $110,000 - $140,000 base salary - Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law. Keywords: Phase One Oncology CRA, Clinical Research Associate, Phase I Oncology, First-in-Human Trials, Dose Escalation, Oncology Clinical Research, GCP, FDA Regulations, Clinical Monitoring, Biotechnology, Pharmaceutical #LI-AG1 #REMOTE