Clinical research coordinator jobs in Fremont, CA

W2 Contract-to-Hire Salary Range: $145,600 - $166,400 per year Requirements and Qualifications: 3+ years of project management experience Direct experience with Epic clinical applications in either an analyst or project management role Experience as a lead project manager responsible for end-to-end delivery of the project, including the development of project management artifacts Demonstrated experience in leading a project team as a project manager. Ability to develop relationships and trust with stakeholders and the project team Change management Proactive and a self-starter Strong communication skills Desired Skills and Experience Project management, EPIC applications, clinical, change management Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at *************************

Role: Senior or Lead Clinical AI Research Scientist Company Stage: Seed ($50 Million) Compensation: 200k-225k salary range, bonus, equity About the Company Our client is an AI-first healthcare technology company transforming how hyper-personalized care is delivered. Their precision care platform empowers clinicians to provide whole-person care by combining generative AI with predictive analytics. Backed by extensive proprietary data assets covering hundreds of millions of patients and healthcare providers, the company is led by a team of experts spanning healthcare, technology, and clinical research. Their mission is to bridge cutting-edge AI innovation with practical, real-world healthcare applications that improve patient outcomes. About the Role We are seeking a Senior Data Scientist with deep expertise in Large Language Models (LLMs) and their application in healthcare. In this role, you will design, build, and deploy advanced AI solutions that seamlessly integrate into existing clinical and operational systems, driving measurable impact for providers and patients. Key Responsibilities End-to-End Development: Lead the design and implementation of LLM-powered healthcare applications that are secure, scalable, and production-ready. Model Specialization: Fine-tune and adapt LLMs such as LLaMA 2, Mistral, and other cutting-edge open-source models for healthcare-specific use cases. Tool Application: Leverage frameworks like LangChain, LlamaIndex, and related tools to create innovative AI-driven healthcare workflows. Problem-Solving: Address complex challenges in healthcare using creative, data-driven approaches that transform AI capabilities into real-world patient outcomes. Cross-Functional Collaboration: Partner with clinicians, engineers, and business stakeholders, translating technical concepts into clear, actionable insights. Continuous Innovation: Stay ahead of emerging trends in AI and healthcare technology, integrating new methodologies and tools where beneficial. Qualifications Advanced degree in Computer Science, Data Science, Artificial Intelligence, or a related discipline. Proven experience developing and deploying LLM applications in a healthcare context. Experience with SFT, RLHF, RAG, Agents, etc. Proficiency with LLaMA 2, Mistral, LangChain, LlamaIndex, and comparable technologies. Strong analytical, problem-solving, and critical-thinking skills. Excellent written and verbal communication abilities, with a collaborative mindset.

Senior Research Associate - Oncology Employment Type: Full-time About the Opportunity Our client, an innovative biotechnology company focused on advancing oncology therapeutics, is seeking a Senior Research Associate to join their clinical development team. This individual will play a key role in supporting oncology clinical studies and cross-functional research efforts from within the company's San Francisco headquarters. This is an on-site role (3 days per week), offering the opportunity to collaborate closely with clinical operations, translational research, and biomarker teams in a highly interactive environment. Key Responsibilities Support the planning, execution, and monitoring of oncology clinical studies across multiple phases. (Phase II and III Preferred) Collaborate cross-functionally with Clinical Operations, Data Management, Biometrics, and Translational Science to ensure study deliverables and timelines are met. Assist with protocol review, study documentation, sample tracking, and data reconciliation activities. Maintain study files and documentation in compliance with GCP and internal SOPs. Contribute to internal study meetings, data reviews, and cross-team communications. Manage and review laboratory samples and data from external partners and CROs. Provide operational and scientific support for biomarker and translational research activities tied to ongoing clinical programs. Required Qualifications Bachelor's or Master's degree in Biology, Oncology, or a related life science field. 3-6 years of relevant industry experience supporting oncology-focused clinical studies. Proven track record contributing to clinical-stage oncology programs. Solid understanding of clinical study workflows, GCP guidelines, and study documentation.

About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting . Overview of Role: The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is $113,500 to $133,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit s Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description Job Responsibilities: · Provide input and assist with harmonization of Clinical Operations databases and tracking tools. · Assist in the maintaining clinical information and training of Clinical Operations personnel in the clinical trials database · Processes re-supply drug shipments. · Order and maintain inventory of clinical supplies. · Order and ships case report forms. Assists with development of documents for site binders. Assembles and coordinates distribution of site binders. · Serves as CRA back up providing verbal and written communication with study personnel. · Under close supervision reviews and participates in the quality assurance of data or documents. Arranges meeting logistics. · rafts meeting agendas and assists in preparing meeting minutes. The position interacts with other departments, as directed, to complete assigned tasks. · May assist with monitoring visits under the direct supervision of senior staff. Travel may be required. Assist with the planning and facilitation of investigator meeting and, when applicable, provide on location support during the meetings. Additional Information Indu Dubey Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - 732-844-8725 Email: indu@ irionline.com

can be 100% remote, but must be located in the United States. Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes HEPLISAV-B, our commercial product approved in the U.S. and the European Union, for prevention of hepatitis B virus in adults. We also supply CpG 1018 to research collaborations and partnerships globally. Currently, CpG 1018 is being used in development of COVID-19, plague, shingles, and Tdap vaccines. At Dynavax, our vision and work ethic are guided by the collective ideals underpinning our core values, and these form the basis of our dynamic company culture. We strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employee. We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary. Dynavax is headquartered in the San Francisco Bay area, and our manufacturing facility is in Düsseldorf, Germany. Under the direction of the clinical operations management, the Clinical Research Associate II will help to execute assigned clinical studies and ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives. Responsibilities * Daily activities may vary depending on the clinical phase of the program and may support more than one study. * Collaborate with contract research organization (CRO) personnel and study sites to ensure studies are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, SOPs and overall clinical objectives. * Manage study deliverables, including clinical study start-up activities, clinical supply logistics, enrollment, data collection, and close-out in consultation with study leads. * Participate in on-site and remote monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. * Review monitoring visit reports and track resolution of action items. * Actively participate in the preparation of study-related clinical documents, including but not limited to, informed consent forms, site training materials, monitoring visit templates, CRFs, CCGs, clinical monitoring plans, source document templates, pharmacy manuals, IRT manuals, etc. * Participate in implementation of study systems and technology including EDC, IRT, eTMF, CTMS, PROs, etc. * Support the selection of sites and CROs and planning of clinical meetings as needed (investigator meeting, steering committee meeting, CRO kick-off meetings, etc.). * Support the review and development of study protocols, clinical sections of INDs, and other regulatory submissions. * Assist with the review of clinical trial data and listings. * Assist with filing of clinical documents in the TMF, as applicable. * Daily activities may vary depending on the clinical phase of the program and this role may support more than one study. * Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork. * Other duties as assigned. Qualifications * A BA/BS in Life Sciences or equivalent. * 2+ years of clinical research associate experience in the biotechnology industry, sponsor experience preferred. * On-site monitoring proficiency required. * Deep working knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials. * Ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches. * Excellent technical writing skills. * Experience working in cross-functional project teams. * Strong verbal and written communication and interpersonal skills. * Computer proficiency a must. * Ability to sit for prolonged periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers. * Occasional travel required, as needed. Highly valued personal attributes include: Integrity and flexibility Proactive in identifying potential problems and seeking successful solutions Action- and goal-oriented Practical approach to clinical and regulatory processes Collaborative and team-oriented Excellent attention to detail Work Schedule * This is a contract position that requires 40 hours per week. $75 - $75 an hour The estimated pay for this position is $75 per hour. Final pay determinations may depend on various factors, including, but not limited to experience level, education, geographical location, knowledge, skills, and abilities. #LI-REMOTE California residents: for information on how we handle your personal information and your privacy rights as a job candidate, please see our Candidate Privacy Notice: ********************************************************************************************* Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Business UnitTencent Games was established in 2003. We are a leading global platform for game development, operations and publishing, and the largest online game community in China. Tencent Games has developed and operated over 140 games. We provide cross-platform interactive entertainment experience for more than 800 million users in over 201 countries and regions around the world. Honor of Kings, PUBG MOBILE, and League of Legends, are some of our most popular titles around the world. Meanwhile, we actively promote the development of esports industry, work with global partners to build an open, collaborative and symbiotic industrial ecology, and create high-quality digital life experiences for players.What the Role Entails About Tencent Games Tencent Games was established in 2003. We are a leading global platform for game development, operations and publishing, and the largest online game community in China. Tencent Games has developed and operated over 140 games. We provide cross-platform interactive entertainment experience for more than 800 million users in over 200 countries and regions around the world. Honor of Kings, PUBG MOBILE, and League of Legends, are some of our most popular titles around the world. Meanwhile, we actively promote the development of esports industry, work with global partners to build an open, collaborative and symbiotic industrial ecology, and create high-quality digital life experiences for players. About Tencent's Central Technology Platform As the technical backbone of Tencent Games, the Tencent Games Central Technology Platform is dedicated to delivering high-quality technical middle-platform services and pioneering innovation guidance for Tencent Games. We actively explore breakthroughs in applying gaming technologies across commercial products and socially impactful scenarios, driving efficiency in game production and elevating user experiences. Committed to fostering an open technical sharing ecosystem, we empower global game developers through our expertise, tools, and products, accelerating the advancement of gaming technologies worldwide. Responsibilities: Research and analyze the latest advancements in gaming AI technologies, including but not limited to AI-driven 2D/3D content generation, intelligent NPCs, AI-assisted coding and AI real time rendering. Build and maintain connections with AI professionals across the gaming industry, tech sector, and academia to stay informed of cutting-edge applications and best practices. Provide strategic insights and recommendations on AI technology adoption for Tencent Games' Central Technology Platform. Initiate, promote, and manage joint research collaborations with leading universities as needed. Who We Look For Key Qualifications: Solid understanding of AI technologies and/or hands-on experience with game development technologies. Strong communication, collaboration, and research skills, with the ability to synthesize complex information effectively. Proficiency in both English and Mandarin for professional communication. Deep passion for the evolution and future potential of gaming AI. Plus: Well-established network with AI experts in the gaming industry, technology sector, or academic research community. Publications in top-tier AI or computer vision conferences or journals, such as SIGGRAPH, AAAI, or CVPR. Education & Experience: Minimum: BS - Artificial Intelligence, Computer Vision, Computer Science, and related fields. Preferred: MS or PhD - Artificial Intelligence, Computer Vision, Computer Science, and related fields. Location State(s) US-California-Palo AltoThe expected base pay range for this position in the location(s) listed above is $110,800.00 to $253,400.00 per year. Actual pay may vary depending on job-related knowledge, skills, and experience. Employees hired for this position may be eligible for a sign on payment, relocation package, and restricted stock units, which will be evaluated on a case-by-case basis. Subject to the terms and conditions of the plans in effect, hired applicants are also eligible for medical, dental, vision, life and disability benefits, and participation in the Company's 401(k) plan. The Employee is also eligible for up to 15 to 25 days of vacation per year (depending on the employee's tenure), up to 13 days of holidays throughout the calendar year, and up to 10 days of paid sick leave per year. Your benefits may be adjusted to reflect your location, employment status, duration of employment with the company, and position level. Benefits may also be pro-rated for those who start working during the calendar year.Equal Employment Opportunity at Tencent As an equal opportunity employer, we firmly believe that diverse voices fuel our innovation and allow us to better serve our users and the community. We foster an environment where every employee of Tencent feels supported and inspired to achieve individual and common goals.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

Who We Are Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes. Description As an AI Applied Scientist on our Clinical Trial Protocol Digitization team, you will help transform how clinical trials are designed and managed. Verily's Viewpoint Site CTMS platform supports better trial management, oversight, and data integration-streamlining processes to reduce costs, accelerate timelines, and ultimately bring treatments to patients faster. In this role, you will design novel algorithms, conduct applied research, and translate findings into practical AI solutions. You will focus on extracting knowledge from unstructured protocols and related medical data, building intelligent tooling that integrates seamlessly into real-world clinical workflows. Success in this role requires both scientific creativity and pragmatic engineering: you'll advance the state of the art in NLP/LLMs while ensuring models are reliable, scalable, and user-friendly for clinical and product stakeholders. Responsibilities Design and develop machine learning models and AI algorithms to extract, structure, and apply information from clinical trial protocols and related medical data. Translate research findings into production-ready solutions that enhance trial digitization and decision-making. Partner closely with clinical experts, product managers, and engineers to ensure solutions meet real-world needs and integrate with existing workflows. Communicate technical concepts and results clearly, adapting style and depth for technical and non-technical audiences. Stay current with advancements in AI/ML research and identify opportunities to apply them within clinical trial contexts. Contribute to an inclusive, collaborative team environment where diverse perspectives are valued and leveraged. Qualifications Minimum Qualifications Advanced degree in a quantitative discipline (e.g., data science, statistics, biomedical informatics, computer science, applied mathematics, or similar), or equivalent practical experience. 5+ years of experience developing and applying advanced machine learning and AI techniques to clinical, biomedical, or similarly complex data. Strong proficiency in Python and experience with modern ML frameworks and Git-based workflows. Demonstrated ability to design and implement novel algorithms or adapt research methods for practical applications. Excellent written and verbal communication skills, with a proactive, collaborative approach to problem-solving. Preferred Qualifications Familiarity with medical terminologies, ontologies, and standards relevant to clinical trials (e.g., FHIR). Experience collaborating with clinical research professionals or other domain experts. Exposure to software engineering practices and experience contributing to production systems. Strong curiosity and adaptability, with a demonstrated ability to learn new domains quickly. This role is eligible for Verily-sponsored immigration support. The US base salary range for this full-time position is $119,000 - $169,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Verily Life Sciences LLC is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form.

+ Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study + Ensures alignment of regional deliverables with overall study goals **Essential Functions of the job:** **Regional Leadership** + Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study + Leads external vendors involved in study delivery on a regional level + Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional study team members **Timelines, Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these + Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study plans as required + Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems and tools is entered and up to date + Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports + Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region + Manages the trial data collection process for the region, drives data entry and query resolution + As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads + Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point in time throughout the study life cycle + Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented + Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate + Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared + Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies + Contributes to development, optimization and review of work instructions and SOPs as required **Budget and Resources** + Works with the sourcing team to select and manage regional study vendors + Manages regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities + Identifies and manages regional team resource needs and establishes contingency plans for key resources + Monitors regional resource utilization over study life cyle and liaises with functional managers as needed **Supervisory Responsibilities:** + Provides performance feedback on team members as required + Might mentor junior team members **Computer Skills:** MS Office, Project Planning Applications **Other Qualifications:** + 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead in clinicial functions + Experience as CRA is preferred **Travel:** Travel might be required as per business need **Education Required:** Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred _*exceptions might be made for candidates with relevant clinical operations experience_ **Competencies:** **Ethics -** Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures. **Planning/Organizing** **-** Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction. **Communication** **-** Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information. **Teamwork -** Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others. **Adaptability -** Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. **Technical Skills** **-** Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others. **Dependability** **-** Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. **Quality** **-** Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. **Analytical** **-** Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. **Problem Solving** **-** Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. **Project Management -** Communicates changes and progress; Completes projects on time and within budget. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company DescriptionJobs for Humanity is partnering with Stanford University to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located. Company Name: Stanford University Job Description The Computational Psychiatry, Neuroimaging and Sleep Laboratory (CoPsyN Sleep Lab) within the Department of Psychiatry and Behavioral Sciences is currently recruiting for a motivated and compassionate Sleep Research Coordinator Associate for projects investigating the relationships between sleep disturbances, brain function, and emotional well-being. The CoPsyN Sleep lab is focused on translational clinical research and utilizes human neuroimaging, high density EEG, computational methods, and clinical psychology to examine the role of sleep physiology in the development, maintenance, and treatment of psychopathology across the lifespan. Current projects include: An NIH funded clinical trial examining the impact of a sleep intervention on emotion regulation brain function in individuals with depression. An NIH funded clinical trial studying sleep disturbance and emotion regulation in individuals with Mild Cognitive Impairment (MCI) and mild Alzheimer's Dementia. An NIH funded observational study examining the mechanistic interrelationship between sleep, co-occurring cannabis and alcohol use disorder, and neurocircuit dysfunction during early abstinence. We are looking for a Research Coordinator to help primarily with data acquisition of EEG sleep recordings and work closely with the Principal Investigator, Dr. Andrea Goldstein-Piekarski and other study team members. The right person for this job will be able to hit the ground running and jump into ongoing projects, requiring them to learn and apply sleep EEG recording, behavioral, and psychological assessment techniques while interacting with participants. Given the primary need will be focused on sleep EEG data acquisition, the ideal candidate will also be comfortable with primarily evening sessions. We are looking for someone who is detail oriented and can trouble-shoot independently while recognizing when to ask questions. Comfort and skill with working with a diverse patient population is essential. There will also be opportunities to gain research experience in additional areas such as in EEG pre-processing procedures, cognitive and neuropsychological assessments, data analysis, actigraphy, scientific presentations and reports to NIH. Due to the nature of the work and studies, this position will work primarily during the evenings and two weekend sessions a month. While there may be some flexibility, we are seeking coverage to help with the preparing for and conducting the evening EEG data acquisition. Work hours would typically be between 12 PM - 9 PM. However, there is some variability, some sessions may start later and therefore go later into the evening. The position will be based within a collaborative team and the CoPsyN Sleep Lab values diversity, cooperation, fairness, efficiency, and conscientiousness. The CoPsyN Sleep lab is committed to maintaining an inclusive and supportive environment for all members regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status. Interested candidates should include a CV and Cover Letter addressing how your education and experience relates to the position as described above. Duties include: Attach and calibrate polysomnography and EEG equipment in clinical setting Coordinate collection of study specimens and processing Administer study cognitive and neuropsychological tests, clinical interviews, and collect medical information according to protocols Collect and manage patient and laboratory data for clinical research projects Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed * - Other duties may also be assigned . . DESIRED QUALIFICATIONS: Strong interest of human neuroscience techniques and experimental design including EEG and fMRI Previous experience in acquiring data that requires a high level of technical skill and attention to detail (including but not limited to functional MRI, EEG, lab-based assays, psychological test administration etc.) Experience working with depressed, anxious, or sensitive populations such as older adults with memory impairments Effective communication skills, both orally and in writing

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world's first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health. The Clinical Scientist will support regulatory, quality, and scientific activities across the Nidra product lifecycle. This role is ideal for a recent PhD graduate in a science or engineering discipline who is eager to contribute to regulatory documentation, clinical data analysis, and compliance activities. The Clinical Scientist will collaborate cross-functionally with Regulatory Affairs, Quality, R&D, Research and Marketing to ensure high-quality regulatory and scientific submissions supporting product development and commercialization. This position reports to the Senior Vice President, Clinical and Regulatory Affairs. Responsibilities: Clinical Evaluation & Post-Market Surveillance: Conduct literature reviews and develop or update Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) reports Regulatory Documentation: Prepare, review, and maintain regulatory submissions, technical documentation, and product labeling in compliance with applicable requirements (e.g., 510(k), De Novo, EU MDR/IVDR) Medical Device Reporting (MDR): Assess and evaluate complaints for Medical Device Reporting compliance, ensuring timely reporting to regulatory authorities Promotional Review: Review marketing and promotional materials to ensure compliance and prevent off-label promotion Product Development Support: Assist in preparing technical documentation, labeling, Regulatory Assessments and Instructions for Use (IFUs) for new product introductions and design modifications Clinical Trial & Public Registry Management: Update and maintain study information on clinicaltrials.gov in accordance with regulatory requirements Data Analysis & Reporting: Compile, analyze, and interpret scientific, clinical, and quality data; create datasets, dashboards, and reports for regulatory, quality, and executive audiences Regulatory Interactions: Support communications with regulatory authorities by preparing briefing materials and ensuring consistency across scientific and technical documentation Regulatory Strategy: Contribute to planning global submissions and post-market compliance activities, ensuring alignment with business objectives Cross-Functional Collaboration: Partner with Quality, Clinical Affairs, and other teams to maintain compliance with internal and external standards (e.g., ISO 13485, 21 CFR 820, GCP, ISO 14155) Issue Identification & Resolution: Proactively identify potential regulatory issues and support the development of effective, compliant solutions Systems Oversight: Assist in developing and maintaining systems for tracking regulatory commitments, submissions, and post-market follow-up activities Requirements: PhD in Biomedical Engineering, Life Sciences, or a related scientific field (required) 0-2 years of relevant industry or regulatory experience (medical device experience preferred) Strong understanding of regulatory principles and frameworks (FDA, EU MDR/IVDR, ISO 13485, ISO 14155) Excellent scientific and technical writing skills; demonstrated ability to interpret and present data effectively Experience compiling and analyzing data for regulatory, quality, or clinical purposes Detail-oriented with strong analytical, problem-solving, and organizational skills Proven collaboration and communication skills across cross-functional teams. Self-motivated, capable of working independently in a fast-paced, compliance-driven environment Compensation: Base pay: $100,000-$130,000 per year + bonus + stock options ***This is a full-time, hybrid position located in our Pleasanton Headquarters. We require an in-office presence of at least 2-3 days per week.***

Description and Requirements JOB STATUS: Full-time WORK SCHEDULE: Mon-Sun 8-9 hours per day (5 days per week) flexibility requested COMPENSATION: $33.00 rate per hour Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Sunnyvale, CA, with additional support staff on-site to manage participant intake and provide technical support. Main Responsibilities * Receive participants at work and guide them through the data collection in a controlled environment. * Follow COVID-19 sanitization procedures after each session. * Represent and promote the TELUS AI brand * The moderator will report to the Site Manager. * Have all participants complete a survey at the end of each session. * Ensure all data collection is done per project guidelines and upload the data. * Assist the Anthropometric moderators in performing body measurements that require close proximity with participants in minimal clothing, including marking the participants with a pen and collecting measurements of different body parts using high-precision technology. * Any additional task needed. Minimum Requirements * Technical/troubleshooting skills; address fundamental problems with launching apps and uploading data * Familiarity with iOS and Mac OS * Experience with data collection and data management * Experience with video recording * Able to commit to a weekly schedule for the duration of the project * Ability to interact professionally with project participants * Experience with progress tracking and reporting, comfortable with Excel or Sheets TELUS International Values: TELUS International recognizes and embraces the importance of values in our ever-changing workplace. To be successful, all applicants must demonstrate behaviors that are reflective of our values: * We embrace change and initiate opportunity * We have a passion for growth * We believe in spirited teamwork * We have the courage to innovate At TELUS International, we are committed to diversity and equitable access to employment opportunities based on ability. Additional Job Description Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Sunnyvale, CA, with additional support staff on-site to manage participant intake and provide technical support. EEO Statement At TELUS Digital, we enable customer experience innovation through spirited teamwork, agile thinking, and a caring culture that puts customers first. TELUS Digital is the global arm of TELUS Corporation, one of the largest telecommunications service providers in Canada. We deliver contact center and business process outsourcing (BPO) solutions to some of the world's largest corporations in the consumer electronics, finance, telecommunications and utilities sectors. With global call center delivery capabilities, our multi-shore, multi-language programs offer safe, secure infrastructure, value-based pricing, skills-based resources and exceptional customer service - all backed by TELUS, our multi-billion dollar telecommunications parent. Equal Opportunity Employer At TELUS Digital, we are proud to be an equal opportunity employer and are committed to creating a diverse and inclusive workplace. All aspects of employment, including the decision to hire and promote, are based on applicants' qualifications, merits, competence and performance without regard to any characteristic related to diversity.

Description Salary Range: $37.51 - $50.65 Under the supervision of Senior Clinical Research Coordinator and Principal Investigator will coordinate and is accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. The position is responsible for, and critically important to the overall operational management of clinical research activities. Maybe responsible for coordination and help prepare protocols for study initiation; help design flowsheets, data forms, and source documents; gather and interpret laboratory data; may help recruit, enroll, register, schedule and retain study subjects; complete study forms to submit to sponsors and/or agencies; collect and enter data into databases, maintaining data quality; assist with preparation with reports and tables; attend team meetings. In addition to performing the essential functions listed below, may also be assigned other duties as required. Washington Hospital Health System does not utilize any form of electronic chatting, such as Google chat for the purposes of interviewing candidates for employment. If you are contacted by any entity or individual attempting to engage you in this format, do not disclose any personal information and contact Washington Hospital Healthcare System.

Clinical Research Coordinator 1449575 Hourly pay: $45/hr Worksite: Leading university (Palo Alto, CA 94304 - Onsite) W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL 40 hours/week, 5 Month Assignment, Possible extension/conversion A leading technology company seeks a Clinical Research Coordinator to join the clinical trials office. The successful candidate will work with the team to ensure the safety and well-being of trial participants and to document related data per protocols and internal guidelines. The company offers a family-oriented culture and environment! Clinical Research Coordinator Responsibilities: Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out. Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Clinical Research Coordinator Qualifications: 2+ years of clinical research experience in an academic setting. Shift: Monday to Friday from 8 am to 5 pm.

Clinical Research Coordinator 1449575 * Hourly pay: $45/hr * Worksite: Leading university (Palo Alto, CA 94304 - Onsite) * W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL * 40 hours/week, 5 Month Assignment, Possible extension/conversion A leading technology company seeks a Clinical Research Coordinator to join the clinical trials office. The successful candidate will work with the team to ensure the safety and well-being of trial participants and to document related data per protocols and internal guidelines. The company offers a family-oriented culture and environment! Clinical Research Coordinator Responsibilities: * Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out. * Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. * Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. * Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed. * Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. * Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Clinical Research Coordinator Qualifications: * 2+ years of clinical research experience in an academic setting. Shift: * Monday to Friday from 8 am to 5 pm.

* This CRC would be focusing on Oncology studies. * The specialty could be Hematology Oncology, Breast Oncology, GU Oncology and GI Oncology. * If someone had Phase I experience they could possibly run with Solid Tumor Oncology studies. * Coordinators vary in their portfolios- but carry approximately 10-20 trials at a time. * There is no patient recruitment- they rely on the PI's and patients who are researching the clinical studies for patient enrollment. * Responsible to screen, consent and enroll patients on an oncology trial and follow that patient through the course of therapy. * Most of the time is spent in clinic- seeing patients with the doctor, go to patient visits, make sure the questionnaires are completed and research procedures outside the clinical norms are done. * Work with clinic staff to make and schedule appointments, for example EKG's or vitals. * Responsible for protocol compliance- making sure things are done in the correct timeframe. * Interacting with nursing staff, MA's. * Collaborating with clinical folks that get insurance authorizations. Job Type & Location This is a Contract to Hire position based out of Palo Alto, CA. Pay and Benefits The pay range for this position is $35.00 - $43.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Palo Alto,CA. Application Deadline This position is anticipated to close on Nov 17, 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. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Job DescriptionIrvine Clinical Research is the largest independent clinical trial group on the West Coast. Most of our research is in neurology (Alzheimer's Disease treatment and prevention studies); we also conduct trials in psychiatry and obesity medicine. In this role, we are seeking CRCs with proven trial experience. Ideally, candidates will have worked as a primary coordinator on a high-enrolling and/or highly complex drug trial and produced quality work.Job Duties Manage daily operations for assigned clinical trial projects Perform study procedures in accordance with GCP and study protocols Organize and maintain paper and electronic study data in a complete and correct manner Cultivate enthusiastic and professional relationships with patients and sponsors alike Work closely with recruitment and prescreening teams to meet study enrollment goals Conduct diagnostic, efficacy, and safety assessments as needed Job Requirements Two (2) or more years of clinical research coordinator experience Attention to detail and the ability to handle multiple tasks with precision Demonstrated ability to work accurately and quickly with CTMS A command of professional spoken and written English Hours and CompensationThis is a full-time employment position based in-person at our clinic in the Alzheimer's Orange County building in Irvine or at one of our other network sites in Los Angeles and Riverside Counties. Training will be at our flagship site in Irvine. The estimated salary for this position is between $66.5k-$80k per year, depending on experience and education. The company pays for 100% of health/dental/vision individual insurance costs for eligible full-time employees. Vacation (PTO) is earned at a rate of 3 weeks per year. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

CT Research Coordinator I- San Rafael Job Number: 1313973 Posting Date: Dec 2, 2024, 10:10:03 PM Description Job Summary: The Clinical Trial Research Coordinator I (CTRC-I) is a novice level position which, under the clinical direction of the Principal Investigator (PI), assists in the operational and administrative research support of the Kaiser Permanente Northern California (KPNC) PI and KPNC Clinical Trials Operations Director or designee, and other research staff conducting multiple FDA-regulated clinical trials. This is a non-licensed position which works under the daily supervision of an experienced Clinical Trial Nurse, Clinical Trial Research Coordinator, and/or KFRI-designated, licensed clinical trial research staff member. This position must adhere to the positions scope of practice as outlined in the Major Responsibilities below. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants. Essential Responsibilities: Compliance Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct). With guidance from PI, assist with ensuring compliance with KPNC IRB Standard Operating Procedures (SOP) and document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures. With supervision, assist with preparation for inspections, audits and monitoring visits. Study Implementation Maintain the security and confidentiality of participants paper or electronic data (e.g., case report forms kept in a secure, locked space). Assist with scheduling participants for study assessments/visits, required tests including visit-specific laboratory kits and/or paperwork preparation. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). Assist with obtaining medical records and test results for all projects/participants. ith supervision and certification, perform packaging and shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations and Sponsor shipping guidelines. Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. According to protocol and/or IRB-approved telephone script, collect and document research data in a timely manner, and report the information to the appropriate licensed staff member and PI for assessment. Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions). Under specific direction, assist with data entry of study activity onto a case report form (paper or electronic), and maintain a database program to track all study activity (i.e., study enrollment and consents). Assist in maintaining research charts and site regulatory files. Assist in ensuring that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates. Assist in obtaining protocol specific regulatory documents including MDs/RNs licenses and CVs. Report any potential protocol violations/deviations to the PI in a timely manner. Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial. With supervision, assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage. Leadership and Communication With direction, communicate compliance and operational needs with internal and external parties, PI, KPNC Clinical Trials Operations Leader or designee, and KPNC Office(s) of Clinical Trial Compliance on an ongoing basis. If applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, continuing review applications, protocol violations, and adverse events) in accordance with departmental and KP policies and procedures. Education and Training With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Work with an assigned mentor on a regular basis for training and resource questions. Attend KP site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested. Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings as requested. Quality Improvement With direction, perform routine quality control activities and assist with quality improvement initiatives. Systems and Infrastructure Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies. Adhere to departmental policies and procedures to support quality implementation and conduct of clinical trials, and assure maintenance of research documentation in compliance with the protocols and KP policies and procedures. Maintain systems and resources to effectively communicate with and obtain required IRB documentation. Staff Supervision No supervisory responsibilities. General Perform job functions according to the factors listed below under Job Criteria. Other duties as assigned by appropriate management. Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change s, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees. Qualifications Basic Qualifications: Experience N/A Education Associates degree or higher OR 2 years of work experience in an ambulatory and/or acute health care setting required (LVN maybe substituted for an Associates degree) High School Diploma or General Education Development (GED) required. License, Certification, Registration N/A Additional Requirements: Willingness to obtain IATA/DOT certification prior to start date.Current BLS certification required prior to start date.Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program.Must be proficient in electronic health systems and databases used in research environment and word-processing or willingness to learn within 3 months of hire.Demonstrate organizational and communication skills.Demonstrate written, verbal, and interpersonal communication skills.Demonstrate proficiency in medical terminology.Demonstrate attention to detail and accuracy.Ability to manage multiple tasks.Demonstrate good prioritization and organizational skills.Ability to be flexible and dependable.Ability to work effectively on cross-functional teams.Present professional manner and appearance.Demonstrated skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.Must be able to work in a Labor Partnership environment. Preferred Qualifications: Clinical trials experience preferred.Primary Location: California-San Rafael-San Rafael Medical Offices 2 Regular Scheduled Hours: 40 Shift: Day Working Days: Tue, Wed, Thu, Fri Start Time: 07:00 AM End Time: 05:30 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Job Level: Entry Level Job Category: Research and Development Public Department Name: Oakland Reg - 2000 Broadway - Rsrch-Invstgtr Staffg Mdl Dept - 0201 Travel: No Employee Group: NUE-NCAL-09|NUE|Non Union Employee Posting Salary Low : 25.26 Posting Salary High: 36.54 Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.Click here for Important Additional Job Requirements. Share this job with a friend You may also share this job description with a friend by email or social media. All the relevant details will be included in the message. Click the button labeled Share that is next to Submit.