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  • Sr. Clinical Trial Manager

    Actalent

    Clinical research coordinator job in Menlo Park, CA

    Sr. CTM role 2 days on site in Menlo Park, CA 3 days remote (hybrid role) + Ability to run a full trial (start up, maintence, close out) independently + Experience with diagnostics is a plus but not required + Bio/pharma experience is recommended as well as the whole team comes from pharma + Ability to work cross functionally with teams and get along with a lot of different personalities + Ability to share knowleddge but also find a solution based on what is best for everyone Description · Serves as the Clinical Operations Study Lead for assigned studies, providing strategic and operational leadership to ensure successful planning, execution, and delivery of clinical studies. · Supports and guides Clinical Trial Managers and Clinical Project Assistants ensuring alignment of study activities, promoting best practices, and driving a unified approach to achieve study objectives. · Acts as the primary point of contact for internal cross functional teams · Leads site management and performance oversight, including ensuring proper training, fostering strong site relationships, and monitoring compliance with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements. · Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out · Develops study related plans and documents, including informed consent forms, ensuring alignment with study objectives, regulatory requirements, and overall study strategy. · Collaborates on site identification and selection. · Participates in EDC set-up by contributing to case report form design, user acceptance testing, development of completion guidelines, and other related activities, supporting study requirements and data quality. · Oversees clinical data entry progress ensuring timely resolution of incomplete data and outstanding queries. · Contributes to the development and management of site budgets and ensures timely and accurate invoice payments in accordance with site payment terms · Partners with cross functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy, align operational plans, and proactively identify and mitigate risks to ensure successful execution. · Provides oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely study execution while proactively addressing risk and performance issues. · Facilitate external communication with site staff and pharmaceutical partners (as applicable). · Ensures electronic Trial Master File (eTMF) is current and maintained Skills Clinical trial, Vendor management, oncology, Project management, Clinical research, Clinical trial management, IVD Top Skills Details Clinical trial,Vendor management,oncology Additional Skills & Qualifications · Bachelor's degree or equivalent in the life sciences or related field required. · Additional coursework in clinical trial planning and execution is strongly desired · Ideal candidate will have at least 5 years of relevant experience in managing clinical trials, with at least 2 years experience in a Clinical Operations study lead role, at a sponsor company (pharma, biotech, or medical device) with a strong track record of successful trial initiation and execution · Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable · Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements · Working experience with an electronic data capture system, CTMS system, and eTMF system. · Strong interpersonal communication (written and verbal), organizational and prioritization skills · Able to work effectively under a fast-paced and changing environment · Strong work ethic and demonstrated ability to deliver assignments on time · Proficient with office automation tools, such as Microsoft Office and the Google suite of apps Experience Level Expert Level Job Type & Location This is a Permanent position based out of Menlo Park, CA. Pay and Benefits The pay range for this position is $140000.00 - $164000.00/yr. Medical, Dental, VIsion, 401k Workplace Type This is a fully onsite position in Menlo Park,CA. Application Deadline This position is anticipated to close on Jan 28, 2026. 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $140k-164k yearly 5d ago
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  • Certified Clinical Research Coordinator

    Option 1 Staffing Services, Inc.

    Clinical research coordinator job in Mountain View, CA

    Contract Mountain View, CA $31 - $36/hour Certified Clinical Research Coordinator - Join a Leading Research Team! Have a chance to drive meaningful research and be a part of a TOP research team conducting clinical trials. This is an incredible opportunity to make a lasting impact by engaging in studies that aim to improve treatments and uncover lasting cures! Responsibilities: Gather consent and determine eligibility for study participants Coordinate collection of specimens Ensure compliance with research protocols Assemble kits for study visits Prepare regulatory submissions Monitor expenditures and budgets Extract, analyze, and interpret research data to support study objectives Qualifications: Minimum 2 years of experience in clinical research Bachelor's degree Experience with EPIC is preferred Experience with treatment trials is required If this opportunity is of particular interest, apply now, and we'll be happy to share the details with you!
    $31-36 hourly 2d ago
  • Clinical Coordinator (RN) $6,500 Sign On Bonus

    Satellite Holdings, LLC

    Clinical research coordinator job in Oakland, CA

    WHAT YOU WILL DO As a Clinical Coordinator (RN) you will be responsible for the delivery of safe, quality care of dialysis treatments by assisting the Center Manager (CM) with oversight of the center's operations and by providing direct patient care. The Clinical Coordinator (RN) acts as a team leader who educates and mentors center staff as appropriate. In the absence of the CM, this position is also responsible for the daily management of the center. WHAT WE EXPECT OF YOU You will play a vital role to ensure that we deliver on our Mission to make life better for those with kidney disease and our Vision to be unsurpassed in our individualized experience, our quality, and our compassion. You approach your work with an indisputable sense of greater purpose. Lastly, you are high energy, seek out opportunities to improve the environment for patients and staff, are goal-oriented, and gain deep satisfaction from building relationships. WHAT YOU WILL GAIN Relationships: You will work directly with a multi-disciplinary team that is as passionate as you in making a difference in others' lives. You will become a servant leader, bringing up your team to provide care that is unsurpassed by others in our industry. Impact: You will set the tone that enables our patients to live a better life and address their needs holistically. You will make a difference for our patients so that they do dialysis to live instead of living for dialysis. Growth: You will have formal and informal opportunities for professional growth in a supportive environment. You will become a subject-matter expert and have a wide range of opportunities for career advancement. MINIMUM QUALIFICATIONS Experience One (1) year of nursing experience required; 1 year of hemodialysis nursing required. Supervisor/Charge Nurse experience preferred Education Graduation from an accredited school of nursing or equivalent; BSN preferred License/Certification Current State license as a Registered Nurse Current CPR/BLS for Healthcare certification (or within 3 months of hire) CNN or CDN certification preferred . All Full Time employees are eligible for the following benefits: Medical / Pharmacy Dental Vision Voluntary benefits 401k with employer match Virtual Care Life Insurance Voluntary Benefits PTO All Part Time employees are eligible for the following benefits: 401k with employer match PTO
    $49k-75k yearly est. 4h ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research coordinator job in San Francisco, CA

    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
    $70k-114k yearly est. 60d+ ago
  • Clinical Study Portfolio and Publication Manager

    Veracyte 4.6company rating

    Clinical research coordinator job in South San Francisco, CA

    At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way - it's about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions. Our Values: * We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care * We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work * We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins * We Care Deeply: We embrace our differences, do the right thing, and encourage each other The Position: Responsible for maintaining metrics and data across the clinical trial portfolio while coordinating and tracking scientific publications. This role combines data management with publication process oversight to support clinical and medical affairs. Responsibilities: * Develops and maintains comprehensive metrics tracking systems for clinical trial portfolio data * Monitors and coordinates scientific publication activities from initiation through submission and publication * Manages manuscript submission process, ensuring compliance with journal requirements and internal guidelines * Creates and updates trial data dashboards to provide real-time visibility into portfolio performance * Supports authors and research teams throughout the manuscript development process, including timeline management and resource coordination * Performs quality control checks to ensure data accuracy and consistency across the clinical trial portfolio * Establishes and maintains effective communication channels between clinical teams, medical affairs, and other stakeholders * Generates regular progress reports and analytics to inform strategic decision-making and track portfolio performance * Implements and maintains publication tracking systems to monitor status, deadlines, and deliverables * Coordinates with internal teams to gather necessary data and documentation for publication submissions * Identifies and resolves data discrepancies across portfolio documentation * Provides regular updates to leadership on portfolio metrics and publication status Publication Coordination: * Track status of scientific publications from inception to completion * Coordinate manuscript reviews and submission processes as needed * Maintain publication planning timeline * Monitor publication deadlines and deliverables * Maintain master schedule of conferences and submission deadlines Administrative: * Organize and maintain documentation * Schedule and coordinate publication-related meetings * Prepare status updates for leadership * Maintain publication tracking databases * Support manuscript development process Who You Are: Required Qualifications: * Bachelor's degree in life sciences, healthcare, or related field * 6 -7 years experience in clinical research or publications * Strong data analysis and management skills * Proficiency in MS Office and data visualization tools * Experience with Veeva Vault Clinical Trial Management System * Excellent organizational and communication skills Preferred Qualifications: * Advanced degree in relevant field * Experience with publication management software * Knowledge of medical publishing requirements * Understanding of clinical research processes * Project management certification * Experience with data analytics tools Skills: * Attention to detail * Strong analytical abilities * Project management * Time management * Communication * Problem-solving * Database management * Statistical analysis This role requires a combination of analytical skills and coordination abilities to effectively manage both data and publication workflows #LI-Hybrid The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to years of experience, skillset, geographic location, industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. Pay range $153,000-$165,000 USD What We Can Offer You Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified Great Place to Work in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose. About Veracyte Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit **************** or follow us on LinkedIn or X (Twitter). Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice. If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to ********************
    $153k-165k yearly Auto-Apply 23d ago
  • Clinical Research Associate

    Alto Neuroscience

    Clinical research coordinator job in Mountain View, CA

    PRIMARY ROLE Alto Neuroscience is seeking a Clinical Research Associate (CRA) to support the execution of clinical studies across our precision psychiatry portfolio. This role oversees assigned investigative sites, ensuring studies are conducted efficiently, compliantly, and with scientific rigor. The CRA serves as the key liaison between clinical sites and Alto s clinical operations team driving recruitment, monitoring data quality, and maintaining high standards of Good Clinical Practice (GCP). DUTIES & RESPONSIBILITIES Manage site activities from initiation through closeout, ensuring compliance with GCP and study protocols. Monitor study progress, data accuracy, and regulatory documentation. Train and support site staff on study procedures and investigational product handling. Identify and resolve site issues promptly to maintain timelines and data quality. Collaborate cross-functionally to achieve clinical and operational goals. LOCATION Remote with approximately 60% travel SALARY RANGE $75,000- $120,000 depending on qualifications and experience level QUALIFICATIONS BS in a scientific field or pharmacy, RN, or BSN degree (or equivalent). 1 3 years of clinical monitoring experience (CRO, biotech, or pharma), , including on-site or remote monitoring experience Strong understanding of GCP/ICH-E6 and clinical research operations. Excellent communication, organization, and problem-solving skills. CCRA certification and experience with rater-administered measures required. Why Alto At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics. Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements. #LI - Remote
    $75k-120k yearly 60d+ ago
  • Clinical Research Associate

    Integrated Resources 4.5company rating

    Clinical research coordinator job in Foster City, CA

    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
    $70k-104k yearly est. 60d+ ago
  • Director, Clinical Scientist

    Summit Therapeutics Sub

    Clinical research coordinator job in Menlo Park, CA

    About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit s team is inspired to touch and help change lives through Summit s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. The Director, Clinical Scientist will strive to drive study enrollment, and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director, Clinical Scientist will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved. Role and Responsibilities: Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.) Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.) Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders Coordinates submissions to scientific meetings and/or other appropriate venues or groups Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes All other duties as assigned Experience, Education and Specialized Knowledge and Skills: MS (or equivalent) required; PhD, PharmD, or MD preferred Minimum of 5+ years overall related experience with PhD or like degree; Minimum of 2+ years experience in conducting / supporting oncology/hematology clinical studies Excellent written and verbal communication skills Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data The pay range for this role is $197,500 - $246,500 per year. 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.
    $197.5k-246.5k yearly Easy Apply 60d+ ago
  • Clinical Trial Research Scientist

    Labelbox 4.3company rating

    Clinical research coordinator job in San Francisco, CA

    Role OverviewThe Clinical Trial Research Scientist evaluates clinical study protocols, trial designs, endpoints, statistical plans, and study results. This role emphasizes methodological rigor, documentation clarity, and accurate interpretation of safety and efficacy outcomes. What You'll Do- Review clinical trial protocols and identify methodological strengths or gaps - Analyze endpoints, inclusion/exclusion criteria, and study controls - Interpret trial results and summarize safety and efficacy findings - Validate statistical analysis plans for completeness and accuracy - Identify operational or scientific risks in trial execution - Support recurring evaluations of clinical documentation and study outputs What You BringMust-Have:- Experience in clinical research, biostatistics, or pharmaceutical science - Strong understanding of trial methodology and regulatory standards - Ability to interpret trial data and communicate findings clearly Nice-to-Have:- Experience with Phase I-IV trials or specific therapeutic areas
    $107k-170k yearly est. Auto-Apply 50d ago
  • Global Clinical Study Manager

    Beone Medicines

    Clinical research coordinator job in Emeryville, CA

    **General Description:** + Accountable for global study delivery with appropriate, inspection readiness quality, within agreed timelines and budget + Leads all aspects of assigned clinical study(ies) + Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies) + Ensures alignment of study goals with clinical operations and corporate goals and objectives + Experience in managing global pediatric studies; preferably in oncology. **Essential Functions of the job:** **Cross-Functional Leadership** + Leads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues + Leads external vendors involved in study delivery + Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives + Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required + Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings **Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities + Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these + Ensures that the clinical studies are operationally feasible, oversees trial feasibility, trial allocation and site selection process across all regions + Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs + Provides oversight to study start up and site activation plans + Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriately + Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems + Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed + Ensures Trial Master File for study is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites + Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor) + Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members **Quality and Risk Management** + Monitors study activities to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness at any point in time throughout the study life cycle + Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented + Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented + Prepares team for quality assurance audits and inspections + Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared + Leads improvements and partners with study team 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 study vendors, approving invoice payment throughout the study + Manages study budgets, including baseline budget evaluation, change control, study closure budget, budget endorsement by senior management + Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts + Identifies and manages study team resource needs and establishes contingency plans for key resources. + Monitors resource utilization over the study life cycle + Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters **Supervisory Responsibilities:** + Provides performance feedback on team members as required **Computer Skills:** + MS Office, Project Planning Applications, Clinical Trial Management Systems **Other Qualifications:** + Proven project management experience in global pediatric studies + Oncology experience preferred + Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes + Able to independently lead large and/or complex global clinical studies + 5 or more years of progressive experience in clinical research within biotech, pharma or CRO industry **Travel:** Limited travel required 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.
    $89k-146k yearly est. 30d ago
  • AI Applied Scientist, Clinical Trials Protocol Digitization

    Verily

    Clinical research coordinator job in Mountain View, CA

    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.
    $125k-168k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Associate - Palo Alto, CA (HQ)

    Sciton 4.5company rating

    Clinical research coordinator job in Palo Alto, CA

    We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Clinical Research Associate (CRA) The Clinical Research Associate (CRA) will be responsible for managing multiple aspects of clinical trials. This includes assisting with study start-up, ongoing monitoring, data management, and analysis, as well as ensuring compliance with study protocols and ethical standards. This role reports to the Senior Clinical Research Leader. Key Responsibilities: Prepare essential clinical study documents, including informed consent forms and source documents. Assist with the initiation and set-up of clinical trial sites. Develop and maintain comprehensive documentation required throughout the clinical study lifecycle. Conduct regular site monitoring visits to oversee data collection and ensure strict adherence to study protocols. Review and validate collected data for accuracy, completeness, and alignment with source documentation. Maintain up-to-date study files, including all regulatory and study-specific documentation. Ensure compliance with regulatory standards, including GCP, ICH guidelines, and IRB requirements. Qualifications: Bachelor's degree in a relevant clinical research or life sciences field. Minimum 3-5 years' experience in clinical research, with a strong background in site monitoring. Demonstrated experience in clinical trial design and data analysis. Skills & Competencies: Proven ability to work independently with a high level of initiative. Collaborative team player with flexibility to adapt in dynamic or uncertain environments; willingness to travel as needed. Excellent written and verbal communication skills. Strong ability to critically review scientific literature and interpret clinical evidence. Advanced analytical and problem-solving abilities. Compensation and Benefits The salary range for this position is $80-$100k. In addition to a competitive market-based salary, Sciton provides an opportunity to participate in equity/stock incentive programs, a profit-sharing bonus, and a comprehensive benefits package, including 401(K) with matching. FULL-TIME/PART-TIME Full-Time POSITION Clinical Research Associate LOCATION Palo Alto, CA (HQ) ABOUT THE ORGANIZATION SCITON is an industry leader and manufacturer of medical aesthetic lasers and light source technologies. With a vision to improve people's lives, our top-tier devices are built to order with integrity by pioneering, customer-focused, and results-driven individuals. At the heart of it, innovation is a fundamental cornerstone of our culture. We strongly believe that new ideas can come from anyone, anywhere, at any time and embrace an open-door culture that welcomes and fosters individuals who are creative, driven, passionate, and willing to take the lead with us. Join us for an opportunity to grow and make an impact. Life at Sciton: At Sciton, people matter. We are more than a company; we are a family, which is why we give all our employees: The support, recognition, and room to grow their careers within Sciton. Empowerment to develop their creative genius and encouragement to be lifelong learners. Incentives for creativity and innovation across the organization.
    $80k-100k yearly 60d+ ago
  • Clinical Research Specialist

    Real Staffing

    Clinical research coordinator job in Santa Rosa, CA

    Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Clinical Research Specialist 5 months with a possibility to extend Medtronic - Santa Rosa, CA Duties: Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Assist in preparation of study materials and/or training. Interface with, and assure training of investigators, site staff, and Medtronic clinical staff. Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review). May arrange conference calls, staff meetings and training events. Assist data management group with review of clinical data/information and oversight of data correction. May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base. Must be willing to assist with other duties as needed such as filing and document tracking. Must have ability to prioritize and critical thinking skills and previous clinical research experience. Must have strong written, oral, and interpersonal communication skills and high attention to detail and accuracy. Qualifications Top 3 qualifications: Previous clinical research experience Ability to prioritize and strong critical thinking skills Attention to detail and strong communication skills Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 619-727-5167 ASAP! I want to know more about your preferences. If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!
    $68k-108k yearly est. 14h ago
  • Clinical Trials Research Coordinator II

    Christian City Inc.

    Clinical research coordinator job in Oakland, CA

    Clinical Trials Research Coordinator II Job Number: 1307729 Posting Date: Nov 25, 2024, 4:03:45 PM Description Job Summary: The Clinical Trial Research Coordinator II (CTRC-II) is a position with demonstrated proficiency in coordinating clinical trial research tasks which, under the clinical direction of the Principal Investigator (PI), provides research, operational, and administrative support to 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. The CTRC-II is a hands-on position responsible for conducting the day-to-day activities of clinical trial project(s) under the supervision of the PI. The CTRC-II works more independently, assumes increased clinical trial responsibilities and requires periodic supervision. 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, ensure 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, prepare for inspections, audits and monitor 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). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol and/or IRB-approved telephone script, collect and document research data and report the information to the appropriate licensed staff member and PI for assessment in a timely manner. Coordinate and schedule participants for study assessments/visits, required tests, including visit specific lab kits and/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). With appropriate guidance, obtain and review medical records and test results of all project/study participants and abstract needed data per protocol requirements. With guidance from PI, complete case report forms (paper or electronic) and maintain a database program to track all study activity including study enrollment and consents. Respond to Sponsor to resolve data queries and delinquencies in a timely manner. Report any potential protocol violations/deviations to the PI in a timely manner. 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). Coordinate and prepare protocol specimens for shipping or storage in accordance with IATA/DOT regulations and Sponsor shipping guidelines. Assist with participants long-term follow-up data collection. Assist PI and/or Clinical Trial Nurse, if applicable, with identifying, screening, and recruiting potential participants. Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage. With guidance, receive, disseminate and maintain study-related communications with internal and external parties involved with clinical trial protocols. Ensure that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates. 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 direction, maintain the site(s) study regulatory binder(s) and ensure that other study-specific documentation is maintained. Assist the Clinical Trial Nurse with quality assurance, training, abstracting and recording data. Coordinate space requirements for study-related equipment/supplies. Leadership and Communication With direction, communicate compliance and operational needs with internal and external parties, PI, Sponsor, Contract Research Organization (CRO), KPNC Clinical Trials Operations Director or designee, and KPNC Offices of Clinical Trial Compliance and Operations 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 Work with an assigned mentor, as needed, for training and resource questions. With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. 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 with direction 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 Minimum one (1) year of experience in clinical trials research OR a bachelors degree. Education Associates degree or higher OR two (2) years of experience in a directly related field.High School Diploma or General Education Development (GED) required. License, Certification, Registration N/A Additional Requirements: Willingness to obtain IATA/DOT certification.Current BLS certification required prior to start date.Satisfies requirements for career advancement as defined by the Clinical Trial Career Ladder Program.Must be proficient in electronic health systems and data bases used in research environment and word-processing and database software 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.Attention to detail and accuracy.Ability to manage multiple tasks Demonstrate prioritization skills.Demonstrate problem-solving skills.Demonstrate project management skills.Ability to be flexible and dependable.Possess ability to work effectively on cross-functional teams.Present professional manner and appearance.Possess ability to abstract pertinent protocol data from medical record.Skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).Knowledge of the principles, methods and procedures of basic medical and/or clinical research processes.Knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations.Knowledge of clinical trials research and research regulations, as well as clinical trial experience in a specific therapeutic area.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: Current ACRP or SoCRA certification preferred.Primary Location: California-Oakland-Oakland Mosswood Medical Offices Regular Scheduled Hours: 40 Shift: Day Working Days: Mon, Tue, Wed, Thu, Fri Start Time: 08:30 AM End Time: 05:00 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: Yes, 10 % of the Time Employee Group: NUE-NCAL-09|NUE|Non Union Employee Posting Salary Low : 36.1 Posting Salary High: 42.45 Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status.Click here for Important Additional Job Requirements. 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    $55k-88k yearly est. Auto-Apply 60d+ ago
  • Sleep Research Coordinator Associate

    Dev 4.2company rating

    Clinical research coordinator job in Stanford, CA

    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
    $47k-68k yearly est. 60d+ ago
  • Clinical Research Patient Recruitment Manager

    Flourish Research

    Clinical research coordinator job in Walnut Creek, CA

    Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring a Patient Recruitment Manager to support our Flourish Research site in Walnut Creek, CA The Manager of Patient Recruitment is a dynamic, strategic, execution-oriented, and performance-driven sales leader assuming full responsibility for the achievement of study enrollment objectives. This leader consistently hits revenue targets by designing study enrollment strategies and directly implementing them with precision by effectively managing a team of recruiting representatives. The Manager is expected to effectively partner with corporate functions to drive high performance in the areas of patient lead generation, funnel conversion metrics, and patient experience. To cultivate and maintain a strong culture of accountability, the Manager employs a servant leadership style, exudes a deep commitment to achieving goals, and provides hands-on, data driven coaching to both recruiting representatives. Shift: On Site Monday-Friday, 8:30 AM - 5:00 PM Location: 2255 Ygnacio Valley Road, Suite M, Walnut Creek, CA 94598 Compensation: $80,000 - $95,000 Salary Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES Create and run strategic recruitment plans for all assigned studies. Achieve study enrollment goals and assigned revenue targets. Communicate and collaborate with corporate support functions (i.e. marketing, revenue operations, business development) regarding needs to effectively fill studies. Study leading and lagging indicators at individual and team level taking targeted action to improve areas of underperformance and/or prevent underperformance. Build and maintain a culture of accountability, collaboration, and results. Prioritize studies and execute patient routing accordingly to generate the best revenue results. Lead and manage patient recruiting representatives to achieve all assigned key performance indicators. Identify and implement coaching, training, and development programs to drive improvement in the call center team. Implement KPIs with support of leadership for direct reporting staff. Identify process and system improvement opportunities and partner with corporate support functions to drive improvement. Participate in sponsor relations and communications as needed. Maintain and manage all vendor relationships (i.e. uber, outsourced marketing/recruiting agencies etc.). Ensure all representatives appropriately document in the CRM and CTMS is entered correctly and with precision. Ensure patient enrollment teams adhere to the appropriate legal and ethical professional conduct standards. Manage community connections, coordinate events and establish new routes of community outreach. Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors. Additional duties as assigned by management. SKILLS Strong leadership and team management abilities. Impeccable organizational skills and attention to detail. Exceptional professionalism and patient-centered focus. Excellent communication and interpersonal skills to engage with clinicians, staff, and community partners. Ethical compass that compels honesty, accountability, and self-motivation. High-level critical thinking and problem-solving skills. Proficiency with computers, databases, and Microsoft Office Suite. Ability to thrive in a fast-paced, productive, and high-performing environment. QUALIFICATIONS Bachelor's Degree Required Minimum 2-3 years of experience in clinical research recruitment or related healthcare field, with at least 1 year in a leadership or supervisory role. Proven success developing and executing recruitment strategies. Proficient knowledge of medical terminology and clinical trial processes. Strong understanding of GCP regulatory requirements. Previous experience with electronic medical records and recruitment databases preferred. Excellent oral and written communication skills. Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
    $80k-95k yearly Auto-Apply 19d ago
  • Clinical Research Coordinator

    Bay Area Retina Associates

    Clinical research coordinator job in Walnut Creek, CA

    Full-time Description The Clinical Research Coordinator (CRC) is the primary point of contact for the study patient and sponsor representatives. The CRC works closely with the Principal Investigator and Sub-Investigator to ensure the safety and well-being of the study patient is protected. CRCs are expected to maintain all documents, processes, and supplies for all assigned duties according to protocol. Essential functions: Study recruiting activity, including pre-screening, screening, and recruitment of patients. Obtains informed consent per ICH/GCP and site SOPs. Interviews and collects data from study patients. Creates and completes source documentation and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintains a thorough understanding of all data collection instruments and collects data accurately and according to protocol. Performs basic data gathering, EDC transcription, and manipulation of source documents. Maintains regulatory binders (ISF) with applicable documents and communicates effectively with study monitors (CRAs) during site visits and audits. Coordinates study visits and performs procedures such as AE collection, ConMeds, and eye pressure assessment. Schedules subject visits as needed and obtains vitals (height, weight, pulse, respiratory rate, blood pressure, etc.) and ECGs. Dispenses and collects study medication and provides accurate Investigational Product (IP) accountability. Reports temperature excursions in a timely manner. Collects and processes laboratory specimens for study participants according to protocol. Other responsibilities: Duties assigned by the Clinical Research Supervisor/Manager or Director of Operations. Requirements Skills Required: Computer literate and experience using EHR, MS Office suite, web browsing, email, and spreadsheets. Adaptable and able to learn quickly. Meticulous and detail oriented. Able to follow directions with minimal supervision. Excellent written and verbal communication skills. Excellent customer service skills. Takes initiative, able to see a task that needs to be completed and completes it. Must be able to multitask and able to handle a high volume of patients. Open to work a flexible work schedule. Experience preferred: 3-5 years as a clinical research coordinator. Additional past medical office experience. Preferred knowledge of the design ad conduct of clinical studies. Phlebotomy certification and experience preferred. Ophthalmology clinical research experience preferred. Education required or equivalent: Bachelor's degree preferred. Physical standards, including lifting and pushing requirements: Must be able to remain in a stationary position for 50% of scheduled shifts or more, be able to frequently move about the office to direct patients, access office supplies and equipment, and be able to lift up to 50 pounds. Must be able to communicate with patients to convey necessary medical and financial information and document accurately in EMR and practice management system. Travel requirements: Study-related travel, including travel to clinic locations as needed and sponsor-related travel (investigator meetings, training, etc.). Equipment: This position requires the use of telephone and office equipment such as computers, copier, fax machine, and scanner. Requires use of Microsoft Office products and occasional use of medical equipment such as exam chairs, imaging equipment, pharmaceutical refrigerators, and diagnostic testing equipment. Unique conditions of the position: OSHA Classification Category I. Job duties include exposure to blood, bodily fluids, or tissues. 2-year commitment preferred. Salary Description $67,800 - $88,400
    $67.8k-88.4k yearly 11d ago
  • Clinical Research Coordinator (Experienced)

    Irvine Clinical Research

    Clinical research coordinator job in Oakland, CA

    Irvine 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
    $53k-80k yearly est. Auto-Apply 60d+ ago
  • Clinic Coordinator

    Lifelong Medical Care 4.0company rating

    Clinical research coordinator job in Oakland, CA

    The Homeless Services Clinic Coordinator in Oakland, Ca is responsible for overseeing the admin needs of clinics offered within homeless services programs. The HSCC plans programs clinic schedules, manages supplies and inventory, assists clinic and program providers to facilitate patient care, conducts patient outreach, oversees admin of contingency management, facilitates referrals, troubleshoots insurance eligibility issues, and provides patient health education. LifeLong Medical Care is a multi-site, Federally Qualified Health Center (FQHC) with a rich history of providing innovative healthcare and social services to a wonderfully diverse patient community. Our patient-centered health home is a dynamic place to work, practice, and grow. We have over 15 primary care health centers and deliver integrated services including psychosocial, referrals, chronic disease management, dental, health education, home visits, and much, much more. Benefits Compensation: $21 - $23/hour. We offer excellent benefits including: medical, dental, vision (including dependent and domestic partner coverage), generous leave benefits including ten paid holidays, Flexible Spending Accounts, 403(b) retirement savings plan. Responsibilities Essential Functions Conduct patient intakes, registers new patients, and maintains accurate medical records Register new patients and scan necessary documents in the Electronic Health Record Look up and enter insurance information into individual health records and trouble shoot eligibility issues Maintain up to date patient demographic and insurance information in agency clinic management and health record systems Maintain provider visit schedule of appointments and provide regular reminders to providers of their scheduled appointments Work with on-duty staff to conduct regular outreach effort to patients to and ensure patients attend scheduled appointments on time Manage patient flow during clinic hours, including check in and check out Assure that clinics have necessary supplies, that clinic facilities are set up prior to scheduled clinic time, and exam rooms are stocked appropriately prior to patient appointments Conduct regular inventory of clinic supplies, submit requisitions for supply orders, and assure out-of-date supplies are disposed of according to relevant agency guidelines Coordinate site waste disposal with appropriate vendors Maintain and record vaccine refrigerator and freezer temperature log Label and organize supplies appropriately to make sure they are retrievable Track patient encounters and enter charges for each completed encounter on a weekly basis Enter and track encounter and billing data to ensure clinic is meeting productivity targets Run insurance and check eligibility for every new patient, at patient intake, and once a month for all patients Assist patients whose Medi-Cal is no longer active or registered in Alameda County to submit applications and recertifications to renew or establish insurance and benefits Contact insurance providers or other funders to obtain authorizations to ensure reimbursement for services Coordinate with case managers, providers, and referral specialists to facilitate referrals for labs, diagnostic tests, specialty care, and follow up appointments Manage day-to-day operational aspects of contingency management and train staff on how to administer rewards Work with site staff to conduct regular outreach efforts to clients Participate in and help conduct group visits at each site Attend all meetings that are required for this position, take notes, and distribute notes to meeting attendees Qualifications Qualifications Commitment to the provision of primary care services for the underserved with demonstrated ability and sensitivity in working with a variety of people from low-income populations, with diverse educational, lifestyle, ethnic and cultural origins. Strong organizational, administrative and problem-solving skills, and ability to be flexible and adaptive to change. Ability to effectively present information to others, including other employees, community partners and vendors. Ability to seek direction/approval on essential matters, yet work independently with little onsite supervision, using professional judgment and diplomacy. Work in a team-oriented environment with a number of professionals with different work styles and support needs. Excellent interpersonal, verbal, and written skills. Conduct oneself in internal and external settings in a way that reflects positively on LifeLong Medical Care as an organization of professional, confident and sensitive staff. Ability to see how one's work intersects with that of other departments of LifeLong Medical Care and that of other partner organizations. Make appropriate use of knowledge/ expertise/ connections of other staff. Be creative and mature with a “can do”, proactive attitude and an ability to continuously “scan” the environment, identifying and taking advantage of opportunities for improvement.
    $21-23 hourly Auto-Apply 26d ago
  • Clinical Research Coordinator in Fremont, CA

    Panoramic Health

    Clinical research coordinator job in Fremont, CA

    Clinical Research Coordinator I will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering, and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects. Responsibilities include: Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”). Prepare for monitoring visits: All Source Documents organized and readily available. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs readily available. Ongoing Study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB and Sponsor in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications: Bachelors' degree preferred; Nursing or Health Science preferred. Bilingual preferred (Spanish). Minimum 2 years' experience as a clinical research coordinator. Therapeutic area experience in CKD, nephrology, or vascular access a plus. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.
    $53k-80k yearly est. 17d ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in San Rafael, CA?

The average clinical research coordinator in San Rafael, CA earns between $44,000 and $97,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average clinical research coordinator salary in San Rafael, CA

$65,000
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