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  • Sr. Clinical Trial Manager

    Actalent

    Clinical research associate 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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  • Clinical Scientist - Director level

    Yoh, A Day & Zimmermann Company 4.7company rating

    Clinical research associate job in South San Francisco, CA

    A clinical-stage biotechnology company is seeking an experienced Clinical Scientist (Director level) to support early stage oncology clinical development programs. This is a 9-month contract role, working hand in hand with the clinical lead to provide medical and scientific expertise on multiple clinical programs. Location: South San Francisco or San Diego (hybrid/onsite) Key Responsibilities Support clinical development strategy and author clinical development plans Draft and review protocol synopses, protocols, amendments, and informed consent forms Collaborate with Clinical Operations on site selection, start-up, and execution Contribute to investigator brochures, clinical study reports, and regulatory submissions Review and interpret clinical and safety data, including SAEs Support medical monitoring activities for Phase 2-3 studies Prepare study materials, slide decks, and support publications and presentations Participate in advisory boards, KOL engagement, and competitive landscape analysis Support health authority interactions, audits, and submissions Qualifications Bachelor's degree required; advanced degree (MS, MD, PharmD, PhD, NP) preferred Minimum 4 years of industry experience in early stage, oncology clinical development Hands-on experience across clinical trial lifecycle (start-up through CSR) Strong protocol development, data interpretation, and safety monitoring experience Knowledge of GCP and regulatory standards Excellent communication skills and ability to thrive in a fast-paced environment Terms: 9-month contract position, paying up to $115/hr DOE Estimated Min Rate: $80.50 Estimated Max Rate: $115.00 What's In It for You? We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include: Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week) Health Savings Account (HSA) (for employees working 20+ hours per week) Life & Disability Insurance (for employees working 20+ hours per week) MetLife Voluntary Benefits Employee Assistance Program (EAP) 401K Retirement Savings Plan Direct Deposit & weekly epayroll Referral Bonus Programs Certification and training opportunities Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit ************************************************ to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: **********************************
    $80.5-115 hourly 3d ago
  • Clinical Coordinator (RN) **$6,500 Sign On Bonus**

    Satellite Holdings, LLC

    Clinical research associate 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 #SHLLC
    $49k-75k yearly est. 1d ago
  • Clinical Research Associate

    Integrated Resources 4.5company rating

    Clinical research associate 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
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research associate 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 Trial Research Scientist

    Labelbox 4.3company rating

    Clinical research associate 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 43d ago
  • Senior Clinical Trial Specialist, CKD

    Maze Therapeutics

    Clinical research associate job in South San Francisco, CA

    At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you'll play a key role in supporting our Clinical Operations team as we deliver an exciting and diverse Chronic Kidney Disease (CKD) pipeline of precision medicines. You'll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is ideal for someone who enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management. The Impact You'll Have You'll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include: Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 CKD study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary. Will also help support Early Development studies in collaboration with Study Lead. Site & Vendor Oversight: Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Study Lead) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs. Supporting Key Study Materials: Assist in the design and development of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials. Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners. Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed. Sample & Data Management: Work with study team to coordinate sample shipments, sample analysis, and data reconciliation efforts. Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team. Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) to optimize study execution. What We're Looking For We're looking for someone who's not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have: A strong clinical operations background: Bachelor's degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment. A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes. Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track. A proactive and collaborative approach: You're a strong team player who takes initiative and builds meaningful relationships with internal and external partners. Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms. Flexibility and adaptability: You're comfortable working in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed. Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary. Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook). This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together - Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed - We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True - Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid #LI-Hybrid
    $125k-152k yearly 15d ago
  • Clinical Research Coordinator

    Bay Area Retina Associates

    Clinical research associate 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 4d ago
  • Study Participant

    Alljoined

    Clinical research associate job in San Francisco, CA

    Alljoined is a biotech research startup using EEG to decode human thought. We are seeking study participants in San Francisco. You will wear a non-invasive EEG cap while seated at a computer, view images and videos, and answer simple questions. The device measures brain responses and does not cause discomfort. Requirements Age 18-55 Comfortable sitting for extended periods Fluent in English Able to attend 5 total sessions No dreadlocks, braids, wigs, or hairstyles incompatible with an EEG headset Location Inner Richmond, San Francisco, CA Session Length Approximately 2.5 hours (budget for 3) Compensation $20 per hour
    $20 hourly Auto-Apply 51d ago
  • EDC/CLINICAL DEVICES RESEARCH COORDINATOR

    Us Tech Solutions 4.4company rating

    Clinical research associate job in South San Francisco, CA

    **Overall Responsibilities:** + The Clinical Research Coordinator, under the oversight of the Clinical Trial Manager and PI, is responsible for independently conducting clinical research sessions with study participants. + These sessions will be conducted on-site in South San Francisco and virtually. **Top 3 Daily Responsibilities:** + Conduct Clinical Research Coordinator activities for assigned clinical research device studies including consenting participants, conducting study sessions, maintaining device accountability, and completing data entry into the Electronic Data Capture (EDC) system. + Maintain Investigator Site Files and support Sponsor eTMF Maintenance. + Coordinate study participant recruitment efforts and ensure participants are compensated for their study participation. **Mandatory:** **Education:** + BS/BA degree in life science, health science, RN, or related field. + 3-5 years of professional working experience as a Clinical Research Coordinator. + Working knowledge of GCP and FDA Regulations. + Proficiency in MS Word, Excel PowerPoint, or Suite. + Experience utilizing Electronic Data Capture (EDC) systems for clinical studies. **Desired:** + Desired Experience with digital medical device research studies. + Experience maintaining an Electronic Trial Master File (eTMF). **Education:** + BS/BA degree in life science, health science, RN, or related field **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (*********************************** . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $52k-73k yearly est. 60d+ ago
  • Senior Clinical Trials Specialist (Biotechnology Oncology)

    Exelixis Inc. 4.9company rating

    Clinical research associate job in Alameda, CA

    SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively * Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL * Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues * Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Review compound-specific ICF and develop study-specific ICF templates * Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents * Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites * May coordinate the preparation, conduct, and presentations at Investigator Meetings * Review monitoring visit reports for completeness, accuracy, and adherence to the protocol * Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation * May conduct UAT for EDC / IRT and data listing review of EDC data for analysis * Compile and review appendices for preparation of clinical study reports * Review and/or create study documents (e.g. newsletters, and various study / site trackers) * Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion * Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately * May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: * Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures * Experience with development of prospective site-selection criteria * Familiar with medical terminology, and basic concepts of clinical research * Ability to deal with time demands, incomplete information or unexpected events * Experience in interactions with outside vendors, e.g., CROs and contract labs * Demonstrated ability to write and present clearly using on scientific and clinical issues terminology * Applies technical standards, principles, theories, concepts and techniques * Advanced computer skills * Good organizational and planning skills * Strong interpersonal skills and communication skills (both written and oral) * Ability to work effectively in a team/matrix environment * Ability to understand technical, scientific and medical information * Demonstrated success in problem-solving * Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: * Works on assigned problems of moderate scope with analysis of situation or data required. * Exercises judgment within defined procedures and practices to determine appropriate action. * Builds productive internal and external working relationships. * Uses professional concepts and company policies and procedures to solve a variety of routine problems. * Demonstrated professional collaboration skills * Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: * Resilient in the context of a rapidly changing environment * Organized with a systematic approach to prioritization * Works independently to meet objectives and completes tasks within established timelines. * Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: * We drive for results, so patients can survive and thrive. * We are resilient in the face of adversity, and tireless in advancing our science. * We celebrate our long history of prolific drug discovery and rigorous drug development. * We unite to launch innovative medicines for difficult-to-treat cancers. * We exist to give people hope - one drug, one patient at a time. * We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: * Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), * Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) * Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: * Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
    $108.5k-153k yearly Auto-Apply 28d ago
  • Study participant - US (PST)

    Prolific 4.2company rating

    Clinical research associate job in San Francisco, CA

    Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.
    $18 hourly Auto-Apply 13d ago
  • Clinical Research Assistant - Health Educator

    Pavir

    Clinical research associate job in Menlo Park, CA

    Job Description Palo Alto Veterans Institute for Research (PAVIR) supports the nation's second largest research program conducted among the VA Hospitals and is seeking a full-time Clinical Research Assistant - Health Educator. The Research Assistant - Health Educator will support several research studies aiming to improve Cancer Care for Veterans with Cancer. For all studies, the Research Assistant will be in direct contact with site leaders, oncology providers, and patients during data collection and intervention implementation activities. With assistance from the PI, Dr. Manali Patel, the Research Assistant will perform data collection, data entry, data management, simple data analysis, and creation of reports for funders as well as peer reviewed publications. This position will be 30-40 hours/week and is a 3-month, temporary position with the possibility of converting to a permanent/regular position depending on performance. BENEFITS PAVIR offers generous benefits, including comprehensive health insurance, vision, dental, sick pay, a 401(k) with a fully vested 6% company match and 3% profit share, a wellness program, commuter benefits, and professional development training. Plus, we pay for life, short-term disability, and long-term disability insurance. MAIN RESPONSIBILITIES: Serve as a primary contact with research participants, sponsors, and regulatory agencies. Assist with screening individuals for enrollment in the studies, determine eligibility, and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient data for clinical research projects. Assist with managing research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Help ensure compliance with research protocols, and review and audit case report forms on REDCap for completion and accuracy with source documents. Help to prepare regulatory submissions and ensure Institutional Review Board renewals and VA Research Review Committee renewals and applications are completed. Participate in monitor visits and regulatory audits. Ensure appropriate registration of trial information on clinicaltrials.gov and maintain renewals and updating information and uploading data upon study completion. Assemble study kits for study visits, monitor scheduling, coordinate documents, and attend monitoring meetings with sponsors and team members, acting as primary contact. Help monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Help prepare manuscripts and reports, including preparing tables and formatting references and assisting with grant applications. Assist with other study-related duties as needed. QUALIFICATIONS: Required: Bachelor's degree or equivalent experience; At least 1 year of relevant research experience (can be undergraduate experience); Preferred: Master's degree; Previous experience working in the VA system and/or experience with intervention trials in oncology, subject recruitment and screening; Understanding of statistics and familiarity with STATA or similar data analysis software; Strong interpersonal skills. Ability to communicate effectively with study participants and the research staff; Proficiency with Microsoft Office; Knowledge of medical terminology preferred; Organized, detail-oriented, self-directed, and dependable; Strong time management skills and ability to prioritize workload; Ability to work as part of a team; Able to learn VA regulations and procedures regarding research; General knowledge of research procedures gained through education or experience. ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR) PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. At PAVIR we work with more than 160 uniquely talented medical scientists. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research. READY TO JOIN OUR RESEARCH TEAM? If you feel that you would be right for this job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you! PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved appointment with VAPAHCS and complete a background check before they can commence work. PAVIR is pleased to be an Equal Opportunity Employer. Minorities, Women, Veterans, and Individuals with a Disability are encouraged to apply. We welcome and encourage diversity in the workplace regardless of race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need special assistance or an accommodation to apply for a posted position, please contact ************** - Human Resources department. Job Posted by ApplicantPro
    $40k-58k yearly est. 13d ago
  • Clinical Research Coordinator I

    Irvine Clinical Research

    Clinical research associate job in Oakland, CA

    Job DescriptionIrvine Clinical Research, a research site specializing in clinical trials of Alzheimer's Disease, is seeking applicants for a Clinical Research Coordinator I. The CRC will work under close supervision of our doctors and a research manager as a coordinator on Phase II/III clinical trials in Neurology and Psychiatry.Job Duties Coordinate the day-to-day clinical operations of a clinical research study Perform study procedures in accordance with GCP and study protocols Organize and maintain paper and electronic study data in a complete and correct manner Recruit, prescreen, and screen potential study participants Conduct diagnostic, efficacy, and safety assessments as needed Job Requirements Interest in working with persons with neurological or psychiatric indications such as Mild Cognitive Impairment, Early Alzheimer's Disease, or Depression Attention to detail and the ability to handle multiple tasks with precision Demonstrated ability to work accurately and quickly with computerized systems A command of professional spoken and written English Bachelor's degree or higher Hours and CompensationThis is a full-time employment position based in-person at our clinic in the Alzheimer's Orange County building in Irvine. The starting salary for this position is $25 per hour (approximately $52k per year). Higher salary is negotiable with candidates who possess relevant degrees in addition to their bachelor's degree. 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.
    $52k yearly 7d ago
  • Clinical Research Assistant

    Mass General Brigham

    Clinical research associate job in Belmont, CA

    Site: The McLean Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. A full-time Research Assistant (RA) position is available within McLean Hospital's Treatment & Etiology of Depression in Youth Laboratory (********************** directed by Christian Webb, PhD (Associate Professor, Harvard Medical School). The lab is part of the Center for Depression, Anxiety and Stress Research (co-directed by Dr. Webb), which is devoted to the study of depression, anxiety, and related conditions (********************************* Our lab uses a multimodal approach (smartphone-delivered ecological momentary assessment, passive smartphone and wearable sensor data, laboratory-based experiments, EEG, fMRI, and clinical interviewing) to investigate the causes of depression in adolescents, as well as predictors and mechanisms of change in psychotherapeutic and smartphone-delivered interventions for depression. As a member of our scientific team, you will work closely with fellow research assistants, postdoctoral fellows, and Dr. Webb. You will gain hands-on experience with recruiting and screening both healthy and depressed teens and adults, as well as conducting experimental procedures with them. See lab website (********************* for examples of our recent and ongoing research. In addition to the below general essential functions we would like to see someone who: Initiates and maintains contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and making an independent judgment as to the suitability of their participation. Coordinates study visits with adolescents and/or adults. Conducts behavioral and neuroimaging (e.g., fMRI) experiments. Works with ecological momentary assessment (EMA) and digital phenotyping devices (smartphones, smartwatches, and smart rings) and associated data. GUIDANCE ON SUBMITTING APPLICATION MATERIALS Applicants applying to TEDY should submit: A CV/resume A cover letter (one, single-spaced page) addressing: Your interest in research Try to be as specific as possible about why you want to work with this lab E.g., What was it about this lab, in particular, that drew you to apply? Future goals/how this job can help you achieve these goals Previous relevant experience (i.e., research, clinical, research, and/or organizational leadership roles, etc.) Optional (but could be helpful at further contextualizing your background) Relevant coursework (optional) Anything else you would like us to know about you? Job Summary Summary Working independently and under very general supervision, provides support to clinical research studies. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials, developing and implementing patient recruitment strategies, recommending changes to protocols, managing existing datasets, and overseeing the work of more entry level staff. Does this position require Patient Care? No Essential Functions -Coordinates the implementation, both internally and externally, of sponsored clinical research studies. -Initiates and maintains contact with study participants. -Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgment as to the suitability of their participation. -Working in concern with the Principal Investigator, develops and implements patient recruitment strategies. -Develops, organizes, and/or maintains the study database. -Responsible for data validation and quality control. -May also conduct preliminary analyses and assist the lab's statistical consultant. -In conjunction with the Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval. -Recommends changes to research protocols. -Performs literature searches to support protocol development for new studies and the interpretation of existing datasets. -Assists Principal Investigator with preparation for presentation and written published articles. -Trains and orients new staff. -May serve as a team leader or in a supervisory capacity in a smaller area. -Assists Principal Investigator in screening subjects for IRB approved protocols and coordinating study visits. Qualifications Education Bachelor's Degree required Licenses and Credentials Knowledge, Skills and Abilities - High degree of computer literacy; knowledge of data management programs. - Ability to work independently. - Excellent interpersonal skills are required for working with the study participants. - Good oral and written communication skills; careful attention to detail. - Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results. - Knowledge of clinical research protocols. - Excellent organizational skills and ability to prioritize a variety of tasks. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. - Must be able to consistently demonstrate McLean Values of integrity, compassion and respect, diversity and teamwork, excellence and innovation in their work activities and interactions. - Must have demonstrated an ability to work independently. Additional Job Details (if applicable) Remote Type Onsite Work Location 115 Mill Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $21.00 - $28.37/Hourly Grade MRA500 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1600 The McLean Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $21-28.4 hourly Auto-Apply 8d ago
  • Spine Assistant Clinical Research Coordinator

    Stanford University 4.5company rating

    Clinical research associate job in Redwood City, CA

    The Department of Orthopaedic Surgery boasts a prominent national and international presence in orthopaedic research, representing a wide range of subspecialties within the field. This research encompasses treatments for musculoskeletal issues in patients spanning from infants to older individuals. The overarching goal of the Orthopaedic Research Program is to cultivate foundational knowledge that propels the advancement of musculoskeletal injury and disease treatments. To further this mission, the Adult Spine Orthopaedic Research Program is seeking an Assistant Clinical Research Coordinator (ACRC) to support the clinical studies. This position is expected to work onsite, engage in all facets of research, including study recruitment and enrollment, grant writing, abstract/manuscript writing, designing and implementing their own projects under faculty mentorship. The successful candidate will demonstrate: * Outstanding communication and relationship building skills. * Strong attention to detail, and competence to manage multiple priorities and respond effectively with limited guidance. * Commitment to uphold Stanford University's compliance with federal, state, local, and sponsor regulation. * Drive to establish themselves as a leading contributor within the Department of Orthopaedic Surgery and Stanford Medicine. Duties include*: * Schedule and/or call subjects for appointments; contact participants with reminders or other requirements. * Prepare, distribute, and process questionnaires. * Perform clerical duties in the preparation of regulatory documents. Maintain all forms and documents, including consent forms and master subject logs. File all appropriate correspondence. * Assist with the screening, recruiting, and obtaining consent of study participants. Review medical records and/or perform telephone or in-person interviews to gather data, as needed. * Administer standard study questionnaires and tests, score test measurements and questionnaires, and code data for computer entry. Perform quantitative review of forms, tests, and other measurements for completeness and accuracy. * Extract data from source documents for research studies as directed. Collect data and complete case report forms. * Perform basic measurements and tests on patients according to protocol, such as obtaining vital signs and performing phlebotomy and EKG, after appropriate training/certification. Collect study specimens according to protocol. * Prepare, process, and ship specimens/samples accurately under well-defined requirements. * Order and maintain equipment and supplies. * Process study compensation payments and thank you letters to subjects upon completion of trial activities. Assist with post-study activities, as needed. * - Other duties may also be assigned. DESIRED QUALIFICATIONS: * Interest in Orthopaedic research. * Ability to work fast and efficiently within time constraints. * Ability to work independently and comfortably with study participants. * Prior data entry and management experience. EDUCATION & EXPERIENCE (REQUIRED): Two year college degree and one year of relevant experience or an equivalent combination of experience, education, and training. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): General knowledge of medical terminology. CERTIFICATIONS & LICENSES: Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG. PHYSICAL REQUIREMENTS*: * Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. * Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. * Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: * Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. * May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS: * Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. * Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. * Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************* The expected pay range for this position is $29.44 to $33.26 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (***************************************************** provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. Additional Information * Schedule: Full-time * Job Code: 1012 * Employee Status: Regular * Grade: E * Requisition ID: 107941 * Work Arrangement : On Site
    $29.4-33.3 hourly 16d ago
  • Senior Clinical Trial Specialist, CKD

    Maze Therapeutics

    Clinical research associate job in South San Francisco, CA

    At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you'll play a key role in supporting our Clinical Operations team as we deliver an exciting and diverse Chronic Kidney Disease (CKD) pipeline of precision medicines. You'll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is ideal for someone who enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management. The Impact You'll Have You'll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include: Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 CKD study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary. Will also help support Early Development studies in collaboration with Study Lead. Site & Vendor Oversight: Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Study Lead) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs. Supporting Key Study Materials: Assist in the design and development of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials. Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners. Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed. Sample & Data Management: Work with study team to coordinate sample shipments, sample analysis, and data reconciliation efforts. Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team. Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) to optimize study execution. What We're Looking For We're looking for someone who's not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have: A strong clinical operations background: Bachelor's degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment. A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes. Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track. A proactive and collaborative approach: You're a strong team player who takes initiative and builds meaningful relationships with internal and external partners. Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms. Flexibility and adaptability: You're comfortable working in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed. Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary. Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook). This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together - Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed - We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True - Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid #LI-Hybrid
    $125k-152k yearly Auto-Apply 15d ago
  • Senior Clinical Trials Specialist (Biotechnology Oncology)

    Exelixis 4.9company rating

    Clinical research associate job in Alameda, CA

    SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively · Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL · Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. · Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues · Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) · Review compound-specific ICF and develop study-specific ICF templates · Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection · Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents · Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites · May coordinate the preparation, conduct, and presentations at Investigator Meetings · Review monitoring visit reports for completeness, accuracy, and adherence to the protocol · Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation · May conduct UAT for EDC / IRT and data listing review of EDC data for analysis · Compile and review appendices for preparation of clinical study reports · Review and/or create study documents (e.g. newsletters, and various study / site trackers) · Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion · Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately · May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: · None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: · BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, · MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, · Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: · Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: · Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation · Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures · Experience with development of prospective site-selection criteria · Familiar with medical terminology, and basic concepts of clinical research · Ability to deal with time demands, incomplete information or unexpected events · Experience in interactions with outside vendors, e.g., CROs and contract labs · Demonstrated ability to write and present clearly using on scientific and clinical issues terminology · Applies technical standards, principles, theories, concepts and techniques · Advanced computer skills · Good organizational and planning skills · Strong interpersonal skills and communication skills (both written and oral) · Ability to work effectively in a team/matrix environment · Ability to understand technical, scientific and medical information · Demonstrated success in problem-solving · Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: · Works on assigned problems of moderate scope with analysis of situation or data required. · Exercises judgment within defined procedures and practices to determine appropriate action. · Builds productive internal and external working relationships. · Uses professional concepts and company policies and procedures to solve a variety of routine problems. · Demonstrated professional collaboration skills · Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: · Resilient in the context of a rapidly changing environment · Organized with a systematic approach to prioritization · Works independently to meet objectives and completes tasks within established timelines. · Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: · We drive for results, so patients can survive and thrive. · We are resilient in the face of adversity, and tireless in advancing our science. · We celebrate our long history of prolific drug discovery and rigorous drug development. · We unite to launch innovative medicines for difficult-to-treat cancers. · We exist to give people hope - one drug, one patient at a time. · We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: · Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), · Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) · Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: · Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
    $108.5k-153k yearly Auto-Apply 60d+ ago
  • Clinical Research Assistant - MRA

    Mass General Brigham

    Clinical research associate job in Belmont, CA

    Site: The McLean Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Summary Working under the supervision of a Senior Research Assistant, Manager or Principal Investigator and following established policies and procedures, provides assistance on clinical research studies. Supervisor available to handle unusual situations and regularly reviews progress of work. Does this position require Patient Care? No Essential Functions -Collects and organizes patient data. -Maintains records and databases. -Uses software programs to generate graphs and reports. -Recruiting patients for clinical trials, conducts phone interviews and schedules patients for visits. -Obtains patient study data from medical records, physicians, etc. -Conducts library searches. -Performs administrative support duties as required. -Verifies accuracy of study forms. -Updates study forms per protocol. -Prepares data for analysis and data entry. -Assists with formal audits of data. -Documents patient visits and procedures. -Assists with regulatory binders and QA/QC procedures. -Assists with interviewing study subjects. -Administers and scores questionnaires. -Provides basic explanation of study and in some cases obtains informed consent from subjects. -Performs study procedures such as phlebotomy. -Assists with study regulatory submissions. -Writes consent forms. -Verifies subject inclusion/exclusion criteria. Qualifications Education Bachelor's Degree required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Related experience 0-1 year Knowledge, Skills and Abilities - Careful attention to details. - Good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - All employees must possess basic computer skills to use a variety of electronic or online systems for communication, clinical and administrative purposes. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. - Works independently under close supervision. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 115 Mill Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $21.00 - $28.37/Hourly Grade MRA500 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1600 The McLean Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $21-28.4 hourly Auto-Apply 4d ago
  • Clinical Research Assistant - Health Educator

    Pavir

    Clinical research associate job in West Menlo Park, CA

    Palo Alto Veterans Institute for Research (PAVIR) supports the nation's second largest research program conducted among the VA Hospitals and is seeking a full-time Clinical Research Assistant - Health Educator. The Research Assistant - Health Educator will support several research studies aiming to improve Cancer Care for Veterans with Cancer. For all studies, the Research Assistant will be in direct contact with site leaders, oncology providers, and patients during data collection and intervention implementation activities. With assistance from the PI, Dr. Manali Patel, the Research Assistant will perform data collection, data entry, data management, simple data analysis, and creation of reports for funders as well as peer reviewed publications. This position will be 30-40 hours/week and is a 3-month, temporary position with the possibility of converting to a permanent/regular position depending on performance. BENEFITS PAVIR offers generous benefits, including comprehensive health insurance, vision, dental, sick pay, a 401(k) with a fully vested 6% company match and 3% profit share, a wellness program, commuter benefits, and professional development training. Plus, we pay for life, short-term disability, and long-term disability insurance. MAIN RESPONSIBILITIES: Serve as a primary contact with research participants, sponsors, and regulatory agencies. Assist with screening individuals for enrollment in the studies, determine eligibility, and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient data for clinical research projects. Assist with managing research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Help ensure compliance with research protocols, and review and audit case report forms on REDCap for completion and accuracy with source documents. Help to prepare regulatory submissions and ensure Institutional Review Board renewals and VA Research Review Committee renewals and applications are completed. Participate in monitor visits and regulatory audits. Ensure appropriate registration of trial information on clinicaltrials.gov and maintain renewals and updating information and uploading data upon study completion. Assemble study kits for study visits, monitor scheduling, coordinate documents, and attend monitoring meetings with sponsors and team members, acting as primary contact. Help monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Help prepare manuscripts and reports, including preparing tables and formatting references and assisting with grant applications. Assist with other study-related duties as needed. QUALIFICATIONS: Required: Bachelor's degree or equivalent experience; At least 1 year of relevant research experience (can be undergraduate experience); Preferred: Master's degree; Previous experience working in the VA system and/or experience with intervention trials in oncology, subject recruitment and screening; Understanding of statistics and familiarity with STATA or similar data analysis software; Strong interpersonal skills. Ability to communicate effectively with study participants and the research staff; Proficiency with Microsoft Office; Knowledge of medical terminology preferred; Organized, detail-oriented, self-directed, and dependable; Strong time management skills and ability to prioritize workload; Ability to work as part of a team; Able to learn VA regulations and procedures regarding research; General knowledge of research procedures gained through education or experience. ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR) PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. At PAVIR we work with more than 160 uniquely talented medical scientists. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research. READY TO JOIN OUR RESEARCH TEAM? If you feel that you would be right for this job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you! PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved appointment with VAPAHCS and complete a background check before they can commence work. PAVIR is pleased to be an Equal Opportunity Employer. Minorities, Women, Veterans, and Individuals with a Disability are encouraged to apply. We welcome and encourage diversity in the workplace regardless of race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need special assistance or an accommodation to apply for a posted position, please contact ************** - Human Resources department.
    $40k-58k yearly est. 42d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Novato, CA?

The average clinical research associate in Novato, CA earns between $56,000 and $142,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Novato, CA

$90,000
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