Clinical research coordinator jobs in Petaluma, CA - 308 jobs

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

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 Manager (Sr. CTM) at Maze Therapeutics, you'll play a hands-on role in driving the execution of our clinical trials. You'll have the opportunity to lead early- to mid-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. If you enjoy taking initiative, working in a fast-paced environment, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you. The Impact You'll Have Clinical Trial Execution & Leadership Co-lead operational activities of a mid-stage clinical trial, ensuring high-quality execution from study design to completion. Manage a Study Execution Team (SET) alongside the Study Lead, from protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR). Maintain active, hands-on oversight of CRO operations by closely tracking study progress, evaluating risks, and intervening early to course-correct. Apply a solution-oriented mindset to optimize study processes, boost study recruitment, and strengthen vendor/site performance. Vendor, CRO & Site Management Provide strategic sponsor oversight of the global CRO monitoring team, guiding the CRO Global CTM and CRAs to ensure alignment with study timelines, recruitment targets, and high-quality data delivery. Initiate methods to better build relationships with sites, address issues, and ensure on-track enrollment and data entry. Lead end-to-end vendor management for all clinical trial vendors, including vendor identification and selection, budget and contract negotiations, onboarding, and ongoing operational oversight, ensuring compliance with study protocols, contracted scope, and ICH-GCP requirements. Develop and manage study-specific plans including site monitoring strategies, blinding plan, etc. Experienced in organizing DMCs, managing clinical trial budgets, and review clinical data listings and summary tables. Budget & Financial Oversight Support Clinical Operations Leadership with study-specific budget tracking and vendor spend management. Data Quality, Compliance & Regulatory Readiness Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH-GCP guidelines through oversight of CROs, vendors, and site monitoring activities. Partner with Quality Assurance on inspection readiness efforts. Process Optimization & Technology Implementation Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS, RBM) to enhance efficiency. Assist in developing SOPs and scalable processes for clinical operations. Cross-functional Collaboration Partner with cross-functional teams like Biostatistics and Clinical science to identify and onboard new study vendors and systems (e.g. ARGUS). Partner with internal teams, such as CMC and Clinical Supply Chain, to manage study drug supply and distribution. Work closely with other functions to ensure smooth study execution. What We're Looking For A Bachelor's degree in a scientific discipline or health related field with 5-8 years of clinical operations experience, including at least 4 years as a CTM, with hands-on experience managing Phases I-III clinical trials. Global trial experience is a plus. Experience in common disease and/or rare disease drug development. Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP) Experience conducting a broad range of clinical trial related activities including study start-up to study close-out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and managing CROs and vendors. Strong executional leadership, problem-solving skills, and ability to manage cross-functional teams at the study level. A startup mindset, willingness to roll up sleeves, and ability to work in a fast-paced, evolving, and collaborative team environment. Excellent communication skills and the ability to manage cross-functional relationships effectively. Are willing to travel up to 30% to support study needs. 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 $176,000 - $215,000. 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

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

The Senior Clinical Trial Manager will lead, manage and co-ordinate the operational strategy, risk management, and overall execution of clinical trials from study start-up to close out at a global level in accordance with ICH-GCP and applicable local regulations. Collaborate with cross functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This position is based in our South San Francisco, CA office. * Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned. * Accountable for the overall operational strategy and delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements. * Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs. * Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF. * Ensures TMF creation and QC completion. * Supports EDC, IxRS, and CTMS systems and data maintenance. * Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions. * Accountable for the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution. * Drives the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale. * Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work. * Leads the Investigator Meeting preparation and execution with the support from cross-functional team members * Stays current on relevant therapeutic area knowledge and clinical research best practices. * Ensures study adherence to ICH/GCP and company SOPs. Qualifications REQUIRED * Undergraduate degree in a scientific or health-related discipline. * Minimum of 8 years relevant experience of which 5 years are clinical experience in the pharmaceutical industry, including 3 years in study management or equivalent combination of education, training, and experience. * Ability to work across several time zones. PREFERRED * Prior people management experience. * Demonstrated ability in clinical study management processes and clinical/drug development. * Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders. * Ability to effectively lead projects and persuade and influence peers; ability to build trusting and collaborative relationships globally. * Experience with effective vendor management. * Strong customer focus with investigators, functional peers, vendors, etc. * Excellent planning and organizational skills. * Working knowledge of international regulatory and ICH Good Clinical Practice guidelines. * Maintains the highest standards of integrity and ethics. If you are interested in this job, please apply via this link: ********************** Additional Information The pay range for this position at commencement of employment is expected to be between $177K and $203K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai Lab, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. That's why our environmental protection, social responsibility, and corporate governance strategy, called "Trust for Life," is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request. If you are interested in this position, please click on the button below:

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

+ Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an indication or across a program as required + Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study + Ensures alignment of regional deliverables with overall study goals + Contributes to the development of regional tools and leads the development of work instructions and SOPs as required **Essential Functions of the job:** **Regional Leadership** + Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study + Leads external vendors involved in study delivery on a regional level + Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional study team members + Displays therapeutic area knowledge and expertise **Timelines, Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these + Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study plans as required + Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems and tools is entered and up to date + Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports + Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region + Manages the trial data collection process for the region, drives data entry and query resolution + As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads + Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point in time throughout the study life cycle + Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented + Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate + Collaborates with CST members and othercolleagues to ensure cross-team, site learnings, and best practices are shared + Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies + Leads the development, optimization and review of work instructions and SOPs as required **Budget and Resources** + Works with the sourcing team to select and manage regional study vendors + Manages regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities + Identifies and manages regional team resource needs and establishes contingency plans for key resources + Monitors regional resource utilization over study life cyle and liaises with functional managers as needed **Supervisory Responsibilities:** + Provides performance feedback on team members as required + Mentors junior team members and might take on line management responsibilities as required **Computer Skills:** MS Office, Project Planning Applications **Other Qualifications:** + 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead in clinical functions + Experience as CRA is preferred **Travel:** Travel might be required as per business need **Education Required:** Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred _*exceptions might be made for candidates with relevant clinical operations experience_ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

PURPOSE OF JOB: The Clinical Trial Manager will provide day-to-day clinical operations oversight and support for RAPT clinical trials as assigned. This cross-functional role involves working directly with the study team, as well as external functional area/support staff and vendors, to ensure execution on the clinical strategy and delivery of high-quality clinical trial data on time and within budget. Works under minimum supervision and contributes technical and operational expertise to achieve RAPT's Clinical Development goals. MAJOR DUTIES AND RESPONSIBILITIES: Responsible for performing or providing Clinical Operations oversight of in-house and outsourced activities in the following areas: Supports/Leads the set-up and on-time execution of clinical study tasks, while ensuring the trial is conducted to RAPT quality standards and in compliance with the protocol, SOPs, ICH-GCP, and applicable regulatory requirements Collaborates with cross-functional teams to ensure effective delivery of the assigned activities to meet project milestones Supports/Leads identification, selection, contracting and management of study vendors/CROs and development of vendor scope of work (SOW) Supports/Leads the development and review of clinical study plans (Clinical Monitoring Plans, Data Management Plans, Safety Management Plans, Communication Plans, etc.), and other project/study-related documents including training materials, forms, logs, presentations, etc. Acts as primary point of contact for assigned trial(s) for vendors, partners, investigational sites, and RAPT internal teams Participates in specification development, design, set-up and UAT of trial infra-structure systems (EDC, IRT, CTMS, eCOA, etc.) As needed, works closely with RAPT Biomarker Team staff and external personnel (Central Labs, specialty labs, clinical trial study sites, etc.) on clinical laboratory activities including specimen management & logistics, data management, and issue identification and resolution Collaborates with RAPT Clinical Drug Supply Manager and internal and external CMC / Supply Chain personnel to forecast investigational product needs and identify distribution, storage, and accountability requirements Collaborates with RAPT Clinical Project Manager and Finance personnel to ensure accuracy and financial information related to clinical trial progress, including enrollment information, timeline status, and budget forecasts and updates Writes/Contributes to clinical trial protocols and protocol-associated documents including Informed Consent Forms and other documents as needed or requested Coordinates/Performs in-house review of clinical data listings for completeness and accuracy and escalates issues to the vendor and RAPT internal team, as needed Manages clinical monitoring activities, overall site performance, and ensures compliance with Good Clinical Practices (GCP) and applicable regulations Reviews monitoring trip reports, ensures follow-up of action items to resolution and escalates critical issues and risks, as necessary Responsible for ongoing review/oversight of TMF and other records as assigned Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings as required Other duties as assigned To accomplish the above, the Clinical Trial Manager will be required to: Develop and maintain strong internal and external relationships with key stakeholders Lead the team when making decisions/recommendations that require cross-functional input and that have cross-functional implications Effectively communicate with key stakeholders at all levels of the organization Quickly and accurately identify issues and propose and implement effective solutions Prospectively identify risks and mitigation approaches, and implement them as appropriate EDUCATION REQUIREMENTS: Bachelor's degree required, preferably in a scientific discipline. Advanced degree preferred. May consider a combination of experience and education in lieu of strict adherence to educational requirements EXPERIENCE REQUIREMENTS: Minimum of 2 years of clinical operations experience Recent experience managing ex-US sites on a Global Clinical Trial is desired The ideal candidate will have recent experience managing clinical trial(s) in immunology and/or dermatology Experience directly managing clinical vendors, including CRO, eCOA, etc. OTHER QUALIFICATIONS: Ability to work on-site at our South San Francisco office 3 days per week California law requires pay information in job postings. The specific rate will depend on the successful candidate's qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $157,400 (entry-level qualifications) to $165,000 (highly experienced).

Hi, Hope you are doing well!!! My name is Shyam and I'm a recruiter at Artech Information Systems, a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is a summary of the position. If you believe you're qualified for this position and are currently in the job market or interested in making a change, please give me a call as soon as possible at **************. You may also respond to me via email with a copy of your updated resume and your best contact number and timings for further discussion. Job Description The Senior Clinical Trial Manager will independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high risk. The Senior Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Nektar SOPs. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff. Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff. Additional Information Shyam Sheriel Associate Recruiter - Staffing Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************

Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients. Elevate your career by leading groundbreaking clinical trials as a Clinical Trial Lead at a forward-thinking biopharmaceutical organization. This pivotal role offers the opportunity to oversee and direct complex trials, collaborate with cross-functional teams, and partner with CROs and vendors to drive scientific innovation and ensure excellence in clinical development. Join a dynamic team committed to advancing therapies that make a real difference in patients' lives. Key Responsibilities: Lead and support end-to-end clinical trial activities, managing budgets, timelines, and resources with a focus on quality and operational efficiency. Develop and oversee clinical operational plans aligned with study objectives, ensuring regulatory compliance (ICH/GCP), SOP adherence, and inspection readiness. Oversee vendor selection, management, and performance, including CRO oversight, site feasibility assessments, and regulatory submissions. Collaborate on clinical documentation such as protocols, investigator brochures, and study reports, ensuring clarity and compliance. Represent Clinical Operations in cross-functional project teams, external stakeholder meetings, and regulatory inspections. Monitor study progress, communicate status, costs, and issues to senior management to facilitate timely decision-making. Lead quality initiatives, SOP development, and continuous process improvements to optimize clinical trial execution. Manage and mentor Clinical Operations staff, fostering development, performance, and a cohesive team environment. Build and maintain strong relationships with investigators, site staff, key opinion leaders, and external partners.

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

Zipongo enables Eating Well Made Simple. We provide Foodsmart--FoodSmart population nutrition analytics integrated with FoodsMart ad-free buying with options ranging from Amazon Fresh & Sun Basket to GrubHub & Compass Cafes, Telenutrition, and Foodscripts health plan food subsidy disease reversal programs to hundreds of employers and health plans, including 5 of the 7 largest health plans in the US. Job Description We are looking for an outstanding Clinical Research Scientist with strong human subjects research and statistics experience (nutritional epidemiology preferred) to evaluate and improve our Foodsmart, Telenutrition and Foodscripts services, as we grow from nearly 1 million enrolled users today to are goal of 10 million users in the coming years. To start, this position is responsible for coordinating new research studies as a Principal Investigator or in collaboration with our Chief Medical Officer, Scientific Advisors or other partner academic PIs, conducting statistical analyses, reviewing literature, drafting manuscripts in collaboration with internal and external co-authors, and assisting with day-to-day activities of the research team to support cross-functional collaboration with clinical education, product, and commercial teams. Responsibilities Coordinate operations and logistics for clinical trials as key study personnel under the direction of the Primary Investigator. Oversight of future clinical trials is a possibility with appropriate experience/expertise. Collaborate with PIs to conduct statistical analyses supporting all Zipongo internal and external clinical research projects including the Zipongo Nutrition Registry, randomized controlled trials and cost-effectiveness analyses. Perform literature reviews to enable evidence-based decision making and written assets. Assist with drafting, editing, and submission of manuscripts for peer review in collaboration with co-authors. Build productive collaborations with co-workers in data science, clinical care and education, graphic design, product, and commercial teams. Develop systematic and semi-automated processes to expedite evaluation of multiple variables via multiple sub-studies. 90 Day Plan As you begin your first 3 months with Zipongo, we you will work to accomplish the following: Coordinate operations and logistics to launch a new research study while working closely with the study PI. Perform data analyses of patient nutrition and health outcomes that prove or improve patient outcomes and health plan costs while gaining fluency with our internal data tools. Lead a retrospective analysis that leads to a strong publication submission and drives hypotheses for future study. Establish strong working relationships with Zipongo team members in research and beyond. Qualifications MS or MPH in nutrition, physiology, public health, psychology, biomedical science, epidemiology, biostatistics, or a related field. 2+ years of statistics experience with SPSS, python, R, or similar tool. (Experience with SQL is a plus.) Experience in human subjects research including study coordination and progress reporting. Strong experience and attention to detail in data collection, management, and reporting. Ability to iterate on processes to increase efficiency and effectiveness in these tasks. Impeccable integrity for research ethics and data analysis/presentation. Exceptional written and verbal communication skills across a variety of audiences (professional, medical/scientific, patients) and with patient-centered tone and personality. Ability to work at start-up speed and possess intellectual curiosity with the desire to improve health outcomes for patients. Bonus requirements: PhD in nutrition, physiology, public health, psychology, biomedical science, epidemiology, biostatistics, or a related field. 4+ years statistics experience with SPSS, python, R, or similar tool. Experience with SQL. Expertise in epidemiology, biostatistics, and use of observational, real world data for deriving insights and developing hypotheses. Minimum of 5 peer-reviewed publications including first author or senior author manuscripts and demonstration of excellent scientific writing. Leadership of research collaborations involving co-authors from multiple fields. Experience with nutrition studies as well as cardiometabolic disease, diabetes, cardiology, lipidology, oncology, autoimmune disease, behavioral medicine, telemedicine, digital and mobile health. Additional Information Values drive Zipongo's culture, so you'll do well if your own values are rooted in being: Measurable: You leverage data and results to iterate on problems rapidly, and do not rely on politics or tradition drive projects Impactful: You let your focus on mission drive you in having a positive impact and not get caught up in small daily challenges; you focus on the biggest rocks over the pebbles and the sand. Collaborative: You are humble, transparent, open to transparent feedback and kind to your colleagues as you seek out their collaboration and share learnings Accountable: You are empowered, and take accountability for your work and projects the team counts on you for Creative: You bring urgency and creativity to overcome challenges with speed and tenacity.

DM Clinical Research, the largest privately-owned research management organization in the Houston area and one of the top 50 CROs in the country, is looking for an experienced Clinical Research Site Director to join our team of professionals. This role will be responsible for managing clinical trials from startup to closeout by coordinating site operations. Responsibilities and Duties: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents and assigned study protocol(s). Responsible for immediate supervision and performance of the assigned site staff. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include, but is not limited to: Sponsor provided and IRB approved Protocol Training All relevant Protocol Amendments Training Any study specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. It is the responsibility of the Site Director to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study. Working knowledge of the recruitment and relevant cross functional departmental processes for their assigned protocol(s) at their respective site(s). Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow up on the action items, at their respective sites. Making sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s). Working with the Regulatory Team to ensure maintenance of Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their as for their assigned protocol(s) at their respective site(s) Working with the cross functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV. Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. Responsible for providing guidance to the site team on planning and monitoring the conduct of the clinical trials. Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations Coaching, counseling and disciplining the employees as applicable. Collaborating with both internal and external cross-functional stakeholders for the successful conduct and management of assigned protocol(s) at their respective sites. To develop, coordinate, and enforce site specific systems, policies, procedures, and productivity standards. Communicating and effective implementation of strategic goals from senior management Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Striving to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Any other matters as assigned by management. Experience and Skill Requirements: Minimum of 8-years experience in Clinical Research. 5 years Experience Managing Multiple Clinical Trials Experience Managing Teams

About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit ***************** and follow @AllogeneTx on X (formerly Twitter) and LinkedIn. About the role: The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required. This is a 6-month contract opportunity with the possibility of extension or contract-to-hire. Responsibilities include, but are not limited to: Manage all clinical aspects of study under oversight of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.). Interface with cross-functional teams as Clinical Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial. May oversee clinical trial execution in one or more regions within a global clinical trial. Review protocol and amendment development, Informed Consent Forms, clinical trial-related training, and Site Study Tools Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF Partner with Clinical Quality Assurance to follow through on corrective and preventative actions (CAPA) identified during internal and external audits Vendor oversight: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel. Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary. Prepare and present project debriefings to Clinical Operations management. Provide study-related guidance and leadership to internal and external partners, as appropriate. Position Requirements & Experience: Bachelor's degree or equivalent combination of education/experience in science or health-related field with at least 3 years of clinical trial management experience in a Pharmaceutical/Biotech organization. Clinical trial management experience as a contractor or employee of an industry sponsor Vendor management Robust understanding of ICH/GCP, and knowledge of regulatory requirements. Strong clinical study/project management skills. Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills. Candidates must be authorized to work in the U.S. Preferred experience: Prior clinical trial experience in oncology therapeutic development with an industry sponsor or Contract Research Organization Multi-regional study management experience advantageous We offer a chance to work with talented people in a collaborative environment. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients. #LI-EL1 #LI-REMOTE

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor Creates and implements subject enrollment strategies for assigned investigative sites Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Job Description: • The Project Manager (PM) provides comprehensive project management for asset teams to ensure alignment and execution of research, development, medical, and commercial strategic and operational objectives. The PM serves as the program operational leader ensuring all cross functional deliverables are achieved on or ahead of schedule, within budget target, and with quality that meets or exceeds business needs. The PM's responsibilities encompass asset strategic and scenario planning, program and submission execution, team effectiveness, resource management, risk management, and information and communication management. The PM needs to have comprehensive understanding of the governance process, strategic and tactical planning, and the foundational tools that support planning, communication, and continuous improvements in the area of operational delivery. Additional Responsibilities - In some instances a PM may provide leadership in the following areas: Alliance Programs (Co-development alliances) • Leads the operations for alliance projects including contributing roles on alliance sub-committees and steering committees. • Plays a leadership role in partnering with Finance to manage alliance budget forecasts and with Portfolio & Decision Analysis on asset valuation assessments. • Provides operational inputs (e.g., timeline and budget) for assessments of new business development/partnerships. Submissions: • Provides comprehensive project management for regulatory submission activities for initial market authorizations in major regions, as well as supplemental applications of significant scope. • Provides operational excellence, planning, and execution leading to successful regulatory submissions and approvals. • Provides support to the team approximately 18 months in advance of a potential submission to map out submission contents and conduct scenario analyses of cost, schedule, and resource demands to identify the most efficient plan. • Applies specialized knowledge of and expertise around endgame to contribute to the identification, evaluation, and optimization alternatives for the submission plan. • Responsible for the development of the submission integrated MS project plans and resourcing plans for endgame activities. • Leads the cross functional submission team. • Partners with the Asset Team Leader to lead advisory committee preparations. • Reports to PM Group Lead or Senior Director level PM • Key unit team relationships include: PM Group Lead, Project Planner, Portfolio Director and other PMs. • Key internal-to-GPD relationships include: Asset Team Leader, Partner Line members, and enabling functions to ensure high functioning matrix asset teams that can deliver our portfolio. • Key external-to-GPD relationships include: Commercial Development, Research Project Leader and other Worldwide Research & Development, Medical Affairs, Global Health and Value, and other enabling functions (e.g., PDA, Finance) to ensure delivery of programs. Qualifications Minimum Training & Education experience required: • Bachelor's degree in one of the disciplines related to drug development or business required. Advanced degree (PhD, PharmD, MBA) desirable. • Mastery of project management skills and product development. •Senior managers are preferred to have 7 or more years of relevant experience; Directors are preferred to have 10 or more years of relevant experience; Senior Directors are preferred to have 15 years or more of relevant experience within the pharmaceutical industry. Levels are determined by the qualifications of the individual and business needs. • Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable. Prior Experience/Skills: •Strong track record of performance on cross-functional teams and results through effective implementation of project management methodology, tools, and techniques. • Extensive knowledge and experience in drug development, medical, and/or commercial disciplines with proven performance in business performance and project delivery. • Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills. • Experience with stakeholder management, governance management, and communicating key messages to senior-level stakeholders. •Demonstrated ability to utilize project management tools and techniques(such as developing integrated project plans, critical path management, project change control, project risk management, and decision analysis). • Extensive hands-on experience using Microsoft Project or equivalent project planning system to create and manage project timelines (Planisware and Snapshot experience highly desirable). •Familiarity with clinical trial execution, working with contract research organizations, budget management, and related areas highly desirable. • Track record for delivery against challenging personal and team goals. • Knowledge of medical and commercial issues that drive late stage development and life cycle management is desired. • Proven ability to succeed in a fast-paced, challenging and complex matrix team environment. Additional Information All your information will be kept confidential according to EEO guidelines.

We're looking for a Senior Experience Researcher to help make looking for health insurance work better. eHealth gives people and small businesses all the tools they need to make providing health insurance for themselves and others simpler, more pleasant, and more productive. The Mission It's complex looking for healthcare. It's not always just about making information consumable, it's can also be about helping customers deal with existential fears. So making that experience better is the perfect challenge for any researcher who is looking to contribute to people's lives and meet real needs. If you've been conducting research for digital natives for your whole career, then be ready to continue helping them, but you will also be working for those on the other side of the digital divide - the poor and the elderly. We are helping them get plans too - plans that include Medicare related plans and family health plans. Whatever product you are working on, you will always find that the customers who are using them are not abstract at all. They may even be your friends and family. Designing Product Our researchers do more than help create better online experiences. We are looking for researchers who are both tactical AND strategic. We work with a product team that wants us to help define product requirements. So, we take the insights we've gained about our customers - how they shop for healthcare, and their needs - and use them to help shape product strategy and invent new products. In many ways, our researchers are closer than anyone to our customer. We need your voice early on in product ideation. That said, you will also have to see both sides of the products. Not only will you see products from the customer viewpoint, you'll learn about how they are shaped by insurance agencies and the government. If you want to be in the middle of one of the most important conversations in America, then work here. If you also have a passion for hard core transactional online experiences, this is an interesting place to hone your craft. For example we need to learn about where the customer is health-wise in order to recommend some plans. We can easily default to how insurance providers ask questions and run customers through a massive decision tree. But people may see the same information differently. It's part of their story. It's what they did last year. It's what has happened to them and where they are headed. So could it be better to help them tell the story of their health first and learn from that - make that our starting point rather than an insurers form? We need researchers partnering with product managers and designers to help sort out these kinds of questions to make real advances. It's a fun and absorbing challenge. Research You will also do your own dirty work by producing a full range of research deliverables that may include screeners, interview scripts, and presentations on accessibility. Your activities may include moderating, conducting primary research, and actively engaging in the process of product design to help keep knowledge about the customer alive and applied. The Team You will be working as part of the Design Team. We have years of experience on the team and have pulled people together from a range of leading design teams such as Amazon's Mobile Innovation and Augmented Reality Team, Disney, Hallmark Labs, Macy's Integrated Retail Labs and Walgreen's retail design team. We have your back and are all bringing something to the table. We provide a highly customer-centric, team-oriented environment in our offices located in San Francisco, California. We also have a secondary location for the team within eHealth's offices in Santa Clara and may consider blending time in the office with working from home. We have a culture that: • demands authentic empathy for our customers • is excited by the business mission of the company • runs on collaboration with other disciplines • requires you to come up with ideas on your own • takes a collectivist approach to creating design processes, tools and methodologies • has strong and opinionated leadership pushing the department to evolve • supports everyone in having long and passionate careers • recognizes the need to have a balanced life that includes family, friends, health and wellness • demands authenticity • seeks to humanize technology • looks for connections into the larger Bay Area design and research community What You Will Be Doing • Contribute to products that may include individual health plans, family plans, plans for small businesses and a range of Medicare related plans • Work with designers to pitch product ideas to cross discipline groups and cowrite product specs • Proactively plan and execute customer research throughout the design and development lifecycle, from early strategic direction through post-release validation • Share customer insights with the broader organization to increase customer intelligence, including posters, theater, blog posts, and workshops • Coach and mentor others on the design team • Work with design leadership to inform and improve design processes • Work with cross discipline leadership to get your insights into our products and help get products out. About eHealth Founded in 1997, eHealth is the nation's first and leading private health insurance marketplace. Millions of individuals, families and small businesses use our top-rated tools to compare and purchase health insurance from leading insurers like Aetna, Humana, Kaiser Permanente and Wellpoint. In addition to health, dental and vision insurance products, eHealth also provides powerful online and pharmacy-based tools to help Medicare beneficiaries navigate Medicare health insurance options, choose the right plan and enroll in select plans online Qualifications Basic Qualifications: • 5+ years of professional research experience • Strong track record of using qualitative and quantitative methods to develop actionable insight that impact product strategy and development • Up-to-date research methods and the agility to work in different ways depending on your context • Ability to collaborate with a wide set of stakeholders including designers, product managers, and engineers • Ability to execute in a fast-paced environment • Excellent communication skills, with the ability to distill complex ideas to their essence Preferred Qualifications: • Knowledge of the healthcare and insurance industry • Experience working with insurance related products and services • Bachelor's degree in cognitive or experimental psychology, human computer interaction, human factors, or related field; MS/PhD preferred • Experience researching multichannel experiences • Mobile experience • Experience with agile software development Additional Information All your information will be kept confidential according to EEO guidelines.

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

Salary: Clinical Research Associate Health Tech Innovation Position Type:Full Time Help Shape the Future of Health Tech Join a team at the forefront of wearable technology and digital health innovation. This is more than a monitoring roleits an opportunity to influence how next-generation medical devices improve lives. If youre an experienced Clinical Research Associate (CRA) who thrives in fast-paced environments and wants to make a tangible impact on groundbreaking clinical trials, we want to hear from you. What Youll Do Lead site qualification, initiation, monitoring, and close-out visits to ensure compliance with protocols and regulatory standards. Monitor studies with precisionverify source data, resolve queries, and maintain data integrity. Build strong relationships with investigators and site teams to ensure smooth trial execution. Drive risk-based monitoring strategies and implement corrective actions when needed. Stay ahead of the curve on FDA regulations, ICH GCP guidelines, and evolving industry trends. Collaborate cross-functionally with clinical operations, data management, and regulatory teams. Prepare detailed monitoring reports and documentation that meet the highest standards. Qualifications for success: Bachelors degree in life sciences, nursing, or related field (Masters preferred). 5 or more years in clinical research, ideally with device studies. 2 or more years as a CRA or Study Monitor with hands-on experience in IMV, SQV, etc. Experience with EDC systems and CTMS. Experience with FDA regulations, ICH GCP, and device-related compliance. Ability to travel up to 80%. CCRA, CCRP, or CPM certification preferred. Why youll love it here: Culture:At Tech Mahindra, we are a culture of driving positive change, celebrating each moment, and empowering all to Rise drives us to dream, do, and become more. Applicants can expect to make between $115,000 to $130,000 upon hire. Pay within this range will vary based upon experience, skills, certifications, education among other factors as required in the job description. Tech Mahindra also offers benefits like medical, vision, dental, life, disability insurance and paid time off (including holidays, parental leave, and sick leave, as required by law). The exact offer terms will depend on the skill level, educational qualifications, experience and location of the candidate. Tech Mahindra is an Equal Employment Opportunity employer. We promote and support a diverse workforce at all levels of the company. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, age, national origin, or disability. All applicants will be evaluated solely on the basis of their ability, competence, and performance of the essential functions of their positions with or without reasonable accommodations. Reasonable accommodations also are available in the hiring process for applicants with disabilities. Candidates can request a reasonable accommodation by contacting the company ADA Coordinator at ADA_******************************.

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