Clinical research coordinator jobs in Vallejo, CA

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

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

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

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

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

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

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. The Lead Clinical Laboratory Scientist (CLS) performs testing in the CLIA-certified laboratory, participates in quality control, quality assurance and troubleshooting activities. A CLS performs duties under general direction, carrying out work assignments in accordance with policies and objectives established by the Clinical Laboratory Manager (CLM)or designee. A CLS is expected to plan and organize his or her own work, determining work methods and assisting in the determination of priorities and deadlines. Completed work is reviewed by the CLM or designee to verify the achievement of expected results. Shift Schedule: Tues-Sat 9am-530pm Responsibilities: * Handle and process patient samples, analyze test results, prepare reports and maintain records of test results * May be required to accession samples into the laboratory information management system (LIMS) to facilitate sample throughput * Comply with CareDx quality control policies and document QC activities including instrument and procedural calibrations and maintenance * Maintain confidentiality of personal health information (PHI) * Identify problems that may affect test performance or results and, following established protocols, correct problems or escalate to Clinical Laboratory Manager, Technical Supervisor, Clinical Consultant or Lab Director * Identify test systems that deviate from acceptable performance specifications and follow established policies and procedures to correct operation * Document corrective actions taken when test systems deviate from established performance specifications * Teach/train CareDx policy, methods and techniques to new employees; may perform inservice and competency testing of employees if qualified. * Participate in drafting and developing standard operating procedures for tasks in which proficiency has been demonstrated * Represent the Reference lab testing, quality control and quality assurance program in interactions with other groups * Under direction of the CLM, investigate and follow-up on proficiency testing, quality control results and patient testing that does not meet standards * Perform additional duties and projects assigned by the Clinical Laboratory Manager * Demonstrate knowledge of, and support, the CareDx mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality standards, and ethical behavior * Comply with all local, state, and federal laws and regulations governing clinical laboratory operations Qualifications: * Held California Clinical Laboratory Scientist (CLS) license * BS/BA in a biology-related science * 2+ years of license lab clinical laboratory experience * Knowledge of workflow timing and efficiency * Strong communicator with the Lab Leadership team including other leads, supervisors, managers, and director * Proficiency in Microsoft Office suite of programs (Outlook, Word, Excel, PowerPoint, etc.) * Demonstrated analytical skills, including working with databases and Excel * Strong interpersonal skills * Ability to build and maintain effective working relationships with CareDx employees at all levels as well as customers and vendors * Demonstrated proficiency in the performance of molecular testing techniques (PCR, real-time PCR, etc.) is highly desirable * Experience in immunology, microbiology or related fields is preferred * Demonstrated understanding of a disease with complex treatment algorithms highly desired Growth: Supervisor: Fully meets the qualification section of this description in addition to the following: * Meet requirements of Lead role described above. * Must have at least 3 + years of licensed experience. * 1-2 years of leadership experience preferred. Additional Details: Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients. Our competitive Total Rewards package for US Employees includes: * Competitive base salary and incentive compensation * Health and welfare benefits, including a gym reimbursement program * 401(k) savings plan match * Employee Stock Purchase Plan * Pre-tax commuter benefits * And more! * Please refer to our page to view detailed benefits at ********************************** In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow. With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it's an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together. CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx. * We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.* Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our Privacy Policy This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the 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. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states. San Francisco Bay Area Roles: $71 - $82 USD

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!

Heluna Health invites applications for the full-time position of Research Study Coordinator in the Center on Substance Use & Health (CSUH), a grant-funded research unit within the San Francisco Department of Public Health (SFDPH). Research in this Unit focuses on the evaluation of behavioral, biological, and pharmacological clinical trials to reduce harms from substance use risk behaviors. Our close-knit team consists of a Medical Director, Senior Research Scientist, Research Study Coordinator, Research Clinicians, Clinical Psychologist, Research Associates and Recruitment Team. This is a temporary, grant-funded, Full time, benefitted position. Employment is provided by Heluna Health. Salary Range: $79,500-$87,500 annually Interested individuals must submit a cover letter and resume for consideration. Applications without a cover letter will not be considered. ESSENTIAL FUNCTIONS • Oversee and coordinate observational and intervention studies addressing substance use, including coordinating study start-up, ensuring that studies are enrolling according to goals; support staff to meet these goals using data-driven problem-solving • Oversee the development and implementation of standard operating procedures (SOPs) and study specific protocols (SSPs) and ensure adherence of study staff to protocols and the principles of Good Clinical Practice (GCP) • Oversee the development of study intervention materials such as qualitative interview guides, counseling manuals, etc. • Facilitate weekly meetings and supervise research associates and other staff working on studies; provide guidance as a supervisor, conduct regularly scheduled supervisory meetings with direct reports • Ensure that study staff are up-to-date with all training requirements, licenses and certifications • Oversee, plan for, manage, and problem-solve the data needs of the Unit including creating and modifying survey instruments, interview guides, and case report forms • Oversee and provide management of study databases, including activities such as chart abstractions from medical records • Create, oversee, and manage the quality control systems for research records, study data, and regulatory obligations • Recruit for and manage focus group sessions and qualitative interviews according to study protocols • Under the guidance of the CRPM, manage regulatory affairs of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Data Safety Monitoring Board, the Food and Drug Administration (FDA), and other funding or regulatory agency reports • Generate as-needed reports for study team, including reports on recruitment, enrollment, retention, and adverse events • Supervise and manage recruitment, contacting and building working relationships with primary providers in the community • Contribute to the coordination and writing of grants and manuscript submissions for the Unit • Plan for Unit staffing needs which may include hiring and training of research associates and clinical staff as needed • Perform other related duties as required JOB QUALIFICATIONS Education/Experience • Master's in Public Health or other relevant Master's level degree • 3+ years conducting/coordinating studies in public health, medical, substance abuse, or social services fields • Experience with qualitative research methods and analyzing qualitative data • Experience applying regulations and guidelines such as Good Clinical Practice Guidelines, Health Insurance Portability and Accountability Act (HIPAA), the Protection of Human Research Subjects, IRB regulations for recruitment and consent of research subjects • Experience writing detailed reports or IRB submissions • Experience supervising and managing research staff • Experience with diverse communities, particularly communities of color, LGBTQ, and substance using communities • Experience managing and analyzing data in Microsoft Access, Excel and/or Stata is a plus Other Skills, Knowledge, and Abilities • Proven high-level of attention to detail and ability to function independently and perform multiple critical tasks simultaneously under dynamic circumstances and competing deadlines • Familiarity with research processes including protocol development, recruitment, quantitative and qualitative research methods, data management, regulatory submissions, and quality assurance monitoring • Strong interpersonal and communication skills (both verbal and written) • Excellent organizational skills • Proficient computer skills including experience with Word, Excel, EndNote and PowerPoint • Proficiency in data management (REDCap, Excel, Atlas.ti) and/or computer coding experience • Knowledge of HIV prevention and harm reduction principles • Knowledge of federal and state laws, regulations, policies and procedures related to the protection of human subjects and confidentiality of research records • Phlebotomy certification PHYSICAL DEMANDS Stand Frequently Walk Frequently Sit Frequently Handling / Fingering Occasionally Reach Outward Occasionally Reach Above Shoulder Occasionally Climb, Crawl, Kneel, Bend Occasionally Lift / Carry Occasionally - Up to 50 lbs Push/Pull Occasionally - Up to 50 lbs See Constantly Taste/ Smell Not Applicable Not Applicable Not required for essential functions Occasionally (0 - 2 hrs/day) Frequently (2 - 5 hrs/day) Constantly (5+ hrs/day) WORK ENVIRONMENT General Office Setting, Indoors Temperature Controlled Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply. All qualified applicants will be considered for this position in accordance with the San Francisco Fair Chance Ordinance. EEOC STATEMENT It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants, without regard to age (40 and over), national origin or ancestry, race, color, religion, sex, gender, sexual orientation, pregnancy or perceived pregnancy, reproductive health decision making, physical or mental disability, medical condition (including cancer or a record or history of cancer), AIDS or HIV, genetic information or characteristics, veteran status or military service.

Clinical Trials Research Coordinator II Job Number: 1307729 Posting Date: Nov 25, 2024, 4:03:45 PM Description Job Summary: The Clinical Trial Research Coordinator II (CTRC-II) is a position with demonstrated proficiency in coordinating clinical trial research tasks which, under the clinical direction of the Principal Investigator (PI), provides research, operational, and administrative support to the Kaiser Permanente Northern California (KPNC) PI and KPNC Clinical Trials Operations Director or designee, and other research staff conducting multiple FDA-regulated clinical trials. The CTRC-II is a hands-on position responsible for conducting the day-to-day activities of clinical trial project(s) under the supervision of the PI. The CTRC-II works more independently, assumes increased clinical trial responsibilities and requires periodic supervision. This is a non-licensed position which works under the daily supervision of an experienced Clinical Trial Nurse, Clinical Trial Research Coordinator, and/or KFRI-designated, licensed clinical trial research staff member. This position must adhere to the positions scope of practice as outlined in the Major Responsibilities below. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants. Essential Responsibilities: Compliance Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct). With guidance from PI, ensure compliance with KPNC IRB Standard Operating Procedures (SOP) and document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures With supervision, prepare for inspections, audits and monitor visits. Study Implementation Maintain the security and confidentiality of participants paper or electronic data (e.g., case report forms kept in a secure, locked space). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol and/or IRB-approved telephone script, collect and document research data and report the information to the appropriate licensed staff member and PI for assessment in a timely manner. Coordinate and schedule participants for study assessments/visits, required tests, including visit specific lab kits and/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). With appropriate guidance, obtain and review medical records and test results of all project/study participants and abstract needed data per protocol requirements. With guidance from PI, complete case report forms (paper or electronic) and maintain a database program to track all study activity including study enrollment and consents. Respond to Sponsor to resolve data queries and delinquencies in a timely manner. Report any potential protocol violations/deviations to the PI in a timely manner. Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions). Coordinate and prepare protocol specimens for shipping or storage in accordance with IATA/DOT regulations and Sponsor shipping guidelines. Assist with participants long-term follow-up data collection. Assist PI and/or Clinical Trial Nurse, if applicable, with identifying, screening, and recruiting potential participants. Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage. With guidance, receive, disseminate and maintain study-related communications with internal and external parties involved with clinical trial protocols. Ensure that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates. Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial. With direction, maintain the site(s) study regulatory binder(s) and ensure that other study-specific documentation is maintained. Assist the Clinical Trial Nurse with quality assurance, training, abstracting and recording data. Coordinate space requirements for study-related equipment/supplies. Leadership and Communication With direction, communicate compliance and operational needs with internal and external parties, PI, Sponsor, Contract Research Organization (CRO), KPNC Clinical Trials Operations Director or designee, and KPNC Offices of Clinical Trial Compliance and Operations on an ongoing basis. If applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, continuing review applications, protocol violations, and adverse events) in accordance with departmental and KP policies and procedures. Education and Training Work with an assigned mentor, as needed, for training and resource questions. With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Attend KP site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested. Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings as requested. Quality Improvement With direction, perform routine quality control activities with direction and assist with quality improvement initiatives. Systems and Infrastructure Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies. Adhere to departmental policies and procedures to support quality implementation and conduct of clinical trials, and assure maintenance of research documentation in compliance with the protocols and KP policies and procedures. Maintain systems and resources to effectively communicate with and obtain required IRB documentation. Staff Supervision No supervisory responsibilities. General Perform job functions according to the factors listed below under Job Criteria. Other duties as assigned by appropriate management. Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change s, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees. Qualifications Basic Qualifications: Experience Minimum one (1) year of experience in clinical trials research OR a bachelors degree. Education Associates degree or higher OR two (2) years of experience in a directly related field.High School Diploma or General Education Development (GED) required. License, Certification, Registration N/A Additional Requirements: Willingness to obtain IATA/DOT certification.Current BLS certification required prior to start date.Satisfies requirements for career advancement as defined by the Clinical Trial Career Ladder Program.Must be proficient in electronic health systems and data bases used in research environment and word-processing and database software or willingness to learn within 3 months of hire.Demonstrate organizational and communication skills.Demonstrate written, verbal, and interpersonal communication skills Demonstrate proficiency in medical terminology.Attention to detail and accuracy.Ability to manage multiple tasks Demonstrate prioritization skills.Demonstrate problem-solving skills.Demonstrate project management skills.Ability to be flexible and dependable.Possess ability to work effectively on cross-functional teams.Present professional manner and appearance.Possess ability to abstract pertinent protocol data from medical record.Skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).Knowledge of the principles, methods and procedures of basic medical and/or clinical research processes.Knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations.Knowledge of clinical trials research and research regulations, as well as clinical trial experience in a specific therapeutic area.Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.Must be able to work in a Labor Partnership environment. Preferred Qualifications: Current ACRP or SoCRA certification preferred.Primary Location: California-Oakland-Oakland Mosswood Medical Offices Regular Scheduled Hours: 40 Shift: Day Working Days: Mon, Tue, Wed, Thu, Fri Start Time: 08:30 AM End Time: 05:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Job Level: Entry Level Job Category: Research and Development Public Department Name: Oakland Reg - 2000 Broadway - Rsrch-Invstgtr Staffg Mdl Dept - 0201 Travel: Yes, 10 % of the Time Employee Group: NUE-NCAL-09|NUE|Non Union Employee Posting Salary Low : 36.1 Posting Salary High: 42.45 Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status.Click here for Important Additional Job Requirements. Share this job with a friend You may also share this job description with a friend by email or social media. All the relevant details will be included in the message. Click the button labeled Share that is next to Submit.

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

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

Description and Requirements JOB STATUS: Full-time WORK SCHEDULE: Mon-Sun 8-9 hours per day (5 days per week) flexibility requested COMPENSATION: $33.00 rate per hour Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Sunnyvale, CA, with additional support staff on-site to manage participant intake and provide technical support. Main Responsibilities * Receive participants at work and guide them through the data collection in a controlled environment. * Follow COVID-19 sanitization procedures after each session. * Represent and promote the TELUS AI brand * The moderator will report to the Site Manager. * Have all participants complete a survey at the end of each session. * Ensure all data collection is done per project guidelines and upload the data. * Assist the Anthropometric moderators in performing body measurements that require close proximity with participants in minimal clothing, including marking the participants with a pen and collecting measurements of different body parts using high-precision technology. * Any additional task needed. Minimum Requirements * Technical/troubleshooting skills; address fundamental problems with launching apps and uploading data * Familiarity with iOS and Mac OS * Experience with data collection and data management * Experience with video recording * Able to commit to a weekly schedule for the duration of the project * Ability to interact professionally with project participants * Experience with progress tracking and reporting, comfortable with Excel or Sheets TELUS International Values: TELUS International recognizes and embraces the importance of values in our ever-changing workplace. To be successful, all applicants must demonstrate behaviors that are reflective of our values: * We embrace change and initiate opportunity * We have a passion for growth * We believe in spirited teamwork * We have the courage to innovate At TELUS International, we are committed to diversity and equitable access to employment opportunities based on ability. TELUS Digital will never ask for any monetary deposit, credit card information, or bank account information to complete a job application. When emailing candidates, our recruitment and sourcing teams only use email addresses that end with telusdigital.com or telusdigital.ai. If you are unsure whether a job offer is legitimate or suspect that TELUS Digital's business name is being used for recruitment fraud, please report this immediately to our Talent Acquisition Team at TINA_**********************************. Additional Job Description Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Sunnyvale, CA, with additional support staff on-site to manage participant intake and provide technical support. EEO Statement At TELUS Digital, we enable customer experience innovation through spirited teamwork, agile thinking, and a caring culture that puts customers first. TELUS Digital is the global arm of TELUS Corporation, one of the largest telecommunications service providers in Canada. We deliver contact center and business process outsourcing (BPO) solutions to some of the world's largest corporations in the consumer electronics, finance, telecommunications and utilities sectors. With global call center delivery capabilities, our multi-shore, multi-language programs offer safe, secure infrastructure, value-based pricing, skills-based resources and exceptional customer service - all backed by TELUS, our multi-billion dollar telecommunications parent. Equal Opportunity Employer At TELUS Digital, we are proud to be an equal opportunity employer and are committed to creating a diverse and inclusive workplace. All aspects of employment, including the decision to hire and promote, are based on applicants' qualifications, merits, competence and performance without regard to any characteristic related to diversity.

Irvine Clinical Research is the largest independent memory research center on the West Coast. Alzheimer's Disease is a serious cognitive illness that affects millions of people each year. Every research trial brings us closer to finding a treatment or cure for Alzheimer's Disease. A recent study conducted at Irvine Clinical Research was successful in slowing cognitive decline by as much as 27%. Irvine Clinical Research is looking for a friendly, outgoing person to join our team as a Clinical Research Recruitment Coordinator. You will be speaking with potential study participants about their health concerns, especially around memory loss, and when appropriate, presenting research as a care option.In this role, expect to Recruit study participants via short telephone interviews; make outbound phone calls to achieve appointment scheduling goal Build rapport with potential participants to ensure engagement and retention Promote Irvine Clinical Research's services and the opportunity to advance the fight against Alzheimer's Disease via study participation Work independently while still being accountable to recruitment goals Input data into electronic systems in a consistently timely and accurate manner Assist with other recruitment, marketing, and outreach efforts as needed To succeed in this role, you have A welcoming, friendly, and professional attitude and demeanor that you bring with you every day Ability to consistently build trust and rapport with persons concerned about memory High attention to detail for all of your work responsibilities Time management skills to coordinate and manage recruitment calls efficiently Nice to have, but not essential Experience speaking with people with cognitive issues or older adults Call center or clinical research experience Salesforce/CRM/CTMS experience Equal Employment OpportunityIrvine Clinical Research is committed to diversity within our organization and building an equitable and inclusive environment for people of all backgrounds and experiences. Irvine Clinical Research provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Irvine Clinical Research complies with all state and local laws governing nondiscrimination in employment in any location. We especially encourage members of traditionally underrepresented communities to apply, including women, people of color, LGBTQ people, veterans, and people with disabilities.

Job Title: Clinical Research CoordinatorJob Description We are seeking a dedicated Clinical Research Coordinator to serve as the primary contact with research participants, sponsors, and regulatory agencies. You will coordinate clinical studies from startup through close-out, ensuring compliance with all protocols and regulatory requirements. This role offers the opportunity to work with one of the most renowned academic institutions in the US, providing a unique and rewarding experience in the field of clinical research. Responsibilities * Determine eligibility of study participants and gather consent according to protocol. * Assist in developing effective recruitment strategies. * Coordinate the collection and processing of study specimens. * Collect and manage patient and laboratory data for clinical research projects. * Manage research project databases and develop study-related documents. * Ensure compliance with research protocols and audit case report forms for accuracy. * Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. * Assemble study kits for visits, monitor scheduling of procedures, and attend sponsor meetings. * Monitor expenditures and adherence to study budgets, resolving billing issues with finance staff. * Regularly interact with the principal investigator to ensure patient safety and proper study conduct. * Ensure documentation and recording of patient and research data according to institutional and regulatory requirements. * Participate in monitor visits and regulatory audits. Essential Skills * Minimum of 2 years of experience as a Clinical Research Coordinator. * Experience with Oncology and complex clinical trials such as Cardio, CAR-T, and Transplant. * Hands-on experience with patient care during treatment trials within Phase I-II. * Proficiency in coordinating interventional sponsored studies. Additional Skills & Qualifications * Experience with treatment oncology trials is highly desirable. * Ability to perform study flow tasks specific to Stanford CRC, including patient-facing activities and data coordination. Work Environment This position offers a hybrid work environment with 4 days onsite and 1 potential flex day. The role involves patient visits, data coordination, and care coordination during the trial. You will be able to perform data-related tasks from home after a training period. The work environment encourages collaboration with a hands-on principal investigator and provides the opportunity to be part of an esteemed academic institution. Job Type & Location This is a Contract to Hire position based out of Palo Alto, CA. Pay and Benefits The pay range for this position is $35.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Palo Alto,CA. Application Deadline This position is anticipated to close on Dec 23, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives. We're starting with an approach that we believe can help the most people the fastest, and also allow us to learn as much about the brain as possible: developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth. This is a vertically integrated effort building cutting-edge hardware, software, and research capabilities to create products that can benefit millions - and eventually billions - of people. We've brought together a team of the best, who believe hard things are worth doing. To succeed, we need to assemble world-class teams across everything we do. We hire people who are exceptional at their craft, do the real work, and execute relentlessly - people who expect the highest levels of both rigor and integrity from each other. About the role Manage the participant recruitment process end-to-end, from first contact through prescreening, screening, and consent Maintain and report up-to-date recruitment metrics Serve as the main point of contact for participants in clinical trials Assist with adverse event documentation and reporting Assist in writing and updating clinical study documents (CRFs, SOPs, study protocols, ICFs) Support IRB and other regulatory submissions Develop trial recruitment and other participant-facing materials in accordance with Good Clinical Practice (GCP) guidelines About you We have preference for at least 2 years of professional experience. Regardless of your career level, you should have: Bachelor's degree in a STEM field or similar Experience in a patient-facing role in clinical trials Experience writing clear and high quality documentation Knowledge of basic medical terminology Strong organizational and communication skills Demonstrated history of exceptional contribution

Clinical Research Coordinator 1458001 Hourly pay: $35/hr Worksite: Leading university (Palo Alto, CA 94304 - Onsite) W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL 40 hours/week, 5-6 Month Assignment, Possible extension/conversion A leading university seeks a Clinical Research Coordinator to join the clinical trials office. The successful candidate will work with the team to ensure the safety and well-being of trial participants and to document related data per protocols and internal guidelines. The company offers a family-oriented culture and environment! Clinical Research Coordinator Responsibilities: Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out. Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Clinical Research Coordinator Qualifications: 1-2 years of related experience. Coordinator site experience (not pharma, CRO, or Lab research experience). Treatment trials experience. EPIC experience. Oncology experience. Shift: Monday to Friday from 8 am to 5 pm. (H)

About Us Catalyst Labs is a leading talent agency specializing in Tax, Tax Technology and Transfer Pricing. We stand out as an agency that is deeply embedded in our clients recruitment operations. We work directly with hiring managers such as Partners and Directors of Big 4/ Big 6 and Big 20, in-house Tax leaders such as CFOs and Head of Tax and startup founders in the Tax Tech ecosystem, who understand the value of strategic tax leadership, and we take pride in facilitating conversations that are aligned with your expertise and long-term goals. Our Client: A fast-growing technology company reshaping digital vehicle commerce based in New York that raised $17m in Funding. Their lightning-fast checkout platform has already driven tens of millions in revenue for over 20 major automotive partners who rely on their technology to power online sales. They support a diverse mix of publicly traded enterprises generating billions in annual GMV, rapidly scaling new entrants backed by significant venture funding, and an extensive network of dealerships. Location: New York Work type: Full time, Hybrid (In-person 4 days/week in NY) Overview The Tax & Compliance Research Specialist will be responsible for establishing and maintaining a comprehensive sales and use tax system for vehicle sales across all U.S. states. The role includes conducting tax research, managing compliance processes, and ensuring accurate reporting and remission. After establishing the tax framework, this position will support wider operational research projects, including DMV compliance and other regulatory initiatives, helping to build a strong compliance framework for the organization. Key Responsibilities Conduct ongoing research on sales and use tax requirements for vehicle sales across all 50 U.S. states. Develop, document, and manage full tax reporting and remission workflows. Assist with audits, reconciliations, and continuous process improvements. Keep thorough records to support filings, compliance checks, and future reviews. Contribute to broader operational research, including DMV regulations, compliance initiatives, and other regulatory topics. Qualifications Required Minimum 2 years of experience in tax compliance, tax accounting, or a similar field. Strong understanding of multi-state Sales and Use Tax processes and remission. Ability to research and interpret state tax statutes, rules, and regulatory requirements. Experience using tax technology platforms; Vertex experience is a major plus. Willingness to take initiative on non-tax projects, including DMV and regulatory research. Based in (or open to relocating to) New York City. Qualifications Preferred Background in automotive or vehicle-related tax compliance. Excellent communication skills with the ability to collaborate across finance, operations, and external teams. Proven ability to work independently in a fast-paced startup environment. Note: We adhere to strict data protection policies to ensure that your information is secure and only shared with potential employers with your explicit consent to ensure your confidentiality throughout the hiring process

**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.