Clinical research coordinator jobs in Fairfield, CA

Senior Clinical Research Coordinator Full-Time - Day Shift Advance the Future of Clinical Research Are you passionate about clinical research and ready to take your expertise to the next level? At University Health, we're seeking a Senior Clinical Research Coordinator to lead and support high-impact studies that shape the future of patient care. This is a unique opportunity to bring your clinical insight and research experience to a role that supports innovation, compliance, and excellence in human subject research. What You'll Do As a Senior Clinical Research Coordinator , you'll play a vital leadership role in the coordination and review of complex human subject research protocols. You will: Evaluate and provide expert clinical and risk assessment on research protocols and procedures Assist the Director with implementing a robust Human Subjects Protection Program Serve as a departmental representative to internal and external research committees, including IRB and OHRP Coordinate, monitor, and educate staff on best practices in research compliance and study execution Support grant applications, budgeting, and program planning across diverse research initiatives What We're Looking For Education & Experience: Required: Bachelor's of Science in Nursing (BSN) from an accredited institution Minimum 3 years of clinical research experience Working knowledge of research methods and federal regulations for human subject research Must possess or qualify to obtain CCRP or CCRA certification within 6 months of hire Core Competencies: Strong leadership and judgment in confidential, regulatory, and ethical matters Ability to navigate complex research protocols with a sharp eye for detail Confident representing the department in multi-institutional settings Excellent communication, planning, and coordination skills Why Join Us? At University Health, you'll be part of a team that is passionate about research, innovation, and improving patient outcomes. We offer: A dynamic, collaborative, and mission-driven environment Opportunities to lead and influence policy at the institutional and national levels A commitment to professional development and clinical research excellence The chance to make a real impact on groundbreaking studies and healthcare transformation Ready to Elevate Clinical Research? Bring your skills, passion, and vision to a team that's shaping the future of healthcare research. Apply today to become our Senior Clinical Research Coordinator.

Piper Companies is currently seeking an Oncology Clinical Research Associate (CRA) for an opportunity in Sacramento, California (CA). The Oncology Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Oncology Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Oncology Clinical Research Associate: * 2-4 years performing on-site monitoring and hands on experience with EDC Systems * Experience with Oncology is highly advantageous * Organization to perform monitoring duties across multiple sites is a must Compensation for the Oncology Clinical Research Associate: * Salary Range: $100,000-$120,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1

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

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 and 401K

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

+ 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.

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

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!

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

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.

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

**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.

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

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

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 + 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.

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

Irvine Clinical Research is the largest independent clinical trial group on the West Coast. Most of our research is in neurology (Alzheimer's Disease treatment and prevention studies); we also conduct trials in psychiatry and obesity medicine. In this role, we are seeking CRCs with proven trial experience. Ideally, candidates will have worked as a primary coordinator on a high-enrolling and/or highly complex drug trial and produced quality work.Job Duties Manage daily operations for assigned clinical trial projects Perform study procedures in accordance with GCP and study protocols Organize and maintain paper and electronic study data in a complete and correct manner Cultivate enthusiastic and professional relationships with patients and sponsors alike Work closely with recruitment and prescreening teams to meet study enrollment goals Conduct diagnostic, efficacy, and safety assessments as needed Job Requirements Two (2) or more years of clinical research coordinator experience Attention to detail and the ability to handle multiple tasks with precision Demonstrated ability to work accurately and quickly with CTMS A command of professional spoken and written English