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Clinical Research Coordinator Jobs in Escondido, CA

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Clinical Research Coordinator
Clinical Research Associate
Clinical Trial Manager
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Research Coordinator
Study Coordinator
  • Senior Clinical Trial Manager

    EPM Scientific 3.9company rating

    Clinical Research Coordinator Job 21 miles from Escondido

    San Diego Metropolitan Area Salary: $160,000-$180,000 A clinical-stage cell therapy company based in San Diego is expanding its clinical operations team. Focused on developing treatments for autoimmune diseases and hematological cancers, the company uses a unique approach to cell therapy, harnessing Natural Killer (NK) cells that target B cells. These NK cells are engineered as an "off-the-shelf" therapy, which means they're produced in advance rather than derived from a patient's own cells, making treatment more accessible and scalable. The team has been a pioneer in cell therapies, with one of the first IND filings for Lupus using cell therapy. Now advancing six indications-four in clinical stages-the company is working to streamline manufacturing and distribution to improve access to novel treatments. Their CEO brings over 20 years of experience in biotech and venture capital, including leadership roles in notable life sciences companies, while the CMO has an extensive background in clinical research from leading pharmaceutical firms. This role offers the opportunity to contribute to the ongoing development of therapies at the intersection of cell therapy and auto-immunology. Primary Responsibilities Support the Clinical Project Manager in planning and overseeing company-sponsored global clinical trials. Take the lead in reviewing work completed by members of the clinical development team. Lead or assist in revising study-related documents, such as informed consent forms, laboratory manuals, pharmacy manuals, case report forms (CRFs), and other tools essential for study execution. Provide assistance with site recruitment, initiation, payments, and close-out activities. Contribute to the training of new clinical site staff and offer additional training for protocol amendments. Coordinate with in-house teams to ensure timely collection of regulatory documents as required. Offer daily guidance to clinical sites, including interpretation of protocols and adherence to protocol safety standards. Lead or assist in training staff within the clinical development group. Work with the CPM to prepare and update trial progress reports for the Clinical Development team. Support the tracking and summarization of patient treatment, response, and survival data for ongoing studies. Perform other tasks as assigned. Qualifications Bachelor's degree with 7-10 years of experience in clinical research. Skills & Competencies Proficiency in MS Word, Excel, PowerPoint, and Outlook. Strong written and verbal communication skills, with excellent organizational and multitasking abilities. Understand and follow job-specific systems and processes as outlined in the company's SOPs, and seek clarification from a supervisor if any requirements are unclear. Consistently maintain corporate confidentiality.
    $160k-180k yearly 16h ago
  • Clinical Research Associate - Sponsor Dedicated

    Us Quintiles

    Clinical Research Coordinator Job 17 miles from Escondido

    Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications • Bachelor's Degree Degree in scientific discipline or health care preferred. • Equivalent combination of education, training and experience may be accepted in lieu of degree. • Some organizations require completion of CRA training program or prior monitoring experience. • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). • Good therapeutic and protocol knowledge as provided in company training. • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). • Written and verbal communication skills including good command of English language. • Organizational and problem-solving skills. • Effective time and financial management skills. • Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. **********************/eoe IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. **********************/covid-19-vaccine-status The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $71.9k-189k yearly 60d+ ago
  • Clinical Research Associate Manager

    Spyglass Pharma

    Clinical Research Coordinator Job 49 miles from Escondido

    At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them. We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn't just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen. This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials. Summary: We are seeking a Clinical Research Associate (CRA) Manager to join our team at SpyGlass Pharma. The CRA Manager is responsible for leading and managing a team of field-based Clinical Research Associates who monitor clinical trials at investigative sites. This position ensures that clinical trials are conducted in compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and applicable standard operating procedures (SOPs). The CRA Manager will oversee the planning, execution, and management of site monitoring activities to ensure data integrity and patient safety. Essential Duties & Responsibilities: Manage, mentor, and provide leadership to a team of field-based CRAs, fostering professional development and high-performance standards. Oversee site selection, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements. Develop and implement monitoring plans and strategies to optimize site performance and data quality. Collaborate with cross-functional teams, including Clinical Operations, Data Management, and Regulatory Affairs, to support clinical trial objectives. Ensure that CRAs are adequately trained on study protocols, SOPs, and regulatory requirements. Review monitoring reports and provide feedback to CRAs to ensure consistency and adherence to monitoring standards. Identify and resolve site-related issues and escalate as appropriate to senior management. Participate in the development and review of study documents, including protocols, case report forms, and informed consent forms. Contribute to the development and improvement of departmental processes and SOPs. Maintain up-to-date knowledge of GCP, FDA regulations, and industry best practices to ensure compliance. Qualifications Required For Position: Bachelor's degree in life sciences, healthcare, or a related field; advanced degree preferred. 10 years of clinical research experience in the pharmaceutical or medical device industry, with at least 2 years in a supervisory or managerial role overseeing field-based CRAs. (A commensurate combination of education and experience will be considered.) Strong knowledge of clinical trial monitoring practices, GCP, FDA regulations, and clinical trial management systems. Proven ability to lead, mentor, and develop a team of clinical professionals. Excellent verbal and written communication skills, with the ability to interact effectively with cross-functional teams and external partners. Strong organizational and problem-solving skills with keen attention to detail. Ability to travel up to 30-50% domestically as required. Proficiency in Microsoft Office Suite and experience with electronic data capture (EDC) systems. Why SpyGlass Pharma? We are offering a range of $150,000 - $175,000, based on experience and qualifications, along with an Annual Bonus opportunity. Share in our success with stock options, giving you a stake in the company's future. Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options. Generous paid time off, including holidays, vacation days, and personal leave. SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to *********************** and let us know the nature of your request and your contact information.
    $150k-175k yearly Easy Apply 60d+ ago
  • Clinical Research Associate

    USC University of Southern California

    Clinical Research Coordinator Job 21 miles from Escondido

    The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Act as main point of contact for assigned clinical sites. Thorough understanding of study protocol and manuals. Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. Participate in monitoring activities to achieve study milestones. Utilize internal and study specific software and tools. Assist in training new monitors on study specific or onsite procedures as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Experience in AD research is preferred. Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.91 - $51.94. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country's regulation pertaining to clinical trials and monitoring. USC is a smoke-free environment USC is an equal opportunity, affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC will con sider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. Read USC's Clery Act Annual Security Report Affirmative Action and Equal Opportunity Plan Pay Transparency Non-Discrimination USC is an E-Verify Employer Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************
    $42.9-51.9 hourly 60d+ ago
  • Clinical Research Associate (CRA)

    Adarx Pharmaceuticals

    Clinical Research Coordinator Job 21 miles from Escondido

    We are seeking a highly motivated and qualified individual to join our Clinical Department as an in-house CRA and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The in-house CRA (CRA) is responsible under supervision for supporting the administration and progress of clinical trial(s) on behalf of ADARx Pharmaceuticals. The CRA monitors the research procedures and ensures that research is always following the proper clinical trial protocol to obtain the correct data. The CRA also ensures that these processes are performed in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP). Essential Responsibilities: * Assist with the identification and set up of the trial sites; ensuring each site has the trial materials, including the investigational product. * Responsible for study start- up activities and tracking study metrics (e.g. feasibility data, * ICF review, regulatory document collection and review, and Trial Master File tracking). * Assure regulatory compliance of investigational sites with ADARx Pharmaceuticals SOPs, FDA regulations, and ICH guidelines. * Review and approve monitoring visit reports. * Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring. * Collect completed CRFs and other trial materials throughout and at the end of the study. * Maintain internal document management system and TMF ensuring important documents and communication filed timely and appropriately. * Assist and support data query process. * Verify internal data listings. * Generate reports or notes to files, and file/collate trial documentation and reports. * Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects. * Utilize clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS), including report generation. * Assist with preparing study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents. * Assist with coordination and be responsible for the design of study materials such as Case Report Forms (CRFs), patient diaries, study participation materials, and source documents. * Assist with protocol development and study report completion. * Assist with planning and participating in investigator meetings. * Assist with preparing training materials used to train site staff during the SIV and at other times to trial-specific industry standards. * May include monitoring the trial throughout its duration for specific tasks or activities. * Coordinate study supplies at all sites. * Assist with preparing final reports. * Archive study documentation and correspondence as appropriate. * Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience. * Establish and maintain excellent working relationships with critical collaborative partners throughout the company. * Maintain all corporate standards for lab safety and hazardous material management. * Other duties as assigned. Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: * BA/BS in a health-related field or ADN. * Minimum 4 years of relevant clinical research experience. * Clinical research related monitoring or study coordinator experience. * Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations. * Proficiency working with Microsoft Office Suite Products. * Ability to travel (domestic/international) if necessary. Preferred Qualifications: * Global clinical trial experience preferred. * Clinical research or life sciences degree preferred. Required Key Attributes: * Must be able to work independently with supervision as needed. * Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role. * Strong problem-solving skills and a proactive attitude towards exploring new approaches. * Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism. * Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment. Compensation: * This is a full-time position, Monday-Friday, occasional overtime. * Pay is commensurate with experience. * Equity-based compensation * Performance-based bonuses * 401(k) with Company Match * Medical, Dental, Vision * Flexible Spending Account * Life Insurance * Employee Assistance Program * Employee Discounts * Gym Membership * Paid Vacation * Paid Holidays * Paid Sick, Jury Duty, Bereavement Work Authorization: * United States (Required) * Background Check * As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the "Company" or "ADARx") located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: * The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. * Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. * The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law. * Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses. * Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.
    $63k-99k yearly est. 53d ago
  • Clinical Research Associate

    Galderma 4.7company rating

    Clinical Research Coordinator Job 17 miles from Escondido

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Job Title: Clinical Research Associate Job Location: Carlsbad Responsibilities: * Clinical trial design in partnership with Director of Clinical Research and the Clinical team. * Coordinate with other departments as necessary for meeting clinical trial and other R&D initiative timelines. * Ensure alignment with regulatory standards, including GCP, GMP, and all other applicable regulatory authorities and guidelines. * Assists with the development and approval of clinical trial documents. * Conduct scheduling, recruitment, pre-screening and enrollment activities for in-house clinical studies in a Clinical Research Coordinator capacity. * Ensure the effective execution of in-house clinical trials through maintaining accurate clinical supply inventory. * Coordination with clinical sites during study start up to ensure delegated staff trainings on devices, cameras, and other instruments for aesthetic studies in accordance with the study protocol. * Coordination with clinical sites in accordance with HIPAA and privacy laws to ensure appropriate storage and organization of raw data and images for all clinical studies. * Work with vendors to ensure timely calibration and maintenance of all Sponsor owned clinical devices and equipment and assist with the procurement of new devices, equipment and supportive materials. * Cross-functional collaboration, working closely with the formulations, operations, and marketing teams to ensure clinical materials align with company goals. * Build positive relationships with clinical trial investigators and their research team. * Coordinate and oversee other key research studies/activities as requested by the Director of Research. * Coordinate the delivery and logistics of clinical trial related materials in collaboration with the clinical team. * Ability to create compelling, results-driven clinical Before & After content for a range of channels including digital, print, and in-person marketing materials to help substantiate product claims. Requirements: * Bachelor's degree required, or equivalent education and with directly related years of experience. Master's degree preferred. * 3+ years of experience executing pharmaceutical or cosmeceutical clinical studies preferred, with knowledge of medical terminology. * Experience working with industry sponsored clinical trials. * Experience working in cosmetic and medical dermatology preferred. * Strong interpersonal and communication skills with ability to work independently, cross-functionally and as part of a team. * Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously. * Ability to maintain timelines and coordination of multiple clinical R&D projects to ensure timely execution. Must be able to work on multiple projects simultaneously. * Ability to problem solve and troubleshoot challenges in a timely manner. * General knowledge of current dermatological device systems, instruments, and products preferred. * Proficient in Microsoft Office (Word, Excel, Power Point) and Web presentation tools. * Ability to organize and prioritize tasks to maximize results, provide timely reports, and arrange meetings for the clinical team. * Ability to communicate effectively both verbally, and in writing. * Ability to create professional reports, presentations, and reporting. * Dedication and embodiment of our core values. * Must possess a valid driver's license. * 15% travel may be required. Physical Requirements: * Must be able to remain in a stationary position for long periods of time, and frequently stoop, bend, and kneel. * This position will also be required to drive to local clinical sites and coordinate sample pick-ups and drop-offs to the local lab in Carlsbad. * Requires preparing shipments to clinical trial sites, printing clinical study source and regulatory documents, preparing subject and regulatory binders, labeling IP and preparing ancillary supply kits. * Ability to lift up to 15 lbs.
    $60k-93k yearly est. 28d ago
  • Clinical Research Associate

    Alastin Skincare 3.8company rating

    Clinical Research Coordinator Job 17 miles from Escondido

    Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Job Title: Clinical Research Associate Job Location: Carlsbad Responsibilities: Clinical trial design in partnership with Director of Clinical Research and the Clinical team. Coordinate with other departments as necessary for meeting clinical trial and other R&D initiative timelines. Ensure alignment with regulatory standards, including GCP, GMP, and all other applicable regulatory authorities and guidelines. Assists with the development and approval of clinical trial documents. Conduct scheduling, recruitment, pre-screening and enrollment activities for in-house clinical studies in a Clinical Research Coordinator capacity. Ensure the effective execution of in-house clinical trials through maintaining accurate clinical supply inventory. Coordination with clinical sites during study start up to ensure delegated staff trainings on devices, cameras, and other instruments for aesthetic studies in accordance with the study protocol. Coordination with clinical sites in accordance with HIPAA and privacy laws to ensure appropriate storage and organization of raw data and images for all clinical studies. Work with vendors to ensure timely calibration and maintenance of all Sponsor owned clinical devices and equipment and assist with the procurement of new devices, equipment and supportive materials. Cross-functional collaboration, working closely with the formulations, operations, and marketing teams to ensure clinical materials align with company goals. Build positive relationships with clinical trial investigators and their research team. Coordinate and oversee other key research studies/activities as requested by the Director of Research. Coordinate the delivery and logistics of clinical trial related materials in collaboration with the clinical team. Ability to create compelling, results-driven clinical Before & After content for a range of channels including digital, print, and in-person marketing materials to help substantiate product claims. Requirements: Bachelor's degree required, or equivalent education and with directly related years of experience. Master's degree preferred. 3+ years of experience executing pharmaceutical or cosmeceutical clinical studies preferred, with knowledge of medical terminology. Experience working with industry sponsored clinical trials. Experience working in cosmetic and medical dermatology preferred. Strong interpersonal and communication skills with ability to work independently, cross-functionally and as part of a team. Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously. Ability to maintain timelines and coordination of multiple clinical R&D projects to ensure timely execution. Must be able to work on multiple projects simultaneously. Ability to problem solve and troubleshoot challenges in a timely manner. General knowledge of current dermatological device systems, instruments, and products preferred. Proficient in Microsoft Office (Word, Excel, Power Point) and Web presentation tools. Ability to organize and prioritize tasks to maximize results, provide timely reports, and arrange meetings for the clinical team. Ability to communicate effectively both verbally, and in writing. Ability to create professional reports, presentations, and reporting. Dedication and embodiment of our core values. Must possess a valid driver's license. 15% travel may be required. Physical Requirements: Must be able to remain in a stationary position for long periods of time, and frequently stoop, bend, and kneel. This position will also be required to drive to local clinical sites and coordinate sample pick-ups and drop-offs to the local lab in Carlsbad. Requires preparing shipments to clinical trial sites, printing clinical study source and regulatory documents, preparing subject and regulatory binders, labeling IP and preparing ancillary supply kits. Ability to lift up to 15 lbs.
    $63k-97k yearly est. 24d ago
  • Clinical Research Associate I

    Glaukos Corporation 4.9company rating

    Clinical Research Coordinator Job 38 miles from Escondido

    How will you make an impact? What will you do? The Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical Manager or Clinical Director. Study Master File Maintenance • Sets up Study Master File and Study Master File Tracker at the beginning of each study • Receives, QC's, scans and files documents in Study Master File • Provides status of documents to Clinical Management Collection of Site Start-Up Documents • Communicates directly with site staff to obtain site start-up documents • Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV) • Obtains site documents from Regional Clinical Research Associates during trial • Receives, QC's, scans and files site documents in Study Master File • Provides status of site documents in Study Master File to Regional Clinical Research Associates prior to Monitoring Visits Establishes and Maintains Tracking of Critical Trial Information • Team and site contact information • Site status information • Enrollment trackers • Adverse event trackers • Site payment trackers and site payments Team Support • Participates in clinical team meetings and may prepare minutes • May assist with meeting logistics, events and training, including Investigator Meetings • Scheduling meetings, set up of AV, teleconference or video conference equipment • Preparation of relevant materials • Support IP shipment and shipment of other materials to sites How will you get here? • 0-2 years' work experience with data entry, and clinical research industry within the ophthalmology field. • Familiarity with clinical trials study documentation • Accurate data entry experience • Excellent problem solving and analytical skills (ability to interpret and summarize data, perform statistics) • Excellent written and verbal communication and presentation skills • Motivated and able to work independently, as well as within a team • Excellent organizational skills • Medical terminology (and ophthalmology terminology) helpful • Exhibits personal integrity, credibility, and responsibility • Meets milestones and schedules • Collaborates with other team members and demonstrates good interpersonal skills • Demonstrates proficiency in study monitoring and auditing • Must be willing to travel up to 80% of the time (estimated) • Medical terminology (and ophthalmology terminology) helpful Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family. Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years! Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
    $68k-103k yearly est. 5d ago
  • Sr. Clinical Research Coordinator- Oncology (Oceanside, CA)*

    Profound Research

    Clinical Research Coordinator Job 16 miles from Escondido

    The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o Mission: Improving Lives by Providing Advanced Therapeutic Options o Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research. o Values: o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. o Solution Oriented: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. o Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Role: Senior Clinical Research Coordinator Company: Profound Research Locations: Oceanside, CA Role & Responsibilities: -Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements. -Create patient recruitment and study execution strategies are implemented so that timelines and recruitment expectations are met. -Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements & Skills: -BS/BA in Life Sciences or related discipline and 4 years as a Clinical Research Coordinator OR -Associate degree and 6+ years as a Clinical Research Coordinator OR -High School Graduate and/or technical degree and 8+ years as a Clinical Research Coordinator -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred. -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens. -Excellent attention to detail, organization, and communication with varied stakeholders. Physical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
    $59k-92k yearly est. 60d+ ago
  • Clinical Research Associate

    Usc 4.3company rating

    Clinical Research Coordinator Job 21 miles from Escondido

    The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Act as main point of contact for assigned clinical sites. Thorough understanding of study protocol and manuals. Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. Participate in monitoring activities to achieve study milestones. Utilize internal and study specific software and tools. Assist in training new monitors on study specific or onsite procedures as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Experience in AD research is preferred. Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.91 - $51.94. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country's regulation pertaining to clinical trials and monitoring. USC is a smoke-free environment USC is an equal opportunity, affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC will con sider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. Read USC's Clery Act Annual Security Report Affirmative Action and Equal Opportunity Plan Pay Transparency Non-Discrimination USC is an E-Verify Employer Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************
    $42.9-51.9 hourly 3d ago
  • Research Coordinator

    Oura

    Clinical Research Coordinator Job 21 miles from Escondido

    Oura is an award-winning and fast-growing startup that helps people track all stages of sleep and activity using the Oura Ring and connected app. By providing daily feedback and practical steps to inspire healthy lifestyles, we've helped over 2.5 million people improve their sleep, understand their bodies, and transform their health. Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work-both in and out of the office. We are looking for a Research Coordinator to join our Research Operations team. This team leads a variety of research studies, both internal and external, to develop new features and continue to enhance the accuracy of our algorithms. Our partnerships often lead to scientific publications and provide public validation of Oura's health sensing capabilities. You will help enable the hardware and human research studies that are the foundation for R&D activities at Oura. Through the work, you will develop an end-to-end understanding of the entire research project lifecycle, from protocol development through data analysis. What you will do: Contribute to two to five hardware and/or human research studies at a time, including data collection, protocol testing, regulatory processes, logistics, training, troubleshooting, data quality control, and budgets Provide frequent updates to internal and external stakeholders Become an expert on both the data collection capabilities of the Oura Ring, as well as any relevant reference devices and tools through first-hand testing Plan studies and design protocols with others on the hardware and science teams Write detailed standard operating procedure documentation Collaborate closely with a range of technical teams to ensure high quality data and documentation Pursue continual improvements to team processes and tools This is a US hybrid role based in our San Diego office. We are looking for candidates that are available to work onsite at least three days per week. Requirements We would love to have you on our team if you have any of the following, but don't worry too much if you don't fill all the requirements: Minimum one year of experience in either hardware testing or human studies research in academic, commercial, or clinical settings (e.g. consent, IRB approval, and data flows) Strong track record of delivering high-quality datasets with meticulous documentation Experience in working with both internal and external collaborators A problem-solving mindset and ability to troubleshoot research challenges. Willingness to work flexible hours for site visits or global team calls (including Finland time zones) We also appreciate if you have familiarity with the following: SQL or Python Regulated clinical trials Wearable devices or remote patient monitoring Multi-modal and sensor data Benefits At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health. What we offer: Competitive salary and equity packages Health, dental, vision insurance, and mental health resources An Oura Ring of your own plus employee discounts for friends & family 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off Paid sick leave and parental leave Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future. San Diego Base Compensation Range:$66,000 - $82,000 Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We've been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note: Our jobs are listed only on the ŌURA Careers page and trusted job boards. We will never ask for personal information like ID or payment for equipment upfront. Official offers are sent through Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.
    $66k-82k yearly 9d ago
  • Lab Research Study Coordinator - 134419

    University of California System 4.6company rating

    Clinical Research Coordinator Job 21 miles from Escondido

    Payroll Title: SRA 2 NEX Department: Cardiothoracic Surgery Lab Hiring Pay Scale $28.88 - $46.46 / Hour Worksite: La Jolla Appointment Type: Career Appointment Percent: 75% Union: RX Contract Total Openings: 1 Work Schedule: Days, 8 Hour Shifts, Monday-Friday #134419 Lab Research Study Coordinator Filing Deadline: Tue 2/25/2025 Apply Now UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply. UCSD Layoff from Career Appointment: Apply by 2/13/2025 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Special Selection Applicants: Apply by 2/25/2025. Eligible Special Selection clients should contact their Disability Counselor for assistance. DESCRIPTION The Department of Surgery is one of the largest departments in the School of Medicine and is comprised of 102 full time faculty members, 220 voluntary faculty members, 20 physicians employed on MSP agreements, 25 doctors employed by the VA or other facilities, 77 accredited and 13 non-accredited trainees and 100 career staff. Activities are organized in 13 sub-specialty divisions. Annual expenditures across the Department total over $66.5M with a global research portfolio of over $19M. The missions of research, education and patient care are intertwined, and are integral to the goals of the department. As a leader in research and patient care, the UC San Diego Department of Surgery is committed to providing the latest in expert and compassionate treatment, performing leading-edge research, and training the next generation of top plastic surgeons. UC San Diego Health is currently ranked among America's best hospitals by U.S. News & World Report. Under supervision of the Principal Investigator (PI), incumbent perform research in an NIH-funded Cardiothoracic Surgery Research Laboratory. Duties include, but are not limited to, performing a variety of basic laboratory procedures, involving mouse developmental biology, genotyping by PCR, animal care, special feeding, and drug administration via oral gavage and intravenous, animal testing, and performing surgical procedures in small species; collecting tissue samples, cardiac, retro-orbital and tail blood draw; processing tissue samples for immunohistochemical analyses; cell culture; confocal microscopy; tissue culturing; protein analysis, Western Blotting, Northen Blotting; RNA analysis; and DNA analysis. Additionally, assist with laboratory maintenance duties include tracking and maintaining appropriate laboratory inventory, ordering supplies, tracking and maintaining appropriate certifications and laboratory employees, preparing and submitting research proposals, serving as liaison between regulatory entities and the PI, etc. MINIMUM QUALIFICATIONS * Advanced theoretical knowledge and/or Bachelor's Degree in medicine, molecular biology, cancer biology, cell biology and histology and/or work experience. * Demonstrated strong experience and knowledge in coordinating major mouse experiments, such as planning injection and drug treatment dosing schedule. * Strong demonstrated experience using laboratory equipment such as centrifuges, spectrophotometers, balances, pH meters, autoclaves and electrophoresis equipment. * Strong demonstrated experience performing DNA and protein characterization techniques using electrophoretic analysis. * Demonstrated experience with protein biochemistry techniques; including quantification, ELISA assays, SDS PAGE, Western and Immunoblotting, phosphorylations and gel electrophoresis. * Demonstrated experience performing sterile eukaryotic cell culture techniques, PCR and agarose gel electrophoresis. * Demonstrated experience performing multi-parametric flow cytometry and cell sorting. * Demonstrated experience in sectioning of paraffin embedded and frozen tissues with microtome and crytome equipment. * Demonstrated experience using histological and immunohistochemical techniques to evaluate protein localization in fixed cells or tissues. * Demonstrated experience performing light, fluorescence and confocal microscopy techniques to visualize protein expression in tissue sections. * Detail-oriented. Demonstrated ability to follow verbal and/or written instructions, including follow-up on previously begun procedures. Demonstrated accurate record data and enter into appropriate medium. * Demonstrated experience in proper handling of chemical and biohazard materials. Demonstrated experience with sterile techniques. * Demonstrated experience to adhere to established UCSD guidelines for safety and environmental issues. * Experience with computer software such as Excel and Prism to analyze data, store results and compute raw data. * Demonstrated experience of computer applications such as Word, Excel and Powerpoint. Internet search and software analysis capabilities. Must be fluent in diverse operative systems, including Microsoft Windows and MAC OS. Adobe skills required, including Photoshop, Acrobat, Fireworks, and Illustrator, as well as mastering of Word, Power Point, Excel and GraphPad Prism, Sigma Plot and SSPS statistical software. * Demonstrated experience handling and working with small animals, including demonstrated experience conducting mouse surgeries, experiments, and injections. Knowledge in conducting euthanization of small animals. * Strong communication skills (both verbal and written) needed to interact professionally and effectively in the work environment, as well as to effectively and accurately document research procedures. Demonstrated ability to read, comprehend and discuss research materials. * Demonstrated experience ordering and maintaining lab equipment and supplies. * Experience in troubleshooting problems for quality control on every immunochemical and histochemical procedures. SPECIAL CONDITIONS * Employment is subject to a criminal background check. * Must be willing to work occasional overtime, weekends and holidays. * Must be willing to work night shifts. * Must be willing and able to work safely with hazardous materials. * Must be willing to work with animal models. Pay Transparency Act Annual Full Pay Range: $60,301 - $97,008 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $28.88 - $46.46 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). Apply Now If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community. UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the University of California's Affirmative Action Policy please visit: ******************************************* For the University of California's Anti-Discrimination Policy, please visit: ******************************************************* UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening. Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer. a. "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment, discrimination, dishonesty, or unethical conduct, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct: * UC Sexual Violence and Sexual Harassment Policy * UC Anti-Discrimination Policy * Abusive Conduct in the Workplace
    $60.3k-97k yearly 3d ago
  • Clinical Research Associate

    University of Southern California 4.1company rating

    Clinical Research Coordinator Job 21 miles from Escondido

    The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: * Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. * Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. * Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. * Act as main point of contact for assigned clinical sites. * Thorough understanding of study protocol and manuals. * Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. * Participate in monitoring activities to achieve study milestones. * Utilize internal and study specific software and tools. * Assist in training new monitors on study specific or onsite procedures as needed. * Participate in sponsor, internal, and regulatory audits as needed. * Participate in eTMF filing efforts as needed. * Experience in AD research is preferred. * Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.91 - $51.94. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country's regulation pertaining to clinical trials and monitoring. USC is a smoke-free environment USC is an equal opportunity, affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. * Read USC's Clery Act Annual Security Report * Affirmative Action and Equal Opportunity Plan * Pay Transparency Non-Discrimination * USC is an E-Verify Employer * Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************
    $42.9-51.9 hourly 60d+ ago
  • Clinical Research Coordinator I

    Camris International 4.6company rating

    Clinical Research Coordinator Job 21 miles from Escondido

    We are seeking a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. OID conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Note: This position is based onsite at NHRC in San Diego, CA. Responsibilities Primary Responsibilities Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines. Help lead recruitment efforts, developing and refining strategies to meet enrollment targets. Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria. Manage and coordinate complex clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study. Study Protocol Design and Oversight: Interprets study protocols, assesses feasibility, and modifies procedures to align with the objectives of clinical trials. Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures. Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS). Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings. Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines. Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager. Regulatory Management Assists with Institutional Review Board (IRB) submissions and protocol amendments. Collaborate with principal investigators and sponsors and provide insights based on field experience. Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities. Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system. Compliance and Monitoring Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle. Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise. Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes. Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies. Regulatory Responsibilities Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements. Ensures all study-related documents are appropriately filed and accessible for audits. Manages study registrations and updates in the Clinical Trial Management System and eIRB system. Other Responsibilities May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel. Remote and On-Site Study Leadership: Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel. Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site. Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety. Qualifications A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of clinical research experience. Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems. Strong organizational, communication, and problem-solving skills. Ability to work both independently and collaboratively in a research setting. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred Certification in clinical research (such as CCRC or CCRP). Experience with infectious disease studies or military health research. Please submit your resume online at ************** . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package to support your health, well-being, and financial security. Our offerings include medical, dental, and vision insurance, FSAs and HSA, life and disability coverage, retirement plans with employer match, tuition reimbursement, public transportation support in the DMV area, and generous paid time off. Additional benefits include legal services, pet insurance, and an employee referral bonus program. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required. Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education, and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully complete any required background check questionnaire during initial onboarding.
    $51k-65k yearly est. 60d+ ago
  • Clinical Research Coordinator in Okinawa, Japan

    Arcetyp LLC

    Clinical Research Coordinator Job 21 miles from Escondido

    Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We are recruiting to fill a position to lead business development activities for a small government contracting firm focused on IT Services and Cyber Security for clients in Civil and DoD markets. We can't sponsor H1B. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. Arcetyp LLC is looking for an experienced Clinical Research Coordinator. This role will be responsible for performing the following tasks: DUTIES AND RESPONSIBILITIES: Coordinates and participates in clinical research studies by performing a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Coordinates and implements procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Assists in the determination of guidelines for the collection of clinical data or administration of clinical studies. EDUCATION AND YEARS OF EXPERIENCE: Bachelor's Degree from an accredited college or university and a minimum experience of 2 years as a Clinical Research Coordinator within the past five years OR current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), OR Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) OR the Society of Clinical Research Associates (SoCRA). Minimum of 2 to 4 years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience. QUALIFICATIONS: Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge. Ability to communicate effectively, both orally and in writing. Possess effective organizational and analytical skills with ability to work independently and in a team environment. Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program. Candidate must possess active/current secret security clearance. Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date Min. Citizenship Status Required: U.S Citizenship. Physical Requirement(s): None Location: Okinawa, Japan COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.
    $48k-70k yearly est. 60d+ ago
  • Clinical Research Coordinator

    Headlands Research

    Clinical Research Coordinator Job 21 miles from Escondido

    Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinical research trials. Together with Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for Clinical Research! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees: * A range of PPO and HMO medical plans * PPO and HMO dental plans * Vision coverage, long term disability plan, and life/AD&D coverage * 401k plan * Paid holidays and paid time off * A welcoming work environment We're looking for a bright, talented new team member to be a part of our story. Check out this current opening and if you think you may be a fit for the role, please apply. The Role Artemis is looking for a Clinical Research Coordinator for the San Diego office. Under the supervision of the Site Director, the Clinical Research Coordinator I is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Clinical Research Coordinator I manages study conduct from planning through study closeout. Position Type: Full Time Pay Range: $27 - $30/hr Location: San Diego-no remote work Travel: 0% Work Schedule: Monday & Thursday - 8:30am-5pm / Tuesday, Wednesday, and Friday 7:00am-3:30 pm Responsibilities * In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality * Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending Investigator Meetings * Providing the highest level of care for study patients and delivering excellent customer service to the Pharmaceutical clients * Assist with lab draws, processing and shipping Qualifications * Bachelor's Degree preferred * Minimum two years of experience as a Clinical Research Coordinator required * Medical assistant or phlebotomist required * Commitment and ability to deliver excellent customer service * Excellent communication, punctual and responsible * Extremely well organized * Excellent verbal and written communication skills * Trustworthy, reliable; attentive to details * Mature and pleasant demeanor * Willingness to learn new tasks and grow with the company
    $27-30 hourly 25d ago
  • Clinical Research Associate

    USC University of Southern California

    Clinical Research Coordinator Job 21 miles from Escondido

    The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Act as main point of contact for assigned clinical sites. Thorough understanding of study protocol and manuals. Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. Participate in monitoring activities to achieve study milestones. Utilize internal and study specific software and tools. Assist in training new monitors on study specific or onsite procedures as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Experience in AD research is preferred. Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.91 - $51.94. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country's regulation pertaining to clinical trials and monitoring. USC is a smoke-free environment USC is an equal opportunity, affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC will con sider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. Read USC's Clery Act Annual Security Report Affirmative Action and Equal Opportunity Plan Pay Transparency Non-Discrimination USC is an E-Verify Employer Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************
    $42.9-51.9 hourly 60d+ ago
  • Clinical Research Associate (CRA)

    Adarx Pharmaceuticals Inc.

    Clinical Research Coordinator Job 21 miles from Escondido

    We are seeking a highly motivated and qualified individual to join our Clinical Department as an in-house CRA and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The in-house CRA (CRA) is responsible under supervision for supporting the administration and progress of clinical trial(s) on behalf of ADARx Pharmaceuticals. The CRA monitors the research procedures and ensures that research is always following the proper clinical trial protocol to obtain the correct data. The CRA also ensures that these processes are performed in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP). Essential Responsibilities: Assist with the identification and set up of the trial sites; ensuring each site has the trial materials, including the investigational product. Responsible for study start- up activities and tracking study metrics (e.g. feasibility data, ICF review, regulatory document collection and review, and Trial Master File tracking). Assure regulatory compliance of investigational sites with ADARx Pharmaceuticals SOPs, FDA regulations, and ICH guidelines. Review and approve monitoring visit reports. Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring. Collect completed CRFs and other trial materials throughout and at the end of the study. Maintain internal document management system and TMF ensuring important documents and communication filed timely and appropriately. Assist and support data query process. Verify internal data listings. Generate reports or notes to files, and file/collate trial documentation and reports. Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects. Utilize clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS), including report generation. Assist with preparing study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents. Assist with coordination and be responsible for the design of study materials such as Case Report Forms (CRFs), patient diaries, study participation materials, and source documents. Assist with protocol development and study report completion. Assist with planning and participating in investigator meetings. Assist with preparing training materials used to train site staff during the SIV and at other times to trial-specific industry standards. May include monitoring the trial throughout its duration for specific tasks or activities. Coordinate study supplies at all sites. Assist with preparing final reports. Archive study documentation and correspondence as appropriate. Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience. Establish and maintain excellent working relationships with critical collaborative partners throughout the company. Maintain all corporate standards for lab safety and hazardous material management. Other duties as assigned. Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications : BA/BS in a health-related field or ADN. Minimum 4 years of relevant clinical research experience. Clinical research related monitoring or study coordinator experience. Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations. Proficiency working with Microsoft Office Suite Products. Ability to travel (domestic/international) if necessary. Preferred Qualifications: Global clinical trial experience preferred. Clinical research or life sciences degree preferred. Required Key Attributes: Must be able to work independently with supervision as needed. Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role. Strong problem-solving skills and a proactive attitude towards exploring new approaches. Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism. Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment. Compensation: This is a full-time position, Monday-Friday, occasional overtime. Pay is commensurate with experience. Equity-based compensation Performance-based bonuses 401(k) with Company Match Medical, Dental, Vision Flexible Spending Account Life Insurance Employee Assistance Program Employee Discounts Gym Membership Paid Vacation Paid Holidays Paid Sick, Jury Duty, Bereavement Work Authorization: United States (Required) Background Check As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law. Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses. Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.
    $63k-99k yearly est. 16d ago
  • Clinical Research Coordinator I

    Camris 4.6company rating

    Clinical Research Coordinator Job 21 miles from Escondido

    We are seeking a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. OID conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Note: This position is based onsite at NHRC in San Diego, CA. Responsibilities Primary Responsibilities Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines. Help lead recruitment efforts, developing and refining strategies to meet enrollment targets. Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria. Manage and coordinate complex clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study. Study Protocol Design and Oversight: Interprets study protocols, assesses feasibility, and modifies procedures to align with the objectives of clinical trials. Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures. Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS). Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings. Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines. Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager. Regulatory Management Assists with Institutional Review Board (IRB) submissions and protocol amendments. Collaborate with principal investigators and sponsors and provide insights based on field experience. Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities. Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system. Compliance and Monitoring Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle. Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise. Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes. Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies. Regulatory Responsibilities Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements. Ensures all study-related documents are appropriately filed and accessible for audits. Manages study registrations and updates in the Clinical Trial Management System and eIRB system. Other Responsibilities May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel. Remote and On-Site Study Leadership: Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel. Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site. Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety. Qualifications Required A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of clinical research experience. Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems. Strong organizational, communication, and problem-solving skills. Ability to work both independently and collaboratively in a research setting. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred Certification in clinical research (such as CCRC or CCRP). Experience with infectious disease studies or military health research. Please submit your resume online at ************** . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package to support your health, well-being, and financial security. Our offerings include medical, dental, and vision insurance, FSAs and HSA, life and disability coverage, retirement plans with employer match, tuition reimbursement, public transportation support in the DMV area, and generous paid time off. Additional benefits include legal services, pet insurance, and an employee referral bonus program. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required. Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education, and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully complete any required background check questionnaire during initial onboarding.
    $51k-65k yearly est. 13d ago
  • Clinical Research Coordinator

    Headlandsresearch

    Clinical Research Coordinator Job 21 miles from Escondido

    Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinical research trials. Together with Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for Clinical Research! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees: A range of PPO and HMO medical plans PPO and HMO dental plans Vision coverage, long term disability plan, and life/AD&D coverage 401k plan Paid holidays and paid time off A welcoming work environment We're looking for a bright, talented new team member to be a part of our story. Check out this current opening and if you think you may be a fit for the role, please apply. The Role Artemis is looking for a Clinical Research Coordinator for the San Diego office. Under the supervision of the Site Director, the Clinical Research Coordinator I is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Clinical Research Coordinator I manages study conduct from planning through study closeout. Position Type: Full Time Pay Range : $27 - $30/hr Location: San Diego-no remote work Travel: 0% Work Schedule: Monday & Thursday - 8:30am-5pm / Tuesday, Wednesday, and Friday 7:00am-3:30 pm Responsibilities In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending Investigator Meetings Providing the highest level of care for study patients and delivering excellent customer service to the Pharmaceutical clients Assist with lab draws, processing and shipping Qualifications Bachelor's Degree preferred Minimum two years of experience as a Clinical Research Coordinator required Medical assistant or phlebotomist required Commitment and ability to deliver excellent customer service Excellent communication, punctual and responsible Extremely well organized Excellent verbal and written communication skills Trustworthy, reliable; attentive to details Mature and pleasant demeanor Willingness to learn new tasks and grow with the company
    $27-30 hourly 18d ago

Learn More About Clinical Research Coordinator Jobs

How much does a Clinical Research Coordinator earn in Escondido, CA?

The average clinical research coordinator in Escondido, CA earns between $40,000 and $84,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average Clinical Research Coordinator Salary In Escondido, CA

$58,000
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