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Clinical research coordinator jobs in San Marcos, CA

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Clinical Research Coordinator
Clinical Research Associate
Clinical Trial Manager
Study Coordinator
Clinical Research Administrator
Clinical Scientist
Clinical Study Manager
Research Compliance Specialist
Clinical Research Manager
Clinical Coordinator
Research Coordinator
Senior Clinical Research Associate
  • Clinical Research Coordinator

    SQRL

    Clinical research coordinator job in Murrieta, CA

    Highlights $70,000 - $79,000 annual salary based on experience Great benefits including 401k w/match and 15 days PTO Consistent schedule, no overnights or weekends Work with cutting edge oncology research trials About Our Client Our client is a fast growing site network that currently has over 30 sites and constantly expanding! They focus on diversity in their trials including therapeutic areas: oncology, cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. Their sites conduct studies spanning Phases I-IV and they've been awarded for excellence in recruitment and recognized in the industry for retention, a best-in-class experience for patients and sponsors. Responsibilities As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process! Conduct procedures such as vital signs, blood draws, EKGs, and scans. Patient recruitment, enrollment, scheduling, and consent Lab procedures and shipments Maintain GCP and follow protocols Data management in EDC systems Overall coordination of the study from start up to close out Focus on oncology based research studies Qualifications: 2+ years of experience working as a CRC on sponsor backed clinical trials Phlebotomy and lab processing experience (ability to perform without supervision) Ability to work on site M-F on site (there is no remote or hybrid days) Experience working with Oncology clinical trials
    $70k-79k yearly 4d ago
  • Clinical Research Associate

    Kumquat Biosciences 3.9company rating

    Clinical research coordinator job in San Diego, CA

    We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team at Kumquat Biosciences. As a CRA, you will play a key role in the coordination and execution of global oncology clinical trials. You will be responsible for ensuring that these trials are conducted in compliance with regulatory guidelines and company protocols. Key Responsibilities: · Support the study lead(s) in day-to-day operational management of one or more clinical trials. · Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements. · May manage one or more key study vendors including central lab, IRT/RTSM, or CRO. · Monitor and track study progress, patient recruitment, and data collection at investigational sites. · Review and verify the accuracy, completeness, and quality of clinical trial data. · Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files. · Collaborate with investigators, study coordinators, and other site staff to provide guidance and support. · Identify and escalate any issues or deviations from the study plan to the appropriate parties. · Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions. · Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. Requirements · Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience. · 2+ years of clinical operations experience or related drug development. · Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research. · Excellent organizational and time-management skills. · Strong communication and interpersonal skills. · Ability to work independently and as part of a cross-functional team. · Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems. · Willingness to travel to investigational sites as required. · Familiarity with early phase clinical trial protocols and procedures a plus. · Prior vendor management experience a plus. Salary Description: $93k - $124k Yearly Salary Description $93k - $124k
    $93k-124k yearly 10d ago
  • Clinical Research Associate - West Coast (California)

    Icon Clinical Research

    Clinical research coordinator job in San Diego, CA

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field. + Minimum of 12 months onsite monitoring experience as a Clinical Research Associate; level (CRA I, CRA II, or Senior CRA) determined by total years of experience. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 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 let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply
    $63k-99k yearly est. 53d ago
  • Clinical/Scientific

    Vtekis Consulting LLP

    Clinical research coordinator job in San Diego, CA

    VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don't consider the process complete until we find the perfect fit. Job Description Education: BS or equivalent in relevant discipline with a minimum of 4 years of relevant industry experience or Master's degree in relevant discipline with a minimum of 1 year of relevant industry experience Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role Experience in developing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays Significant experience in an FDA-regulated environment Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic Excellent organizational and communication skills Experience with JMP statistical software a plus. Representative responsibilities will include, but not necessarily be limited to, the following: Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy protein chemistry assays, and molecular biology assays for process monitoring and drug product release, such as HPLC, ELISA, CE-SDS, western immunoassay, droplet digital PCR or qPCR, culture of primary mammalian cells, and cell‑based potency assays. Collaborate with research, analytical and process development teams to determine critical quality attributes (CQAs), monitor process and method performance, and troubleshoot Develop timelines, protocols and reports for assay transfers, qualifications / validations. Contribute to establishing material specifications for drug substance and drug products Author and review QC analytical SOPs, protocols, and reports Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures. Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated Software Use Expectations: Utilize the LIMS system to submit samples, enter data, and track samples. Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria. Learn and become proficient in all laboratory instrument software to conduct testing. Skills: Insmed is seeking a QC Scientist with broad knowledge and expertise in chemical/biochemical assays and molecular biology assays as applied to AAV gene therapy products. The QC Scientist will be involved method development and/or method transfer. The QC Scientist will author and execute phase appropriate qualification/validation protocols and reports of QC methods to support product release and stability. The role will perform analysis on characterization, lot release and stability samples for clinical phase Insmed AAV Gene Therapy products. Regards, Mohammed ilyas, PH - ************ or text - ************ or you can share the updated resume at Mohammed@vtekis. com Additional Information All your information will be kept confidential according to EEO guidelines.
    $117k-155k yearly est. 5h ago
  • Clinical Trial Manager

    Janux Therapeutics

    Clinical research coordinator job in San Diego, CA

    Job DescriptionThe Clinical Trial Manager will play a pivotal role in the strategic implementation and execution of clinical trials from study start-up to close-out. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs. Ensure inspection readiness by maintaining comprehensive study documentation and files. Organize and lead study and departmental meetings, including minute-taking and document archiving. Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings). Ensure team compliance with study-specific training and perform TMF reviews for completeness. Support clinical sites in audit and inspection preparation. Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements. Monitor subject and site activity/metrics and perform quality checks across study components. Proactively identify, troubleshoot, and escalate issues impacting deliverables. Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation. Collaborate with CROs to ensure timely collection and archiving of TMF documents. Partner with regulatory affairs on essential document submissions. Support study close-out activities including TMF and drug reconciliation and CSR readiness. Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads. Participate in process improvement and quality initiatives related to study execution. Other duties as deemed necessary. REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES Bachelor's degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered. Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out. Global clinical trial management experience, especially in the EU, highly desirable. Strong working knowledge of ICH/GCP regulations. Proficiency with electronic systems such as eTMF, CTMS, EDC, etc. Ability to work independently and thrive in a collaborative team environment. Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset. Excellent interpersonal, written, and verbal communication skills. Proficiency in MS Office and comfort with technology. Minimal travel required (0 to 5%). In addition to a competitive base salary ranging from $134,000 to $153,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-time Benefits:· 401K· Medical insurance· Dental insurance· Vision insurance· Supplemental disability insurance plans· Flexible schedule· Life insurance· Flexible vacation· Sick time· Incentive stock option plan· Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $134k-153k yearly 13d ago
  • Clinical Study Manager

    Modular Medical Inc. 4.2company rating

    Clinical research coordinator job in San Diego, CA

    At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn't have to be a tech expert or a math genius to take charge of your health. Please note: This is an on-site position based in San Diego, CA with up to 50% travel. This role is not eligible for relocation assistance. The Clinical Study Manager's responsibilities include, but may not be limited to the following: Role and Responsibilities: Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables are completed on time and within budget Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents. Develop clinical study reports for submission to regulatory authorities. Oversee and review deliverables produced by study team members to ensure quality and compliance. Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work. Ensure that studies comply with MMI policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations. Develop and implement standardized processes and operating procedures for conducting clinical research. Create and maintain clinical study documents as part of the trial master file (TMF). Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants. Conduct on-site clinical monitoring activities as needed. Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States). Support the submission of FDA Investigational Device Exemption (IDE) applications, including drafting clinical protocols, investigator brochures, and IDE summary reports. Maintain and update the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in accordance with EU MDR, ensuring integration of clinical data, risk-benefit analysis, and PMS findings. Design and execute Post-Market Clinical Follow-up (PMCF) activities, including studies, surveys, and literature reviews, to support ongoing safety and performance of Modular Medical products. All other duties as assigned Education and Experience: BA/BS degree in Health or Life Sciences required, advanced degree preferred. Five (5) or more years of experience in Clinical Research. Three (3) or more years of experience managing medical device and/or combination products clinical research studies. Experience in the diabetes industry preferred. Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies Skills Preferred: Strong analytical and problem-solving skills, including the ability to conduct risk assessments and develop risk management plans. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies. The ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded. Ability to handle multiple tasks while ensuring timely and accurate completion Clinical Research certifications from ACRP or SOCRA preferred. Physical Requirements: • Ability to sit or stand for extended periods of time • Ability to lift and/or move up to 35 pounds
    $72k-114k yearly est. Auto-Apply 60d+ ago
  • Senior Clinical Trial Manager

    Mycareer

    Clinical research coordinator job in San Diego, CA

    Senior Clinical Trial Manager Employment Type: Full-time About the Company A clinical-stage biopharmaceutical company in San Diego is advancing first- and best-in-class therapies targeting metabolic, endocrine, and rare diseases. With multiple programs entering critical development stages, the organization is poised for significant breakthroughs and is seeking an experienced Senior Clinical Trial Manager to help lead pivotal early-phase programs. Position Overview The Senior Clinical Trial Manager will be responsible for overseeing all operational aspects of assigned Phase 1-2+ clinical trials from initiation to closeout. This individual will serve as the primary operational lead, ensuring that studies are executed on time, within budget, and in compliance with regulatory and quality standards. This role offers the opportunity to work in a dynamic, science-driven environment where your contributions will have a direct impact on advancing therapies for patients in need. Key Responsibilities Lead the planning, execution, and completion of Phase 1-2+ clinical trials. Oversee and manage CROs, vendors, budgets, contracts, and timelines. Ensure operational excellence and compliance with GCP, regulatory guidelines, and company SOPs. Collaborate cross-functionally with clinical, regulatory, medical, and project management teams. Anticipate and resolve study-related issues to maintain trial quality and integrity. Prepare and present trial updates, progress reports, and key metrics to leadership. Contribute to strategic decision-making to support program goals and development milestones. RequirementsQualifications Bachelor's degree in life sciences or related field (advanced degree preferred). 5+ years of clinical trial management experience in biotech, pharmaceutical, or CRO settings. Proven track record overseeing early-phase (Phase 1-2+) clinical trials. Strong vendor and CRO management experience. Excellent organizational, communication, and leadership skills. Ability to thrive in a fast-paced, collaborative biotech environment. Knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements. n. BenefitsWhat's Offered Competitive compensation package. Opportunity to work on innovative therapies with a meaningful patient impact. Collaborative and supportive work culture. Direct involvement in high-impact decision-making within a growing biotech organizatio
    $87k-139k yearly est. 60d+ ago
  • Senior Clinical Research Associate (level dependent on experience)

    CTI Clinical Trial Services 3.7company rating

    Clinical research coordinator job in San Diego, CA

    Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
    $80k-123k yearly est. 60d+ ago
  • Clinical Research Manager

    Orso Health

    Clinical research coordinator job in San Diego, CA

    Job Description Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standards of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team. Position Summary We are seeking an experienced Clinical Research Site Manager to lead operations across multiple clinical research sites, with primary responsibility for our La Jolla, CA location. This role provides leadership to Clinical Research Coordinators at more than one site and ensures consistent, high-quality, compliant execution of clinical studies. The Site Manager will oversee staff development, operational efficiency, regulatory compliance, and data quality, while ensuring data integrity and high standards of research conduct across all assigned sites. This position requires travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is an exempt, full-time role, working standard business hours with flexibility for early or late visits as needed for study conduct. 40 hours per week, Monday through Friday, onsite in our La Jolla Clinic. Key Responsibilities Multi-Site Leadership & Operational Oversight: Provide operational leadership and management across multiple clinical research sites, ensuring consistency in workflow, quality, and compliance. Hire, onboard, train, and evaluate Clinical Research Coordinators and support staff across sites. Monitor staffing levels and coordinate resource allocation across all active trials and locations. Oversee day-to-day clinical operations, visit scheduling, and subject care across sites. Ensure research staff at all locations follow protocols, SOPs, GCP, and institutional policies. Maintain and document training standards across all assigned sites. Contribute to patient recruitment and retention strategies across the site network. Foster a culture of teamwork, accountability and "Quality Without Compromise" Protocol Compliance & Site Execution: Supervise the implementation and adherence to study protocols across multiple sites. Ensure timely and accurate source documentation and data entry at each location. Ensure all sites meet electronic regulatory requirements and maintain audit-ready regulatory documentation. Support internal and external audits across all assigned research sites. Data Quality, Monitoring, & Documentation: Monitor data quality across locations to ensure accuracy, completeness, consistency, and data integrity. Conduct remote or onsite monitoring visits at various sites to review source documents, CRFs, and regulatory materials. Maintain data integrity and research conduct through ongoing oversight and timely resolution of data discrepancies. Coordinate and support external monitoring visits across locations, including preparation, communication, and follow-up. Document monitoring activities in compliance with SOPs, GCP, and ICH guidelines. Implement and support quality assurance initiatives that enhance operational consistency and research conduct across all sites. Regulatory, Audit, & Quality Assurance Support: Assist in audit preparation and regulatory inspections across multiple sites. Maintain compliant regulatory files and electronic systems for each assigned location. Identify operational or documentation gaps across sites and support corrective and preventive action plans. Perform additional responsibilities as needed to support multi-site clinical operations. Skills & Qualifications Education: Bachelor's degree in life sciences, healthcare, or related field. Experience: Minimum of 5 years of experience in clinical research, preferably involving multi-site management, monitoring, or data oversight. Prior supervisory or team leadership experience strongly preferred. Strong working knowledge of FDA regulations, ICH-GCP, and clinical trial operations Skills & Abilities: Strong understanding of GCP, ICH guidelines, and end-to-end clinical trial operations across multiple sites. Excellent attention to detail and organizational skills, particularly in multi-site environments. Strong communication skills to effectively support and coordinate cross-site teams. Proficiency with CTMS, EDC platforms, electronic regulatory systems, and Microsoft Office Suite. Analytical mindset with strong problem-solving capabilities. Ability to manage priorities effectively across multiple locations. Commitment to quality, data integrity, ethical research conduct, and regulatory compliance. Core Values and Culture: The Clinical Research Manager is expected to embody our organization's commitment to integrity, quality, collaboration, and continuous improvement. We value leaders who promote teamwork, foster innovation, and ensure excellence in research execution. Compensation The annual salary range for this position is $85k - $105k. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience. Physical Requirements Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable. What We Offer Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network) An opportunity to play an active role in medical advancement If this role excites you, please submit your resume and a cover letter outlining your relevant experience and why you're passionate about joining our team. We look forward to hearing from enthusiastic candidates ready to drive our success! California Consumer Privacy Act (CCPA) Notice Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.
    $85k-105k yearly 25d ago
  • Undergraduate Studies Coordinator

    Details

    Clinical research coordinator job in San Diego, CA

    Title & Department: Undergraduate Studies Coordinator; College of Arts and Sciences Posting # 5231 Department Description: As the liberal arts heart of the University of San Diego, the College of Arts and Sciences is filled with students who are versatile and multi-talented. No matter their major, graduates from the college are equipped with transferable skills that benefit them wherever their professional and personal ambitions lead. Founded in 1949, the college has a rich history of providing the core curriculum for every undergraduate USD student, a tradition that continues today. By offering 32 majors, 38 minors, one certificate and three graduate programs, the college is where undergraduate students begin and graduate students refine their paths towards academic excellence and personal achievement. University Description: The University of San Diego, an engaged and contemporary Catholic institution, was founded by the Diocese of San Diego and the Society of the Sacred Heart in 1949. Governed by an independent board of trustees since 1972, USD remains committed to a liberal arts education grounded in the Catholic intellectual tradition and the pursuit of truth, goodness and beauty. Inspired by this centuries old tradition of Catholic higher education, the University welcomes people of all faith traditions and any, or no, religious background. The future success of USD relies on the contributions of those who seek to foster the development of engaged global citizens and an earnest confrontation of humanity's urgent challenges. Detailed Description: Performs detailed, complex coordination, and administrative tasks for the College of Arts and Sciences Dean's Office. Assists the Associate Dean and Assistant Deans of Undergraduate Studies in all aspects. Is responsible for coordination, communication, and marketing activities and events for Learning Communities and Undergraduate Studies. Liaises with other offices on campus to program. Collaborates with the Undergraduate Studies Learning Communities teams to support faculty, students, and staff in the Living Learning (LLC) and Transfer Learning Communities (TLC) programs. Duties and Responsibilities: Undergraduate Studies Coordination: Coordinates, with the Associate Dean, academic onboarding for incoming students in fall and spring. Coordinates and attends meetings with campus partners for first-year and transfer processes throughout the entire year. To support first year experiences for students, coordinates LLC course and housing placements, with Residential Life. Maintains and updates new student advising questionnaires for academic onboarding. Communicates with faculty advisors and professional advisors in the undergraduate units throughout the first-year scheduling process. Creates and maintains manuals for faculty for summer scheduling and LLC advising. Implements plans faculty development training and other events co-sponsored by Undergraduate Studies and Learning Communities offices. Supports Associate Dean with faculty applications and tracking compensation for LC courses and Faculty Integration Coordinators. Supports Associate Dean administratively with curricular and enrollment management, including Census tracking and LC courses. Oversees the input of data from Learning Community Surveys into Qualtrics. Undergraduate Student Support: Maintains the official university database for AP/IB/CLEP scores, including updating tables and websites. Coordinates and administers official notifications to students in mail merges, including highly confidential letters such as disqualification, academic notice / probation, reinstatement, readmittance, and academic integrity letters. Coordinates hearings for grade grievances and academic integrity in collaboration with the Special Assistant to the Associate Dean. Maintains the College's online database (i.e., Maxient) for Academic Integrity. Surveys faculty for the last date of class student attendance for tuition refunds, Faculty Alert Outreach (FAO), wellness-checks, and general academic support. Events and Communication: Plans, implements, and attends Undergraduate Studies, College of Arts and Sciences, and College Academic District events connected to the mission in collaboration with the Associate Dean and Assistant Deans. Schedules meeting for the Associate Dean and Assistant Deans, as needed. Supports the Associate Dean and the Creative Manager who organize the annual New Student Convocation. Administrative Support: Manages communication with other campus and community partners on campus with collaborative efforts in Undergraduate Studies from Advisors, Assistant, and Associate Deans. Review and manage incoming emails from students and forwards to appropriate partner. Coordinates communication efforts for the College Dean's Office. Supports the College of Arts and Sciences Dean's Office, the College Academic District, and the Learning Communities Office as needed. In collaboration with the Dean's office executive assistant, supports the reception process and front desk staffing, as needed. Supervises the training of work study students so that they are familiar with Department, University and the College Dean's Office policies and procedures. Performs other duties as assigned. Special Conditions of Employment: Background check: Successful completion of a pre-employment background check. Degree Verification Requirement: Persons offered employment in this position will be required to provide official education transcripts for degree verification purposes. Job Requirements: Minimum Qualifications: Bachelor's Degree and two years of office work experience OR High School Diploma and four years of office work experience required Above experience must include one year of experience in general office coordination and/or event planning. Preferred Qualifications: Advanced computer skills in Microsoft Office (all applications), website maintenance, and Salesforce preferred. Performance Expectations - Knowledge, Skills and Abilities: Take responsibility for dealing appropriately with problems, exercising independent judgment, and making decisions while engaging with diverse personalities and demographics. Implement skills for organizing and managing concurrent projects, prioritizing workload, and meeting tight deadlines. Excellent professional written, verbal, proofreading, and communication skills. Develop and use empathetic listening skills, communicate with clarity and maintain an attitude that conveys respect, assistance, honesty and resourcefulness. Cooperate as a team to support the mission of Undergraduate Studies and the College of Arts and Sciences Dean's Office. Demonstrate flexibility and versatility to respond to evolving work situations. Establish and maintain strong working relationships with colleagues, staff, administrators, students, and the general public. Knowledge of and ability to learn multiple software platforms--SalesForce, Cascade, Banner, Excel, project management software, MySanDiego portal, Qualtrics, Maxient. Thorough knowledge of general office practices and procedures. Posting Salary: $26.00 - $33.00 per hour; Excellent Benefits The University of San Diego offers a very competitive benefits package including; medical, dental, vision, a retirement contribution given to you by the University, and access to on-campus Fitness Centers. Please visit the benefits section of our website to view all of the perks and benefits that USD has to offer. USD: Human Resources: Benefits The salary range provided in this posting reflects what we reasonably expect to pay for this position. Actual compensation offered or earned is dependent on experience, education and other factors including departmental budget. Special Application Instructions: Resume Required, Cover Letter Preferred Click the 'Apply Now' button to complete our online application and, for full consideration, please upload a resume to your application profile for the hiring managers' review. You are also strongly recommended to upload a cover letter to your application profile for the hiring managers' review. If you have any questions or difficulties please contact the Employment Services Team at *****************. Additional Details: Hours: 37.5 hours per week Closing date: Open until filled Note: External job postings will be up for at least three days. After that time, applications will be reviewed by the hiring manager/committee throughout the posting period. A candidate may be selected at any time which could then close this posting on a date earlier than listed. The University of San Diego is a smoking and tobacco-free campus. For more information, visit ***************************
    $26-33 hourly Easy Apply 60d+ ago
  • Clinical Research Program Administrator - Alzheimer's Clinical Trials Consortium-Down Syndrome (ACTC-DS)

    Usc 4.3company rating

    Clinical research coordinator job in San Diego, CA

    The Program Administrator will provide comprehensive administrative and programmatic support for the Alzheimer's Clinical Trials Consortium-Down Syndrome (ACTC-DS), working closely with Dr. Michael Rafii, MD, PhD, Director of ACTC-DS. This role requires in-depth knowledge of Down syndrome and/or Alzheimer's disease, clinical trial operations, human subjects research, grant writing, and community recruitment and outreach. The ideal candidate will coordinate multiple aspects of the program to ensure smooth execution of clinical trials and effective communication among stakeholders and liaise with pharma and biotech partners. Key Responsibilities: Assist Dr. Rafii and the leadership team in the administration and coordination of ACTC-DS clinical trials and related research activities. Support grant proposal development, including drafting, budget preparation, and submission tracking.. Coordinate recruitment strategies and outreach initiatives to engage individuals with Down syndrome and their families for participation in clinical trials. Manage communication and collaboration across multiple trial sites, investigators, community partners, and advocacy organizations. Track project timelines, milestones, deliverables, and budgets to ensure adherence to grant and institutional requirements. Organize and or travel to meetings, workshops, and conferences related to ACTC-DS activities. Prepare reports, presentations, and correspondence for internal and external stakeholders. Maintain comprehensive documentation, databases, and records related to clinical trial operations and participant engagement. Reporting Structure: Reports directly to Dr. Michael Rafii and collaborates closely with the ACTC-DS leadership team. Application Instructions: Please submit a cover letter, resume/CV. Will require no less than three references. The annual base salary range for this position is $96,215.67 - $137,753.37. 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. Required Qualifications: - Bachelor's degree in Psychology, Life Sciences, Public Health, or related field; advanced degree preferred. - Demonstrated knowledge of Down syndrome and/or Alzheimer's disease clinical research. - Experience in clinical trial administration or coordination, preferably within neurodegenerative disease research. - Familiarity with human subjects protection, IRB processes, and regulatory requirements. - Strong skills in community outreach and participant recruitment, particularly with populations affected by developmental disabilities. - Excellent organizational, project management, and multitasking abilities. - Strong interpersonal and communication skills, with ability to engage diverse stakeholders. - Proficiency with standard office software and research management tools. Preferred Qualifications: - Experience working in a multi-site clinical trial consortium or network. - Understanding of data management and clinical trial software platforms. - Knowledge of NIH and other major funding agency processes. USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. 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. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment 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: *************************************************************
    $96.2k-137.8k yearly Auto-Apply 59d ago
  • Study Moderator

    LXT

    Clinical research coordinator job in San Diego, CA

    LXT is an emerging leader in AI training data to power intelligent technology for global organizations. In partnership with an international network of contributors, LXT collects and annotates data across multiple modalities with the speed, scale, and agility required by the enterprise. Our global expertise spans over 145 countries and more than 1,000 language locales. Founded in 2010, LXT is headquartered in Toronto, Canada with a presence in the United States, UK, Egypt, India, Turkey, and Australia. The company serves customers in North America, Europe, Asia Pacific, and the Middle East. We are seeking experienced moderators to support a large-scale, on-site user research study in San Diego (near UTC Mall). Moderators will guide participants through defined technical protocols, manage equipment setup and data collection, and ensure study compliance across all sessions. This role requires attention to detail, professionalism, and comfort with technology in general and working closely with the research leads and participants to ensure smooth study execution, and participant engagement. Key responsibilities & duties: Conduct on-site participant sessions following strict research protocols. Set up, verify, and troubleshoot data capture equipment prior to and during sessions. Interact with participants in a professional and supportive manner Set up, use, and troubleshoot project-specific software and hardware Monitor correct execution of study procedures and participant gestures per instructions. Handle device offloads and confirms successful data recording and metadata tagging. Log collection details accurately and manage session documentation in real time. Maintain neutral tone and non-leading communication throughout sessions. Communicate effectively with the Project Manager and Study Lead to escalate technical or participant issues. Qualifications: Minimum 2 years of experience moderating technical or human-factors research studies. Proven ability to follow structured procedures with no deviation. Familiarity with hardware setup, troubleshooting, or lab environments preferred. Excellent interpersonal and communication skills - able to keep participants comfortable and engaged. Strong observation and documentation skills. Able to work on-site full-time in a secure environment (no remote option). Comfortable standing or moving between stages for extended periods. Must be available to work on-site full-time in San Diego (near UTC Mall). Preferred Qualifications Background in usability testing, HCI, psychology, or human-factors research. Experience working with motion capture, gesture studies, or device-based testing. Technical proficiency with recording equipment, tablets, or cameras. Project Details: Engagement Type: Hired through an Employer of Record (EOR) arrangement Target Start Date: Jan 5th (not negotiable) Duration: 4 weeks (through January 30, 2026) Location: On-site in San Diego (near UTC Mall) Additional information: LXT is an equal opportunity employer and ensures that no applicant is subject to less favorable treatment on the grounds of gender, gender identity, marital status, race, color, nationality, ethnicity, age, sexual orientation, socio-economic, responsibilities for dependents, or physical or mental disability. Any hiring decision is made on the basis of skills, qualifications, and experiences. We measure our success as a business, not only by delivering great products and services and continually increasing our assets under administration and market share but also by how we positively impact people, society, and the planet.
    $45k-65k yearly est. 2d ago
  • Cardiovascular Clinical Research Coordinator (RN or LVN)

    San Diego Cardiac Center Medical Group

    Clinical research coordinator job in San Diego, CA

    The position of Cardiovascular Clinical Research Coordinator facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. Responsibilities Include: Promotes the ethical conduct of research. Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Schedules research subject appointments and serves as the patient liaison to the PI and other participating physicians. Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections. Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process. Coordinates and attends (SIV) site initiation visits, monitor visits, study termination visits. Completes case report forms in timely manner. Extracts data from research subject charts in a timely manner. Coordinates the completion of all protocol required forms by the investigator during study visits. Responds to data clarification requests in a timely manner. May attend investigator meetings in person or remote and report pertinent information back to research team members. Coordinates with investigators to help ensure that clinical research and related activities are performed in accordance with Federal regulations, sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around tasks related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training. Maintains weekly subject screening logs. Promptly report protocol deviations to sponsor/regulatory coordinator(s). Assess whether protocol deviations meet IRB requirements for promptly reportable information with regulatory coordinator(s). Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB's, Regulatory agencies, CRO's and sponsors. Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations. Cooperates with sponsor on compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. Properly documents study visit tasks in the form of a research note. Ensures that all materials for each clinical trial protocol are available for subject enrollment. Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data. Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. Establishes and organizes study files, study specific source documentation and other materials as required. Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, sponsors, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures. Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer. May perform other job-related duties as requested or required. Ability to perform intramuscular injections, venipuncture, peripheral intravenous lines, collect biological specimens and administer medications via all routes. Use of standard patient care equipment such as 12-lead ECG, pulse oximeter, blood pressure monitor, thermometer, IV pumps, & centrifuge. Knowledge of medications, indications, dosage ranges, side effects, and potential toxicity. Job Type: Full-time Salary: $37.00 - $45.00 per hour Benefits: 401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance Schedule: 8-hour shift Monday to Friday Education: Active State of California Nursing License (RN) or Active State of California Licensed Vocation Nurse (LVN) (Required) Associate or Bachelor degree (Required) License must be free from any disciplinary actions. Experience: Two years' experience in a clinical research setting (preferred), working as a coordinator on Industry-Sponsored clinical trials. Cardiac Research experience is preferred, but not a requirement. Six months or more of active nursing experience. Cardiac Nursing experience is preferred, but not a requirement. Annual TB/Immunization Clearance required for Hospital Badge. Documentation of current, negative TB (Tuberculosis) Test within past three months OR documentation of negative chest x-ray within six months (if individual has a positive history). Badge Immunization Requirements include the following. Proof of Influenza Immunization during Flu Season (November - March) and/or declination form. Proof of two doses for the following Immunizations: Measles, Mumps, Rubella and Varicella (OR) positive titers. Proof of Tdap Immunization given within the last ten years. Proof of at least one dose of any COVID-19 immunization series. GCP (Good Clinical Practice) Certification within the last two years (preferred). If the certificate is not current, testing will be performed after hire before participation on any study protocol can occur. IATA Dangerous Goods Certificate within last two years (preferred). If the certificate is not current, testing will be performed after hire before participation in any study protocols with laboratory testing can occur. Primary Work Location: Kearny Mesa Office & Sharp Memorial Hospital
    $37-45 hourly 28d ago
  • Research Coordinator

    The Geneva Foundation 4.4company rating

    Clinical research coordinator job in San Diego, CA

    About The Project: The Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) Program delivers high value research, education, training, and infrastructure for over 60 clinically relevant musculoskeletal injury (MSKI) studies within the military health system (MHS). MIRROR supports a broad scope of projects, including epidemiological investigation, investigator initiated pilots, and prospective randomized multisite clinical trials. Areas of clinical evaluation comprise general MSKI care process models and highly prevalent anatomically-specific (e.g. back, knee, shoulder pain, etc.) targeted interventions with protocols examining effective return-to-duty activities. This role will support a variety of protocols in the MIRROR Program, including projects aiming to track patients enrolled into the Military Orthopedics Tracking Injuries and Outcomes Network (MOTION) system. MOTION is an official DHA program of record that captures patient reported outcome measures (PROMs) as part of the patient's standard of care. MOTION is supported and administered by MIRROR infrastructure. About The Position: The Research Coordinator provides assistance to the Principal Investigator and Study Team coordinating research activities that may include recruiting research participants, data collection and management, and other research activities as assigned. The Research Coordinator will also assist with report generation and project close-out support. PLEASE NOTE: Applicants MUST be located within commutable distance to the Naval Medical Center San Diego area and can work for any employer in the US without future sponsorship. Salary: $55k- $65k/annually. Salaries are determined based on several factors including external market data, internal equity, and the candidate's related knowledge, skills, and abilities for the position. Responsibilities Promote safety and confidentiality of research participants at all times Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control procedures Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives Document all correspondence and communication pertinent to the research Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization Qualifications Bachelor's degree or equivalent work experience required 2-4 years' experience in clinical research preferred 2-4 years' non-profit, research, or healthcare experience desired Demonstrate competence in oral and written communication Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software Knowledge of CFR, GCP and ICH guidelines
    $55k-65k yearly Auto-Apply 51d ago
  • Clinical Research Coordinator 1

    MPF Federal

    Clinical research coordinator job in San Diego, CA

    MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by coordinating and managing clinical research studies. The OID Directorate 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. Compensation: $68,000-$71,000 annually 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. Requirements Required Qualifications: · A BA/BS in biological sciences, public health, or equivalent OR 5 plus years of clinical research experience. · Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. · Willingness to obtain a phlebotomy certificate in accordance with the other duties. · 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. · Ability to wear a N95 mask (or similar) if/when required. Preferred: · Certification in clinical research (such as CCRC or CCRP). · Experience with infectious disease studies or military health research. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19, and proof of vaccination may be required. Benefits MPF Federal is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status or on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.
    $68k-71k yearly Auto-Apply 60d+ ago
  • Clinical Research Coordinator Onsite in Okinawa, Japan

    Arcetyp LLC

    Clinical research coordinator job in San Diego, CA

    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 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 a Clinical Research Coordinator. This position is onsite and located in Okinawa, Japan. 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. 27d ago
  • Clinical Research Coordinator I

    Headlands Research

    Clinical research coordinator job in San Diego, CA

    At 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. 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 - $32/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 Duties/Responsibilities In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality Support Clinical Research Coordinator II (CRCs)/Sr. CRCs in 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 supporting monitoring visits. 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 one to two (1-2) 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
    $27-32 hourly Auto-Apply 21d ago
  • Clinical Research Coordinator

    Flourish Research

    Clinical research coordinator job in Murrieta, CA

    Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Clinical Research Coordinators at our Murrieta site location. This is one of our three oncology research sites in the Greater Los Angeles area. These locations are formerly Valkyrie Clinical Trials - we are proud to welcome Valkyrie Clinical Trials to the Flourish Research network! The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends) Location: 25405 Hancock Ave, Suite 110, Murrieta, CA 92562 Compensation: $72,000 - $79,000 ($34.60 - $37.98/hr) Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES Execute protocol-specified patient visits and procedures, which may include, but not limited to, phlebotomy, IVs, injections, vital signs, ECG/EKG, etc. Document assessments and study data per regs/GCP; maintain complete source; accurately complete CRFs/eCRFs. Obtain informed consent per federal regs, GCP, and IRB requirements. Ethically recruit qualified subjects to meet enrollment timelines. Complete required/ongoing training; attend investigator meetings/courses; stay current with changing regulations and Flourish policies. Schedule and conduct visits per protocol timelines. Protect confidentiality per HIPAA and all confidentiality agreements. Report AEs promptly; report SAEs to sponsor within 24 hours and notify PI/Sub-I/supervisor. Account for and ensure availability of trial materials (study drug, labs, CRFs, supplies). Maintain and document communication with Leads, Managers, PIs/Sub-Is, and study team per protocol and policy. Perform duties safely, and in a time-/cost-effective manner compliant with Flourish policies. Represent Flourish professionally in all interactions. Additional duties as assigned by management. QUALIFICATIONS Bachelor's degree preferred, but not required Must have oncology clinical research experience Minimum of two years of clinical research experience Clinical skills highly preferred: vital signs, EKG/ECG, phlebotomy, and injections Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
    $72k-79k yearly Auto-Apply 28d ago
  • Clinical Research Compliance Specialist

    Alliance Clinical LLC

    Clinical research coordinator job in San Diego, CA

    Monday - Friday / On-Site / San Diego, CA COMPANY OVERVIEW: At Alliance Clinical Network we're people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day. Summary: The Clinical Research Compliance Specialist supports clinical research studies by monitoring protocol and regulatory compliance, reviewing research data for accuracy, managing documentation and milestones, auditing essential documents, writing monitoring reports, and developing risk monitoring plans and study-related documents. Essential Duties and Responsibilities: Conduct SOP/GCP/Compliance Training with coordinators at site. Ensure sites are adhering to ACN' s policies and procedures. Perform on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity. Ensure valid findings from the audit/inspection report are managed effectively by the organization, and in accordance with our procedures. Escalate significant findings to CTNx Management. Coach and Support CRCs and PIs on a continuous basis based upon audit findings. Monitor the protocol and regulatory compliance of clinical research studies (with low -to high-risk research designs) in multiple treatment areas. Review research data from source documentation for accuracy, completeness, and timeliness. Collaborate with the offshore compliance team and the onsite study team to effectively address critical findings. Strictly adhere to confidentiality and compliance standards. Collect, review, maintain, and audit essential documents Assist with developing documents and implementing study-specific risk monitoring plans. Support ongoing communication with study teams regarding trial qualification, initiation, monitoring, remote monitoring, and close-out activities. Serves as the main point of contact in compliance audits and interim monitoring visits. Read and comprehend new research protocols as well as amended protocols. Meet assigned targets, goals, and completion deadlines. Utilize analytical, problem-solving, and critical thinking. Utilize precise attention to detail. Perform other duties as assigned to meet the goals and objectives of the department and institution Comply with all company policies, procedures, and conduct. Qualification Requirements: To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions. Education and Experience: An associate degree in healthcare or a related field is preferred. At least two (2) years of clinical research experience as a Clinical Research Coordinator (CRC) or one (1) year of experience as a Clinical Research Associate (CRA) is required. Proficient in Microsoft Word, Excel and Adobe Acrobat. Working knowledge of medical and/or clinical trial terminology. Working knowledge in relevant scientific fields. Strong attention to detail. Must be able to prioritize competing demands. Must possess excellent verbal and written communication skills. A proven ability to multi-task in a rapidly changing environment. Special Skills, Knowledge, and Abilities: Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes. Adapts quickly to changing priorities to perform as needed in his/her role. Remains calm when faced with changes to (and in) his/her work. Effectively relays understanding of diverse perspectives. Can handle communication upwards and downwards as needed. Presents information in a clear, well-thought-out way and tailored to the audience. Shows support for the new direction even when the details have not been finalized. Spots early indications of underperformance and takes corrective actions. Celebrates successes. Works with partners inside his/her function to find the best solutions that align with functional priorities. Is easy to work with to find solutions. Supports the creation/implementation of data management plans by understanding site/study data sourcing techniques and overall compilation. Independently assists data management tasks/processes in line with study-related data plans. Identifies and resolves data queries and requirements based on knowledge of the origin, flow, and management of data through a clinical study. Ensures compliance with SOPs related to data quality within assigned studies. Contributes to study management and research procedures by consistently executing assigned tasks in compliance with GCP guidelines, with minimal supervision Applies understanding of clinical study/site operations to address requirements (e.g., study selection and set-up, clinical monitoring, risk mitigation support). Shows awareness of basic safety, ethical, and HPP considerations, and regulatory requirements in terms of documentation and study conduct. Assists in the development of relevant technical, study, and/or regulatory materials to ensure compliance with regulatory, safety, & ethical requirements. Certificates, Licenses, Registrations: Maintain GCP certification and other on-the-job certifications as required. Travel Required: 5-10% Physical Demands and Working Conditions: The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, sit, kneel, use hands to finger, handle, or feel, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. This job requires Specific vision abilities, including close vision, depth perception, and the ability to adjust focus. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. An essential function of the job is to be able to comply with all applicable federal, state and local safety and health regulations that would apply to this job. The employee must move about the workspace to access work surface and shelves, cabinets, drawers, and equipment that are at, below or above the work surface. Nothing in this limits management's right to assign or reassign duties and responsibilities to this job at any time as business needs dictate. This job description reflects management's assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned. The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor is it intended to be an all-inclusive list of the skills and abilities required to do the job. While every attempt has been made to outline the basic job responsibilities, adjustments in the process may change and expand the job duties. In addition, employees may be asked to perform duties outside of this description at the discretion of the Executive Management Team. BENEFITS: 401 (k) Retirement Plan Medical, Dental, and Vision Insurance Paid Time Off (PTO) Floating Holidays And more!
    $50k-69k yearly est. 21d ago
  • Surgical Technology Clinical Coordinator- North-West College/San Diego

    Success Education Colleges

    Clinical research coordinator job in San Diego, CA

    Job Details San Diego - San Diego, CA $65000.00 - $83000.00 Salary/year Description ESSENTIAL DUTIES AND RESPONSIBLITIES · Ensures that students are performing at appropriate academic level and following policy and procedures. · Arranges for each instructor's hours at the healthcare facility according to the number of students under his/her supervision · Assigns and schedules students for their clinical and externship experience · Assigns students according to healthcare facility needs. · Prepares clinical/externship advisement packets containing documents for the healthcare facility and give to the student's' clinical instructor. · Ensures that all documents (before, during and after clinical experience) are safeguarded and maintained for a minimum of five (5) years in compliance with current programmatic accreditation. · Conducts orientation for students eligible to begin the clinical experience portion of the program. · Instructs students on the organization, maintenance, and care of clinical documentation. · Discusses general and specific rules of academic standing and attendance requirements at the affiliate sites. · Instructs students on current HIPAA and PHI regulations, administer written test on the subject, document results, and maintain related paperwork. · Assists the Program Director in orienting new instructors and staff · Substitutes for instructors as needed. · Performs all other duties as assigned. Qualifications KNOWLEDGE AND SKILLS · Thorough knowledge of the Surgical Technology and Central Service Technician programs and affiliate sites requirements, faculty and students obligations, and relevant clinical documents. · Interacts effectively and professionally with students, staff, faculty, and external customers of the College including Advisory Board members, clinical sites and externship and other off-campus sites. · Exceptional customer focused skills. Ability to address student needs and resolve issues with diplomacy and tact. Commitment to the success of the students and the school. · Interpersonal skills including questioning, listening and showing concern and respect for others. · Solid writing skills to communicate effectively in memos, letters, and via email. · Highly organized and detail oriented. · Excellent verbal communication skills including ability to project voice and be clearly understood when speaking in front of a group. · Ability to maintain confidentiality. · Possess a high degree of integrity and commitment to comply with policies, regulations, and codes of conduct governing all aspects of job responsibilities EDUCATION AND EXPERIENCE · Requires a credential in the field of Surgical Technology that is through a national credentialing organization accredited by the National Commission on Certifying Agencies (NCCA). · Requires a minimum of three (3) years of operating room experience or teaching in the field, or a combination of the two, within five years prior to hire date
    $65k-83k yearly 60d+ ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in San Marcos, CA?

The average clinical research coordinator in San Marcos, 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 San Marcos, CA

$58,000
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