Clinical research associate jobs in Santee, 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

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

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. * Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team * Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials * Ensures consistency across studies and provide oversight of all clinical studies within assigned area * May serve as a Clinical Trial Lead or Co-Lead as needed * May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities * Serves as a key cross functional collaborator; initial point of escalation cross functions Key Responsibilities * Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical development and lifecycle planning * Lead implementation of assigned clinical development and/or lifecycle plans * Maintain an advanced understanding of all protocols within assigned Program * Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members * Represent Clinical Science Team on the Program Team as appropriate/requested * Support resourcing and budget planning activities for team * Review and present data and information to external investigators and internal stakeholders as needed * Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice * Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management * Author/Review abstracts/publications * Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as: * Evaluation of innovative trial designs * Protocol and ICF development * Site-facing activities * CRA training materials * Data quality activities; ensure consistent, quality data review across trial teams * Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities * Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Qualifications & Experience * Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) Experience Requirements: * 5+ years of experience in clinical science, clinical research, or equivalent * Experience in driving, managing and collaborating in a team/matrix work environment * Recognized internally and externally as a Therapeutic Area and Functional expert * Preferred experience in Neuroscience and/or Psychiatric Key Competency Requirements: * Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations * Ability to plan and manage * Advanced ability to analyze, interpret, and present data * Advanced knowledge and skills to support program specific data review, trend identification, data interpretation * Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements * Advanced medical writing and presentation skills * Ability to self-supervise, and act independently to identify/resolve program level issues * Proficient critical thinking, problem solving, decision making skills * Effective planning and time management * Advanced verbal, written and interpersonal skills (communication skills) * Adaptable and analytical * Strong presentation skills / leadership presence * Commitment to Quality * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism * Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) * Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools * Travel Required * Domestic and International travel may be required. Travel Required * Domestic and International travel may be required. The starting compensation for this job is a range from $182,000-$257,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #li-hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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.

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

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

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

The 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%). 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.

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: *************************************************************

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.

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 ***************************

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.

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

MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC). Compensation: $68,000-$71,000 annually Primary Responsibilities Patient Recruitment and Consent: Identifies, 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 biosurveillance. Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifying 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. Performs other duties as assigned. Requirements Required A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of infectious disease Biosurveillance experience. Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems. Strong organizational, communication, and problem-solving skills. Ability to work both independently and collaboratively in a research setting. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred Certification in clinical research (such as CCRC or CCRP). Experience with infectious disease studies or military health research. 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.

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.

Job Description We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures. Key Responsibilities: Coordinate day-to-day clinical research activities to ensure study protocols are followed. Recruit, screen, and enroll study participants. Obtain informed consent and ensure ethical conduct in all study interactions. Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples). Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs). Maintain accurate and timely documentation in case report forms and electronic databases. Communicate with sponsors, monitors, and IRBs regarding study progress and compliance. Schedule participant visits and follow-ups; ensure visit windows are met. Ensure proper storage, handling, and accountability of investigational products, if applicable. Maintain regulatory documents and assist with IRB submissions. Qualifications: Bachelor's degree in a health-related field or equivalent experience. At least 1-2 years of experience in clinical research preferred. Phlebotomy certification or MA certification preferred. Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Excellent organizational skills and attention to detail. Strong interpersonal and communication skills. Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms). Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications: Experience working in clinical trials, especially in a hospital or academic setting. Familiarity with IRB processes and clinical trial documentation. Bilingual skills (depending on patient population) may be a plus. Job Type: Full-time Work Location: In person Schedule: 8 hour shift Monday to Friday Weekends as needed

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

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role: Leads and manages the operational activities to support planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Manages studies using Contract Research Organizations (CROs) as well as managing internally run studies. _ Your Contributions (include, but are not limited to): Ensures clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies Serves as primary point of contact for clinical operations aspects of assigned clinical studies Participates in technical and study design discussions and provides input to clinical trial outlines, protocols, and clinical study reports Manages contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies Leads study team meetings and manages study issues. Develops and manages study timelines in accordance with corporate goals. Identifies barriers to enrollment and develops recruitment solutions Manages internally run studies (without CROs) including the management of CRAs and develops monitoring plans, on-site monitoring guidelines, forms, tools and performs onsite monitoring and co-monitoring visits, as necessary Works collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs Other duties as assigned Requirements: BS/BA degree and 6+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required OR Master's and 4+ years of related experience Must have detailed knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive Excellent knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out Broad trial management protocol and process knowledge Strong understanding of Clinical Research industry and the relevant environments in which it operates Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Sees broader picture, impact on multiple departments/divisions Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management skills Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently Proven ability at analyzing data and information to derive conclusions and drive sound decision making Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines Works to improve tools and processes within functional area Developing reputation inside the company as it relates to area of expertise Ability to work as part of and lead multiple teams #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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