Clinical research coordinator jobs in Santee, 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

Responsibilities: A Senior Research Scientist (IVD) with clinical trial experience is typically responsible for designing, conducting, and analyzing clinical studies that demonstrate the performance of diagnostic assays and instruments. These studies are essential for regulatory submissions (e.g., FDA 510(k), EUA, CE-IVDR, NMPA registration). Clinical Study Design & Protocol Development Develops clinical protocols in accordance with FDA, CLIA, ISO 13485 and IVDR requirements. Defines inclusion/exclusion criteria, sample size, study endpoints, and comparator/reference methods. Works closely with Clinical Affairs or CROs (Contract Research Organizations). Clinical Performance Evaluation (CPE) Oversees clinical testing for sensitivity, specificity, accuracy, reproducibility, and precision. Collects and manages patient samples (prospective or retrospective). Performs data analysis to demonstrate “substantial equivalence” for 510(k) submissions. Regulatory Submission Support Prepares clinical sections of FDA 510(k), EUA, or IVDR Technical Files. Supports responses to regulatory questions (deficiency letters, additional information requests). Ensures all study activities comply with Good Clinical Practice (GCP) and Quality Management Systems (QMS) under ISO 13485. Cross-Functional Collaboration Works with R&D to refine assay design and performance claims. Partners with Regulatory Affairs, Biostatistics, and QA to ensure data integrity and traceability. Coordinates site training and monitoring visits. Post-Market Clinical Follow-Up (PMCF) For CE/IVDR products, contributes to ongoing clinical evidence collection after commercialization. Requirements Master's degree in a relevant scientific discipline (e.g., Materials Science, Chemistry, Biochemistry, or related field). 3 to 5 years of hands-on experience in research and development, with a focus on materials for the IVD industry. Proven expertise in material characterization techniques, experimental design, and statistical analysis. Familiarity with regulatory requirements for IVD products and experience in contributing to regulatory submissions. Strong collaboration and communication skills, both within cross-functional teams and with external partners. Demonstrated ability to lead projects, drive innovation, and contribute to the advancement of IVD materials. Benefits Medical Insurance Plan Retirement Plan Paid Time Off Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or

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

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

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

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

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

Profound Research:Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research. Our Mission: Improving Lives by Providing Advanced Therapeutic Options Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research Our Values: Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Why this Role Exists The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values. Responsibilities-Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements-Bachelor's degree and 2 years relevant experience in the life science industry OR -Associate's degree with 4 years relevant experience in the life science industry OR -High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year -Clinical Research Coordinator experience -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens -Proficient ability to work independently, plan and prioritize with minimal guidance -Excellent attention to detail, organization, and communication with varied stakeholders -Ability to work as a team player with the ability to adapt to changing schedules and assignments Travel RequirementsDaily commute to site(s) Physical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

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.

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.

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.

Compensation Range: Annual Salary: $80,031.00 - $101,985.00 National University is seeking a dynamic and experienced nursing leader to serve as the Academic Program Director (APD) for the Bachelor of Science in Nursing (BSN) Licensure Programs. This is a full-time faculty position that combines program leadership with teaching, scholarship, and service responsibilities. In this role, the APD provides vision, leadership, and administrative oversight for the BSN licensure programs across three campuses. The APD ensures excellence and compliance with the standards of the California Board of Registered Nursing (CABRN), the Commission on Collegiate Nursing Education (CCNE), and the policies of National University. Responsibilities include developing and evaluating curriculum, recruiting and mentoring faculty, guiding student advisement, and overseeing clinical partnerships and budgetary operations. The APD plays a vital role in maintaining program quality, supporting accreditation efforts, and fostering innovation in nursing education. As a faculty member, the individual in this role also contributes directly to the student experience by teaching, advising, and mentoring. Faculty responsibilities include engaging course content, contributing to curriculum design, participating in departmental initiatives, and collaborating with colleagues across the university to support the success of a diverse student population. This position offers a balance of leadership and teaching, with appropriate course release provided to support administrative responsibilities. The APD collaborates closely with the Associate Dean of Nursing and serves as a key leader in advancing the mission of the Department of Nursing and the School of Health Professions. Academic Program Director, BSN Licensure Programs Essential Functions Responsible for the continued, successful accreditation/approval of the BSN licensure programs through curriculum assessment, evaluation and completion of reports required for accreditation. Plan, organize and administer the processes and operations of the BSN licensure programs. Responsible for maintaining NCLEX pass rates as established by California Board of Registered Nursing (CABRN) and Commission of Collegiate Nursing Education (CCNE). Develop program curriculum according to National University processes with input from faculty. Collaborating with the Associate Dean of Nursing develop the budget for the BSN licensure programs. Collaborating with the Associate Dean of Faculty and the Associate Dean of Nursing, is responsible for hiring faculty for all three campuses. Assess and determine faculty load in collaboration with the Associate Dean of Nursing and Associate Dean of Faculty. Work with Campus Operations and Staffing to plan, schedule, and ensure adequate staff for courses and clinical experiences. Ensure all university required processes are completed by designated deadlines (i.e., PARs, 5-year reviews, compliance trainings, FAPs, AARs, , etc.). Responsible for annual program assessment and comprehensive program reviews; gather and analyze data including student outcomes on formative and summative exams, NCLEX reports, progression and persistence data, student enrollment processes, and maintain the systematic evaluation plan. Work in collaboration with the SOHP Director of Assessment and Accreditation for WSCUC, CABRN and CCNE accreditations to support continuous improvement. Responsible for monthly reporting to the Associate Dean of Nursing to include program updates and decisions made by nursing committee meetings for the BSN programs. Committees include Curriculum, Student Affairs, and Faculty Affairs. Communicate changes in state and federal regulations to appropriate people. Participates in the grievance process if student issues escalate. Support Campus-Assistant Program Directors, Nursing Campus Operations and BSN students through quarterly visits to all BSN campuses. Participate, as able, in all three campus pinning ceremonies and support community events in which BSN students are present. Establish and maintain collaborative relationships with clinical partners and make routine clinical site visits. Network with community, business, and industry partners to build a strong advisory board to gather feedback from stakeholders to maintain currency with industry trends. Collaborate with professional organizations to understand changes in the field and explore future trends. Serves as the acting BSN liaison between National University, SOHP, and the CABRN. Instruction Include multiple methods of engagement to create a positive learning environment that encourages motivation and persistence, maintaining frequent communication with students; offering opportunities for ongoing interaction to discuss feedback, addressing concerns, and plans; making accommodations to address learning styles by personalizing teaching and using appropriate tools or models of instruction. Apply innovative, uniquely competitive, and distinct high-performing techniques, approaches, and content knowledge in program courses. Maintain the rigor, high standards and consistency of courses that attract, retain, and prepare a diverse body of students to meet workforce demands. Leverage adaptive and advanced technology-based educational approaches to student engagement and learning outcomes. Ensure course and program practices are aligned with compliance and accreditation standards, as applicable. Utilize effective teaching methods/ clinical teaching methods while encouraging higher order thinking. Reinforces alignment of course activities to course and program outcomes as evidenced by announcements, discussion participation, and feedback. Incorporate supplemental content in announcements, discussions, and assignment feedback to support student learning and engagement. Seek out and encourage higher order thinking through Socratic questioning, open-ended questions, multiple perspectives, and critical thinking and evaluation. Consistently model good discussion practices and encourage active participation from students. Establishes personal and authentic presence while sharing experience, skills, and knowledge with students. Reinforces meaningful connections between course content and broader concepts. Provides personalized, substantive, timely, and constructive feedback on assignments that empowers and encourages students to improve. Participate in course/clinical discussions actively and substantively. Provide timely, substantive communication and feedback utilizing technology tools. Provide and regularly reinforce available communication methods, response timelines, and office hours. Interact and reply to students within the introductory period, on discussion forums, and on assignment feedback. Posts announcements providing guidelines for success and introducing topics and expectations. Provide an inclusive learning environment that encourages student success and motivation. Encourage student interactions and collaboration while providing direct and indirect support. Consistently demonstrates awareness of the importance of inclusive practices and accessibility. Consistently provide support to at-risk students. Adhere to National University's academic integrity policy. Adhere to all policies of National University and the School of Health Professions. Scholarship Scholarship forms the foundation for maintaining the university's excellence in instruction, meeting program accreditation qualifications, and contributing to the body of knowledge that defines the university's civic role in society. Refer to the Faculty Polices for examples of approved scholarship activities. In collaboration with the Associate Deans, faculty will describe their plans for research and scholarly activities in their Faculty Annual Plan (FAP) and report progress in their Annual Review (AAR). Service ensures faculty leadership through shared governance to facilitate academic quality, the student experience, and the processes of the university. All FT Faculty are expected to participate in substantive service within the university (e.g. at the program, department, school, or university level) each year. Refer to the Faculty Policies for examples of approved service activities. In collaboration with the Associate Deans, faculty will describe their plans for required service in their Faculty Annual Plan (FAP) and report progress in their Annual Activities Review (AAR). Requirements: Education & Experience: Hold and maintain an unencumbered nursing license in the State of California, required. Master's degree in nursing required, with specialization in psych mental health preferred. A minimum of five (5) years clinical experience in the field related to the clinical appointment required. At least 1 year experience as a CABRN approved Assistant Program Director/Director with validated performance of administrative responsibilities consistent with CABRN regulations for administrators of prelicensure registered nursing program, required. At least 3 years' experience teaching in pre or post licensure nursing programs, required. At least 5 years of direct patient care experience as a Registered Nurse or at least one academic year teaching in a clinical area in the last 5 years, required. Leadership in a higher education setting, required. The successful candidate will bring proven leadership, administrative, and communication skills, along with demonstrated experience in nursing education, curriculum development, and program assessment, required. Experienced in applying the Commission on Collegiate Nursing Education (CCNE) or Accreditation Commission for Education in Nursing (ACEN) standards required. Intermediate use of computers and Microsoft Office Suite Applications such as Word, Excel, Power Point, Outlook required. Doctorate degree in nursing or higher education preferred. CNE (Certified Nurse Educator) from National League for Nursing (NLN) preferred. Project management in higher education preferred. Working knowledge, principles, and practices of office management/systems within a higher education environment, preferred. Location: San Diego, preferred. LA or Fresno will be considered. Travel: Travel to BSN campuses and University/School events as required. #LI-Onsite Candidate receiving offers will be offered a salary/pay rate commensurate with experience that vary based on a candidate's qualifications, skills, and competencies. Absent exceptional circumstances, candidates will be offered a salary within this range for this position. Base pay is one component of National University's total rewards package, as we are dedicated to supporting the needs of the “whole you” with our holistic approach to employee benefits by offering comprehensive well-being benefits for you and your family. For full details about our benefit plan offerings, please visit benefits.nu.edu. For part-time positions, please click here. National University is proud to be an equal opportunity employer and does not discriminate against any employee or applicant per applicable federal, state and local laws. At NU, a mix of highly talented, innovative, and creative people come together to make the impact of a lifetime for each of our student learners. All qualified applicants will receive equal consideration for employment, education, and admission at National University.

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

Clinical Diagnostics Associate The Clinical Diagnostics Associate will provide project oversight, support, and program management for biomarker and diagnostic projects for the precision oncology pipeline. This position will collaborate with both external biomarker and diagnostic testing providers and internal clinical development and clinical operations teams in a small fast-paced, dynamic work environment. They will assist in managing the development, outsourcing, and validation of clinically applicable biomarker testing and diagnostic assays. ESSENTIAL JOB FUNCTIONS: · Manage biospecimen sample sourcing for internal Translational Medicine projects, external biomarker testing, and Companion Diagnostics analytical validation. Utilize technical and clinical insights to source the appropriate biospecimens for assay validation activities. · Work with external vendors and service providers on contracting and monitoring of assay development and sample testing projects, including financial transactions between company and them. · Track project progress and proactively evaluate potential delays and adverse situations and escalate them to the manager immediately. · Support the biomarker testing and companion diagnostic strategies in accordance with the requirements of quality, ethical, and regulatory standards, including ICH/GDPR/GCP/GLP. · Support Companion Diagnostic partnership requests and actively participate in Joint Project Team calls. Ensure that the meeting minutes are captured appropriately, including all action items. · Support Clinical Operations on the lifecycle of patient samples for biomarker testing and diagnostic technology development, including sample procurement from commercial sources (biobanks and biorepositories), sample collection at study sites, processing, storage, transfer to central lab, shipment to vendors for testing, analysis, input on relevant documentation, and final sample disposition (including long-term storage), while maximizing sample quality based on biomarker testing and diagnostics sample requirements. Be the point person to support Clinical Operations requests and obtain technical and regulatory input from other Diagnostic Team members when needed. · Utilize available internal and external tracking systems to monitor and report progress, address issues, and ensure resolutions relating to samples that will be used for biomarker testing and diagnostics. Ensure that all risks related to biomarker testing and diagnostic technologies are accurately captured for the Project Management Team. · Support data transfer agreements (DTAs) and monitor and report progress, address issues and ensure resolutions relating to biomarker testing and diagnostic data transfers. Be the point person for Data Management Team. · Address questions from the program teams on biomarker testing and companion diagnostic vendors regarding sample collection, handling, transfer, testing, storage, etc. for all biomarker testing and companion diagnostics projects. · Support Diagnostics Team on contracts, budgets, project, and development timelines and work closely with the Finance and Project Management Team to ensure that information is accurately captured. · Invite and process work proposals for diagnostic projects and biomarker testing. Be the point person for obtaining proposals, work orders, statements of works, etc. from diagnostic and biomarker testing vendors based on the technical and regulatory needs related to the testing. · Provide support for all activities involving start-up execution and close-out of all contracts, budgets, and timelines. · Bring issues to Manager or Program team's as necessary and participate in the resolution of delays or potential delays. · Manage Diagnostics team meetings as well as minutes, agendas, action items, etc. Prepare PowerPoints summarizing progress for Senior Leadership. · Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre-clinical, clinical or commercial). JOB REQUIREMENTS: · BS, MS, in Biochemistry, Biology, Medical Technology, immunology, pharmacy, or related pharmaceutical science. · 2-4 years of work experience in drug development, diagnostics, or clinical trial management. · Experience with Microsoft Office, including Excel, required. Experience with Microsoft Project as well as other database and timeline management software preferred but not essential. · Assay development experience preferred. · High level of integrity, accuracy, and attention to detail. · Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills. · Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making. · Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment. · Outstanding interpersonal, communication, and negotiation skills.