Clinical research coordinator jobs in Chula Vista, CA

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

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 a detail-oriented and proactive Clinical Research Associate to monitor clinical study data and ensure the integrity and quality of research processes. The CRA will play a key role in supporting our Quality Assurance team by verifying data accuracy, compliance with study protocols, and regulatory requirements. Additionally, the CRA will assist in handling external monitoring visits to ensure smooth and compliant site audits. This position requires minimal travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is non-exempt (hourly) and full-time, working 40 hours per week, Monday through Friday, Onsite in our La Jolla Clinic. Key Responsibilities Monitor and review clinical study data for accuracy, completeness, and consistency throughout the study lifecycle. Conduct site visits (remote or on-site) to review source documents, case report forms (CRFs), and other study documentation. Assist in handling and coordinating external monitoring visits, including preparation, communication, and follow-up. Collaborate with site staff and internal teams to resolve data discrepancies and ensure timely data entry. Support the implementation and maintenance of quality assurance standards for clinical trials. Assist in audit preparation and support regulatory inspections as needed. Document monitoring activities in accordance with company SOPs and Good Clinical Practice (GCP) guidelines. Contribute to continuous improvement initiatives to enhance data quality and compliance processes. Additional duties as assigned. Skills & Qualifications Education: Bachelor's degree in life sciences, healthcare, or related field. Experience: Minimum of 5 years in clinical research monitoring or data management preferred. Skills & Abilities: Strong understanding of GCP, ICH guidelines, and clinical trial processes. Excellent attention to detail and organizational skills. Ability to communicate effectively with cross-functional teams and site staff. Proficiency in CTMS, EDC systems, and Microsoft Office Suite. Analytical mindset with problem-solving skills. Ability to prioritize tasks and manage time effectively. Commitment to quality and regulatory compliance. Compensation The hourly range for this position is $35.00-52.00/hour. 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.

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

**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. + Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct + May serve as Clinical Trial Lead for one or more trials + May lead or support trial level activities for one or more trials with the necessary supervision + May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members + Collaborate and liaise with external partners (e.g., KOLs) + Seek out and enact best practices with instruction + Provide regular and timely updates to manager/management as requested + Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required + Conduct literature review + Submit clinical documents to TMF + Develop site and CRA training materials and present these at SIVs and Investigator meetings + Review clinical narratives + Monitor clinical data for specific trends + Develop Data Review Plan in collaboration with Data Management + Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming + Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.) + Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry) + Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Ability to understand assigned protocol(s) and their requirements + Basic knowledge skills to support program-specific data review and trend identification + Intermediate medical writing skills and medical terminology + Basic planning/project management skills (develop short range plans that are realistic and effective) + Detail-oriented with commitment to quality + Basic knowledge of disease area, compound, current clinical landscape + Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees + Intermediate critical thinking and problem-solving skills + Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) + Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools) Domestic and International travel may be required. Compensation: Brisbane, CA and Cambridge, MA $173,390-$210,110 New Jersey $150,770 - $182,701 San Diego, CA and Seattle, WA $165,850-$200,974 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Compensation Overview:** The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: + **Health Coverage:** Medical, pharmacy, dental, and vision care. + **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). + **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. **Work-life benefits include:** Paid Time Off + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) + Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. ***Eligibility Disclosure:** T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. **Supporting People with Disabilities** BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ************************** . Visit careers.bms.com/ (****************************************** eeo-accessibility to access our complete Equal Employment Opportunity statement. **Candidate Rights** BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* **Data Protection** We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at **************************************** . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ******************** . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1598007 : Clinical Scientist, Early Development **Company:** Bristol-Myers Squibb **Req Number:** R1598007 **Updated:** 2025-12-28 01:25:42.547 UTC **Location:** Seattle 400 Dexter-WA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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.

Senior Clinical Trial Manager Location: San Diego, CA (On -site) 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

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

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

Clinical Operations Spec 1 Medical Devices Company Duration : 12 Months Total Hours/week : 40.00 Level Of Experience: Entry Level Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Description: • Work hours: 8:00am - 4:30pm • Onsite • 3 Must haves on the resume: Bachelor degree in Chemistry/Biology, pipetting experience, ability to independently manage time/switch between tasks MD Biosciences, a segment of Medical Device Company, is one of the world's leading businesses focused on bringing innovative tools to life science researchers and clinicians. Its product lines include: flow cytometers, cell imaging systems, monoclonal antibodies, research reagents, diagnostic assays, and tools to help grow tissue and cells. MD Biosciences is an Equal Opportunity/Affirmative Action Employer. Sirigen, Inc. is a subsidiary of MD Biosciences and produces polymeric reagents for use in Flow Cytometry and Cell Imaging systems. The Operations Specialist I is a multi-functional role, responsible for inventory control of materials and finished goods, formulation, packaging, and order fulfillment. The Operation Specialist I also supports Quality Control of finished goods by performing dye labeling reactions and sample preparation. In addition, this position supports laboratory supply receiving and restocking. Roles & Responsibilities Support security and accuracy of inventory of materials and finished goods through transaction documentation and by conducting physical cycle counts and reconciliation of any discrepancies. Assist in the management of physical inventory within a Glovebox for raw materials, intermediate products, finished goods, analytical samples, and QA Retains. Perform small scale chemical reactions (dye labeling) for Quality Control testing. Fulfill internal requests for samples from inventory and perform sample preparation for quality testing. Perform Aliquoting/Vialing of air and water sensitive finished goods using manual and automated processes and equipment. Perform lyophilization of finished good products. Perform Weight Checks and Packaging of air and water sensitive finished goods within a glovebox. Prepare packaged products for QA inspection and shipments, including all required documentation. Accurately complete required documentation (batch records, data entry, etc.) on time. Receives deliveries of chemicals, materials, and lab supplies. Verifies accuracy of shipment and specifications. Checks materials into inventory management system and restock in proper storage areas. Support document control and data archiving activities as assigned. Promotes a safe work environment. Provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices. Participates in safety audits of safety equipment and laboratory processes. Other responsibilities or projects as assigned by reporting manager. Experience Required Typically requires a minimum of a Bachelor's Degree in Chemistry or Biology with 0-2years relevant experience. Skills & Certifications • Ability to follow standard operating procedures is essential. • Experience with manual (pipette) and automated filling/dispensing is preferred. • Prior experience in a chemistry lab is preferred. • Experience working in a glovebox is preferred. • Proficiency in MS Office Skills (Word, Excel, and PowerPoint) is required. • Experience with FileMaker Pro, BMRAM, and DocuNECT is preferred. • Must possess strong organizational skills, attention to detail, and the ability to adapt to changing priorities in a fast-paced environment. • Be a self-starter, quick learner with the ability to work independently and efficiently. • Strong interpersonal communication skills, effective written and oral communications skills. Eligibilities & qualifications Typically requires a minimum of a Bachelor's Degree in Chemistry or Biology with 0-2years relevant experience.

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

MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC). Compensation: $68,000-$71,000 annually Primary Responsibilities Patient Recruitment and Consent: Identifies, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines. Help lead recruitment efforts, developing and refining strategies to meet enrollment targets. Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria. Manage and coordinate complex biosurveillance. Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifying procedures to align with the objectives of clinical trials. Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures. Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS). Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings. Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines. Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager. Regulatory Management Assists with Institutional Review Board (IRB) submissions and protocol amendments. Collaborate with principal investigators and sponsors and provide insights based on field experience. Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities. Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system. Compliance and Monitoring Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle. Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise. Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes. Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies. Regulatory Responsibilities Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements. Ensures all study-related documents are appropriately filed and accessible for audits. Manages study registrations and updates in the Clinical Trial Management System and eIRB system. Other Responsibilities May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel. Remote and On-Site Study Leadership: Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel. Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site. Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety. Performs other duties as assigned. Requirements Required A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of infectious disease Biosurveillance experience. Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems. Strong organizational, communication, and problem-solving skills. Ability to work both independently and collaboratively in a research setting. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred Certification in clinical research (such as CCRC or CCRP). Experience with infectious disease studies or military health research. Benefits MPF Federal is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status or on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

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

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

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. The Clinical Trial Neuropathology and Data Sharing Coordinator will work under the ACTC Program Administrator to support clinical sites in their efforts to establish post-mortem brain donation procedures for multi-site clinical trials for Alzheimer's Disease. This position will also lead implementation working groups for the data and sample sharing initiatives. The incumbent will be responsible for a wide range of work assignments and must be well organized, able to manage several projects at the same time; functioning well in both a project lead role as well as part of a team in a fast-paced environment. Ideal candidate must be a self-starter, have high attention to detail, able to think critically, and effectively problem solve. Must be able to work efficiently independently and be an effective collaborator in a team environment. The ideal candidate will have experience with clinical trials, brain donation procedures, data sharing, development and implementation of research protocols. Prior comparable experience that relates to the following position goals is also desirable. • Assist clinical research sites in establishing sustainable practices for participant education and follow up, as well as establishing logistical arrangements to facilitate postmortem brain donation. • Working with the scientific Leads of ACTC Neuropathology Unit, facilitate development of Master and study-specific protocols and procedures for tissue collection, analysis, banking and sharing. • Lead implementation working groups for the data and sample sharing initiatives for ACTC clinical trials. The hourly rate range for this position is $30.14 - $38.71.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. Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Skills: Directly related project or administrative experience. Preferred Education: Master's degree Preferred Experience: 3 years 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: *************************************************************

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

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. The Clinical Trial Neuropathology and Data Sharing Coordinator will work under the ACTC Program Administrator to support clinical sites in their efforts to establish post-mortem brain donation procedures for multi-site clinical trials for Alzheimer's Disease. This position will also lead implementation working groups for the data and sample sharing initiatives. The incumbent will be responsible for a wide range of work assignments and must be well organized, able to manage several projects at the same time; functioning well in both a project lead role as well as part of a team in a fast-paced environment. Ideal candidate must be a self-starter, have high attention to detail, able to think critically, and effectively problem solve. Must be able to work efficiently independently and be an effective collaborator in a team environment. The ideal candidate will have experience with clinical trials, brain donation procedures, data sharing, development and implementation of research protocols. Prior comparable experience that relates to the following position goals is also desirable. * Assist clinical research sites in establishing sustainable practices for participant education and follow up, as well as establishing logistical arrangements to facilitate postmortem brain donation. * Working with the scientific Leads of ACTC Neuropathology Unit, facilitate development of Master and study-specific protocols and procedures for tissue collection, analysis, banking and sharing. * Lead implementation working groups for the data and sample sharing initiatives for ACTC clinical trials. The hourly rate range for this position is $30.14 - $38.71.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. Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Skills: Directly related project or administrative experience. Preferred Education: Master's degree Preferred Experience: 3 years 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: *************************************************************

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.

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