Clinical research coordinator jobs in Bonita, CA - 51 jobs

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

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will lead and provide guidance to clinical monitors for sponsor and investigator initiated clinical research studies. Assists in administration of the consent process, and ensures maintained records are accurate, complete, timely, and compliant. Serves as communications liaison for clinical monitoring and study teams, identifying, resolving, and escalating any issues, as appropriate. Develops and administers clinical trial education and training. Duties will include but are not limited to: Develop and maintain study specific clinical monitoring documentation. Review and contribute to clinical monitoring sections of other study documents. Support development and maintenance of departmental and study SOPs and Work Instructions. Conduct study specific onboarding and training of team members new to the study. Conduct onsite training visits. Represent Clinical Monitoring Team at study specific meetings. Provide study updates on Clinical Monitoring team metrics, site escalations, and other monitoring efforts. Support study start up, maintenance, and close out activities. Participate in interdepartmental meetings to accomplish study milestones. Collaborate with colleagues to address study issues. Expert knowledge and awareness of study manuals to serve as main point of contact for issues identified by study CRAs. Review study status reports and prioritize monitoring activities with study CRAs to meet study milestones. Review Monitor Visit Reports (MVR) and provide feedback to team. Provide oversight of monitor visit compliance with study plans. Escalate problematic behavior and poor performance to CRA Managers as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Review study data in accordance with Clinical Monitoring Plan. Issue and resolves queries in a timely manner. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Conduct onsite and remote monitoring visits for assigned clinical sites. Review Investigator Site Files, study data, perform IP accountability, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Up to 50% travel may be required. Act as main point of contact for assigned clinical sites and respond to communication via study inbox ticketing system in a timely manner. Experience in AD research is preferred. Location: San Diego, CA The annual base salary range for this position is $128,039.82- $161,336.75. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 5 years Minimum Skills: Extensive experience with monitoring of clinical trials and thorough knowledge of medical terminology. Demonstrated experience with the drug development process. Experience with ICH guidelines and Good Clinical Practices (GCP). Proven ability to interpret and apply all relevant federal, state, and local laws, regulations, and policies regarding clinical trials and monitoring. Thorough knowledge of all applicable local and/or national regulations pertaining to clinical trials and monitoring. Preferred Education: Bachelor's degree Preferred Experience: 6 years Preferred Skills: Demonstrated leadership skills. Comprehensive understanding of all aspects of clinical trials. Experience maintaining currency with changing laws, regulations and policies. 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: *************************************************************

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.

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

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

Research Coordinator ASAP Status: Fulltime 40 hours per week; Benefits eligible Work Schedule: Monday - Friday, hours between 8:00am to 4:30pm Service/Division: Clinical Trial Center Work Location: VMRF Job Code: MS 1395 Salary: $26.00 -$28.50 DOE Under general supervision, performs duties related to the coordination and support of clinical research projects and trials. Responsibilities include assisting with study start-up, participant recruitment and consent, data collection and regulatory submissions, and ensuring compliance with protocols and institutional guidelines. This role facilitates smooth study operations from initiation through closure while maintaining accurate documentation and communication among stakeholders. Assists Principal Investigators (PIs) to ensure smooth, accurate progress of research projects from the planning stage through the project completion and post-project closure. • Conducts study start-up activities; oversees daily operations of research projects and study closures. • Meets with PI, current and potential research study participants as required by study protocols. • Recruits and screens research study participants for eligibility, reviews medical charts, prepares source documentation, and oversees participant follow up in clinic along with PI and Co-Investigators • Consent and explain study requirements to participants • Coordinates research study participant treatment and conducts in-person structured assessments with study participants throughout the study. • Identify potential Adverse Events and report as required • Collects and maintains data for all study participants. • Handle, process, package and ship human samples per protocol. • Documents chain of custody for biological samples; ensures proper storage and shipping per IATA guidelines. • Submits regulatory documents to Research and Development Committee and the Institutional Review Board to initiate new studies, modifications, investigative new drug safety reports, and patient adverse events. • Maintains compliance with Good Clinical Practice (GCP), HIPAA, and institutional policies; assists with audit readiness and monitoring visits. Monitors patient participation in the study by tracking patient follow-up according to the specific requirements of the research study protocol. • Performs accurate data entry and quality checks in EDC systems; resolves discrepancies. • Follows up and works closely with research participants to ensure the trial meets all regulatory requirements. • Keep physicians and other clinical staff apprised of data collection and reporting requirements • Arrange and schedule radiographic, laboratory, and clinical evaluations for study subjects. • Identify problems in execution of protocol and assist physicians, nursing staff, and pharmacy staff in rectifying the problems. • May provide support to multiple PIs and projects/trials at any given time. • Works closely with the project administrator and other research coordinators to ensure all trials in the division are running smoothly, identified issues are addressed, and timelines are met. • Serves as a liaison between PI, sponsors, CROs, and institutional departments; coordinates sponsor monitoring visits. • Assists with the maintenance of VMRF CTC space and equipment. Such as cleaning and scheduling of rooms for PI/Research teams, opening and closing of doors as needed for reserved rooms, maintaining supplies and equipment calibration logs. • Tracks study-related expenses and supports post-award financial processes. • Complies with safety and security policies and procedures. • Participates in protocol training sessions and maintains required certifications. Reports on potentially unsafe working conditions. • Phlebotomy certification is preferred but not mandatory. • May perform additional duties as assigned. Requirements Bachelor's degree (BA/BS) in a related field from an accredited college or university AND at least 1 year of related experience; or an equivalent combination of education and experience. Salary Description $26.00 - $28.50 DOE

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

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

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

: Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms. No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements. Job Description: No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinical research projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives. Job Duties: Maintaining regulatory binders, inventory of study-specific and clinical supplies. Recruiting, and enrolling study subjects. Obtaining informed consent. Collecting nasal swab samples. Testing samples on investigational laboratory PCR analyzers. Data collection and entry. Query resolution. Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc. Key Success Factors: Ability to work independently. Desire to work in a clinical environment with direct patient contact. Genuine interest in research. Timely in all communications. Superior attention to detail. While not a requirement, senior pre-medical students who hope to gain experience in clinical research or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees. Job Type: Full-time Pay: $28.00 per hour Expected hours: 40 per week Benefits: 401(k) Dental Insurance Health Insurance Paid time off Vision Insurance Schedule: Monday to Friday Work Location: In person

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

Job Description Research Coordinator Position: Research Coordinator (temporary, part time) Reports to: Lead Research Coordinator Hourly Rate: $20.00 - $23.00 Make Your Mark: SleepScore Labs is looking for a Research Coordinator to become an integral part of our Research team. SleepScore Labs partners with industry leaders to put science at the core of sleep improvement. As Research Coordinator, you will assist with activities including designing in-home product studies, participant recruitment, survey composition, data management, and report writing. We are looking for someone proactive who thrives in an exciting, small team environment. You'll Get to: Assist with design of online surveys and preparation of research materials. Develop and implement creative approaches to recruit research participants. Correspond with research participants by email and phone. Manage self-report survey data files. Conduct descriptive and basic inferential statistical analyses. Translate data into simple textual and visual representations. Help summarize research findings into presentations and reports. Coordinate and assist with finding and reviewing sleep improvement products. What You'll Bring: At least one year of research experience required. Participant recruitment experience preferred. Bachelor's degree in relevant area of study. A background in sleep science, health science, or social science required. Industry experience preferred. Strong organizational & follow-up skills and the ability to handle sensitive information confidentially. Strong Microsoft Excel skills. Experience with online survey platforms, such as Qualtrics. Strong email/written communication. Experience with/willing to learn Cordial (participant mass email communication platform). Proactive and willing to take initiative. Excels both independently and in a team environment. Reliable and dependable with a strong work ethic and positive attitude. Self-motivated, persistent, and tenacious. Comfortable rolling up your sleeves in a hands on work environment. We're Even More Excited If You Have: Thrive at SleepScore Because You Are Joining: A technology-based company with a strong mission and vision for the future. We understand that bringing new ideas and innovative technology is mission critical. At SleepScore, we encourage our team to learn something new and expand their creativity that will accelerate their careers. A culture that is kind, open and accepting. It's a place where people can embrace what makes them unique and the mix of cultural backgrounds and varying interests cultivates diverse thought and perspectives. We offer competitive rewards and compensation and health and wellness benefits programs that are comprehensive and meet the needs of our team. SleepScore recognizes that the ways we work and the workplace itself has shifted. We innovate in a workplace that optimizes a combination of virtual and in-person interactions to maximize collaboration and nurture our culture. Candidates who live in a reasonable commute to our office will work in the office at least 2 days a week. Click here to apply. About SleepScore Labs: SleepScore Labs is the sleep improvement company, which spun out of ResMed, the global leader in clinical sleep solutions. SleepScore Labs developed the most advanced sleep technology platform and leverages actionable and personalized sleep insights derived from 100M+ hours of sleep data to empower billions of people to achieve their best sleep, benefiting their physical, mental, and emotional well-being. We partner with world-leading companies on our journey - companies such as ResMed, Mattress Firm, IFF and L'Oreal. Our goal is to build an unassailable strategic advantage that solidifies our position as the most trusted and preferred sleep improvement resource for leading companies and consumers. Learn more at ******************* SleepScore Labs is proud to be an equal opportunity employer committed to a diverse and inclusive work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status, or any other basis protected by law.

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:Contribute to overall clinical trial strategy and responsible for managing the operational activities to support planning, initiation, conduct and close out phases of clinical studies. Leads and manages the end-to-end operational activities of assigned Clinical Studies (domestic and global studies). Manages studies using multiple Contract Research Organizations (CROs) as well as managing internally run studies. Responsible for integrity of clinical trial data and completeness of Trial Master File (TMF) documentation. _ Your Contributions (include, but are not limited to): Responsible for developing, leading and managing NBI trials on an end-to-end basis and contribute to the overall trial study strategy and planning Serves as primary point of contact for clinical operations aspects of assigned clinical studies, may oversee other clinical trials assigned to lower level team members Participates, and may lead, in technical and study design discussions and provides expert level counsel and input to clinical trial outlines, protocols, and clinical study reports Manages multiple contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies Oversees 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 trial monitoring team(s) and develops various study 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. Manages Trial Master File (TMF) content ensuring all study documents are appropriately filed and inspection ready throughout the conduct of the study as well as at study completion 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 Incorporates Risk Based Monitoring with Clinical Quality Assurance counterparts to assure subject safety and data integrity across NBI Development Programs May support the recruitment, training, management, and career development of subordinates within the clinical operations group Other duties as assigned Requirements: BS/BA degree AND 8+ 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 6+ years of similar experience noted above Anticipates business and industry issues; recommends relevant process / technical / service improvements Demonstrates broad expertise or unique knowledge Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams. Excellent computer skills Excellent communications, problem-solving, analytical thinking skills. Sees broader picture and longer-term impact on division/company. Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency. Excellent project management, strong project leadership 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 Works to improve tools and processes within functional area Expert 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 and understands clinical development efforts of trials Strong understanding of trial development and extensive trial management protocol and process knowledge across all phases of clinical studies In-depth understanding of Clinical Research industry and the relevant environments in which it operates Ability to identify and organize clinical resources needed to accomplish major projects, set overall trial(s) objectives and provide clear direction to others; expertise planning activities in advance and taking account of possible changing circumstances; manages time effectively Must posses strong presentation and communication skills for internal and external presentations Strong computer skills, organizational skills, interpersonal and team participation skills are essential 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 $156,900.00-$214,000.00. 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.

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

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

Research Coordinator ASAP Status: Fulltime 40 hours per week; Benefits eligible Work Schedule: Monday - Friday, hours between 8:00am to 4:30pm Service/Division: Clinical Trial Center Salary: $26.00 -$28.50 DOE Under general supervision, performs duties related to the coordination and support of clinical research projects and trials. Responsibilities include assisting with study start-up, participant recruitment and consent, data collection and regulatory submissions, and ensuring compliance with protocols and institutional guidelines. This role facilitates smooth study operations from initiation through closure while maintaining accurate documentation and communication among stakeholders. Assists Principal Investigators (PIs) to ensure smooth, accurate progress of research projects from the planning stage through the project completion and post-project closure. * Conducts study start-up activities; oversees daily operations of research projects and study closures. * Meets with PI, current and potential research study participants as required by study protocols. * Recruits and screens research study participants for eligibility, reviews medical charts, prepares source documentation, and oversees participant follow up in clinic along with PI and Co-Investigators * Consent and explain study requirements to participants * Coordinates research study participant treatment and conducts in-person structured assessments with study participants throughout the study. * Identify potential Adverse Events and report as required * Collects and maintains data for all study participants. * Handle, process, package and ship human samples per protocol. * Documents chain of custody for biological samples; ensures proper storage and shipping per IATA guidelines. * Submits regulatory documents to Research and Development Committee and the Institutional Review Board to initiate new studies, modifications, investigative new drug safety reports, and patient adverse events. * Maintains compliance with Good Clinical Practice (GCP), HIPAA, and institutional policies; assists with audit readiness and monitoring visits. Monitors patient participation in the study by tracking patient follow-up according to the specific requirements of the research study protocol. * Performs accurate data entry and quality checks in EDC systems; resolves discrepancies. * Follows up and works closely with research participants to ensure the trial meets all regulatory requirements. * Keep physicians and other clinical staff apprised of data collection and reporting requirements * Arrange and schedule radiographic, laboratory, and clinical evaluations for study subjects. * Identify problems in execution of protocol and assist physicians, nursing staff, and pharmacy staff in rectifying the problems. * May provide support to multiple PIs and projects/trials at any given time. * Works closely with the project administrator and other research coordinators to ensure all trials in the division are running smoothly, identified issues are addressed, and timelines are met. * Serves as a liaison between PI, sponsors, CROs, and institutional departments; coordinates sponsor monitoring visits. * Assists with the maintenance of VMRF CTC space and equipment. Such as cleaning and scheduling of rooms for PI/Research teams, opening and closing of doors as needed for reserved rooms, maintaining supplies and equipment calibration logs. * Tracks study-related expenses and supports post-award financial processes. * Complies with safety and security policies and procedures. * Participates in protocol training sessions and maintains required certifications. Reports on potentially unsafe working conditions. * Phlebotomy certification is preferred but not mandatory. * May perform additional duties as assigned. Requirements Bachelor's degree (BA/BS) in a related field from an accredited college or university AND at least 1 year of related experience; or an equivalent combination of education and experience.

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

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.

: Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms. No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements. Job Description: No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinical research projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives. Job Duties: Maintaining regulatory binders, inventory of study-specific and clinical supplies. Recruiting, and enrolling study subjects. Obtaining informed consent. Collecting nasal swab samples. Testing samples on investigational laboratory PCR analyzers. Data collection and entry. Query resolution. Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc. Key Success Factors: Ability to work independently. Desire to work in a clinical environment with direct patient contact. Genuine interest in research. Timely in all communications. Superior attention to detail. While not a requirement, senior pre-medical students who hope to gain experience in clinical research or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees. Job Type: Full-time Pay: $28.00 per hour Expected hours: 40 per week Benefits: 401(k) Dental Insurance Health Insurance Paid time off Vision Insurance Schedule: Monday to Friday Work Location: In person