clinical research management associate

Align Technology

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
Job Summary<br>
</div><div>
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The Clinical Research Development Associate should have strong skills with program/project management. The Clinical Research Development Associate will provide full-time program/project management support for Align&rsquo;s Clinical Research Development team.<br>
</div><div>
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Essential Duties and Responsibilities<br>
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<ul><li>Owns the Clinical Studies Network (CSN) system configuration in both testing and production environments</li></ul></div><div><br>
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<ul><li>Develop documentation for Research Awards and Collaborative Research programs</li></ul></div><div><br>
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<ul><li>Resolves internal/external program inquiries in a timely manner to ensure customer satisfaction</li></ul></div><div><br>
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<ul><li>Exercises judgment within defined procedures to onboard program vendors</li></ul></div><div><br>
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<ul><li>Streamlines technical design assessments (TDAs), business user preferences (BUPs), and/or user assessment tests (UATs) for Clinical Affairs and Product Innovation processes</li></ul></div><div><br>
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<ul><li>Apply professional procedures to support Clinical Affairs research activities</li></ul></div><div><br>
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<ul><li>Applies professional internal/external communication</li></ul></div><div><br>
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<ul><li>Builds productive internal/external relationships with cross-functional teams</li></ul></div><div><br>
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<ul><li>Under moderate supervision, support Clinical Research Development and Clinical Affairs projects</li></ul></div><div><br>
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Additional responsibilities<br>
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<ul><li>Manage delivery and shipment of research items to universities, orthodontists, and/or general dentists</li></ul></div><div><br>
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<ul><li>Apply company policies and procedures to resolve a variety of issues</li></ul></div><div><br>
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<ul><li>Support Clinical Research Operations team projects, as assigned</li></ul></div><div><br>
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<ul><li>Support Clinical Data Management team projects, as assigned</li></ul></div><div><br>
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<ul><li>Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources</li></ul></div><div><br>
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<ul><li>Participate in proactive team efforts to achieve departmental and company goals</li></ul></div><div><br>
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<ul><li>Perform other duties, as assigned</li></ul></div><div><br>
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Qualifications<br>
</div><div>
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<ul><li>Project/program management skills/experience</li></ul></div><div><br>
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<ul><li>Strong organizational skills</li></ul></div><div><br>
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<ul><li>Knowledge and experience using Adobe Professional</li></ul></div><div><br>
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<ul><li>Ability to think critically and scientifically</li></ul></div><div><br>
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<ul><li>Competency with data management software, including using word-processing, spreadsheet and database software</li></ul></div><div><br>
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<ul><li>Willingness to be reassigned to different tasks in a fast-paced research environment</li></ul></div><div><br>
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<ul><li>Regard for patient information privacy</li></ul></div><div><br>
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<ul><li>Professionalism in interacting with practitioners and academicians</li></ul></div><div><br>
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<ul><li>Strong oral and written communication skills essential</li></ul></div><div><br>
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<ul><li>Ability to prioritize tasks to meet deadlines</li></ul></div><div><br>
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<ul><li>Strong attention to detail and ability to ask clarifying questions</li></ul></div><div><br>
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<ul><li>Ability to work independently with minimal supervision</li></ul></div><div><br>
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Education<br>
</div><div>
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<ul><li>Associate degree</li></ul></div><div><br>
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<ul><li>2+ years of experience in the medical device industry preferred</li></ul></div><div><br>
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<ul><li>Good Clinical Practice (GCP) certification, preferred</li></ul></div><div><br>
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Work Schedule/Hours<br>
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<br>
<ul><li>Regular business hours</li></ul></div><h3 class="jobSectionHeader"><b><br>
.</b></h3><div><br>
.</div><h3 class="jobSectionHeader"><b><br>
About Align Technology</b></h3><div>
<b>Your growth and well-being:</b><br>
<br>
At Align, every smile matters. We&rsquo;re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:</div><ul>
<li>Health and well-being programs to keep you thriving in both body and mind.</li>
<li>Employee-exclusive discounts on Invisalign products.</li>
<li>Learning opportunities through online learning resources and support for your individual development plans.</li>
<li>Inclusive, global workplace that fosters collaboration, recognition and belonging.</li>
</ul><div>Country and/or role specific details will be shared with you by your recruiter during the interview process.</div><div>
<br>
<b>Discover Align:</b><br>
<br>
We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.<br>
</div><div>Align&rsquo;s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another&mdash; ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.<br>
</div><div>We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.<br>
</div><div>At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.</div><div>
<br>
As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.</div><div>
<br>
Eager to learn how we embrace our global differences and nurture employee well-being?
<br>
<b>Explore Align's culture here!</b><br>
</div><div>Want to discover more about <b>exocad</b> and <b>Cubicure</b>? Click on their names for additional information.</div><div><br>
<b>
Applicant Privacy Policy:</b><br>
<br>
Review our <b>Applicant Privacy Policy</b> for additional information.<br>
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<b>Equal Opportunity Statement:</b><br>
<br>
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.</div></div>

Clinical Research Development Associate

The University of Michigan

<p></p><div><div><div><h2 class="jobSectionHeader"><b>How to Apply</b></h2><p>
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.</p><h2 class="jobSectionHeader"><b>
Job Summary</b></h2><p>
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.</p><p>
This position will serve as a Clinical Research Coordinator in the Pediatric Hematology/Oncology division, providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan CS Mott Children's Hospital. Our program is renowned for our expertise in cancers like leukemia, lymphoma, and solid tumors including neuroblastoma, sarcoma and brain tumors which affect children, adolescents, and young adults. We are members of national clinical trials organizations like COG, NANT, TACL and PNOC for pediatric and AYA cancer patients. Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society. As a team member, we will invest in your education, training, career development and certification.</p><h2 class="jobSectionHeader"><b>
Mission Statement</b></h2><p>
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.</p><h2 class="jobSectionHeader"><b>
Why Join Michigan Medicine?</b></h2><p>
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.</p><p><b>
What Benefits can you Look Forward to?</b></p><ul><li>
Excellent medical, dental and vision coverage effective on your very first day</li><li>
2:1 Match on retirement savings</li></ul><h2 class="jobSectionHeader"><b>
Responsibilities*</b></h2><p><b>
Characteristic Duties and Responsibilities:</b></p><p><b>
Experience as part of a team with all 8 competency domains is expected:</b></p><ul><li>
Scientific Concepts and Research Design</li><li>
Ethical Participant Safety Considerations</li><li>
Investigational Products Development and Regulation</li><li>
Clinical Study Operations (GCPs)</li><li>
Study and Site Management</li><li>
Data Management and Informatics</li><li>
Leadership and Professionalism</li><li>
Communication and Teamwork</li></ul><ul><li>
Assist study teams with all aspects of clinical trial coordination including identifying potential subjects, screening subjects, consenting (minimal risk) and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects</li><li>
Coordinate and facilitate correct timing of study visits and procedures with patients and clinic staff</li><li>
Coordinate the collection and integrity of research specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)</li><li>
Monitor and report abnormal or unexpected findings</li><li>
Create source documents for accurate tracking, collection, and recording of experimental data</li><li>
Utilize critical thinking skills to recognize and solve patient/participant problems including billing issues</li><li>
Work collaboratively with nurses, research pharmacy, physicians, NPs/PAs, phlebotomists and other clinical, research and administrative staff to correct/prevent protocol errors</li><li>
Expeditiously route AE and SAE information between staff, PI, and oversight agencies as appropriate</li><li>
Possibly attend investigator and scientific meetings</li><li>
Serve as a resource and contact person for active protocols</li><li>
Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication</li><li>
Integrate the workflow of many studies running simultaneously</li><li>
Maintain current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations, and maintain knowledge of current ICH and CFR guidelines</li><li>
Assist in the completion of regulatory duties including new study activation and processing of amendments and continuing reviews</li><li>
Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports</li><li>
In coordination with the CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures</li><li>
Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues</li></ul><p><b><br>
Supervision Received:</b></p><p>
This position receives direct supervision and reports directly to a CRC-Lead, CRC-Senior, a unit Administrator, Director, or Faculty Principal Investigator. Functional supervision may be received from the Clinical Research Coordinator Senior in the team.</p><p><b>
Supervision Exercised:</b></p><p>
None.</p><h2 class="jobSectionHeader"><b>
Required Qualifications*</b></h2><ul><li>
Bachelor's Degree or higher preferably in health science or health related field or an equivalent combination of related education and experience.</li><li>
At least two years of experience coordinating Clinical Trials.</li><li>
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.</li><li>
Excellent computer skills including proficiency in Microsoft software applications.</li><li>
Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.</li><li>
Willingness to be flexible in a dynamic working environment.</li><li>
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.</li><li>
Good attendance record</li></ul><p><b><br>
Intermediate Level:</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is necessary.
</li><li>Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.</li><li>
Minimum 3 years of directly related experience in clinical research and clinical trials.</li></ul><p><b>
Associate Level:</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is necessary.
</li><li>Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.</li><li>
Minimum 2 years of directly related experience in clinical research and clinical trials.</li></ul><p><b><br>
Technician Level:</b></p><ul><li>
Associate degree or an equivalent combination of related education and experience.</li><li>
Minimum 1 year of directly related experience in clinical research and clinical trials.<br>
<br>
OR<br>
</li><li>
an advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD<br>
<br>
OR<br>
</li><li>
Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research</li></ul><h2 class="jobSectionHeader"><b>
Desired Qualifications*</b></h2><ul><li>
6+ years of direct related experience</li><li>
Masters Degree</li><li>
Reasonable understanding of clinical research</li><li>
Understanding of medical terminology related to oncology</li><li>
Some IRB/regulatory experience</li><li>
Previous experience with Epic, MiChart, eResearch, OnCore, RedCap</li><li>
Certification or planned certification through ACRP or SOCRA<br>
</li></ul><h2 class="jobSectionHeader"><b>
Work Schedule</b></h2><p>
The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.</p><h2 class="jobSectionHeader"><b>
Modes of Work</b></h2><p>
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.</p><h2 class="jobSectionHeader"><b>
Underfill Statement</b></h2><p>
This position may be underfilled at the CRC-Associate or CRC-Technician titles based on selected candidates' qualifications.</p><h2 class="jobSectionHeader"><b>
Background Screening</b></h2><p>
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.</p><h2 class="jobSectionHeader"><b>
Application Deadline</b></h2><p>
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.</p><h2 class="jobSectionHeader"><b>
U-M EEO Statement</b></h2><p>
The University of Michigan is an equal employment opportunity employer.</p></div></div></div><p></p>
<br><div><div><h3 class="jobSectionHeader"><b>Job Opening ID</b></h3>
<div><p>275216</p>
</div></div><div><h3 class="jobSectionHeader"><b>Working Title</b></h3>
<div><p>Clinical Research Intermediate/Associate</p>
</div></div><div><h3 class="jobSectionHeader"><b>Job Title</b></h3>
<div><p>Clinical Research Coord Inter</p>
</div></div><div><h3 class="jobSectionHeader"><b>Work Location</b></h3>
<div><p>Ann Arbor Campus</p>
</div></div><p>Ann Arbor, MI</p>
<div><h3 class="jobSectionHeader"><b>Modes of Work</b></h3>
<div><p>Hybrid
</p></div></div><div><h3 class="jobSectionHeader"><b>Full/Part Time</b></h3>
<div><p>Full-Time</p>
</div></div><div><h3 class="jobSectionHeader"><b>Regular/Temporary</b></h3>
<div><p>Regular</p>
</div></div><div><h3 class="jobSectionHeader"><b>FLSA Status</b></h3>
<div><p>Exempt</p>
</div></div><div><h3 class="jobSectionHeader"><b>Organizational Group</b></h3>
<div><p>Medical School</p>
</div></div><div><h3 class="jobSectionHeader"><b>Department</b></h3>
<div><p>MM Pediatrics-Hematology Oncol</p>
</div></div><div><h3 class="jobSectionHeader"><b>Posting Begin/End Date</b></h3>
<div><p>3/19/2026 - 4/20/2026</p>
</div></div><div><h3 class="jobSectionHeader"><b>Career Interest</b></h3>
<div><p>Research</p></div></div></div>

Clinical Research Intermediate/Associate

ImmunityBio, Inc.

<div>
 <strong>
  Company Overview
  <br/>
  <br/>
 </strong>
 ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient&rsquo;s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient&rsquo;s immune system and treat the host rather than just the disease.
 <br/>
 <br/>
 Why ImmunityBio?
 <br/>
 <br/>
 <ul>
  <li>
   ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
  </li>
  <li>
   Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
  </li>
  <li>
   Work with a collaborative team with the ability to work across different areas of the company.
  </li>
  <li>
   Ability to join a growing company with professional development opportunities.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Position Summary
  <br/>
  <br/>
 </strong>
 The Clinical Research Associate, In-House will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.
 <br/>
 <br/>
 <strong>
  Essential Functions
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Review of study-related materials including site initiation training slides, site specific informed consent form templates, procedures and laboratory manuals and development/procurement of applicable appendix documents
  </li>
  <li>
   Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects, safety, data evaluation methods to support review of study-related materials
  </li>
  <li>
   Track and maintain ImmunityBio study personnel list and training records for assigned studies
  </li>
  <li>
   Communicate study rationale for assigned studies to study team members and clinical sites
  </li>
  <li>
   Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
  </li>
  <li>
   Create/edit site feasibility questionnaire template, track feasibility/start-up activities
  </li>
  <li>
   Create regulatory document templates, oversee and support collection of essential documents during site start-up
  </li>
  <li>
   Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
  </li>
  <li>
   File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
  </li>
  <li>
   Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
  </li>
  <li>
   Partner with field CRAs and CTAs to resolve document issues identified during site visits
  </li>
  <li>
   Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial as well as work with SC to ensure IP temperature monitoring excursions are documented and train or assist sites with corrective actions
  </li>
  <li>
   File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
  </li>
  <li>
   File documents to the TMF on behalf of functional groups that do not have access to the TMF as needed
  </li>
  <li>
   Perform content review and post approval review of documents filed to the TMF
  </li>
  <li>
   Provide approved study manuals and form templates to clinical sites in anticipation of Site Initiation Visit
  </li>
  <li>
   Support training of suppliers, investigators, and study coordinators on study requirements and provide guidance on site issues
  </li>
  <li>
   Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
  </li>
  <li>
   Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers, create and manage site shipping accounts
  </li>
  <li>
   Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
  </li>
  <li>
   Conduct remote monitoring tasks including reconciliation of site investigational product accountability
  </li>
  <li>
   Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission, perform invoice reconciliation at site close-out
  </li>
  <li>
   Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations and functional groups as needed. Request invoice approval from internal supplier designee(s).
  </li>
  <li>
   Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
  </li>
  <li>
   Provide data listings and compile clinical study report documents to support medical writing activities
  </li>
  <li>
   Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
  </li>
  <li>
   Participate in clinical operations safety reporting activities including distribution to sites, tracking, IRB submission, TMF filing and completion of required form for updates to Safety Distribution System for site personnel or site status changes
  </li>
  <li>
   Submit clinical trial documentation to central IRB after initial submission by the CTM as needed
  </li>
  <li>
   Collaborate with other functional groups such as data management, pharmacovigilance, biostatistics etc. to ensure clinical trial activities are documented efficiently, compliant with regulations and standards, and aligned with project objectives
  </li>
  <li>
   Assist CTM with management of trial projects as delegated by the CTM
  </li>
  <li>
   Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education &amp; Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree with 4+ year experience as a Clinical Trials Associate (or 7+ years&rsquo; clinical research experience) required; or
  </li>
  <li>
   Associate&rsquo;s degree with 7+ years&rsquo; experience as a Clinical Trials Associate (or 10+ years clinical research experience) required
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Knowledge, Skills, &amp; Abilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
  </li>
  <li>
   Excellent written/oral communication skills
  </li>
  <li>
   Strong organizational and multi-tasking skills
  </li>
  <li>
   Maintain corporate confidentiality at all times
  </li>
  <li>
   Ability to set priorities and independent decision making
  </li>
  <li>
   Ability to work independently as well as in teams
  </li>
  <li>
   Strong oral and written communication skills
  </li>
  <li>
   Outgoing and confident demeanor
  </li>
  <li>
   Independent thinker and persuasive communicator
  </li>
  <li>
   Detail oriented, with solid organization and time management skills
  </li>
  <li>
   Completes projects with reliability and minimal guidance
  </li>
  <li>
   Knowledge of drug development process
  </li>
  <li>
   Computer literacy: EDC, eTMF, CTMS, etc.
  </li>
  <li>
   Working knowledge of ICH E6, and the Code of Federal Regulations
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Working Environment / Physical Environment
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate
  </li>
  <li>
   Regular work schedule is Monday &ndash; Friday, within standard business hours. Flexibility is available with manager approval.
   <br/>
   <br/>
  </li>
 </ul>
 This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate&rsquo;s qualifications, prior experience as well as geographic location.
 <br/>
 <br/>
 National Market (all markets unless identified as Premium)
 <br/>
 <br/>
 $82,000 (entry-level qualifications) to $90,200 (highly experienced) annually
 <br/>
 <br/>
 Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, &amp; Boston)
 <br/>
 <br/>
 $87,000 (entry-level qualifications) to $95,700 (highly experienced) annually
 <br/>
 <br/>
 The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
 <br/>
 <br/>
 ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
 <br/>
 <br/>
 <ul>
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   Health and Financial Wellness Programs
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   Employer Assistance Program (EAP)
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   Company Paid and Voluntary Life/AD&amp;D, Short-Term and Long-Term Disability
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   Healthcare and Dependent Care Flexible Spending Accounts
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   401(k) Retirement Plan with Company Match
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   529 Education Savings Program
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   Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
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   Paid Time Off (PTO) includes: 11 Holidays
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   Exempt Employees are eligible for Unlimited PTO
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   Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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   We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
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  </li>
 </ul>
 At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
</div>


Clinical Research Associate, In-House

ACL Digital

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  <strong>
   Title: Clinical Research Associate
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   Location: Santa Monica, CA
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   Duration: 18 months
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  <strong>
   Description:
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  Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required. Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines. Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors. Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans. Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies. Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams. May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues. May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants. Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives. Travel is required.
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  Excellent verbal, written, interpersonal and presentation skills are required. Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Ability to develop tools and processes that increase measured efficiencies of the project. Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. Must have a general understanding of functional issues and routine project goals from an organizational perspective.
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</div>


Clinical Research Associate

Castle Biosciences, Inc.

<div><p><b>Castle Biosciences Earns &quot;Top Workplaces USA Award&quot; for Phoenix, Pittsburgh, and Friendswood!</b></p><p></p><p>
Learn more at www.CastleBiosciences.com</p><p><b>
Castle Biosciences Inc. </b>is growing, and we are looking to hire a <b>full-time Clinical Research, Regulatory Associate working from our Phoenix, AZ office location,</b> with a start date of May 15, 2026.</p><p><b>
Why Castle Biosciences?</b></p><p><b>
Exceptional Benefits Package:</b></p><ul><li><b>
Excellent Annual Salary + 20% Bonus Potential</b></li><li><b>
20 Accrued PTO Days Annually + 10 Paid Holidays</b></li><li><b>
401K with 100% Company Match up to 6%</b></li><li><b>
3 Health Care Plan Options + Company HSA Contribution</b></li><li><b>
Company Stock Grant Upon Hire</b></li></ul><p><b>
A DAY IN THE LIFE OF A Regulatory Associate,</b></p><b>
The Regulatory Associate organizes and supports the day‑to‑day regulatory activities for assigned clinical studies. This role coordinates site outreach, study and site start‑up activities, IRB submissions, and ongoing electronic Trial Master File (TMF) management. A typical day includes collecting and reviewing critical regulatory documents to support study start‑up, maintenance, and close‑out, ensuring documents submitted by CRAs are complete, compliant, and filed accurately in CTMS or TMF systems. The Regulatory Associate regularly reviews TMF inventories to identify missing, incomplete, or expiring documents and communicates gaps to study team members. Serving as a regulatory resource, this role supports preparation of regulatory submissions and advises study teams on Good Clinical Practice (GCP), FDA, and applicable regulatory requirements.</b><p><b>
REQUIREMENTS</b></p><ul><li>
Bachelor's degree in a scientific, engineering, regulatory, or related field preferred, or demonstrated equivalent experience supporting medical device regulatory activities</li><li>
Minimum of 1 year of experience in medical device regulatory affairs, clinical research, or related regulated industry required</li><li>
Familiarity with medical device product development lifecycle, including design controls and risk management processes</li><li>
Working knowledge of U.S. (e.g., 21 CFR 820, 21 CFR 812), European (e.g., EU MDR 2017/745), and/or other global medical device regulations and standards (e.g., ISO 13485, ISO 14971, ISO 14155)</li><li>
Experience supporting regulatory submissions (e.g., 510(k), De Novo, Technical Documentation, IDE) preferred</li><li><b>Please see the full job description at the end of the job ad.</b></li></ul><p><b>
SCHEDULE</b></p><ul><li>
Monday-Friday, 40 hour work week, working on-site from our Phoenix, AZ office, flexible hours between 7am-5pm.</li></ul><p><b>
READY TO JOIN OUR BIOTECH TEAM?</b></p><p>
We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our <b>mobile-friendly application.</b> We're excited to learn more about you and look forward to connecting soon!</p><p><b>
Castle Biosciences Awards and Research Developments!</b></p><p></p><p><b>
WORK AUTHORIZATION</b></p><p><b>
All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.</b></p><p><b>
ABOUT CASTLE BIOSCIENCES INC.</b></p><p>
At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.
</p><p>Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both <b>challenging and rewarding</b>. We behave with <b>integrity</b> and treat our colleagues with <b>respect and kindness</b>. Our culture fosters an <b>environment of trust, transparency, and collaboration</b>. We prioritize and encourage <b>internal growth</b> and <b>professional development</b>.</p><p>
Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
</p><p>If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail <b>ReasonableAccommodationsRequest@castlebiosciences.com</b>.</p><p>
This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.</p><p>
** No third-party recruiters, please</p></div>

Clinical Research, Regulatory Associate (PHX)

IQVIA

<div><div><div>Durham, United States of America | Full time | Field-based | R1530895</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies.</i></div><div>
We&rsquo;re seeking an experienced Clinical Research Associate with <b><i>1-3 years of onsite monitoring</i></b> to oversee clinical trial sites and ensure high‑quality study execution. In this role, you&rsquo;ll monitor study activity, support site teams, and ensure adherence to protocols, regulations, and sponsor expectations. Preference would be to have oncology experience but open to other therapeutic areas.</div><div><h3 class="jobSectionHeader"><b>
Key Responsibilities</b></h3><ul><li>
Conduct site visits (selection, initiation, monitoring, and close‑out) in compliance with GCP, ICH, and study requirements.</li><li>
Partner with sites to drive patient recruitment and meet study enrollment goals.</li><li>
Provide study protocol and procedure training to site staff and maintain consistent communication to support study progress.</li><li>
Assess site performance, data quality, and regulatory compliance; escalate issues when needed.</li><li>
Track study milestones including submissions, approvals, enrollment, data entry, and query resolution.</li><li>
Ensure accurate and complete maintenance of site documentation and Trial Master File materials.</li><li>
Prepare monitoring reports, follow‑up letters, and other required documentation.</li><li>
Collaborate closely with the study team and provide support with start‑up activities as applicable.</li><li>
(If applicable) Support site‑level recruitment planning and financial management.</li></ul><h3 class="jobSectionHeader"><b>
Qualifications</b></h3><ul><li>
Bachelor&rsquo;s degree in a scientific or healthcare field (or equivalent experience).</li><li>
Minimum 1 year of on‑site clinical monitoring experience.</li><li>
Strong knowledge of GCP/ICH guidelines and clinical research regulatory requirements.</li><li>
Proficiency with Microsoft Office and digital tools (laptop, mobile devices).</li><li>
Excellent communication, organization, and problem‑solving skills.</li><li>
Ability to build strong working relationships with study teams, site staff, and sponsors.</li></ul></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be 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, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div>
The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

Cedars-Sinai Medical Center

<div><h2 class="jobSectionHeader"><b>Job Description</b></h2>
<p>
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.</p>
<p>
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.</p>
Primary Duties and Responsibilities
<ul><li>Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.</li>
<li>Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.</li>
<li>Completes Case Report Forms (CRFs). Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.</li>
<li>Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.</li>
<li>Assists with clinical trial budgets and patient research billing.</li>
<li>Responsible for sample preparation and shipping and maintenance of study supplies and kits.</li>
<li>Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.</li>
<li>Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.</li>
<li>May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.</li>
</ul><h2 class="jobSectionHeader"><b>Qualifications</b></h2>
<p><b>
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.</b></p><p><b>
Requirements:</b></p><ul><li>
High School Diploma/GED required.</li></ul><h2 class="jobSectionHeader"><b>
Preferred:</b></h2><ul><li>
Bachelor's Degree preferred.</li><li>
1 year Clinical research related experience preferred.</li></ul></div>

Clinical Research Associate I, Hybrid

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