clinical research regulatory specialist

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assistant clinical research coordinator

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assistant clinical research manager

staff research associate 1

University of California Los Angeles

<div><div>Under the direct supervision of the Principal Investigator, the research assistant will be responsible for assistance with screening and recruiting of study participants, study testing, administrative duties and data management and will assist with IRB submissions. This study, funded by the UC Tobacco-Related Disease Research Program, is focused on investigating the cardiovascular effects of exposure to secondhand flavored hookah smoke.</div> 
Salary &amp; Compensation
 
 
*UCLA provides a full pay range. Actual salary offers consider factors, including budget, prior experience, skills, knowledge, abilities, education, licensure and certifications, and other business considerations. Salary offers at the top of the range are not common. Visit UC Benefit package to discover benefits that start on day one, and UC Total Compensation Estimator to calculate the total compensation value with benefits.
 
Qualifications 
 
<ul><li>Ability to work on a per diem basis and meet the needs of the study. (Required)</li></ul>
<ul><li>Able to work collaboratively and communicate effectively with PI (Required)</li></ul>
<ul><li>Proficient in English. Demonstrates strong oral and written communication and interpersonal skills (Required)</li></ul>
<ul><li>Practice appropriate self-time management and organizational skills. (Required)</li></ul>
<ul><li>Demonstrate ability to work independently with minimal supervision (Required)</li></ul>
<ul><li>Demonstrate basic knowledge of Medical Terminology (Required)</li></ul>
<ul><li>Demonstrate ability to work with persons of various backgrounds and ethnicities. (Required)</li></ul>
<ul><li>Consistently maintain professional behavior in all interaction with co-workers and recruitment site personnel, reflecting a &ldquo;customer service&rdquo; approach. (Required)</li></ul>
<ul><li>Demonstrate professional behavior and appropriate physical attire when working with study participants (Required)</li></ul>
 
Education, Licenses, Certifications &amp; Personal Affiliations 
 
<ul><li>Bachelor's Degree in health, biologic, or social sciences; or equivalent combination of education and experience. (Required)</li></ul>
 
Special Conditions for Employment 
 
<ul><li>Background Check: Continued employment is contingent upon the completion of a satisfactory background investigation.</li></ul>
<ul><li>Live Scan Background Check: A Live Scan background check must be completed prior to the start of employment.</li></ul>
 
Schedule
 
 
TBD
 
Union/Policy Covered
 
 
RX-Research Support Professionals
 
Complete Position Description
 
 
https://universityofcalifornia.marketpayjobs.com/ShowJob.aspx?EntityID=38&amp;jobcode=TBD_4577 Apply</div>
 <div><div>Campus Requisition #:</div>
<div>11089</div>
<div>UC Payroll Title:</div>
<div>SRA 1</div>
<div>Department:</div>
<div>SCHOOL OF NURSING</div>
<div>Appointment Type:</div>
<div>4 - Staff Limited</div>
<div>Anticipated Hiring Pay Scale:</div>
<div>$30.12 Hourly</div>
<ul><li>Full Salary Range:</li></ul>
<div>USD $30.12/Hr. - USD $35.92/Hr.</div>
<div>Onsite | Remote | Hybrid Type:</div>
<div>Hybrid</div>
<div>Department Location:</div>
<div>700 Tiverton Avenue School of Nursing</div>
<div>Full or Part Time:</div>
<div>PART_TIME</div></div>

Staff Research Associate 1

University of Southern California

<div>Job ID REQ20178019 Category Libraries</div>
 <div>Founded in 1896, the Gould School of Law has a distinguished past built on the principles of equity and excellence, and the courage to break new ground. USC first introduced legal education in Southern California. Today, the Law School continues to make history through its philosophy of innovation and through its people. USC Gould cultivates analytical ability, ethical values, and a spirit of collegiality that prepare students for meaningful careers benefiting society. It was one of the first law schools to engage students in clinical programs and remains a leader in experiential education.
The Gabriel and Matilda Barnett Information Technology Center and The Asa V. Call Law Library (&ldquo;Law Library&rdquo;) supports the teaching and research activities of the USC Law community and the greater USC community. It is administered by the USC Gould School of Law. The Access Services Department is an administrative unit within the Law Library.
The Gould School of Law is seeking to hire a Law Library Supervising Assistant who will be part of a dynamic team and will be instrumental in helping us support the teaching and research activities of the USC Law community.
ATTENTION: Applicants must upload a cover letter and a resume to be considered for this position. This is a part-time (20 hours per week), 1-year fixed-term position with the possibility of extension contingent on funding and business needs.
Primary Responsibilities
<ul><li>Customer service. Works with other library staff to provide in-person services, including circulation, room reservations, library access control, and a wide range of student, faculty, and visitor needs.
</li><li>Library Service Counter operations. Assists with Service Counter operations and the day-to-day supervision of student assistants, in collaboration with other departmental staff.
</li><li>Faculty research support. Works with library staff to obtain physical and electronic research materials for law faculty and assists reference librarians with faculty research projects. Provides occasional basic reference services when librarians are unavailable.
</li><li>Course reserves and Interlibrary Loan support. Assists with course reserve operations and provides backup support for Interlibrary Loan services, including requests from faculty, students, and law journals, as needed.
</li><li>Library notices and patron records. Generates overdue, hold, and recall notices; processes renewals; and maintains patron records and circulation files.
</li><li>Library materials processing. Receives, checks in, and processes newly received library materials, including books, serials, and loose-leaf publications. Assists with filing, claiming, maintaining catalog records, communicating with vendors, and training student assistants assigned to loose-leaf maintenance.
</li><li>Library facilities support. Assists with facilities-related matters, communicates with custodial and repair staff, performs periodic walkthroughs of the library, and reports maintenance needs as assigned.
</li><li>Mail and deliveries. Assists with receiving, sorting, and distributing library mail and deliveries.
</li><li>Instructional and departmental support. Provides Legal Research course support, assists with publication and maintenance of online research guides, social media, and other departmental projects.
</li><li>Faculty scholarship support. Assists with maintaining citations to faculty publications and scholarship on the law school website.
</li><li>Statistics and reporting. Assists with collecting, maintaining, and reporting library statistics, including circulation, document delivery, and occupancy data.
</li><li>Documentation. Prepares and maintains departmental procedures manuals and other operational documentation.
</li><li>Student assistant supervision. Assists with training, supervising, and assigning work to Law Library student assistants, as needed.
</li><li>Backup staffing. May occasionally provide evening or weekend coverage, or other backup staffing during absences or periods of increased operational need.
</li><li>Law School support. Assists with final examination administration and proctoring, commencement activities, and other law school events and committees, as assigned.
</li><li>Additional duties. Performs other related duties as assigned or requested. The University reserves the right to add or modify duties at any time.
</li><li>Reporting Relationship: Reports to the Head of Access Services or the Director of the Law Library, as assigned.
</li></ul>The ideal candidate will exhibit:
<ul><li>Team mentality and commitment to supporting coworkers in order to achieve the library&rsquo;s goals.
</li><li>Reliability.
</li><li>Ability to work effectively and self-motivate, both independently and as part of a team.
</li><li>Strong organizational skills.
</li><li>Aptitude for accuracy and detailed work.
</li></ul>Preferred Qualifications:
<ul><li>3 years&rsquo; experience working in a library public services department.
</li><li>Familiarity with circulation modules of a library management system, such as Innovative Interfaces&rsquo; Sierra or Millennium.
</li><li>Experience with document search and retrieval (books, articles, etc.) in library online catalogs, databases, and/or OCLC WorldShare.
</li><li>Experience maintaining statistics.
</li><li>Familiarity with facilities and/or building maintenance issues.
</li><li>Familiarity with interlibrary loan procedures.
</li><li>Familiarity with library shelving classification systems.
</li><li>Familiarity with Quest or other project management systems.
</li><li>Proficiency in standard office software, especially MS Word &amp; MS Excel.
</li><li>Experience working with loose-leaf publications.
</li><li>Bachelor&rsquo;s degree, combined experience/education as substitute for minimum education.
</li></ul>ATTENTION: Applicants must upload a cover letter and a resume to be considered for this position. This is a part-time (20 hours per week), 1-year fixed-term position with the possibility of extension contingent on funding and business needs.
Learn more about our benefits and perks here: https://employees.usc.edu/full-time-faculty-staff/
Equity, diversity, inclusion, opportunity and access are of central importance to the Gould School of Law (Gould). Gould holds a unique position in society, and within the university, as every aspect of these principles are influenced by and can be protected through legal rules and institutions. At Gould, we are proudly committed to maintaining a community in which each person respects the rights of others to live, work, and learn in peace and dignity, to be proud of who and what they are, and to have equal opportunity to realize their full potential as individuals and members of society.
The hourly rate range for this position is $27.35 - $33.34. 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&rsquo;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: High school or equivalent Additional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 1 year Additional Experience Requirements Combined experience/education as substitute for minimum work experience Minimum Skills: Experience in and comprehensive knowledge of library operations. Ability to lead other staff in work assignments.
<div>Job ID REQ20178019 Posted Date 07/24/2026</div></div>

Supervising Library Assistant, Law Library (Part-Time)

Cedars-Sinai Medical Center

<div><div><div><div>Job ID 19244 Location Los Angeles, California, United States Job Category Academic / Research Date posted 07/24/2026
</div></div><div>
</div></div><div><h2 class="jobSectionHeader">Job Description</h2>
Are you ready to be a part of breakthrough research?
The Clinical Research Coordinator III (CRC Lead) is responsible for project allocation and immediate oversight of clinical research coordinators and clinical research associates, along with primary coordination of assigned studies. This includes managing schedules and coverage for the coordinator team, improving efficiency of research systems and processes, training of personnel, and resolution of day-to-day administrative and operational problems to ensure the successful implementation of research protocols.
Primary Duties and Responsibilities:
<ul><li>Responsible for immediate oversight of CRC team, including project allocation, staff scheduling and staff training; contributes to performance reviews for CRC team.</li>
<li>Identifies and ensures needed resources and logistics for research activities, including determining appropriate course of action in solving day-to-day research operations problems.</li>
<li>Responsible for departmental reporting related to protocol activity, accrual data, workload, and other research information; present this information to management.</li>
<li>Participates in project feasibility reviews and study initiation visits and provides strategic guidance on study set-up and implementation.</li>
<li>Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality and efficiency.</li>
<li>Provides oversight for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions.</li>
<li>Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation.</li>
<li>Provides study coordination for assigned projects, including patient screening and consenting, regulatory reporting, completion required data collection, maintenance of source documents, facilitation of all study logistics to ensure successful protocol implantation and patient safety.</li>
<li>Attend meetings and conferences related to research activities, including research staff meetings.</li>
<li>Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested.</li>
</ul><h2 class="jobSectionHeader">Qualifications</h2>
Education:
<ul><li>Bachelor's degree in a related field is required. Master's degree is preferred.</li>
</ul>Licenses and Certifications:
<ul><li>SoCRA or ACRP certification within one (1) year of hire.</li>
<li>Basic Life Support (BLS) from the American Heart Association is required.</li>
<li>Phlebotomy Certification (CPT) from CDPH is preferred.</li>
<li>Certified Registered Medical Assistant is preferred.</li>
</ul>Experience and Skills:
<ul><li>Five (5) years of clinical research coordination or related experience is required.</li>
<li>Maintains comprehensive knowledge of all departmental research protocols to ensure the compliant execution of studies in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements.</li>
<li>Ability to use software applications and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.</li>
<li>Acts as a team lead to include overseeing the work of others, assigning or allocating work to team, and ensuring tasks are completed according to deadlines and quality standards.</li>
<li>Establishes effective working relationships with cross-functional team(s)</li>
<li>Collaborates to problem solve and make decisions to achieve desired outcomes</li>
<li>Responds timely, effectively and appropriately to deliverables</li>
<li>Shares knowledge, time and expertise to assist other members of the team</li>
<li>Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups</li>
<li>Identifies and responds appropriately to both internal and external customer needs utilizing available resources</li>
<li>Represents the company with external constituents</li>
</ul>Physical Demands:
<ul><li>Able to perform moderate lifting.</li>
<li>Able to sit, stand and walk for prolonged periods of time.</li>
<li>Able to read papers and online documents.</li>
<li>Able to operate standard office equipment.</li>
<li>Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.</li>
</ul><h2 class="jobSectionHeader">About Us</h2>
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
<h2 class="jobSectionHeader">About the Team</h2>
With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai&rsquo;s medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.
</div><div><div>Req ID 19244</div> <div>Working Title Clinical Research Coordinator III - Cardiology</div> <div>Department Cardiology - Towers</div> <div>Business Entity Cedars-Sinai Medical Care Foundation</div> <div>Job Category Academic / Research</div> <div>Job Specialty Research Studies/ Clin Trial</div> <div>Overtime Status EXEMPT</div> <div>Primary Shift Day</div> <div>Shift Duration 8 hour</div> <div>Base Pay $85,280 - $132,184</div></div></div>
 <div><div><h3 class="jobSectionHeader">Diversity and Inclusion at Cedars-Sinai</h3>
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve &ndash; because that&rsquo;s what our patients, colleagues and communities deserve Quality Care and Research&mdash;For All, By All.
</div><div><h3 class="jobSectionHeader">Cedars-Sinai is an Equal Employment Opportunity employer.</h3>
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.</div></div>

Clinical Research Coordinator III - Cardiology

Easterseals Southern California

<div>Easterseals Southern California transforms lives every day. For over a century, Easterseals has championed inclusion and independence&mdash;delivering essential services like early childhood programs, autism services, employment and independent living support to more than 29,000 people each year. Through advocacy and education, we break barriers and create opportunities for the one-in-four Americans with disabilities.
Starting salary $78,000 annually.
OVERVIEW OF POSITION: Under general supervision, monitors and analyzes the clinical quality of assigned social skills groups; maintains group capacity; provides caregiver training; and provides supervision of direct reports. Functions as a liaison between organization, families, community, and health care providers to ensure a clear work flow of referral, screening, intervention, and transition of all participants receiving social skills services. Monitors the productivity of direct reports and maintains productivity standards as set forth by the agency.
ESSENTIAL FUNCTION:<ul><li>
Creates regional inquiry lists of potential social skills participants. Maintains trial exposures for participants to maintain group capacity of all assigned groups. Manages attendance compliance of a minimum of 80% across all groups assigned. Oversees the trial exposure process for all participants and associates. Monitors the accurate billing of direct reports across assigned social skills groups.</li><li>
Creates initial treatment plans, generates progress reports and term reports of all social skills participants. Leads caregiver training activities, ensuring caregiver involvement and accomplishment of caregiver goals set forth within the authorized period of service. Connects families with community resources and agencies who serve children and adults, as needed.</li><li>
Leads a team a of Social Skills associates; analyzes data collected by the team and guides treatment decisions accordingly; initiates lesson plans for assigned groups; conducts regular staff meetings with team and provides ongoing direction and guidance.</li><li>
Manages parent inquiries and reports parent concerns to Manager. Addresses associate inquiries and concerns. Maintains safety regulations set forth across all Easterseals Center Sites and reports all safety violations to Manager.</li><li>
Conducts assessments and provides supervision to Social Skills associates and participants to meet monthly productivity requirements as set forth by the agency.</li><li>
Maintains materials for Social Skills Group, re-stocking supplies as needed. Manages social skills administrative work tasks (creating materials, inputting data, purging data, etc.) of assigned team members.</li><li>
Performs other duties as assigned.</li></ul>
EDUCATION:<ul><li>
Typically requires a Master&rsquo;s degree from an accredited college or university with a concentration in early childhood education/development, early childhood special education, special education, psychology or related field.</li><li>
Requires a Board-Certified Behavior Analyst (BCBA) certification in good standing or Marriage Family Therapist (MFT) or licensed psychologist.</li></ul>
EXPERIENCE:<ul><li>
3 years of related professional experience working with children with Autism Spectrum Disorders (ASD) in a multi-disciplinary team setting.</li><li>
1-2 years&rsquo; of management experience.</li><li>
Specific locations will require 1-2 years experience in delivery of telehealth treatment AND 1-2 years experience working with adults with Autism Spectrum Disorders (ASD) in a multi-disciplinary team setting.</li></ul>
KNOWLEDGE, SKILLS, ABILITIES:<ul><li>
Strong clinical, administrative, and leadership skills.</li><li>
Demonstrated proficiency in Microsoft Office Applications (Outlook, Word, Excel, etc.).</li><li>
Expert knowledge of scientifically-validated methodologies and behavioral analytic approaches found to benefit children with ASD; familiar with current related research findings.</li><li>
Able to interpret and implement policies, procedures, and regulations.</li><li>
Able to consistently demonstrate good judgment and decision-making skills.</li><li>
Ability to maintain customer service orientation and professionalism in all interactions.</li><li>
Ability to communicate effectively, through oral and written skills, and work cooperatively with a variety of individuals and groups. Must relate well to adults, children and their families and maintain positive affect.</li><li>
Ability to exercise discretion, demonstrate good judgement, and maintain a high level of confidentiality to handle sensitive and confidential situations and documentation.</li><li>
Ability to exercise good judgement and maintain discretion when handling sensitive and/or confidential situations and documentation.</li><li>
Ability to pass a post-offer physical examination and a TB test.</li><li>
Ability to provide proof of required vaccinations or positive titer showing immunity. A signed declination may be acceptable for certain vaccinations.</li><li>
Ability to maintain driving record in compliance with Transportation Safety Standards; maintain auto insurance and vehicle registration.</li><li>
Ability to obtain and maintain a criminal record/fingerprint clearance from the Department of Justice and Federal Bureau of Investigation per Easterseals of Southern California and/or program requirements.</li></ul>
Carrying/Lifting: Occasional / Up to 30lbs. 
Standing: Occasional / Up to 3 hours per day 
Sitting: Occasional / Up to 3 hours per day 
Walking: Occasional / Up to 3 hours per day 
Repetitive Motion/Activity: Keyboard activity, telephone use, writing 
Visual Acuity: Able to view computer monitor and read newsprint 
Travel: Ability to travel locally 
Environmental Exposure: Good working conditions with almost complete absence of disagreeable elements. Exposure to unpleasant or hazardous working conditions (noise, heat, dust, bodily fluids, etc.) less than 5% of work time</div>

BCBA Social Skills Lead

Keck Medicine of USC

<div>Clinical Research Coordinator (eRegulatory Implementation Lead)
University of Southern California (USC)
Founded in 1880, the University of Southern California (USC) is one of the world's leading private research universities and the largest private employer in the City of Los Angeles. As a member of the Trojan Family, you will join a dynamic community of faculty, staff, students, and researchers dedicated to advancing knowledge, innovation, and excellence in education, research, and patient care.
Position Summary
The Department is seeking an experienced and highly motivated Clinical Research Regulatory Specialist to support both clinical trial operations and the implementation of a transformative electronic regulatory (eRegulatory) platform. Reporting to the Assistant Director of Clinical Research Operations , this individual will serve as the primary liaison between research teams, institutional leadership, and technology partners in the development, implementation, and optimization of the electronic Investigator Site File (eISF/eBinder) system.
This role offers a unique opportunity to lead digital transformation initiatives while ensuring regulatory compliance, operational excellence, and successful adoption of innovative clinical research technologies. The ideal candidate will combine strong clinical research experience with a passion for process improvement, training, and change management.
Key Responsibilities:
eRegulatory System Implementation and Development
<ul><li>Partner with departmental leadership to support the strategic implementation, configuration, and expansion of the selected eRegulatory platform.
</li><li>Design, map, and validate electronic binder structures, folder hierarchies, and user access permissions in alignment with industry standards and trial reference models.
</li><li>Collaborate with internal stakeholders and system implementation teams to configure workflows that support activities such as remote monitoring, electronic signatures, and eConsent processes.
</li><li>Standardize and centralize commonly used site documentation (e.g., CVs, medical licenses, FDA Form 1572s, training records) to improve efficiency and reduce duplication across studies.
</li><li>Identify opportunities to streamline regulatory processes and enhance operational effectiveness through technology-enabled solutions.
</li></ul>Training, User Support, and Leadership Collaboration
<ul><li>Serve as the departmental eRegulatory Super User and subject matter expert.
</li><li>Assist leadership in developing and maintaining standard operating procedures (SOPs), work instructions, and quick-reference guides related to eRegulatory processes.
</li><li>Provide training and ongoing support to Principal Investigators (PIs), sub-investigators, study coordinators, and research staff on system navigation, electronic signatures, document management, and task workflows.
</li><li>Facilitate onboarding sessions for new users and monitor adoption metrics to identify training needs and continuous improvement opportunities.
</li><li>Act as a resource for troubleshooting system issues and escalating concerns when appropriate.
</li></ul>Clinical Operations and Regulatory Compliance
<ul><li>Support Principal Investigators and study teams with study start-up, maintenance, continuing reviews, and close-out activities within the eRegulatory environment.
</li><li>Manage the electronic filing and maintenance of essential regulatory documents, including IRB approvals, protocol amendments, safety reports, and study correspondence, ensuring inspection readiness and audit-compliant documentation.
</li><li>Serve as a primary point of contact for clinical research associates (CRAs), monitors, and auditors, facilitating remote review of study records and electronic source documentation.
</li><li>Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor requirements across all assigned studies.
</li><li>Promote a culture of quality, compliance, and continuous process improvement within the research program.
</li></ul>Minimum Qualifications:
Education
<ul><li>Bachelor's degree in Life Sciences, Health Administration, Public Health, or a related field.
</li><li>Equivalent combinations of education and experience may be considered in lieu of a degree.
</li></ul>Experience
<ul><li>Minimum of three (3) years of experience as a Clinical Research Coordinator, Regulatory Specialist, or related clinical research professional.
</li><li>Experience supporting multiple clinical trials and regulatory requirements in an academic medical center, hospital, or research setting preferred.
</li></ul>Technical Skills
<ul><li>Proficiency with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and electronic Investigator Site Files (eISF).
</li><li>Experience with Florence eBinders, Complion, or similar eRegulatory platforms strongly preferred.
</li><li>Demonstrated ability to learn and support new technologies and digital workflows.
</li></ul>Knowledge and Competencies
<ul><li>Strong understanding of FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
</li><li>Excellent organizational, project management, and problem-solving skills.
</li><li>Exceptional attention to detail and ability to manage multiple priorities in a fast-paced environment.
</li><li>Strong interpersonal and communication skills with the ability to build consensus, influence adoption, and train diverse stakeholder groups.
</li><li>Commitment to delivering high-quality service and advancing operational excellence.
</li></ul>Follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.
This position is remote. Work hours and remote days may be subject to change depending on business needs.
The annual range for this position is $75,968.95 - $ 101,364.43 . 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
 
Addtional Experience Requirements Combined experience/education as substitute for minimum work experience
 
Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g., Google suite, Slack, Skype).
 
Preferred Education: Bachelor's degree
 
 
Preferred Experience: 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector
 
Preferred Skills: Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research. 
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 (213) 821-8100, or by email at uschr@usc.edu . Inquiries will be treated as confidential to the extent permitted by law.
<ul><li>Notice of Non-discrimination
</li><li>Employment Equity
</li><li>Read USC&rsquo;s Clery Act Annual Security Report
</li><li>USC is a smoke-free environment
</li>Digital Accessibility 
<li>
</li></ul>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:
https://wd5.myworkday.com/usc/d/inst/1$9925/9925$150974.htmld</div>

Clinical Research Regulatory Specialist

<div>Job ID REQ20178332 Category Nursing</div>
 <div>Clinical Research Regulatory Specialist - Operations
The University of Southern California (USC), founded in 1880, is one of the world&rsquo;s leading private research universities and the largest private employer in the City of Los Angeles. As a member of the Trojan Family, you will join a vibrant community of faculty, staff, students, and researchers dedicated to advancing knowledge, innovation, and excellence in education, research, and patient care.
Position Summary:
Reporting to the Assistant Director of Clinical Research Operations, the Regulatory Affairs Specialist is responsible for overseeing and managing the regulatory aspects of clinical research studies conducted through the Clinical Trials Office. This role independently manages complex, multi-phase clinical research protocols from study start-up through closeout, ensuring compliance with all applicable federal, state, local, sponsor, and institutional regulations governing human subjects research.
The Regulatory Affairs Specialist serves as the primary regulatory resource for non-cancer clinical trials and is responsible for coordinating, preparing, and maintaining regulatory documentation for industry-sponsored, federally funded, and investigator-initiated studies. The incumbent will lead regulatory-related study meetings, maintain investigator site files, ensure the timely collection and maintenance of essential documents, and support study teams in meeting all regulatory requirements throughout the lifecycle of a clinical trial.
This position plays a key role in developing and implementing processes that promote regulatory compliance, data integrity, and adherence to Good Clinical Practice (GCP), institutional standard operating procedures (SOPs), and University policies.
Key Responsibilities:
<ul><li>Manage all regulatory activities for assigned clinical research studies from study initiation through closeout.
</li><li>Prepare, submit, and track regulatory submissions, including Initial Applications, Amendments, Continuing Reviews, and Reportable Events to the Institutional Review Board (IRB), Food and Drug Administration (FDA), sponsors, and other regulatory agencies as required.
</li><li>Ensure timely reporting of regulatory submissions, adverse events, protocol deviations, and other reportable events in accordance with applicable regulations and study requirements.
</li><li>Maintain accurate and audit-ready investigator site files and essential regulatory documentation.
</li><li>Collaborate with Principal Investigators, study coordinators, sponsors, and research staff to ensure ongoing regulatory compliance.
</li><li>Serve as a liaison with regulatory and compliance entities, including the IRB, FDA, sponsor representatives, monitors, and external agencies.
</li><li>Participate in and lead study-related regulatory meetings, providing guidance on regulatory requirements and compliance considerations.
</li><li>Maintain accurate study information within the Clinical Trial Management System (OnCore) and electronic regulatory system (Florence).
</li><li>Develop and implement workflows and best practices that enhance regulatory oversight, documentation quality, and study compliance.
</li><li>Support audit and inspection readiness activities and assist with responses to regulatory findings, when necessary.
</li><li>Ensure adherence to Good Clinical Practice (GCP), institutional policies, sponsor requirements, and all applicable regulatory standards.
</li></ul>Required Qualifications:
<ul><li>Demonstrated experience preparing and submitting IRB applications, including Initial Reviews, Amendments, Continuing Reviews, and Reportable Events.
</li><li>Strong knowledge of clinical research regulatory processes and documentation requirements.
</li><li>Excellent interpersonal skills with the ability to build and maintain effective working relationships across the Health System.
</li><li>Exceptional organizational skills with meticulous attention to detail.
</li><li>Ability to effectively manage multiple priorities, adapt to changing demands, and meet critical deadlines in a fast-paced environment.
</li><li>Strong analytical and problem-solving skills, with the ability to identify issues, develop solutions, and implement corrective actions independently.
</li><li>Proven ability to exercise sound judgment, discretion, and independent decision-making.
</li><li>Excellent written and verbal communication skills.
</li><li>Ability to research, evaluate, interpret, and synthesize complex information and prepare clear, concise reports and correspondence.
</li><li>Strong customer service orientation and commitment to responsive stakeholder support.
</li><li>High level of professionalism, integrity, and discretion in handling confidential information.
</li><li>Ability to work independently while contributing effectively as part of a collaborative team.
</li><li>Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams) and virtual meeting platforms such as Zoom.
</li><li>Demonstrated ability to establish and maintain accurate files, records, and regulatory documentation.
</li><li>Experience working effectively with individuals from diverse cultural, educational, and professional backgrounds.
</li></ul>Minimum Qualifications:
<ul><li>High school diploma or equivalent combined with sufficient experience and demonstrated competencies required to successfully perform the duties of the position.
</li><li>Bachelor&rsquo;s degree preferred.
</li><li>Minimum of 3-5 years of clinical research regulatory experience as a Regulatory Affairs Coordinator (RAC) or Assistant Regulatory Affairs Coordinator, or an equivalent combination of education and experience.
</li></ul>Preferred Qualifications:
<ul><li>Working knowledge of federal, state, local, and institutional regulations governing clinical research and human subject protections.
</li><li>Experience supporting a variety of clinical trial types, including industry-sponsored, federally funded, cooperative group, and investigator-initiated studies.
</li><li>Research certification such as ACRP, SoCRA, CCRP, or equivalent.
</li><li>Current CITI Human Subjects Research certification.
</li><li>Demonstrated expertise in clinical research regulatory compliance, including Phase I-IV drug studies and medical device trials.
</li><li>Comprehensive understanding of IRB processes, FDA regulations, and regulatory requirements throughout the clinical trial lifecycle.
</li><li>Experience with Clinical Trial Management Systems (OnCore) and electronic regulatory systems (Florence) preferred.
</li></ul>Follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.
This position is remote. Work hours and remote days may be subject to change depending on business needs.
The annual range for this position is $75,968.95 - $ 101,364.43. 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 Addtional Experience Requirements Combined experience/education as substitute for minimum work experience Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g., Google suite, Slack, Skype). Preferred Education: Bachelor's degree Preferred Experience: 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector Preferred Skills: Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research.
<div>Job ID REQ20178332 Posted Date 07/30/2026</div></div>

Innovative Clinical Research Institute, LLC

Job OverviewWe are seeking a highly motivated and detail-oriented Assistant Clinical Research Manager to join our dynamic research team. In this vital role, you will support the planning, execution, and oversight of clinical trials, ensuring adherence to regulatory standards and ethical guidelines. Your energetic approach will help drive research projects forward, facilitate compliance, and maintain high-quality data collection. This position offers an exciting opportunity to contribute to groundbreaking healthcare advancements while developing your expertise in clinical research management.Responsibilities<ul><li>Assist in coordinating all phases of clinical trials, from protocol development to study completion, ensuring timely progress and compliance with regulatory standards.</li><li>Supervise research staff and study coordinators, providing guidance on clinical procedures, documentation review, and data collection methods, and at the same time, step in as study coordinator when needed.</li><li>Monitor patient safety and well-being throughout the trial process, including blood sampling, patient monitoring, and adverse event reporting.</li><li>Review study documentation for accuracy and completeness, ensuring adherence to FDA regulations, ICH GCP guidelines, and clinical ethical standards.</li><li>Manage data entry and analysis using statistical software and ensure data management practices align with CDISC standards.</li><li>Oversee compliance with healthcare regulations and clinical quality assurance standards across all research activities.</li><li>Collaborate with cross-functional teams to ensure proper use of EMR systems and adherence to project timelines in a fast-paced research setting.</li></ul>Experience<ul><li>Proven supervising experience in a clinical research environment or healthcare setting.</li><li>Strong knowledge of medical terminology, clinical laboratory procedures, and blood sampling techniques.</li><li>Experience reviewing documentation for accuracy and compliance within clinical trials or research projects.</li><li>Familiarity with statistical software tools used for data analysis in clinical studies.</li><li>Understanding of FDA regulations, ICH GCP guidelines, and healthcare compliance standards related to clinical research.</li><li>Hands-on experience with EMR systems, project management tools, and data management platforms such as CDISC standards.</li><li>Certification in ICH GCP (Good Clinical Practice) from a recognized issuer is required; valid CA certification is preferred for applicable regions.</li><li>Demonstrated ability to manage multiple projects simultaneously while maintaining attention to detail and quality assurance standards.</li><li>Minimum 2 to 5 years clinical research experience</li><li>Foreign Medical Graduate or Bachelor's Degree</li></ul>Join us in advancing healthcare through innovative research! We are committed to fostering a collaborative environment where your skills can thrive while making a meaningful impact on patient care worldwide. All roles are paid positions that support your professional growth within a vibrant research community dedicated to excellence.Pay: $29.00 - $33.00 per hourBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Employee assistance program</li><li>Employee discount</li><li>Flexible spending account</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Assistant Clinical Research Manager

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