clinical research specialist

University of Maryland, Baltimore

<div></div><div><div>The University of Maryland, Baltimore (UMB) Marlene &amp; Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has an exciting opportunity for a full-time Clinical Research Specialist for the Solid Tumor research program. Following an extensive training program, the Clinical Research Specialist will be assigned a portfolio of cutting-edge novel therapeutic trials and will be the primary interface, along with the faculty member, for cancer patients enrolled in the studies. The Clinical Research Specialist will be responsible for screening, consenting, and enrolling patients as well as subsequently guiding them through procedures and visits required by the research protocol. The Research Specialist is also responsible for data collection, resolving standard of care issues and direct research support. The Clinical Research Specialist will interface directly with the Principal investigators on the protocols within their assigned portfolio as well as the medical care team, ancillary hospital staff, Sponsor representatives, and data managers within UMGCCC.
This full-time position works Monday through Friday and work scheduling flexibility that includes working outside of normal working hours is highly preferred. 
Benefits Information
UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). 
UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.
Essential Functions<ul><li>
Performs as a single Specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities. The position develops, recommends, modifies, and implements policies and procedures for clinical research, as well as develop protocol manuals and data collection instruments. This position significantly contributes to the conduct of research.</li><li>
Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities.</li><li>
Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history. May obtain tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.</li><li>
Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access. Perform data checks, audits, and data cleaning.</li><li>
Check validity and accuracy of data ensuring compliance with quality control requirements and study relevance.</li><li>
Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data. May develop data collection instruments such as survey questionnaires.</li><li>
Maintains communication with participants and colleagues regarding protocol specific information and research orders. Provides assessments and ensure protocol compliance while participants are in a study.</li><li>
Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.</li><li>
Oversees and coordinates the day to day clinical research operations, study initiation, execution, and completion. Assist in the design and provide expert recommendation regarding research studies. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.</li><li>
May provide working coordination and feedback to others.</li><li>
Performs day-to-day operational duties such as: monitoring the budget; budget negotiation and review, ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develops policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.</li><li>
Searches relevant literature, develops conclusions on research findings, writes reports, prepare and deliver presentations of relevant findings and conclusions, and recommends appropriate actions. May conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals.</li><li>
Provides training to less experienced researchers; assisting in developing and submitting grants, papers, abstracts, manuscripts and presenting studies; developing protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals, institutions, government agencies, and funding agencies; and participating in the design of research studies.</li><li>
Performs other duties as assigned.</li></ul><div>
</div></div><div>
Qualifications<div></div> 
Education: Bachelor's degree in a scientific field of study or related to the research of the clinical setting. 
Experience: Three (3) years of clinical research including two (2) years in the relevant research specialization. Prior experience with patients and patient interaction preferred. 
Other: Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted.
Some schedule flexibility is highly preferred. 
Knowledge, Skills, and Abilities<ul><li>
Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications. 
</li><li>
Ability to perform independent projects. 
</li><li>
Ability to network with and provide information to key groups and individuals, and work as part of a team. 
</li><li>
Knowledge of human subjects research, the regulations and policies surrounding it. 
</li><li>
Ability to represent the Cancer Center and its faculty in a professional manner. 
</li><li>
Ability to keep patient information confidential and possess knowledge of HIPPA regulations.</li></ul> 
Hiring Range: $65,000 - $75,000, commensurate with education and experience. 
UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.
If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request. You may also contact leave_and_accom@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address. 
 
The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.<div> 
</div></div><div>
Job: Reg or CII Exempt Staff - E3304E</div><div>
Employee Class : Exempt Regular</div><div>
Full Time/Part Time: Full-Time</div><div>
Shift: Day Job</div><div>
Financial Disclosure: No</div><div>
Organization: School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center</div><div>
Job Posting: Jul 28, 2026</div><div>
Unposting Date: Aug 11, 2026, 10:59:00 PM</div></div>

Clinical Research Specialist

Hospital Sisters Health System

<div>Pay Range:
$22.05 - $33.08<div><div><div><div><div><div><div>
A successful candidate's actual pay rate will be based on several factors including relevant experience, skills, training, certifications and education.</div></div></div></div></div></div></div>
Hospital Sister Health System is seeking a Clinical Research Specialist who coordinates research activities across treatment sites to maintain quality and promote efficiency relative to the clinical activities of the applicable entity, service line, or other component of the HSHS system. This position is also responsible for ensuring compliance with regulatory requirements for all applicable study protocols and assists front line research study personnel in all research study activities. 
 
Position Specifics: 
Department: Prairie Education Research
 
Core Function: Clinical Research 
Schedule: Days, Monday-Friday (no holidays, weekends, or call), 8:00 AM - 4:30 PM 
Facility: Springfield - St. John's Hospital 
Location: Springfield, IL 
Compensation that aligns with your experience 
Education Qualifications<ul><li>
Associate degree in a science or healthcare related field or a degree in nursing required; high school diploma plus 3 years of relevant experience may be considered in lieu of degree.</li><li>
A bachelor&rsquo;s degree in a healthcare related field is preferred.</li></ul>
Experience Qualifications 
<ul><li>
Two years of experience in a health care related; two years of experience in research is preferred.</li></ul>
Certifications, Licenses and Registrations<ul><li>
Research certification preferred.</li><li>
Human Subject Protection and Good Clinical Practices Training through the Collaborative Institutional Training Initiative (CITI) required within 30 days of hire.</li></ul>
Scheduled Weekly Hours:
40
Throughout communities in Illinois and Wisconsin, 13 hospitals, numerous community-based health centers and clinics, our 13,000+ colleagues have built a culture based on our solid core values of respect, care, competence, and joy. These are the ideals we believe in, work by, and live each day.
Built upon more than 145 years of service to the communities we serve, we now look to the future and our place in it as a health care system that strives to continually improve processes, procedures, and outcomes with the latest and most advanced technologies and treatments.
Regardless of how far our passion for excellence carries us, our focus will always remain on the most important person in our entire organization: The patient.
Benefits: HSHS provides a benefits package designed to support the overall well-being of our colleagues including their physical, emotional, financial, spiritual, and work health. Colleagues budgeted to work at least 32 hours per pay period are eligible for HSHS benefits.<ul><li>
Comprehensive and affordable health coverage includes medical, prescription, dental and vision coverage for full-time and part-time colleagues.</li><li>
Paid Time Off (PTO) combines vacation, sick, and personal days into one balance to allow you the flexibility to use your time off as you need.</li><li>
Retirement benefits including HSHS 
contributions.</li><li>
Education Assistance benefits include up to $5,250 of educational assistance each calendar year and tuition discounts to select colleges with no waiting period.</li><li>
Adoption Assistance provides financial support up to $7,500 for colleagues growing their families through adoption to reimburse application and legal fees, transportation, and more!</li><li>
Other benefits include: Wellness program with incentives, employer-paid life insurance and short-term and long-term disability coverage, flexible spending accounts, employee assistance program, ID theft coverage, colleague rewards and recognition program, discount program, and more!</li></ul>
Benefits
HSHS and affiliates is an Equal Opportunity Employer (EOE).
HSHS is proud to be an equal opportunity workplace dedicated to pursuing and hiring a diverse workforce.
Notice Regarding Potential Use of Artificial Intelligence in the Hiring Process
Hospital Sisters may use automated tools, including artificial intelligence or machine-learning technologies, to assist with certain administrative aspects of the recruitment process. These tools may help our recruiting team organize applications, search for resumes, identify qualifications reflected in application materials, and facilitate communications or scheduling with applicants.
Information used by these tools may include materials you provide during the application process, such as your resume, work history, education, qualifications, and responses to application questions.
These tools are used only to support our recruiting process. Hiring decisions are made by HSHS personnel, and automated tools do not make employment decisions on behalf of HSHS.
Applicants who have questions about this notice or who require a reasonable accommodation or alternative evaluation method may contact HSHS Human Resources at Contact@hshs.org</div>

Indiana University

<div>Department
MMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
Department Information
One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for NIH Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.
Job Summary
Department Specific Responsibilities<ul><li>
Assists study team in managing travel arrangements for participants with Parkinson's disease, or with an increased risk for developing Parkinson's disease.</li><li>
Processes reimbursements and coordinate with clinical research teams across the US and Canada to aid in study retention.</li></ul>
General Responsiblities<ul><li>
Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.</li><li>
Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.</li><li>
Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders.</li><li>
Monitors study team compliance with protocol and standard operating procedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.</li><li>
Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.</li><li>
Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.</li><li>
Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).</li><li>
May provide guidance and/or support to less experience clinical research staff.</li></ul>
Qualifications
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education
EDUCATION/ WORK EXPERIENCE
Required<ul><li>
Bachelor's degree in science or a health-related field and 1 year of health-related or research experience. OR</li><li>
Associate's degree in an allied health profession and 3 years of health-related or research experience.</li></ul>
SKILLS
Required<ul><li>
Proficient communication skills.</li><li>
Maintains a high degree of professionalism.</li><li>
Demonstrates time management and priority setting skills.</li><li>
Demonstrates a high commitment to quality.</li><li>
Possesses flexibility to work in a fast paced, dynamic environment.</li><li>
Highly thorough and dependable.</li><li>
Possesses a high degree of initiative.</li><li>
Ability to build strong customer relationships.</li></ul>
Working Conditions / Demands
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
Additional Information
This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.
This position is not eligible for visa sponsorship.
Work Location
IU Indianapolis
This position is eligible for remote work or in-person work. However, this is subject to change in the future based on university policy and business needs.
Advertised Salary
$47,589.00 per year to $52,589.00 per year based upon experience and internal equity within the department.
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:<ul><li>
Comprehensive medical and dental insurance</li><li>
Health savings account with generous IU contributions</li><li>
Healthcare and dependent care flexible spending accounts</li><li>
Basic group life insurance paid by IU</li><li>
Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance</li><li>
Base retirement plan with generous IU contributions, subject to vesting</li><li>
Voluntary supplemental retirement plan options</li><li>
Tuition subsidy for employees and family members taking IU courses</li><li>
10 paid holidays plus a paid winter break each year</li><li>
Generous paid time off plans</li><li>
Paid leave for new parents and IU-sponsored volunteer events</li><li>
Employee assistance program (EAP)</li></ul>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Mastery
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.
Contact Us
Request Support 
Telephone: 812-856-1234</div>

Louisiana State University

<div><div><div><div><div><div><div><div><h2 class="jobSectionHeader">About Us:</h2></div></div></div></div></div></div></div><div><div><div><div><div><div><div>
At the forefront of medical discovery as it relates to understanding the causes of obesity, diabetes, cardiovascular disease, cancer and dementia, Pennington Biomedical Research Center is a campus of Louisiana State University and conducts basic, clinical and population research. The Center includes Basic Science, Clinical Research, and Population and Public Health, enabling both focused research and translational science. Research at Pennington Biomedical is supported broadly by multiple NIH Research Centers, and includes approximately 65 faculty and 20 postdoctoral fellows who comprise a network of 44 laboratories and 13 highly specialized core service facilities. Pennington Biomedical is located within state-of-the-art research facilities on a 222-acre campus in Baton Rouge, Louisiana.</div></div></div></div></div></div></div><h2 class="jobSectionHeader">
All Job Postings will close at 12:01a.m. CST (1:01a.m. EST) on the specified Closing Date (if designated).</h2><h2 class="jobSectionHeader">
If you close the browser or exit your application prior to submitting, the application progress will be saved as a draft. You will be able to access and complete the application through &ldquo;My Draft Applications&rdquo; located on your Candidate Home page.</h2><h2 class="jobSectionHeader">
Job Posting Title:</h2>
Clinical Research Specialist 1, 2, or 3 - Mass Spectrometry 
<h2 class="jobSectionHeader">Position Type:</h2>
Professional / Unclassified 
<h2 class="jobSectionHeader">Department:</h2>
LSUPBRC Cores - Mass Spectonomy Stable Isotopes and Energy Expenditure (Valery Berrigan Hymel (00007182)) 
<h2 class="jobSectionHeader">Work Location:</h2>
LSU - Pennington Biomedical 
<h2 class="jobSectionHeader">Pay Grade:</h2>
Professional 
<h2 class="jobSectionHeader">Job Description:</h2>
Pennington Biomedical Research Center, a world-renowned academic research institute of Louisiana State University, is seeking a Clinical Research Specialist in the Stable Isotopes and Mass Spectrometry Laboratory.
As part of a career progression group, this vacancy may be filled as a Clinical Research Specialist 1, 2, or 3 depending on the level of experience of the selected applicant.
The Clinical Research Specialist will be responsible for operating and maintaining mass spectrometry instruments, developing and optimizing analytical methods, and preparing and processing biological samples. Key duties include data analysis, maintaining accurate records, and collaborating with interdisciplinary teams. The role also involves preparing supplies and specimens for shipping and contributing to various research projects. This position offers an exciting opportunity to work on cutting-edge research and make significant contributions to our scientific endeavors.
Major Responsibilities<ul><li>
Operate, calibrate, and perform routine maintenance on mass spectrometry instruments and related laboratory equipment to ensure reliable operation.</li><li>
Prepare biological samples for mass spectrometry analysis by following established laboratory procedures for sample processing and quality control.</li><li>
Perform mass spectrometry analyses, review data for accuracy, and assist in interpreting and reporting research results.</li><li>
Help develop and improve laboratory methods and procedures to support research projects and ensure consistent, high-quality data.</li><li>
Maintain accurate laboratory records, including experimental procedures, instrument maintenance, and research data.</li><li>
Assist with the preparation of scientific reports, manuscripts, presentations, and grant materials.</li><li>
Prepare laboratory supplies, biological specimens, and research materials for shipping in accordance with laboratory and institutional procedures.</li><li>
Collaborate with investigators and research staff by providing technical support for studies involving stable isotopes and mass spectrometry.</li><li>
Maintain laboratory inventory, order supplies, and help ensure the laboratory remains organized, clean, and compliant with safety requirements.</li><li>
Perform other related duties as assigned in support of the laboratory's research programs.</li></ul>
Required Qualifications
Clincial Research Specialist 1 - Entry level with basic duties and responsibilities.<ul><li>
Bachelor&rsquo;s degree in Biology, Chemistry, Biochemistry, Biomedical Sciences, or a related scientific field.</li><li>
Exposure to laboratory research through academic coursework, laboratory classes, undergraduate research, or internships is preferred.</li><li>
Demonstrated proficiency in laboratory research methods, procedures, and analytical techniques.</li><li>
Ability to operate, maintain, and troubleshoot laboratory equipment while following established protocols.</li><li>
Ability to collaborate effectively with researchers, laboratory personnel, and interdisciplinary teams.</li><li>
Ability to organize, prioritize, and manage multiple research projects, experiments, and deadlines.</li><li>
Ability to learn new laboratory techniques, instrumentation, and research methodologies.</li></ul>
Clincial Research Specialist 2 - Differs from Clinical Research Specialist 1 by working more independently and taking on greater responsibility.<ul><li>
Bachelor&rsquo;s degree in Biology, Chemistry, Biochemistry, Biomedical Sciences, or a related scientific field.</li><li>
Minimum of two (2) years of laboratory research experience in an academic, clinical, or relevant setting.</li><li>
Experience with biological sample preparation, laboratory instrumentation, data collection, and maintaining accurate research records.</li><li>
Ability to accurately collect, analyze, and maintain research data and laboratory records.</li><li>
Knowledge of quality control practices and the ability to ensure accuracy and reproducibility of laboratory results.</li></ul>
Clincial Research Specialist 3 - Differs from Clinical Research Specialist 2 by the presence of mentoring junior staff and contributing to protocol development.<ul><li>
Bachelor's degree in Biology, Chemistry, Biochemistry, Biomedical Sciences, or a related scientific field.</li><li>
Minimum of four (4) years of progressively responsible laboratory research experience.</li><li>
Demonstrated experience operating and maintaining laboratory instrumentation, analyzing research data, implementing laboratory procedures, and supporting multiple research projects.</li><li>
Experience training or mentoring laboratory personnel and assisting with laboratory operations is preferred.</li></ul>
Pennington Biomedical Research Center seeks to recruit a highly productive workforce with a broad range of backgrounds and perspectives and will provide equal employment opportunities to all employees and prospective employees. Employment decisions shall be based strictly on merit and without regard to religious or political beliefs, sex, race, or any other non-merit factor. 
<h2 class="jobSectionHeader">Additional Job Description:</h2><h2 class="jobSectionHeader">
Competencies:</h2>
None<h2 class="jobSectionHeader">
Special Instructions:</h2>
Interested candidates should include a resume and a list of three (3) professional references to the online application. Professional references should be the name, title, company, and contact information from past employers. Professional references should include current or previous supervisors and/or coworkers. Personal references should not be considered for the reference check process. We will respect the request that we not contact a current employer. However, we will need to contact a prior supervisor if such a request is made. 
 
A letter of application/cover letter is recommended but not required. Official transcripts are required prior to hire and are not required at the time of application. 
<h2 class="jobSectionHeader">Posting Date:</h2>
July 29, 2026 
<h2 class="jobSectionHeader">Closing Date (Open Until Filled if No Date Specified):</h2>
August 12, 2026 
<h2 class="jobSectionHeader">Additional Position Information:</h2>
Pennington Biomedical is located within state-of-the-art research facilities on a 222-acre campus in Baton Rouge, Louisiana. For more information, visit PBRC.
Questions regarding career opportunities at Pennington Biomedical should be sent to hrm@pbrc.edu.
Background Check - An offer of employment is contingent on a satisfactory pre-employment background check.<div><div><div><div><div><div><div>
Benefits - Pennington Biomedical Research Center offers outstanding benefits to eligible employees and their dependents including health, life, dental, and vision insurance; flexible spending accounts; retirement options; various leave options; paid holidays; wellness benefits; tuition exemption for qualified positions; training and development opportunities; employee discounts; and more!</div></div></div></div></div></div></div><div><div><div><div><div><div><div> 
</div></div></div></div></div></div></div><div><div><div><div><div><div><div>Positions approved to work outside the State of Louisiana shall be employed through Louisiana State University&rsquo;s partner, nextSource Workforce Solutions, for Employer of Record Services including but not limited to employment, benefits, payroll, and tax compliance. Positions employed through Employer of Record Services will be offered benefits and retirement as applicable through their provider and will not be eligible for State of Louisiana benefits and retirement.</div></div></div></div></div></div></div> 
<h2 class="jobSectionHeader">Essential Position (Y/N):</h2> 
<h2 class="jobSectionHeader">Pennington Biomedical Research Center/LSU is an Equal Opportunity Employer.</h2> 
<h2 class="jobSectionHeader">Contact Information:</h2>
Questions or concerns can be directed to PBRC Human Resources at 225-763-2776 or hrm@pbrc.edu.</div>

Clinical Research Specialist 1, 2, or 3 - Mass Spectrometry

University of Miami

<div>Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet .
The Department of Surgery is currently seeking a temporary Clinical Research Data Specialist to work part time hours in Miami.
CORE JOB SUMMARY
 
The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
 
 
CORE JOB FUNCTIONS
<ul><li>Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
</li><li>Manages a workload of studies commensurate to level of experience
</li><li>Answers data clarifications (i.e., data queries) for each study.
</li><li>Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
</li><li>Develops source data worksheets specific to each assigned study.
</li><li>Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
</li><li>Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
</li><li>Maintains logs (i.e., TAS submissions, Velos etc.) in a timely manner according to department SOPs.
</li><li>Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
</li><li>Assists multidisciplinary team in research activities.
</li><li>Maintains study binders and filings according to protocol requirements and department policy.
</li><li>Adheres to all UM and department policies and procedures.
</li><li>Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
</li><li>Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
</li><li>Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
</li><li>Adheres to University and unit-level policies and procedures and safeguards University assets. 
</li></ul> 
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
 
 
CORE QUALIFICATIONS
<ul><li>High School Diploma or equivalent/relevant experience, certification or license
</li><li>No previous experience required
</li><li>Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
</li><li>Teamwork: Ability to work collaboratively with others and contribute to a team environment.
</li><li>Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
</li><li>Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. 
</li></ul> 
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status:
Part time
Employee Type:
Temporary</div>

Clinical Research Data Specialist

University of Southern California

<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>

Clinical Research Regulatory Specialist

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>

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