clinical research specialist

University of Maryland, Baltimore

<div></div><div><div><p><b>The Division of Transplant Surgery at the University of Maryland, Baltimore (UMB) are currently seeking a</b> <b>FULL-TIME</b> <b>Clinical Research Specialist to join their fast-paced, high-reward clinical research team.</b></p><p>
The University of Maryland organ transplant center is one of the largest in the United States, performing more than 400 transplants per year, including 300 kidneys, 80 livers, 20 pancreas, and 45 thoracic transplants. The clinical center receives more than 1,500 new patient referrals each year and follows more than 4,800 patients who have been transplanted over the last two decades, as well as more than 1,400 patients on the organ transplant waiting lists.<br>
Our leaders hold national and international prominence in their fields and have translated their discoveries into clinical management guidelines. We are one of only two transplant centers serving more than 5 million people in Maryland.</p><p>
The position is responsible for assisting with coordinating the day-to-day operations of one or more research studies or clinical trial protocols. The position coordinates data collection and maintenance, project evaluation, meeting scheduling, and research subject interfacing. The Clinical Research Project Assistant adheres to good clinical practices, study protocols, and applicable regulations, conducts complex work, contributes to measurable team objectives, and uses discretion to solve issues. The position will work in the Division of Transplant Surgery at the University of Maryland, Baltimore School of Medicine. The division of Transplant Surgery is located within the School of Medicine at the University of Maryland, Baltimore, and maintains a large research portfolio involving the heart, lung, liver, kidney, and pancreas.</p><p></p><p><b><br>
BENEFITS (Exempt Regular):</b></p><p>
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 (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave days, 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).</p><p><b>
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.</b></p><p></p><p><b><br>
PRIMARY DUTIES</b></p><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.<br>
<ul><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></ul></li><li>
Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access. Perform data checks, audits, and data cleaning. 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><b>
Qualifications</b><div></div><p><b><br>
MINIMUM QUALIFICATIONS</b></p><p><b>
Education:</b> Bachelor's degree in a scientific field of study related to the research of the clinical setting.</p><p><b>
Experience:</b> Three (3) years clinical research including two (2) years in the relevant research specialization.</p><p><b>
Supervisory Experience: </b>N/A</p><p><b>
Certification/Licensure:</b> N/A</p><p><b>
Other: </b>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.</p><p><b><br>
KNOWLEDGE, SKILLS, ABILITIES</b></p><p>
Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.</p><p></p><p><b><br>
HIRING RANGE:</b> $64,000 - $75,000 per year / Commensurate with education and experience</p><p></p><p><br>
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.</p><p>
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.</p><p>
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.</p><div><br>
</div></div><div><b>
Job</b><b>:</b> Reg or CII Exempt Staff - E3304E</div><div><b>
Employee Class </b><b>:</b> Exempt Regular</div><div><b>
Full Time/Part Time</b><b>:</b> Full-Time</div><div><b>
Shift</b><b>:</b> Day Job</div><div><b>
Financial Disclosure</b><b>:</b> No</div><div><b>
Organization</b><b>:</b> School of Medicine - Surgery</div><div><b>
Job Posting</b><b>:</b> Apr 7, 2026</div><div><b>
Unposting Date</b><b>:</b> Apr 15, 2026, 10:59:00 PM</div></div>

Clinical Research Specialist

Temple University Health System

<div></div><div><div><p>The Temple University&rsquo;s Lewis Katz School of Medicine&rsquo;s Division of Gastroenterology Department is searching for a <b>Clinical Research Specialist </b>to join our team!</p><p><b>
Become a part of the Temple family and you will have access to the following:</b><br>
<i>Full medical, dental, vision coverage</i><br>
<i>Paid time off</i><br>
<i>11 Paid Holidays</i><br>
<i>Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE</i><br>
<i>A generous retirement plan and so much more!</i><br>
<br>
<b>Salary Grade: T24</b><br>
Learn more about the &ldquo;T&rdquo; salary structure</p><p><b>
Salary Range: Up to $52,000.00 per year</b><br>
<i>A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant&rsquo;s education and experience, all relevant internal equity considerations, department budget, and funding source.</i></p><div><b>
Job Details:</b><br>
<ul><li>This position is full-time</li><li>This position will be on-site</li><li>This position requires the following background checks: Personally Identifiable Information/Cash Handling</li></ul></div><p><b>
Position Summary:</b><br>
The Division of Gastroenterology at Temple University Lewis Katz School of Medicine is seeking a highly motivated individual to assist with ongoing research projects in the field of Gastroenterology involving the areas of gastrointestinal motility and gastroparesis.</p><p>
This person will work closely with the principal investigator (Dr. Henry Parkman) on projects. These studies involve disorders of gastric motility and function such as gastroparesis, functional dyspepsia, and chronic nausea and vomiting. The individual should be energetic, and willing to work with others on a variety of projects.</p><p>
This position will play an important part in the success of the research studies and must be able to work independently and within a team. In this capacity, this person will work closely with the principal investigator on the primary project which will involve assessing gastrointestinal motility as measured by high resolution electrogastrography (EGG).</p><p>
Responsibilities include patient recruitment, screening, obtaining informed consent, and enrolling research subjects in clinical studies, coordinating research-related tests, scheduling study visits, performing the high-resolution EGG studies, data collection, data entry and regulatory submissions (IRB).</p><div><b>
Required Education and Experience:</b><br>
<ul><li>Bachelor&rsquo;s degree in a life science or other health professions field and a minimum of two years of related experience.</li><li>An equivalent combination of education and experience may be considered.</li></ul></div><div><b>
Essential Functions of Position:</b><br>
<ul><li>Perform high resolution electrogastrographic (EGG) recordings on patients and normal subjects.</li><li>Primary contact for research subjects</li><li>Manage data collection, data entry, and processing</li><li>Present project updates at clinical research meetings</li><li>Day to day management of research project activities</li><li>Assist with conducting clinical trials</li><li>Performs other duties as assigned</li></ul></div><div><b>
Required Skills and Abilities:</b><br>
<ul><li>Strong knowledge of computer programs, computer spreadsheets &amp; data analysis.</li><li>Excellent written and oral communications skills</li><li>Able to resolve problems/issues</li><li>Detail oriented</li><li>Knowledge of medical terminology</li><li>Flexible in an ever-changing environment</li><li>Proficient in standard computer programs (word, excel, PowerPoint, etc.)</li><li>Conduct oneself in a professional and courteous manner</li></ul></div><div><b>
Additional Miscellaneous Information:</b><br>
<ul><li><b>This position requires PII/Cash Handling Clearance prior to the commencement of service</b></li></ul></div><p><b>
Temple University </b>is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.<br>
<br>
<b>Compliance Statement:</b> In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.<br>
<br>
<b>Temple University's Annual Security and Fire Safety Report</b> contains statistics, policies, and procedures related to campus safety. Go here to review.<br>
<br>
You may request a copy of the report by calling Temple University&rsquo;s <b>Campus Safety Services at 215-204-7900</b>.</p></div></div><p></p>

Indiana University

<div><p><b>Department</b></p><p>
MMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
</p><p><b>Department Information</b></p><p>
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.</p><p><b>
Job Summary</b></p><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><p><b>
Qualifications</b></p><p><i>
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.</i></p><p>
</p><p>EDUCATION/WORK EXPERIENCE</p><p><b>
Required</b></p><ul><li>
Bachelor's degree in science or a health-related field and 1 year of health-related or research experience. <b>OR</b></li><li>
Associate's degree in an allied health profession and 3 years of health-related or research experience.</li></ul><p>
SKILLS</p><p><b>
Required</b></p><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><p><b>
Working Conditions / Demands</b></p><p>
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.</p><p><b>
Additional Information</b></p><p>
This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.</p><p>
This position is not eligible for visa sponsorship.</p><p><b>
Work Location</b></p><p>
IU Indianapolis</p><p>
This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.
</p><p><b>Advertised Salary</b></p><p>
$41,924.80 per year to $46,924.80 per year based upon experience and internal equity within the department.
</p><p><b>Benefits Overview</b></p><p>
For full-time staff employees, Indiana University offers a wide array of benefits including:</p><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><p>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.</p><p><b>
Job Classification</b></p><p>
Career Level: Mastery</p><p>
FLSA: Nonexempt</p><p>
Job Function: Research</p><p>
Job Family: Clinical Research</p><p></p><p><b><br>
Posting Disclaimer</b></p><p>
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.</p><p>
If you wish to include a cover letter, you may include it with your resume when uploading attachments.</p><p><b>
Equal Employment Opportunity</b></p><p>
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.</p><p><b>
Campus Safety and Security</b></p><p>
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.</p><p><b>
Contact Us</b></p><p>
Request Support<br>
Telephone: 812-856-1234</p></div>

<div></div><div><div><p>Temple University&rsquo;s Lewis Katz School of Medicine&rsquo;s Clinical Research Coordinator Department is searching for a <b>Clinical Research Specialist-Katz</b> to join our team!</p><p><b>
Become a part of the Temple family and you will have access to the following:</b><br>
<i>Full medical, dental, vision coverage</i><br>
<i>Paid time off</i><br>
<i>11 Paid Holidays</i><br>
<i>Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE</i><br>
<i>A generous retirement plan and so much more!</i><br>
Click here to learn more about the benefits of working at Temple University.</p><p><b>
Salary Grade: T24</b><br>
Learn more about the &ldquo;T&rdquo; salary structure.</p><p><b>
Salary Range: Up to $52,000.00 per year</b><br>
<i>A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant&rsquo;s education and experience, all relevant internal equity considerations, department budget, and funding source.</i></p><p><b>
This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details.</b></p><div><b>
Job Details:</b><br>
<ul><li>This position will be on-site</li><li>This position requires the following background checks: PII/Cash Handling</li><li>This is a grant funded position</li></ul></div><p><b>
Position Summary:</b><br>
The Clinical Research Specialist works under the leadership of the Principal Investigator and/or other Research Staff and is responsible for specific research tasks associated with clinical research projects or clinical trials, ensuring high-quality data collection, regulatory compliance, and seamless study operations. As a Clinical Research Coordinator, you will also have the opportunity to advance your career through our structured career ladder.</p><p>
At Temple University&rsquo;s Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine.</p><p>
This is a grant-funded position and requires a background check. Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator. Hybrid work options may be considered depending on study and departmental needs.</p><div><b>
Required Education and Experience:</b><br>
<ul><li>Bachelor's degree in a life science or other health professions field and a minimum of two years of related experience.</li><li>An equivalent combination of education and experience may be considered.</li></ul></div><p><b>
Responsibilities:</b><br>
The Clinical Research Specialist supports study coordination activities under the direction of senior staff, following established protocols and procedures. The Specialist performs routine tasks to help ensure the accurate and compliant execution of clinical research projects and refers decisions requiring interpretation of policies or procedures to the Clinical Research Coordinator or other supervisors.</p><ul><li>Perform day-to-day activities of all assigned research projects and clinical trials.</li><li>Screens, tracks, and enrolls patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University. Schedule and attend sponsor visits.</li><li>Enrolls human subjects for clinical trials. Obtains informed consent, schedules subjects for visits, performs clinical assessments and collects and enters study data.</li><li>Performs various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data.</li><li>Organizes and maintains documentation required for clinical trials and/or other research projects. Maintains up-to-date regulatory binders.</li><li>Inform the Principal Investigator or designated individual about any issues regarding patient responses to treatment, medication, or adverse effects.</li><li>May submit IRB paperwork to ensure compliance with IRB regulations.</li><li>Adheres with FDA, IRB, Pennsylvania, and other applicable regulations.</li></ul><div><b>
Other duties and responsibilities:</b><br>
<ul><li>May present project updates at clinical research meetings and/or assist with grant or manuscript preparation.</li><li>Performs other duties as assigned.</li></ul></div><div><b>
Required Skills and Abilities:</b><br>
<ul><li>Demonstrated computer skills, and proficiency with MS Office Suite software programs.</li><li>Aptitude in professionalism</li><li>Excellent written and oral communications skills</li><li>Ability to work evenings/weekends hours as needed.</li><li>Knowledge of medical terminology</li><li>Able to resolve problems/issues</li><li>Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants</li><li>Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously.</li><li>Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.</li><li>Ability to travel to off-site locations that may not be accessible via public transportation.</li><li>Strong time management skills</li></ul></div><div><b>
Preferred Skills and Abilities:</b><br>
<ul><li>Knowledge of IRB and human subject protection</li><li>Prior experience with IRB submissions.</li><li>Prior experience processing and shipping biological samples.</li><li>Prior phlebotomy certification or willing to learn.</li><li>Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders.</li><li>Prior Electronic Data Capture (eDC) data entry skills.</li><li>Prior research experience in a healthcare setting.</li><li>Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies.</li></ul></div><p><b>
Temple University</b> is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.</p><p><b>
Compliance Statement:</b> In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.</p><p><b>
Temple University's Annual Security and Fire Safety Report</b> contains statistics, policies, and procedures related to campus safety. Click here.</p><p>
You may request a copy of the report by calling Temple University&rsquo;s <b>Department of Public Safety at 215-204-7900</b>.</p></div></div><p></p>

Clinical Research Specialist-Katz

Duke University

<p></p><div><div><div><div><div><b>Work Arrangement: </b>Hybrid (On-Site and Remote mix)
</div></div></div></div><div><div><div><div><b>Requisition Number: </b>268889
</div></div></div></div><div><div><div><div><b>Regular or Temporary: </b>Regular
</div></div></div></div><div><div><div><div><b>Location:
</b>Durham, NC, US, 27710
</div></div></div></div><div><div><div><div><b>Personnel Area: </b>MEDICAL CENTER
</div></div></div></div><div><div><div><div><b>Date: </b>Apr 10, 2026
</div></div></div></div><div></div><div><div><div><div>School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.<p><b>
Clinical Research Specialist, Sr &ndash; Psychiatry &ndash; Behavioral Medicine &ndash; Merwin</b></p>
<p><b>
Be You.</b></p>
<p>
This role involves a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator or similar Clinical Research Units (CRU), Oversight Organization (OO) designee. Participates in day-to-day operations related to the collection, compilation, and documentation of clinical research data.</p>
<p><b>
Minimum Requirements:</b></p>
<ul>
<li>Work requires an Associate&rsquo;s degree.</li>
<li>One year of relevant experience required. A Bachelor's degree may substitute for required experience.</li>
</ul>
<p><b>Be Bold.</b></p>
<p><b>
Position Description:</b></p>
<p>
The study population includes teens and young adults with disordered eating with and without T1D. This position will support the study team in recruiting, screening and scheduling study visits, psychiatric assessments and data collection.
</p><p><b>Choose Duke.</b></p>
<p>
The Department of Psychiatry &amp; Behavioral Sciences, founded in 1943, is one of 26 departments in the Duke University School of Medicine (SOM). The department is comprised of more than 500 faculty, staff, and trainees. Our goal is to help people with behavioral health challenges live their best life. We pursue this goal through a three-fold mission of superior specialty and integrated patient care for all, ground-breaking research, and exceptional training and education.
</p><p>Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from Duke's competitive benefits package, including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.</p><br>
<div></div>
<br>
<div><div><b>Anticipated Pay Range:</b> Duke University provides an annual base salary range for this position as USD $20.76 to USD $31.44. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.<br>
</div><br>
<div><div>Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/<br>
</div><br>
<div><div><b>Equal Opportunity Employer:</b> Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.<br>
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<div><div>Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas&mdash;an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.<br>
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<b>Essential Physical Job Functions:</b>
<div>Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: DAAS@duke.edu; phone: 919-668-1267).<br>
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<b>Nearest Major Market: </b>Durham
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<b>Nearest Secondary Market: </b>Raleigh</p></div>

Clinical Research Specialist, Sr - Psychiatry - Behavioral Medicine - Merwin

Semmes Murphey Foundation

<div>Description: The Semmes Murphey Foundation, affiliated with Semmes Murphey Clinic, is an independent, research-focused, public benefit corporation (501(c)3) dedicated to advancing innovation and excellence in neuroscience. We are growing our clinical research department and looking to add new talent to our team.<br>
This role provides our Foundation with critical regulatory support across various industry-sponsored clinical trials, PI-initiated and grant-funded studies, and quality registries. You will ensure regulatory compliance, timely IRB submissions, document control, and audit-ready study files throughout the lifecycle of clinical research projects.<p><b>
Essential Duties and Responsibilities:</b></p><ul><li>
Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures</li><li>
Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence</li><li>
Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track</li><li>
Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies</li><li>
Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files</li><li>
Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol</li><li>
Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager</li></ul>
Requirements:
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MINIMUM:</p><ul><li>
Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field</li><li>
Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities</li></ul><p>
PREFERRED:</p><ul><li>
Five plus years of clinical research regulatory experience</li><li>
Master's degree in related field</li><li>
Professional certifications such as CCRC (ACRP) or CCRP (SOCRA)</li><li>
Experience supporting multi-site or industry-sponsored clinical trials</li></ul><p>
Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail.</p><p><br>
</p><p>Equal Opportunity Employer/Veterans/Disabled</p><p>
#SMF</p></div>

Clinical Research Regulatory Specialist

University of Southern California

<div><p>The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the &quot;Trojan Family,&quot; which is comprised of the faculty, students and staff that make the university what it is.</p><p></p><p><b>
JOB ACCOUNTABILITIES:</b></p><ul><li><p>
Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Submits protocols and supportingdocuments to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.</p></li><li><p>
Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Manages and maintains CISO electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations.</p></li><li><p>
Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed.</p></li><li><p>
Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.</p></li><li><p>
Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.</p></li><li><p>
Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial progress.</p></li><li><p>
Participates in KSOM centralized activities to support and promote research regulatory requirements. Coordinates with and assists other CISO staff and departments with educational efforts, helping ensure highest quality research and protection of human subjects. Identifies compliance training and educational needs, coordinates the reporting of serious adverse events and protocol deviations, and proposes, completes, and submits amendments to protocols and trial forms and documentation, as needed.</p></li><li><p>
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.</p></li></ul><p></p><p><b>
Position location:</b> On-site</p><p></p><p><b>
Salary range:</b></p><p>
The annual rate 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.</p><p></p><p>
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.</p><br>
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Minimum Education: Bachelor's degree Minimum Experience: 2 years/Combined education/experience as substitute for minimum experience Minimum Field of Expertise: 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 diverse 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: Three years Supervises: No Preferred Field of Expertise: Three years&rsquo; experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research. Special Instructions to Applicants: Applicant Attachments (Required): R&eacute;sum&eacute; &amp; Cover Letter Applicant Questions: N/A Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Updates all databases, and regulatory binders with information pertinent to studying milestone progress. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.</div>

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