institutional research coordinator

University Of Washington

<div><p><b>Job Description
</b></p><p></p><p><b>The Department of Neurology has an outstanding opportunity for Research Coordinator to join their team.
</b></p><p></p><p><b>About this Opportunity
</b></p><p>Reporting to Roblin Lawrence, the Research Coordinator is responsible for ongoing research of the UW Medicine Memory and Brain Wellness Center (MBWC) and UW Alzheimer&rsquo;s Disease Research Center (ADRC). These Centers house multidisciplinary teams of clinical specialists and researchers who care for patients with Alzheimer&rsquo;s Disease and Related Dementias (ADRD) and work to advance discoveries and treatments for these disorders.
</p><p></p><p><b>Key Responsibilities
</b></p><p></p><p><b>Study Subject Coordination (85%)
</b></p><ul><li><p>Perform research interviews and administer and score neuropsychometric assessments for multiple participant visits on a weekly basis;
</p></li><li><p>Complete all study related forms, including consent, data collection materials, database tracking, data corrections;
</p></li><li><p>Document and maintain policies and procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines. Review and suggest appropriate revisions, as necessary, for research instruments (e.g., case report forms, neuropsych testing measures, database tracking) to ensure quality data that satisfies research objectives;
</p></li><li><p>Manage study administrative work, including scheduling study appointments, engaging in study participant recruitment and tracking, developing and adhering to study workflows and SOPs, performing quality control assessments to ensure accurate and reliable data collection.
</p></li><li><p>Assist in monitoring and administering patient protocol, interacting closely with clinical providers to ensure patient safety and protocol adherence;
</p></li><li><p>Assist in biospecimen collection, processing, and transfer;
</p></li></ul><p><b>Analysis and Reporting (10%)
</b></p><ul><li><p>Participate and provide participant level feedback during consensus meetings with providers, psychometrists, and other research professionals;
</p></li><li><p>Assist in preparing reports and summaries for the Clinical Core Principal Investigator and Co-Leads, and contribute to Institutional Review Board (IRB) submissions, amendments, and continuing review documentation as needed;
</p></li></ul><p></p><p><b>Other (5%)
</b></p><ul><li><p>Perform related duties as required
</p></li></ul><p></p><p><b>Required Qualifications
</b></p><p>To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
</p><p></p><p><b>Minimum Qualifications
</b></p><p>Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Department.
</p><ul><li><p>Bachelor&rsquo;s degree in science or humanities and one year of relevant experience; or
</p></li><li><p>Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
</p></li></ul><p></p><p><b>Additional Qualifications
</b></p><ul><li><p>Strong critical thinking and independent problem-solving skills
</p></li><li><p>Ability to follow detailed research protocols accurately and independently
</p></li><li><p>Strong organizational skills and attention to detail
</p></li><li><p>Ability to work compassionately and professionally with clinical research subjects with varying levels of cognitive ability and their family members
</p></li><li><p>Ability to work as a collaborative, cooperative, and congenial member of a close-knit scholarly and administrative team, as well as work independently
</p></li></ul><p></p><p><b>Preferred Qualifications
</b></p><ul><li><p>Fluent in Spanish
</p></li><li><p>Experience performing and scoring neuropsychometric tests
</p></li><li><p>Experience working on research projects
</p></li><li><p>Experience with REDCap data management system
</p></li><li><p>Training and/or knowledge in ethical conduct of research with human subjects
</p></li><li><p>Knowledge and prior experience with working with geriatric or cognitively or neurologically impaired populations
</p></li></ul><p></p><p><b>Compensation, Benefits and Position Details
</b></p><p></p><p><b>Pay Range Minimum:
</b></p>$55,944.00 annual
<p><b>Pay Range Maximum:
</b></p>$79,200.00 annual
<p><b>Other Compensation:
</b></p><ul><li></li></ul><p><b>Benefits:
</b></p>For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
<p><b>Shift:
</b></p>First Shift (United States of America)
<p><b>Temporary or Regular?
</b></p>This is a regular position
<p><b>FTE (Full-Time Equivalent):
</b></p>100.00%
<p><b>Union/Bargaining Unit:
</b></p>UAW Research
<p></p><p><b>About the UW
</b></p><p></p><p>Working at the University of Washington provides a unique opportunity to change lives &ndash; on our campuses, in our state and around the world.
</p><p></p><p>UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.
</p><p></p><p><b>Our Commitment
</b></p><p></p><p>The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81 .
</p><p></p><p>To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu .
</p><p></p><p>Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law .</p></div>

Research Coordinator 1 (NE S UAW Research)

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Department of Psychiatry and Behavioral Sciences is seeking a Research Coordinator II for a clinical research study with Dr. Ellen Teng. The ideal candidate would be detail-oriented, self-motivated, and able to multitask in a clinical research setting. The Research Coordinator II will be primarily responsible for research duties while also assisting with clinical and administrative tasks. This position will include data collection, organization, scoring, and management. The Research Coordinator II will also assist with preparation of reports and perform tasks such as participant recruitment and screening, scheduling, payment, and record-keeping.</p><p></p><p><br>
This position requires an individual with strong interpersonal and organizational skills who adapts well to change.</p><p></p><p><br>
This position will physically sit at the MEDVAMC.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Assists with preparation and maintenance of intervention and assessment materials.</li><li>
Data entry and management, including extracting and compiling data from self-reports, diagnostic interviews, and medical records.</li><li>
Conducts recruitment and screening tasks and assists with participant coordination and scheduling.</li><li>
Implements appropriate activities for participant retention and follow-up procedures as directed.</li><li>
Conducts literature searches and summarizes information in an appropriate format for a particular study.</li><li>
Assists the project coordinator with various administrative tasks, such as recruitment tracking and progress reports.</li><li>
May facilitate and manage participant payments.</li><li>
Performs other job-related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.</li><li>
One year of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Bachelor's degree required.</li><li>
Minimum of one year of clinical research experience</li><li>
Must be comfortable working in a VA-affiliated research environment.</li><li>
Experience with Qualtrics and REDCap is preferred.</li></ul></div></div></div><p></p><p><b><br>
Work Authorization Requirement:</b></p><p><b>
This position is not eligible for visa sponsorship.</b> Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.</p><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div><p></p>

Research Coordinator II - Psychiatry & Behavioral Sciences

University of Minnesota

<div><p>Required Qualifications:</p><ul><li>
BA/BS degree plus at least four years of relevant experience, or a master&rsquo;s degree plus at least two years of relevant experience.</li></ul><p>
Preferred Qualifications:</p><ul><li>
Master&rsquo;s or Doctoral/advanced degree</li><li>
Familiarity with OUR and University undergraduate research programs, databases, and financial systems is preferred.</li><li>
Prior experience with research conventions across disciplines.</li><li>
Strong verbal and written communication skills with attention to detail.</li><li>
Excellent interpersonal skills and a demonstrated ability to work effectively in a highly collaborative environment.</li><li>
Sensitive to the needs and barriers faced by first generation undergraduate student populations.</li></ul><p>
Undergraduate Research Coordinator</p><p><i>
Please note, this position is not eligible for H-1B or Green Card sponsorship. This position does not offer a STEM OPT training program.</i><br>
<br>
Summary:<br>
<br>
This position contributes to the operation of OUR (100%) and also includes maintaining and developing OUR&rsquo;s InfoReady database infrastructure for the efficient administration of UROP and RISE competitions, developing the new Undergraduate Research System-wide Analytics (URSA) to track undergraduate research participation across the University system, managing OUR communications including the Undergrad Research Connection monthly newsletter and OUR Instagram account, maintaining the OUR website, updating the Undergraduate Research Ethics Canvas training module, advising and connecting students with potential research advisors, staffing at University events to encourage students to participate in OUR programs, supervision of undergraduate student workers, and participation in OUR strategic planning.<br>
<br>
This position reports to the OUR Associate Director and works closely with the OUR Faculty Director for OUR, and other staff within OUE and across campus on a variety of projects, initiatives, and committee assignments.<br>
<br>
Essential Functions:<br>
50% Administration of UROP and RISE programs</p><ul><li><p>
This position has shared responsibility with the OUR Associate Director for routine operational support of the UROP and RISE programs, including overseeing maintenance and development of OUR&rsquo;s InfoReady database infrastructure, coordinating the review process of &gt;700 applications per academic year with collegiate representatives across all five UMN campuses, and communicating the outcomes of the review process to student applicants.<br>
o In some instances, this work will also involve directly evaluating the academic merit of research proposals. Both UROP and RISE have funding competitions three times a year. Importantly, this position involves the management of payments and expenses associated with the UROP and RISE programs, which requires the Coordinator to maintain strong, positive relationships with departmental accountants. Prior to any payments being issued, the Coordinator must confirm that students complete program requirements at the beginning (agreement letter, research ethics course, holds resolved) and end (presentation, report, faculty verification) of any UROP, GIA UROP, or RISE award.</p></li></ul><p></p><p><br>
15% Organization of Undergraduate Research Symposiums</p><ul><li>
The Coordinator works independently and in collaboration with the OUR Associate Director and Faculty Director, OUR student employees, OUE marketing, UMN Libraries, and UMN Honors Program to organize the Fall semester virtual and Spring semester (Great Hall of Coffman Student Union) Undergraduate Research Symposiums for students to disseminate their research to the broader UMN community.</li><li>
The Coordinator leads the logistics (space reservations, catering, poster printing), and planning (including program preparation and grouping of student presentations by common disciplines), recruitment strategy, website development (including production of hundreds of unique web pages with text, photos, and video), and storage of poster files in the UMN Digital Conservancy.</li></ul><p>
15% Student and Faculty Support &amp; Advising</p><ul><li>
The Coordinator advises individual students and groups to help refine research interests, find willing mentors, identify research opportunities, and recruit new research applications for the UROP and RISE programs as well as other non-OUR opportunities.<br>
o This may involve providing feedback on draft student research grant applications across all disciplines and colleges for content and coherency.<br>
o This role provides support to faculty who are looking for adequately trained students to help advance their research and the development of student-faculty connectivity tools through the UMN&rsquo;s Handshake platform.<br>
o The Coordinator also contributes to advising through OUR&rsquo;s monthly newsletter, which goes out to all students who have previously participated in OUR programs, through our social media accounts, and through the continuous updating of the OUR website.<br>
o The coordinator also designs and participates in workshops and outreach activities associated with events like Think Like a Researcher, Welcome Week, and admissions and class functions. The Coordinator works in collaboration with the OUR Associate Director to supervise undergraduate student workers in maintaining social media and data entry.</li></ul><p>
15% OUR Innovation and Outreach</p><ul><li>
Collaboration among the OUR Faculty Director, Associate Director, and Coordinator is crucial for developing new programs and services that expand research opportunities for students and improve OUR&rsquo;s ability to track participation. This function may occasionally involve proposal preparation. Examples of this function between 2024-2026 include:<br>
o The development of and rollout of the RISE program, the creation of the Undergraduate Research Ethics Canvas training module in collaboration with the UMN Libraries and Faculty Senate Committee on Research Ethics.<br>
o The construction of the new InfoReady database and funding software.<br>
o Brainstorming potential new programmatic elements like Vertically Integrated Projects (VIPs), Curriculum-based Undergraduate Research Experiences (CUREs), the Research Enhanced Curriculum (REC) program, and a virtual assistant to help answer common student research questions.<br>
o Co-organizing the 2025 Big Ten+ Academic Alliance Meeting at the University of Minnesota, e. Representing OUR at external disciplinary-specific conferences, such as the annual meeting of the Council for Undergraduate Research (ConnectUR).</li></ul><p>
5% Perform Various Other Duties<br>
This position involves management of payments and expenses associated with the UROP and RISE programs and close coordination with departmental accountants.</p><p>
The Office of Undergraduate Research (OUR) is a tight-knit, highly collaborative team that serves the 5-campus University of Minnesota (UMN) system with the aim of expanding and tracking undergraduate participation in all forms of research and creative scholarship. Competitive funding programs administered by OUR include the Undergraduate Research Opportunities Program (UROP) and its affiliate programs (Grant-In-Aid UROP and International UROP), and the Researcher-Initiated Student Employment (RISE) program. To provide students with a venue to disseminate their research, OUR organizes a virtual research symposium every Fall semester and a larger in-person Undergraduate Research Symposium every Spring semester. Additionally, OUR manages and supervises the Minnesota Undergraduate Research Academic Journal (MURAJ), where students publish their undergraduate research.</p><p>
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.</p><p>
Additional documents may be attached after application by accessing your &quot;My Job Applications&quot; page and uploading documents in the &quot;My Cover Letters and Attachments&quot; section.</p><p>
To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.</p><p>
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.</p><p>
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu</p><p>
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.</p><p></p><p>
The University of Minnesota, Twin Cities (UMTC)</p><p>
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.</p><p>
At the University of Minnesota, we are proud to be recognized by Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence &amp; Industry Awards recognition for employee appreciation and work-life flexibility.</p></div>

Undergrad Research Coordinator

University of Alabama, Birmingham

<div></div><div><div><div><div><div><b>Description</b><div></div><p>
The University of Alabama at Birmingham (UAB), General Internal Med &amp; Population Science, is seeking a Clinical Research Coordinator I.</p><p><b>
Please attach a cover letter and a current resume with this application.</b></p><p><b>
General Responsibilities</b></p><ul><li><p>
To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.</p></li><li><p>
To support screening and participant eligibility determination, working with more senior team members to ensure compliance.</p></li><li><p>
To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).</p></li><li><p>
To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.</p></li></ul><p><b>
Key Duties &amp; Responsibilities</b></p><ul><li><p>
Physical or Logistical Requirements: Ability to travel locally for participant visits. Ability to lift or transport study materials or equipment (e.g., 25-50 lbs). Availability for occasional early morning, evening, or weekend appointments based on project needs.</p></li><li><p>
Work Style Expectations: Flexibility and willingness to take on varied tasks as study needs evolve. Comfort working in both structured and unstructured environments. Initiative to troubleshoot small issues independently and communicate effectively with the team.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><p><b>
Annual Salary Range</b>: $43,890 - $71,320</p><div><br>
</div></div><div><b>
Qualifications</b><div></div><p>
High School diploma or GED required.</p><p><b>
Preferences</b></p><ul><li><p>
Experience with research data collection in clinical, community, or behavioral settings.</p></li><li><p>
Strong organizational skills and exceptional attention to detail.</p></li><li><p>
Ability to follow study protocols and work effectively as part of a research team and independently.</p></li><li><p>
Experience working directly with participants, including recruitment, screening, and assessment delivery.</p></li><li><p>
Comfort delivering structured lifestyle or behavioral intervention components after training (e.g., physical activity, weight management, health coaching).</p></li><li><p>
Familiarity with health behavior change principles or motivational interviewing.</p></li><li><p>
Experience with wearable devices, mobile health tools, or remote data collection platforms.</p></li><li><p>
Ability to adapt to shifting priorities in a dynamic environment.</p></li><li><p>
Ability to take initiative.</p></li><li><p>
Strong interpersonal and communication skills with diverse populations.</p></li><li>
Up-to-date research compliance training, including IRB/Human Subjects Protection certification.</li></ul><p><br>
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.</p><div><br>
</div></div><div><b>
Primary Location</b><b>:</b> University</div><div><b>
Job Category</b><b>:</b> Clinical Research</div><div><b>
Organization</b><b>:</b> 311401800 General Internal Med &amp; Population Science</div><div><b>
Employee Status</b><b>:</b> Regular</div><div><b>
Shift</b><b>:</b> Day/1st Shift</div><div><b>
Work Arrangement (final schedule to be determined by the department/hiring manager)</b><b>:</b> Hybrid Eligible</div></div></div></div></div><div></div>

CLINICAL RESEARCH COORDINATOR I

University of Pittsburgh

<div><div><p><b>Clinical Research Coordinator II</b></p></div><div>
Health Sciences Core Research Facilities - Pennsylvania-Pittsburgh - (26004680)</div><div></div><div><p><br>
The newly formed Clinical Research Support Office, within the Senior Vice Chancellor of Health Science is seeking a Clinical Research Coordinator II. The individual in this role primary responsibilities include coordinating working with the PI and study team of record to screen, enroll and randomize study recruits. This individual will be responsible for study management duties, as required by protocol. Coordinator experience preferred. This position will require travel from in and around Pitt and UPMC campuses. The University reserves the right to assign additional duties not listed here. Conducts research assessments on study participants. Assists with and adheres to study protocols, and Institutional Review Board (IRB) renewal, modification, and approved protocols. Assists with training staff on proper and best study research techniques as directed. Mentors and educates staff and student workers as directed. Ensures proper protocols are followed and quality assurance of research and related</p></div><div><div><b>
Job Summary</b></div><p>
Conducts research assessments on study participants. Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Assists with training staff. Ensures adherence to protocols and corrects issues with data collection.</p></div><div><div><b>
Essential Functions</b></div><p>
The newly formed Clinical Research Support Office, within the Senior Vice Chancellor of Health Science is seeking a Clinical Research Coordinator II. The individual in this role primary responsibilities include coordinating working with the PI and study team of record to screen, enroll and randomize study recruits. This individual will be responsible for stud management duties, as required by protocol. Coordinator experience preferred. This position will require travel from in and around Pitt and UPMC campuses. Conducts research assessments on study participants. Assists with and adheres to study protocols, and Institutional Review Board (IRB) approval, renewal, modification, and approved protocols. Assists with training staff on proper and best study research techniques as directed. Mentors and educates staff and student workers as directed. Ensures proper protocols are followed and quality assurance of research and related work. Corrects data collection issues. Conducts research assessments on study participants. Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Assists with training staff. Ensures adherence to protocols and corrects issues with data collection. The University reserves the right to assign additional duties not listed here.</p></div><div><div><b>
Physical Effort</b></div><p>
Standing and sitting for long periods. Walking around campus. Reading small print. Bending and lifting up to 10 pounds. Working under normal office lights. Walking around campus to attend meetings.</p></div><p></p><div><p><i><br>
The University of Pittsburgh is an equal opportunity employer / disability / veteran.</i></p><div><br>
</div></div><div><div><b>
Assignment Category</b></div> Full-time regular</div><div><div><b>
Job Classification</b></div> Staff.Clinical Research Coordinator II</div><div><div><b>
Job Family</b></div> Research</div><div><div><b>
Job Sub-Family</b></div> Clinical Research</div><div><div><b>
Campus</b></div> Pittsburgh</div><div><div><b>
Minimum Education Level Required</b></div> Bachelor's Degree</div><div><div><b>
Minimum Years of Experience Required</b></div> 2</div><div><div><b>
Will this position accept substitution in lieu of education or experience? </b></div>Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.</div><div><div><b>
Work Schedule</b></div> Monday - Friday, 8:30 a.m. - 5:00 p.m, schedule as set with supervisor</div><div><div><b>
Work Arrangement</b></div> On-Campus: Teams that work on campus, in an office, or in a lab.</div><div><div><b>
Hiring Range</b></div> TBD Based Upon Qualifications</div><div><div><b>
Relocation Offered</b></div> No</div><div><div><b>
Visa Sponsorship Provided</b></div> No</div><div><div><b>
Background Check</b></div> For position finalists, employment with the University will require successful completion of a background check</div><div><div><b>
Child Protection Clearances</b></div> Not Applicable</div><div><div><b>
Required Documents</b></div> Resume, Cover Letter</div><div><div><b>
Optional Documents</b></div> Not Applicable</div></div>

Clinical Research Coordinator II

Brown University Health

<div><ul><li>Job ID: JR-112254
</li><li>Entity: Rhode Island Hospital
</li><li>Location Name: Rhode Island Hospital
</li><li>City, State: Providence, RI
</li><li>Work Type: FULL TIME
</li><li>Hours Per Week: 40
</li><li>Shift: Day
</li><li>Posted Date: 7/30/2026
</li></ul><div><h2 class="jobSectionHeader"><b>SUMMARY</b></h2>
<p>
The Sr. Research Regulatory Coordinator is responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Sr. Research Regulatory Coordinator performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for the department. The Sr. Research Regulatory Coordinator will provide support in managing the clinical trials within the department, instructs and advises other staff in regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries. The Sr. Research Regulatory Coordinator shall work closely with department leadership.</p>
<p>
Brown University Health employees are expected to successfully role model the organization&rsquo;s values of <b>Compassion</b>, <b>Accountability</b>, <b>Respect</b>, and <b>Excellence</b> as these values guide our everyday actions with patients, customers and one another.</p>
<p>
In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:</p>
<ul>
<li>Instill Trust and Value Differences</li>
<li>Patient and Community Focus and Collaborate</li>
</ul><h2 class="jobSectionHeader"><b>RESPONSIBILITIES</b></h2>
<p>
The Sr. Research Regulatory Coordinator is responsible for all duties listed under the Regulatory Coordinator position, such as:</p>
<ul>
<li>Develops protocols with the Principle Investigator and provides recommendations on research plan</li>
<li>Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors</li>
<li>Prepare and maintain study specific regulatory binder(s) and documents</li>
<li>Serves as the regulatory subject matter expert through all phases of a clinical study, including regulatory documents and/or processes related to clinical trials conduct</li>
<li>Initiates and leads special projects, to include process improvement and regulatory training</li>
<li>Ensures proper regulatory compliance in accordance with sponsoring agency requirements</li>
<li>Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines</li>
</ul>
<p>Additionally, the Sr. Research Regulatory Coordinator position will be responsible for the following:</p>
<ul>
<li>Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. Manages the preparation of annual reports to the FDA, as necessary. Manages and updates clinical trial/study information located on the clinicaltrials.gov website, as needed</li>
<li>Ensuring the collection and maintenance of credentialing information for study personnel. Such include conflict of interest forms (COI), CV&rsquo;s, MLs, HSP and GCP training</li>
<li>Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting of audit responses</li>
<li>Assist with training of all regulatory affairs personnel with regards to regulatory compliance. Act as a mentor for new employees and find ways to improve the department&rsquo;s mentorship program</li>
<li>Work directly with department leadership to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems</li>
<li>Compile regulatory-related metrics for use by department leadership</li>
<li>Performs other duties as assigned</li>
</ul><h2 class="jobSectionHeader"><b>MINIMUM QUALIFICATIONS</b></h2>
<h3 class="jobSectionHeader"><b>BASIC KNOWLEDGE</b></h3>
<ul><li>Bachelor&rsquo;s degree in health-related or scientific field is required; Master&rsquo;s degree preferred</li>
<li>SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire</li>
<li>Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research</li>
<li>Must be an independent person, who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements. Must demonstrate strong leadership and organizational skills</li>
</ul>
<p>Must possess the following skills:</p>
<ul>
<li><p>Detail-oriented and excellent organizational skills</p>
</li>
<li><p>Strong self-starter</p>
</li>
<li><p>Interpersonal skills</p>
</li>
<li><p>Strong problem-solving skills</p>
</li>
<li><p>Team-oriented</p>
</li>
<li><p>Excellent oral and written communication skills</p>
</li>
<li><p>Proficient in Microsoft Office and in various database applications</p>
</li>
<li><p>Comprehensive knowledge of FDA guidelines</p>
</li>
<li><p>Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations necessary</p>
</li>
</ul><h3 class="jobSectionHeader"><b>EXPERIENCE</b></h3>
<ul><li>3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience</li>
<li>Past experience in federal, state and/or local programmatic regulations compliance</li>
</ul><h2 class="jobSectionHeader"><b>WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS</b></h2>
<p>
This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.</p>
<h2 class="jobSectionHeader"><b>
INDEPENDENT ACTION</b></h2>
<p>
This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies, including, but not limited to study sponsors, local and federal agencies. The candidate should be able to answer protocol regulatory inquiries from researchers and physicians, as well as from the local Institutional Review Board. This person should also be able to work with outside monitors and work independently. He/she should be able to answer inquiries related to regulatory issues, and if not known, communicate with the correct person to determine the answer.</p>
<h2 class="jobSectionHeader"><b>
SUPERVISORY RESPONSIBILITY</b></h2>
<p>
One to three regulatory staff members.</p>
<h2 class="jobSectionHeader"><b>
Pay Range</b></h2>
<p>
$64,480.00-$106,412.80</p>
<h2 class="jobSectionHeader"><b>
Location</b></h2>
<p>
Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903</p>
<h2 class="jobSectionHeader"><b>
Work Type</b></h2>
<p>
M-F 8am-4:30pm</p>
<h2 class="jobSectionHeader"><b>
Work Shift</b></h2>
<p>
Day</p>
<h2 class="jobSectionHeader"><b>
Daily Hours</b></h2>
<p>
8 hours</p>
<h2 class="jobSectionHeader"><b>
Driving Required</b></h2>
<p>
Yes</p>
<p><i>
Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.</i></p></div></div>

Sr Research Regulatory Coordinator 1

University of Southern California

<div><b>Job ID</b> REQ20178332 <b>Category</b> Nursing</div>
<br><div><p><b>Clinical Research Regulatory Specialist - Operations
</b></p><p>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.</p>
<p></p><p>Position Summary:</p>
<p></p><p>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.</p>
<p>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.</p>
<p>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.</p>
<p></p><p>Key Responsibilities:</p>
<ul><li><p>Manage all regulatory activities for assigned clinical research studies from study initiation through closeout.</p>
</li><li><p>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.</p>
</li><li><p>Ensure timely reporting of regulatory submissions, adverse events, protocol deviations, and other reportable events in accordance with applicable regulations and study requirements.</p>
</li><li><p>Maintain accurate and audit-ready investigator site files and essential regulatory documentation.</p>
</li><li><p>Collaborate with Principal Investigators, study coordinators, sponsors, and research staff to ensure ongoing regulatory compliance.</p>
</li><li><p>Serve as a liaison with regulatory and compliance entities, including the IRB, FDA, sponsor representatives, monitors, and external agencies.</p>
</li><li><p>Participate in and lead study-related regulatory meetings, providing guidance on regulatory requirements and compliance considerations.</p>
</li><li><p>Maintain accurate study information within the Clinical Trial Management System (OnCore) and electronic regulatory system (Florence).</p>
</li><li><p>Develop and implement workflows and best practices that enhance regulatory oversight, documentation quality, and study compliance.</p>
</li><li><p>Support audit and inspection readiness activities and assist with responses to regulatory findings, when necessary.</p>
</li><li><p>Ensure adherence to Good Clinical Practice (GCP), institutional policies, sponsor requirements, and all applicable regulatory standards.</p>
</li></ul><p></p><p>Required Qualifications:</p>
<p></p><ul><li><p>Demonstrated experience preparing and submitting IRB applications, including Initial Reviews, Amendments, Continuing Reviews, and Reportable Events.</p>
</li><li><p>Strong knowledge of clinical research regulatory processes and documentation requirements.</p>
</li><li><p>Excellent interpersonal skills with the ability to build and maintain effective working relationships across the Health System.</p>
</li><li><p>Exceptional organizational skills with meticulous attention to detail.</p>
</li><li><p>Ability to effectively manage multiple priorities, adapt to changing demands, and meet critical deadlines in a fast-paced environment.</p>
</li><li><p>Strong analytical and problem-solving skills, with the ability to identify issues, develop solutions, and implement corrective actions independently.</p>
</li><li><p>Proven ability to exercise sound judgment, discretion, and independent decision-making.</p>
</li><li><p>Excellent written and verbal communication skills.</p>
</li><li><p>Ability to research, evaluate, interpret, and synthesize complex information and prepare clear, concise reports and correspondence.</p>
</li><li><p>Strong customer service orientation and commitment to responsive stakeholder support.</p>
</li><li><p>High level of professionalism, integrity, and discretion in handling confidential information.</p>
</li><li><p>Ability to work independently while contributing effectively as part of a collaborative team.</p>
</li><li><p>Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams) and virtual meeting platforms such as Zoom.</p>
</li><li><p>Demonstrated ability to establish and maintain accurate files, records, and regulatory documentation.</p>
</li><li><p>Experience working effectively with individuals from diverse cultural, educational, and professional backgrounds.</p>
</li></ul><p></p><p>Minimum Qualifications:</p>
<ul><li><p>High school diploma or equivalent combined with sufficient experience and demonstrated competencies required to successfully perform the duties of the position.</p>
</li><li><p>Bachelor&rsquo;s degree preferred.</p>
</li><li><p>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.</p>
</li></ul><p></p><p>Preferred Qualifications:</p>
<ul><li><p>Working knowledge of federal, state, local, and institutional regulations governing clinical research and human subject protections.</p>
</li><li><p>Experience supporting a variety of clinical trial types, including industry-sponsored, federally funded, cooperative group, and investigator-initiated studies.</p>
</li><li><p>Research certification such as ACRP, SoCRA, CCRP, or equivalent.</p>
</li><li><p>Current CITI Human Subjects Research certification.</p>
</li><li><p>Demonstrated expertise in clinical research regulatory compliance, including Phase I-IV drug studies and medical device trials.</p>
</li><li><p>Comprehensive understanding of IRB processes, FDA regulations, and regulatory requirements throughout the clinical trial lifecycle.</p>
</li><li><p>Experience with Clinical Trial Management Systems (OnCore) and electronic regulatory systems (Florence) preferred.</p>
</li></ul><p></p><p>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.</p>
<p></p><p>This position is remote. Work hours and remote days may be subject to change depending on business needs.</p>
<p></p><p>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</p><br>
<br>
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><b>Job ID</b> REQ20178332 <b>Posted Date</b> 07/30/2026</div></div><p></p>

Clinical Research Regulatory Specialist

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