research compliance specialist

Brown University Health

<div><ul><li>Job ID: JR-108149
</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: 4/10/2026
</li></ul><div><h2 class="jobSectionHeader"><b>SUMMARY</b></h2>
<p>
The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to:</p>
<ul>
<li>Analyze and interpret applicable regulations</li>
<li>Develop/revise institutional policies and procedures</li>
<li>Audit the conduct of human subjects research (biomedical, social &amp; behavioral) and research oversight programs</li>
<li>Assess compliance with all applicable regulations, guidance, and policies and procedures</li>
<li>Identify areas of risk</li>
<li>Oversee the development and implementation of corrective and preventive action plans</li>
</ul>
<p>Ensures adherence to the standards for the responsible conduct of research and compliance. Assists with preparation for external quality reviews and regulatory audits. Brown University Health employees are expected to successfully role model the organization'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>
<ul><li>Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, standards for accreditation, etc.), align, amend and enforce institutional policies and procedures, and protect human research participants.</li>
<li>Provides current and accurate compliance information and resources to the research community.</li>
<li>Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance.</li>
<li>Evaluates compliance by planning and performing monitoring for investigator-initiated trials, in order to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP).</li>
<li>Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform internal assessments of the conduct of clinical research at the institution.</li>
<li>Documents detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified (including root cause analysis) and the conclusions drawn.</li>
<li>Exercises appropriate judgment in evaluating audit findings, develops corrective and preventive action (CAPA) plans, provides targeted education and resources for resolution in a collegial and educational manner.</li>
<li>Assists research teams in resolving issues and ensures responses and corrective and preventative action plans are implemented in a timely manner.</li>
<li>Collects data on audit findings, prepares comprehensive reports (QA metrics), and analyzes trends to identify process failures and direct quality improvement and training initiatives.</li>
<li>Presents data, trends, and risk assessments to Brown University Health Office of Cancer Research (LOCR) Quality Committee.</li>
<li>Works with LOCR Leadership to develop and deliver educational offerings driven by audit findings (e.g., forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators, research staff, and other members of the Brown University Health Cancer Institute to promote the responsible conduct of research and assists with site or study-specific self-assessments.</li>
<li>Investigates compliance breaches, gathers relevant information, assesses impact, determines steps to mitigate risk, and reports findings.</li>
<li>Assists in the management of external audits by regulatory agencies or business partners.</li>
<li>Provides information and services to help research with FDA inspection readiness.</li>
<li>Other job functions as assigned.</li>
</ul><h2 class="jobSectionHeader"><b>MINIMUM QUALIFICATIONS</b></h2>
<p><b>
EDUCATION:</b></p>
<ul>
<li>Bachelor's degree in a healthcare-related field required. Nursing degree preferred.</li>
<li>Certification or eligibility to sit for Certification Exam in relevant area (i.e., Certified IRB Professional (PRIM&amp;R), Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP), Society for Quality Assurance and the American Society for Quality, etc.).</li>
<li>Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research.</li>
<li>Working knowledge of local and federal regulations for human subjects research (ICH-GCP, OHRP, FDA regulations).</li>
</ul>
<p><b>EXPERIENCE:</b></p>
<ul>
<li>A minimum of 5 years substantive experience with Phase I through Phase III trials at the Clinical Research Coordinator or Research Nurse. Training or leadership experience preferred.</li>
<li>Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, produce results, and cope with the inherent pressures.</li>
<li>Excellent organizational and analytical skills: ability to apply presentation and training skills.</li>
<li>Ability to perform multiple tasks with a high level of accuracy and attention to detail.</li>
<li>Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC)).</li>
</ul>
<p><b>SUPERVISORY RESPONSIBILITY:</b></p>
<p>
May supervise 5-10 FTEs.</p>
<h2 class="jobSectionHeader"><b>
PAY RANGE</b></h2>
<p>
$71,136.00 - $117,353.60</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>
Mon-Thur 7:00 am - 5:30 pm</p>
<h2 class="jobSectionHeader"><b>
WORK SHIFT</b></h2>
<p>
Day</p>
<h2 class="jobSectionHeader"><b>
DAILY HOURS</b></h2>
<p>
10 hours</p>
<h2 class="jobSectionHeader"><b>
DRIVING REQUIRED</b></h2>
<p>
No</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>

Clinical Research Quality Assurance & Improvement Specialist

Global Software Resources

<p><div><div><div><div><b>Job Title: IT Audit And </b><b>Compliance Project Specialist</b>
<br>
<b>Location: </b>Oakland<b>, </b>CA<br>
<b>Duration: </b>May 04, 2026<b> </b>&ndash; November 03, 2026,
<br>
<b>ONLY W2 Candidate</b></div>
</div><br>
</div></div><div><div><div><div><b>Account Manager Notes: </b>Hybrid Onsite Requirement: 1-2 days onsite depending on need for that week</div>
</div><br>
</div></div><div><div><div><div><b>Job Description:
</b><br>
<b>Role Overview</b><br>
<br>
The IT Compliance Project Specialist acts as a compliance and governance partner across the IT project portfolio. This role ensures that IT initiatives are planned, designed, and delivered in compliance with applicable regulations, company policies, and compliance standards.<br>
<br>
Working closely with the Compliance Lead, the Specialist provides analysis, documentation, and due diligence to support risk-based decision-making and to maintain compliance throughout the full project lifecycle.<br>
<br>
<b>Key Responsibilities</b><br>
<br>
Project Advisory &amp; Engagement
<ul><li>Serve as a dedicated compliance advisor to project managers and delivery teams.</li>
<li>Identify regulatory, policy, and control requirements early in the project lifecycle and ensure they are embedded into technical designs and project plans.</li>
</ul>Gate Review &amp; Approval Support
<ul><li>Participate in project phase-gate reviews to assess compliance readiness.</li>
<li>Review project artifacts and provide formal recommendations to the Compliance Lead to support approval, conditional approval, or remediation decisions.</li>
</ul>Compliance Lead Support
<ul><li>Function as the primary support resource for the Compliance Lead.</li>
<li>Assist with executive reporting, remediation tracking, and escalation of project-level compliance risks.</li>
</ul>Regulatory &amp; Framework Alignment
<ul><li>Ensure project alignment with applicable regulations and frameworks, including SOX, CCPA, ISO 55001, and internal company standards.</li>
<li>Map project controls and artifacts to regulatory requirements to support a consistent and defensible compliance posture.</li>
</ul><b>Qualifications</b><br>
Experience
<ul><li>5+ years of experience in IT Compliance, IT Audit, or Governance, Risk &amp; Compliance (GRC), preferably supporting large-scale IT projects.</li>
</ul><b>Tools &amp; Systems</b>
<ul><li>Experience using Planisware for project tracking, portfolio governance, and milestone management.</li>
</ul><b>Education</b>
<ul><li>Bachelor&rsquo;s degree in information technology, Cybersecurity, Business, or a related discipline.</li>
</ul><b>Certifications (Preferred)</b>
<ul><li>CISA (Certified Information Systems Auditor)</li>
<li>CRISC (Certified in Risk and Information Systems Control)</li>
<li>CISSP (Certified Information Systems Security Professional)</li>
<li>PMP (Project Management Professional)</li>
</ul><b>Delivery Methodologies</b>
<ul><li>Strong understanding of the Software Development Life Cycle (SDLC).</li>
<li>Experience applying compliance controls in both Agile and Waterfall delivery models.</li>
</ul><b>Professional Skills &amp; Attributes</b>
<ul><li>Regulatory Expertise: Ability to interpret complex regulatory and control requirements and translate them into clear, actionable guidance for technical and project teams.</li>
<li>Analytical Rigor: Strong attention to detail, particularly in validating technical evidence and identifying compliance gaps or control weaknesses.</li>
<li>Consultative Mindset: Ability to function as a trusted advisor while maintaining independence and objectivity when providing recommendations to leadership.</li>
<li>Communication Skills: Strong written and verbal communication skills, with the ability to bridge technical delivery requirements and compliance expectations.</li>
GRC &amp; Project Tool Proficiency: Experience with GRC platforms (e.g., ServiceNow, Archer) and project management tools (e.g., Jira), in addition to Planisware, to maintain visibility across projects and compliance activities.<li>-</li></ul></div></div></div></div></p>

Compliance Project 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>
<p></p>
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>

Clinical Research Regulatory Specialist

Emory University

<div>Discover Your Career at Emory University: Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Description:
<div>
JOB DESCRIPTION:</div><ul><li>
As the Assistant Director of Research Compliance Program Effectiveness in the Office of Research Compliance and Regulatory Affairs (RCRA), this role ensures the institution's research compliance program is consistent with state and federal laws and regulations.
</li><li>Leads, conducts, and coordinates policy development and approvals for Office of Research Administration (ORA) policies.
</li><li>Assists with investigation triage, interviews, investigation and reports for research noncompliance concerns.</li><li>
Conducts employee, faculty and student research related training and education programs.
</li><li>Monitors effectiveness of the training program.
</li><li>Assists in development of institution's research compliance training program, to include learning management system's course content, new employee orientation and department-specific training activities.
</li><li>Conducts periodic reviews/assessments to determine gaps between established policies and procedures and actual institutional practices to identify deficiencies.
</li><li>Works with affected areas to develop an action plan to mitigate deficiencies.
</li><li>Facilitates, conducts, and coordinates the annual Research Compliance Risk Assessment.
</li><li>In coordination with ORA and RCRA leadership, establishes and administers a university-wide research compliance program, including the identification/prioritization of risks, as well as the execution of scheduled compliance reviews.
</li><li>Provides guidance and advice to various researchers and/or research compliance staff with respect to the establishment of internal controls and intradepartmental compliance monitoring activities.</li><li>
Assists leadership in the preparation of periodic reports.</li><li>
Leads awareness and education initiatives geared on building the research compliance brand across Emory.</li><li>
Facilitates and conducts assessments for new research regulations and their impact to Emory's research enterprise.</li><li>
Provides input and assists in drafting compliance reports, including the development of review findings and recommendations for specific remedial/corrective actions.</li><li>
Performs related responsibilities as required.</li></ul><p>
MINIMUM QUALIFICATIONS:</p><ul><li>
A JD and five years research, regulatory and compliance experience.</li></ul><p>
NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to employee.</p>
Additional Details: Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).
<br>
<br>
Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.</div>

Assistant Director, Research Compliance Program Effectiveness

TriWest Healthcare Alliance

<div><div><div><h2 class="jobSectionHeader"><b>Profile</b></h2><div><br>
<div><div>
</div><div>We offer remote work opportunities (AK, AR, AZ, CO, FL, HI, IA, ID, IL, KS, LA, MD, MN, MO, MT, NE, NV, NM, NC, ND, OK, OR, SC, SD, TN, TX, UT, VA/DC, WA, WI &amp; WY only).</div><div></div><div><br>
Our Department of Defense contract requires US citizenship and a favorably adjudicated DOD background investigation for this position.</div><div></div><div><br>
Veterans, Reservists, Guardsmen and military family members are encouraged to apply!</div><p></p><p><b><br>
Job Summary</b></p><p></p><p>
This position is responsible for ensuring compliance with the DFARS requirements surrounding Business Systems and ensuring that costs are recorded in our accounting system and documented in manner that satisfies the Government Contract Accounting Compliance requirements of Federal Acquisition Regulations (FAR), Department of Defense Federal Acquisition Regulations Supplement (DFAR), Cost Accounting Standards (CAS), and TriWest's Disclosure Statement as well as compliance with regulations regarding the Accounting System, Cost Estimating System, Material Management and Accounting System (MMAS), Purchasing System and Property Management System. Working closely with Finance and Accounting personnel this position develops and implements processes that will address new types of accounting transactions to meet Government Contract Accounting Compliance requirements, analyzes cost accounting data through our Microsoft Excel based cost accounting model, and builds cost accounting reports for senior management using our PeopleSoft Financials system and nVision reporting tools. This position supports audits of our cost accounting records by the Defense Contract Audit Agency (DCAA) and audits of other Business Systems by the Defense Contract Management Agency (DCMA).</p><p></p><p><b><br>
Education &amp; Experience</b></p><p></p><div><b>
Required:</b><br>
<br>
<ul><li>Bachelor's degree in Accounting or equivalent experience</li><li>U.S. Citizenship</li><li>Must be able to receive a favorable Interim and adjudicated final Department of Defense (DoD) background investigation</li><li>5 years Accounting experience</li><li>Working knowledge of Federal Acquisition Regulations (FAR)</li><li>Working knowledge of Department of Defense Federal Acquisition Regulations Supplement (DFAR)</li><li>Working knowledge of Cost Accounting Standards (CAS)</li><li>Working knowledge of PeopleSoft Financials System and PeopleSoft and Vision reporting tools</li><li>Strong Excel Skills</li></ul></div><div><b>
Preferred:</b><br>
<br>
<ul><li>Experience with Federal Government Cost Proposals</li><li>Familiarity with Defense Contract Audit Agency (DCAA) audit procedures</li><li>Familiarity with Defense Contract Management Agency (DCMA) audit procedures</li></ul></div><p></p><p><b><br>
Key Responsibilities</b></p><p></p><ul><li>Analyzes documentation in support of accounting transactions to determine accounting treatment that is in compliance with FAR, DFAR, CAS, and Disclosure Statement requirements.</li><li>Partners with the process owners and Subject Matter Experts to develop and implement internal control processes that support compliance with FAR, DFAR, CAS, and Disclosure Statement requirements.</li><li>Builds cost accounting reports of overhead rates that comply with FAR, DFAR, CAS, and Disclosure Statement requirements.</li><li>Conducts internal oversight on Accounting System, Cost Estimating System, Material Management and Accounting System (MMAS), Purchasing System and Property Management System to ensure DFARS compliance.</li><li>Analyzes and presents report of analysis on overhead rates to senior management</li><li>Compiles, analyzes, and develops documentation in support of Government Cost Reports such as Incurred Costs Report and Forward Pricing Rate Proposal.</li><li>Supports audits of cost accounting reports conducted by the Defense Contract Audit Agency (DCAA) and Defense Contract Management Agency (DCMA).by answering questions</li><li>Regular and reliable attendance is required.</li></ul><p></p><p><b><br>
Competencies</b></p><p></p><p><b>
Commitment to Task: </b>Ability to conform to established policies and procedures; exhibit high motivation.</p><p><b>
Communication / People Skills: </b>Ability to influence or persuade others under positive or negative circumstances; adapt to different styles; listen critically; collaborate.</p><p><b>
Computer Literacy: </b>Ability to function in a multi-system Microsoft environment using Word, Outlook, TriWest Intranet, the Internet, and department software applications.</p><p><b>
Empathy / Customer Service: </b>Customer-focused behavior; Helping approach, including listening skills, patience, respect, and empathy for another's position.</p><p><b>
Information Management: </b>Ability to manage large amounts of complex information easily, communicate clearly, and draw sound conclusions.</p><p><b>
Multi-Tasking / Time Management: </b>Prioritize and manage actions to meet changing deadlines and requirements within a high volume, high stress environment.</p><p><b>
Organizational Skills: </b>Ability to organize people or tasks, adjust to priorities, learn systems, within time constraints and with available resources; detail-oriented.</p><p><b>
Problem Solving / Analysis: </b>Ability to solve problems through systematic analysis of processes with sound judgment; Has a realistic understanding of relevant issues.</p><p><b>
Technical Skills: </b>Working knowledge of Federal Acquisition Regulations (FAR), Department of Defense Federal Acquisition Regulation Supplement (DFAR), Cost Accounting Standards, fundamentals of accounting and sound business processes, Word and Excel proficiency, research and project management skills</p><p></p><p><b><br>
Working Conditions</b></p><p></p><div><b>
Working Conditions:</b><br>
<br>
<ul><li>Works within a standard office environment , with minimal travel required</li><li>Extensive computer work with long periods of sitting</li><li>Onsite: Works within a standard office environment</li><li>Remote: Private and secure work space and work station with high speed internet is required</li></ul></div>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Company Overview</b></h2><div><br>
<div><div>
</div><p><b>Taking Care of Our Nation&rsquo;s Heroes.
</b></p><p><b>It&rsquo;s Who We Are. It&rsquo;s What We Do.</b></p><p>
Do you have a passion for serving those who served?
</p><p><b>Join the TriWest Healthcare Alliance Team! We&rsquo;re On a Mission to Serve&reg;!</b></p><p>
Our job is to make sure that America&rsquo;s heroes get connected to health care in the community.
</p><p>At TriWest Healthcare Alliance, we&rsquo;ve proudly been on that important mission since 1996.</p><br>
<p></p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
DoD Statement</b></h2><div><br>
<div><div>
</div><p>Our Department of Defense contract requires US citizenship and a favorably adjudicated DOD background investigation for this position.</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Benefits</b></h2><div><br>
<div><div>
</div><p>We&rsquo;re more than just a health care company. We&rsquo;re passionate about serving others! We believe in rewarding loyal, hard-working people who are willing to learn as they grow. TriWest Healthcare Alliance values teamwork. Join our team, fulfill your responsibilities, and you may also be considered for frequent pay raises, overtime opportunities to earn even more, recognition and reward programs, and much more. Of course, we also offer a comprehensive and progressive compensation and benefits package that includes:</p><ul><li>
Medical, Dental and Vision Coverage</li><li>
Paid time off</li><li>
401(k) Retirement Savings Plan (with matching)</li><li>
Short-term and long-term disability, basic life, and accidental death and dismemberment insurance</li><li>
Tuition reimbursement</li><li>
Paid volunteer time</li></ul><div>
TriWest job postings typically include a salary range, <b>which can vary based on the specific role and location</b>, but generally this position ranges from around $70,000 to $74,000 per year.</div>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Equal Employment Opportunity</b></h2><div><br>
<div><div>
</div><p>TriWest Healthcare Alliance is an equal employment opportunity employer. We are proud to have an inclusive work environment and know that a diverse team is a strength that will drive our success. To that end, TriWest strives to create an inclusive environment that supports diversity at every organizational level, and we highly encourage candidates from all backgrounds to apply. Applicants are considered for positions based on merit and without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or any other consideration made unlawful by applicable federal, state, or local laws.</p></div></div></div></div></div><p></p>

Contract Compliance Specialist

University of Maryland, Baltimore

<div></div><div><div><p><b>The Pulmonary, Critical Care, and Sleep Medicine Division</b> has an exciting opportunity for a <b>Contractual Clinical Research Specialist or</b> <b>a Senior Clinical Research Assistant </b>to join our fun and productive team. This will be an excellent opportunity for an individual seeking stability and/or professional advancement.</p><p><b>
Benefits: Contingent Category II</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. Contingent Category II staff receive a generous leave package that includes over 2 weeks of vacation each year, paid holidays, sick time, and time for community service; subsidized comprehensive health insurance and supplemental retirement options; professional learning and development programs; limited tuition remission for employees enrolled at UMB; life insurance and long-term disability; 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><b>
Primary Duties</b></p><p><b>
Contractual Senior Clinical Research Assistant</b></p><ul><li><p>
Responsible for facilitating and coordinating clinical research patient visits and data collection. The position will support the conduct of clinical trials, including the coordination of start-up activities, scheduling and preparing for patient visits, assisting with data collection and clarification, and general administrative duties.</p></li><li><p>
Assist in 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. May assist in developing and recommending policies and procedures and/or design methods for clinical research activities.</p></li><li><p>
Coordinates data collection of the research study including obtaining medical records, lab results, diagnostic results, visit notes, etc. Coordinates recruitment and screening subjects for research studies according to IRB approved protocols. May communicate directly with study participants.</p></li><li><p>
Coordinates paperwork for submission of IRB protocol, IRB amendments, and IRB continuing reviews. Document and report all adverse events as appropriate. Participates in audits and monitor visits as needed according to policy.</p></li><li><p>
Performs the coordination of data analysis and interpretation and develops statistical reports of study data using descriptive statistics using SAS, STATA, and SPSS statistical software. Assists in developing, submitting, and providing content for grants, papers, abstracts, manuscripts, and presentations. Conducts and analyzes literature searches. Develops and establishes a database to track research data.</p></li><li><p>
Coordinates development of research protocols and materials by providing study analysis and forming conclusions and recommendations.</p></li><li><p>
Documents in accordance with state and federal standards pertaining to specific research participant enrolled in the study. 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.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><p><b>
OR</b></p><p><b>
PRIMARY DUTIES</b></p><p><b>
Contractual Clinical Research Specialist</b></p><ul><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
Oversees and coordinates the day-to-day clinical research operations, study initiation, execution, and completion. Assist in the design and provide expert recommendations 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.<br>
May provide working coordination and feedback to others.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><div><br>
</div></div><div><b>
Qualifications</b><div></div><p><b><br>
Contractual Senior Clinical Research Assistant</b></p><p><b>
Education: </b>Bachelor&rsquo;s degree in a scientific field of study related to the research of the clinical setting.</p><p><b>
Experience:</b> Two (2) years of experience in clinical research in research being performed in unit.</p><p><b>
Other:</b> May consider a combination of directly related experience and education</p><p><b>
OR</b></p><p><b>
Contractual Clinical Research Specialist</b></p><p><b>
Education: </b>Bachelor&rsquo;s degree in a scientific field of study related to the research of the clinical setting.</p><p><b>
Experience:</b> Three (3) years of experience in clinical research including two (2) years in the relevant research specialization.</p><p><b>
Other: </b>May consider a combination of directly related experience and education</p><p><b>
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><b>
Hiring Ranges: Commensurate with education and experience</b></p><p><b>
Contractual Senior Clinical Research Assistant: $57,500 - $60,000</b></p><p><b>
Contractual Clinical Research Specialist: $64,000 - $75,000</b></p><p>
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 - E3302D</div><div><b>
Employee Class</b> Exempt Contingent II</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 - Department of Medicine</div><div><b>
Job Posting</b><b>:</b> May 5, 2026</div><div><b>
Unposting Date</b><b>:</b> May 19, 2026, 10:59:00 PM</div></div>

OPEN RANK Contractual Senior Clinical Research Assistant or Contractual Clinical Research Specialist

Temple University Health System

<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

Search 10000+ Research compliance specialist jobs near you this May. New roles added regularly across leading industries. Apply today.