Qureos Mentor

The Emmes Company, LLC

<div>Overview:
<div><b>
Clinical Research Associate II</b><br>
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<b>Be Part of One Team, One Purpose.</b><br>
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At <b>Emmes Group</b>, we&rsquo;re shaping the future of clinical research&mdash;<b>where human intelligence meets cutting-edge technology</b> to drive meaningful advancements in healthcare. With over <b>47 years of scientific excellence</b>, we&rsquo;ve led groundbreaking research in <b>cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.</b><br>
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Through our two business units&mdash;<b>Emmes, a full-service CRO</b>, and <b>Veridix AI, our technology, data, and analytical solutions</b> &mdash;we are modernizing clinical trials and accelerating the development of life-changing therapies.<br>
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We believe that every clinical breakthrough starts with <b>people</b>&mdash;people who are <b>passionate, purpose-driven, and ready to make an impact.</b> At <b>Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact.</b> Our culture is built on <b>integrity, collaboration, and innovation</b>, ensuring that every challenge is met with perseverance and accountability.<br>
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The Clinical Research Associate (CRA) II is responsible for monitoring clinical study sites either onsite at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP.</div>
Responsibilities:
<ul><li>Under supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., independently schedules and conducts remote and on-site monitoring visits such as qualification pre study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for cause visits.</li><li>
As part of the site visits, independently conducts Informed Consent ICF review, source data verification source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.</li><li>
Documents observations and monitoring activities in a site visit report at the conclusion of the visit.</li><li>
Facilitates and oversees Action Item resolution post visit.</li><li>
Helps to ensure that clinical sites are conducting the study in compliance with protocol clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.</li><li>
Provides training and retraining to site staff including protocol, GCP GDP, and other training under direction from the project CRA staff oversight lead.</li><li>
Identifies areas requiring follow up and improvement at each clinical study site and reports findings to project CRA staff oversight lead.</li><li>
Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures</li><li>
Serves as point of contact for study site personnel to answer questions and resolve studyrelated issues under the direction of the project CRA staff oversight lead.</li><li>
May assist with the development and or review of study related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.</li><li>
Prepares for and attends project team meetings and provides updates on project status and site specific performance</li><li>
Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines.</li><li>
Participates in Investigator Meetings or other client meetings as needed.</li><li>
Assists with filing and archiving of study documents.</li><li>
Assists in preparing sites for audits and may provide support and cooperation during audits inspections including translation to Auditor if needed.</li><li>
May assist with coordination of clinical study supplies.</li><li>
May assist with submission of applications notifications to Institutional Review Board IRB Ethics Committee EC Regulatory Authority.</li><li>
May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans.</li><li>
Performs site management activities as required</li><li>
Performs other duties as assigned</li><li>
Complies with all policies and standards</li></ul>
Qualifications:
<ul><li>Bachelor's Degree Scientific discipline preferred or equivalent work experience Required</li><li>
1-3 years 1-2 years of relevant monitoring experience (on-site and remote) Required</li><li>
Proficient with MS Office Suite High</li><li>
Excellent computer and organizational skills High</li><li>
High level of attention to detail required High</li><li>
Ability to work on varying projects and exercise critical thinking High</li><li>
self starter who can work remotely and a team player who can work cross functionally with some oversight High</li><li>
Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA High</li><li>
Excellent organizational, interpersonal, and communication skills both oral and written High</li><li>
Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High</li><li>
Knowledgeable in prioritization, problem solving, organization, critical thinking, decisionmaking, time management, and planning activities High</li><li>
Ability to collaborate with internal and external colleagues and work well in a team oriented setting High</li></ul><div></div><div><br>
If you&rsquo;re looking for a career where your work <b>advances global health</b> and where <b>scientific excellence meets real-world impact</b>, join us and be part of something bigger. <b>One Team, One Purpose.</b><br>
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<b>CONNECT WITH US!</b><br>
<i>Find us on LinkedIn:/the-emmes-group/</i><br>
Visit our website:https://www.theemmesgroup.com/</div></div>

Clinical Research Associate II

<div>Overview:
<h1 class="jobSectionHeader"><b>Job Title: Technical Project Manager I, II, III (Multiple Openings | Contingent Roles) - Essex Management</b></h1><h3 class="jobSectionHeader"><b>
Notice to Candidates</b></h3><p>
Employment in this position is expressly contingent upon Essex Management's receipt of a contract award from the Federal Government.</p><h3 class="jobSectionHeader"><b>
Location</b></h3><p>
US Remote</p><h3 class="jobSectionHeader"><b>
About Essex</b></h3><p>
This position supports &quot;Essex, an Emmes Company&quot;. Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.</p><h1 class="jobSectionHeader"><b>
Primary Purpose</b></h1><p>
Essex is seeking multiple Technical Project Managers at Levels I, II, and III to support a growing portfolio of life science, health informatics, and Federal Government programs.</p><p></p><p><br>
The Technical Project Manager (TPM) role is responsible for supporting, managing, and leading technical projects and programs throughout the project lifecycle. Depending on experience and qualifications, selected candidates will be aligned to the appropriate TPM level and entrusted with increasing levels of responsibility, autonomy, stakeholder engagement, and strategic leadership.</p><p></p><p><br>
Across all levels, TPMs partner with technical teams, program leadership, and government stakeholders to ensure projects are delivered on time, within budget, and in compliance with contractual, regulatory, and organizational requirements.</p><p></p><p><br>
Candidates should possess a strong foundation in project management principles, experience working within technical or regulated environments, and the ability to effectively coordinate cross-functional teams while maintaining a commitment to quality, compliance, and continuous improvement.</p><br>
<div></div>
Responsibilities:
<h2 class="jobSectionHeader"><b>Technical Project Management &amp; Execution</b></h2><h3 class="jobSectionHeader"><b>
TPM I</b></h3><ul><li>
Support project planning, coordination, scheduling, and execution activities across assigned projects.</li><li>
Maintain project documentation, action item trackers, deliverable logs, risk registers, and reporting tools.</li><li>
Participate in project meetings and prepare meeting minutes, status updates, and follow-up communications.</li><li>
Assist with project performance tracking and reporting activities.</li><li>
Escalate project risks, issues, and schedule concerns to project leadership.</li><li>
Support compliance with organizational governance policies and contractual requirements.</li></ul><h3 class="jobSectionHeader"><b>
TPM II</b></h3><ul><li>
Manage end-to-end technical project delivery for assigned projects.</li><li>
Apply project controls including scope, schedule, budget, deliverable, and risk management.</li><li>
Support development and execution of project plans, milestones, and resource coordination activities.</li><li>
Track project KPIs and provide performance reporting to leadership and clients.</li><li>
Contribute to project reviews and decision-making activities.</li><li>
Support compliance with applicable regulatory and contractual requirements.</li></ul><h3 class="jobSectionHeader"><b>
TPM III</b></h3><ul><li>
Lead complex technical programs and enterprise-level project portfolios.</li><li>
Establish and oversee project governance, delivery frameworks, reporting standards, and performance metrics.</li><li>
Drive strategic planning, resource allocation, forecasting, and risk management activities.</li><li>
Provide expert consultation regarding software development, systems integration, cloud infrastructure, and IT modernization initiatives.</li><li>
Lead executive-level project reviews and portfolio health assessments.</li><li>
Develop and mature organizational project management methodologies and best practices.</li></ul><h2 class="jobSectionHeader"><b>
Contract, Financial &amp; Resource Management</b></h2><h3 class="jobSectionHeader"><b>
TPM I</b></h3><ul><li>
Support deliverable tracking and contract compliance activities.</li><li>
Assist with Monthly Status Reports (MSRs), Financial Status Reports (FSRs), and project documentation.</li><li>
Support budget tracking and resource coordination activities.</li><li>
Assist with onboarding and project staffing logistics.</li></ul><h3 class="jobSectionHeader"><b>
TPM II</b></h3><ul><li>
Monitor project budgets, forecasts, and resource utilization.</li><li>
Support contract compliance reporting and project performance tracking.</li><li>
Coordinate staffing assignments and identify resource constraints.</li><li>
Contribute to organizational process improvement and training initiatives.</li></ul><h3 class="jobSectionHeader"><b>
TPM III</b></h3><ul><li>
Lead budget planning, forecasting, and financial management activities across programs.</li><li>
Ensure contract compliance and successful delivery of all contractual obligations.</li><li>
Oversee resource allocation strategies and workforce planning activities.</li><li>
Contribute to organizational capability development, strategic initiatives, and service offering expansion.</li></ul><h2 class="jobSectionHeader"><b>
Stakeholder Engagement &amp; Communication</b></h2><h3 class="jobSectionHeader"><b>
TPM I</b></h3><ul><li>
Maintain effective communication with internal teams and stakeholders.</li><li>
Prepare project communications, status updates, and presentation materials.</li><li>
Support cross-functional collaboration and coordination activities.</li></ul><h3 class="jobSectionHeader"><b>
TPM II</b></h3><ul><li>
Build productive relationships with clients and project stakeholders.</li><li>
Communicate project status, risks, and mitigation strategies effectively.</li><li>
Facilitate collaboration across technical and business teams.</li></ul><h3 class="jobSectionHeader"><b>
TPM III</b></h3><ul><li>
Serve as a trusted advisor to clients, program leadership, and executive stakeholders.</li><li>
Translate complex technical concepts into actionable business recommendations.</li><li>
Drive strategic alignment across multiple projects, teams, and organizational priorities.</li></ul><h2 class="jobSectionHeader"><b>
Business Development</b></h2><h3 class="jobSectionHeader"><b>
TPM I</b></h3><ul><li>
Support proposal coordination, formatting, research, and documentation activities.</li></ul><h3 class="jobSectionHeader"><b>
TPM II</b></h3><ul><li>
Contribute to proposal development, capture support, and technical solution development.</li></ul><h3 class="jobSectionHeader"><b>
TPM III</b></h3><ul><li>
Lead and support business development initiatives by developing technical project management approaches, delivery strategies, and client-focused solutions.</li></ul><h2 class="jobSectionHeader"><b>
Project Lifecycle Framework</b></h2><h3 class="jobSectionHeader"><b>
TPM I</b></h3><ul><li>
Support project intake, initiation, and readiness activities.</li><li>
Maintain project dashboards, milestone tracking, risk logs, and reporting data.</li></ul><h3 class="jobSectionHeader"><b>
TPM II</b></h3><ul><li>
Manage project lifecycle activities from initiation through closeout.</li><li>
Maintain project reporting and contribute to portfolio-level dashboards and performance reviews.</li></ul><h3 class="jobSectionHeader"><b>
TPM III</b></h3><ul><li>
Establish and enhance portfolio reporting frameworks, governance processes, and project management standards.</li><li>
Drive continuous improvement through reporting, lessons learned, and organizational best practices.</li></ul>
Qualifications:
<h2 class="jobSectionHeader"><b>Education</b></h2><ul><li>
Bachelor's degree in Health Informatics, Clinical Research Administration, Public Health, Information Technology, Computer Science, or a related field required.</li><li>
Master's degree (MBA, MHA, MS, or related discipline) preferred for TPM II and TPM III candidates.</li></ul><h2 class="jobSectionHeader"><b>
Experience</b></h2><h3 class="jobSectionHeader"><b>
TPM I</b></h3><ul><li>
3+ years of project coordination, project management support, or related experience.</li><li>
Relevant internship, co-op, academic, or professional experience may be considered.</li></ul><h3 class="jobSectionHeader"><b>
TPM II</b></h3><ul><li>
6+ years of progressive technical project management experience.</li><li>
4+ years may be acceptable with a relevant Master's degree.</li></ul><h3 class="jobSectionHeader"><b>
TPM III</b></h3><ul><li>
8+ years of progressive technical project management experience.</li><li>
5+ years may be acceptable with a relevant Master's degree.</li><li>
Demonstrated experience leading large-scale, cross-functional technical initiatives and programs.</li></ul><h2 class="jobSectionHeader"><b>
Core Competencies</b></h2><ul><li>
Knowledge of project management methodologies including PMI/PMBOK, Agile, Scrum, Kanban, Waterfall, and SDLC.</li><li>
Experience using project management tools such as Jira, Confluence, Smartsheet, and Microsoft Project.</li><li>
Strong analytical, organizational, and problem-solving skills.</li><li>
Excellent written and verbal communication abilities.</li><li>
Ability to manage competing priorities and work effectively within matrixed environments.</li><li>
Understanding of project budgeting, forecasting, risk management, and resource planning appropriate to experience level.</li><li>
Familiarity with federal regulatory and compliance frameworks including NIST, FISMA, FedRAMP, SOC 2, and related standards.</li><li>
Experience supporting software development, systems integration, IT infrastructure, cloud modernization, health informatics, or life science programs is preferred.</li></ul><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2><ul><li>
Project Management Professional (PMP)</li><li>
Certified Associate in Project Management (CAPM)</li><li>
Certified ScrumMaster (CSM)</li><li>
SAFe Agilist (SA) or SAFe Program Consultant (SPC)</li><li>
ITIL 4 Foundation</li><li>
Lean Six Sigma Green Belt or Black Belt</li></ul><p>
Additional preferred experience includes:</p><ul><li>
Federal health agency support (FDA, CDC, or similar organizations).</li><li>
Federal contracting environments including IDIQs, task orders, CPARs, MSRs, and FSRs.</li><li>
GxP and 21 CFR Part 11 regulated environments.</li><li>
Proposal development, capture support, and business development activities within Federal IT, life science, or health informatics consulting organizations.</li></ul><h3 class="jobSectionHeader"><b>
Position Leveling</b></h3><p>
Candidates will be evaluated and hired at the Technical Project Manager I, II, or III level based on their education, experience, certifications, demonstrated competencies, and business needs. Multiple openings are anticipated across all levels.</p><p></p><h3 class="jobSectionHeader"><b><br>
Emmes Group: Building a Better Future for Us All</b></h3><p>
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the U.S. Government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry-leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.</p><p>
We believe the work we do has a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being both performance-driven and people-driven. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our passion for research, come join us.</p><div></div><div><i><br>
Why work at Emmes?</i></div><div></div><div><br>
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our <b>Emmes Cares</b> community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:</div><div></div><div><div><ul><li><b><br>
Flexible Approved Time Off</b></li></ul><p></p><ul><li><b><br>
Tuition Reimbursement</b></li></ul><p></p><ul><li><b><br>
401k Retirement Plan</b></li></ul></div><div><ul><li><b><br>
Work From Home Anywhere in the US</b></li></ul><p></p><ul><li><b><br>
Maternal/Paternal Leave</b></li></ul><p></p><ul><li><b><br>
Casual Dress Code &amp; Work Environment</b></li></ul></div></div><div></div><div><b><br>
CONNECT WITH US!</b></div><div><i>
Follow us on Twitter - @EmmesCRO</i></div><div><i>
Find us on LinkedIn - Emmes</i></div><div></div><div><i><br>
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.</i></div><div></div><div><br>
#LI-Remote</div></div>

Technical Project Manager I, II & III - Essex Management (Contingent Role)

Join The Emmes Company, LLC and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

The Emmes Company, LLC

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Clinical Research Associate II

Technical Project Manager I, II & III - Essex Management (Contingent Role)