study lead

IQVIA

<div><div><div>Istanbul, Turkey | Full time | Home-based | R1535388</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><br>
To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</div><div>
Responsabilities:</div><ul><li>
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.</li><li>
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies</li><li>
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.</li><li>
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.</li><li>
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.</li><li>
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.</li><li>
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.</li><li>
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.</li><li>
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.</li><li>
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.</li><li>
Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).</li><li>
Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.</li><li>
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.</li><li>
Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.</li><li>
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.</li><li>
Proactively identifies risks and facilitates resolution of complex study problems and issues.</li><li>
Organises regular Local Study Team meetings on an agenda driven basis.</li><li>
Actively works towards achieving good personal relationships with all Local Study Team members, sites&rsquo; staff and global stakeholders.</li><li>
Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.</li><li>
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.</li><li>
Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.</li><li>
Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.</li><li>
Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.</li><li>
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.</li><li>
Provides input to process development and improvement.</li><li>
Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.</li><li>
Updates Line Managers about the performance of the CRAs/CSAs.</li><li>
Ensures that study activities at country level comply with local policies and code of ethics.</li><li>
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.</li><li>
Ensures compliance with Sponsor&acute;s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).</li><li>
Collaborates with local Medical Affairs team.</li><li>
Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.</li></ul><div>
Requirements:</div><ul><li>
Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).</li><li>
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).</li><li>
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.</li><li>
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.</li><li>
Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas</li><li>
Good knowledge of the Drug Development Process.</li><li>
Excellent understanding of the Clinical Study Process including monitoring.</li><li>
Very good understanding of the Study Drug Handling Process and the Data Management Process.</li><li>
Excellent project management skills.</li><li>
Excellent team building and interpersonal skills, organizational skill and verbal and written communication skills</li><li>
Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.</li><li>
Excellent knowledge of spoken and written English and local languages.</li><li>
Good ability to learn and to adapt to work with IT systems.</li><li>
Ability to travel nationally and internationally as required</li></ul><div><i>
&quot;Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered&rdquo;.</i></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div></div><div></div>

Local Study Associate Director - Sponsor Dedicated (m/w/d)

Gentex Services LLC

<p>We are seeking an energetic, bilingual and detail-oriented Shop Lead to oversee daily operations. You will manage inventory, make sure all vehicles and machinery are running correctly and have all the proper equipment they need. We are looking for a person with mechanic experience and is willing to go out to the field and work if necessary. Need a valid driver's license to be able to do shop runs, multitask have great communication skills, organized and is tech inclined willing to learn more about technology.</p><p>Pay: $24.00 - $35.00 per hour</p><p>Work Location: In person</p>

Shop Lead

Mace Group

<div><p>Mace combines construction expertise with consultancy to unlock potential in every person or project and redefine the boundaries of ambition. Our values shape the way we consult and define the people we want to join us on our journey.</p><p>
The project:</p><p>
This project offers the chance to join a talented Mace team in delivering a major mixed use programme in a remote location, collaborating with renowned architects and global consultants. The project involves extensive infrastructure and built assets, delivered rapidly through a hands-on Project/Construction Management approach, ideal for those experienced in managing both main and sub-contract packages.</p><p>
You&rsquo;ll be responsible for:</p><ul><li>
Lead projects from inception to completion, ensuring delivery on time, within budget, and aligned with client expectations.</li><li>
Champion Mace&rsquo;s Safety First culture, embedding health, safety, and wellbeing into every stage of delivery.</li><li>
Drive collaboration across clients, consultants, contractors, and stakeholders to achieve seamless project outcomes.</li><li>
Provide expert guidance and subject matter leadership to strengthen delivery across wider Mace programmes.</li><li>
Manage design, procurement, and construction programmes, integrating sequencing and staging plans to meet milestones.</li><li>
Proactively identify risks, issues and constraints; implement mitigation and recovery actions.</li><li>
Coordinate with engineering, planning, commercial and logistics teams for seamless package execution.</li><li>
Build trusted relationships with senior stakeholders, influencing and negotiating to secure successful outcomes.</li><li>
Promote innovation and continuous improvement by applying best practice, digital tools, and sustainability principles.</li><li>
Lead and develop project teams, fostering excellence, accountability, and alignment with Mace&rsquo;s strategic priorities.</li></ul><p>
You&rsquo;ll need to have:</p><ul><li>
Degree qualified in Construction Management, Civil Engineering or an equivalent subject.</li><li>
Minimum 15 years proven experience delivering major Build and Infrastructure packages on large scale programmes.</li><li>
Previous Middle East major project exposure is preferred.</li><li>
Strong Project leadership skills with a hands on approach when required.</li><li>
Excellent contractor management and field supervision skills coupled with pre contract design/procurement know how.</li><li>
Able to work in remote environments and adapt to evolving project demands.</li><li>
Solid understanding of HSE, construction methodology, QA/QC, permits and sequencing.</li><li>
Strong communication and coordination skills across multidisciplinary teams.</li></ul><p>
Our values</p><p>
Safety first - Going home safe and well: You will champion a safe, diverse and inclusive working environment, understanding the importance of wellbeing in your team and local health and safety rules or regulations of the work you&rsquo;re involved with.</p><p>
Client focus - Deliver on our promise: You will lead on the cost management services including estimating, procurement and cost planning, owning the quality of deliverables, strategic outcomes and building long term relationships with your clients.</p><p>
Integrity - Always do the right thing: You will lead operations that are fiscally and ethically viable, influencing the achievement of business objectives that align with business and legislative compliance obligations.</p><p>
Create opportunity - For our people to excel: You will mentor, coach, and develop teams, demonstrating effective leadership to ensure excellence in delivery against plans, championing a continuous improvement culture throughout all activities.</p><p>
Mace is an inclusive employer and welcomes interest from a diverse range of candidates. Even if you feel you do not fulfil all the criteria, please apply as you may still be the best candidate for this role or another role within our organisation.</p><p>
We are also open to discussing part time, flexible, and hybrid working options if suitable with-in the role.</p><p>
#LI-On-site</p></div>

Package Lead

Coca-Cola HBC

<div>
 <p>
  <strong>
   Department:
  </strong>
  Group Test Management Team
 </p>
 <p>
  <strong>
   Location:
  </strong>
  Egypt, Cairo
 </p>
 <p>
  As an experienced Test Lead with expertise in "Azure Test Plan" and certified as an ISTQB Foundation Level Agile Tester (CTFL-AT).
 </p>
 <p>
  The ideal candidate will possess deep expertise in test management within Azure DevOps and play a crucial role in leading and managing testing activities, ensuring the quality and reliability of our software products, and ensuring that our processes adhere to Agile testing practices and quality standards.
 </p>
 <p>
  Responsibilities include designing, implementing, and executing testing strategies, plans, scripts, overseeing the resolution of data issues and defining UAT and automation scope.
 </p>
 <p>
  <strong>
   YOUR NEW KEY RESPONSIBILITIES:
  </strong>
 </p>
 <ul>
  <li>
   Lead and oversee the entire testing lifecycle for projects, including planning, execution, and reporting.
  </li>
  <li>
   Develop and implement comprehensive test strategies, test coverage, test plans, test scenarios, and data preparation for all test cycles, including functional, regression, performance, and user acceptance testing (UAT).
  </li>
  <li>
   Utilize "Azure Test Plan" for effective test management, including test suites and test cases creation, execution, peer-review and defect tracking.
  </li>
  <li>
   Monitor and report test activities, progress, issues, and quality metrics using to ensure testing is efficient and within the project's timeline
  </li>
  <li>
   Mentor and provide guidance to testing teams, fostering a culture of continuous improvement and Agile principles, methodologies, and best practices.
  </li>
  <li>
   Administer and configure ADO environments to optimize test processes and maintain test repositories, ensuring version control and traceability.
  </li>
  <li>
   Provide training to all teams on best practices in test management using Azure DevOps and offer continuous support and troubleshooting for related issues.
  </li>
  <li>
   Collaborate with the Country Coordinator to analyze country specifications and create relevant E2E test scenarios customized for each country. Collect input data, define criteria for generating this data, and work with the Automation Engineer to support their activities.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  &middot;
  <strong>
   ARE THESE YOUR SECRET INGREDIENTS?
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree in computer science, Information Technology, or a related field. Master&rsquo;s degree preferred.
  </li>
  <li>
   7-10 years of hands-on experience in testing, with at least 1 year specializing in test management within Azure Test Plan for test management, configuration, integration, and reporting.
  </li>
  <li>
   Certification in ISTQB Foundation Level Agile Tester (CTFL-AT) is required.
  </li>
  <li>
   Proven ability to develop and execute test strategies, test plans, and test cases.
  </li>
  <li>
   Experience in leading and mentoring testing teams, promoting collaboration and continuous improvement.
  </li>
  <li>
   Strong understanding of Agile principles and experience working in Agile testing methodologies
  </li>
  <li>
   Excellent communication, leadership, and interpersonal skills to effectively interact with diverse stakeholders and teams.
  </li>
  <li>
   Attention to detail and quality-oriented mindset
  </li>
  <li>
   Experience with eCommerce Platforms such as SAP Hybris/SAP Commerce Cloud, Microsoft Dynamics 365, HR Workday, and others will be considered as strong advantage
  </li>
  <li>
   Proficient in Azure DevOps (ADO) for test management, as well as other tools used for testing activities at various levels, including API testing tools (Postman, SoapUI, JMeter) and database management (HANA-specific SQL for data validation, Oracle/SQL Server).
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   ABOUT YOUR NEW TEAM:
  </strong>
 </p>
 <p>
  We are Coca-Cola Hellenic, a growth-focused consumer goods business and strategic bottling partner of the Coca-Cola Company. We bottle, distribute and sell an unrivalled range of products in 29 markets in Europe, Africa and Eurasia. As we do, we create value for all stakeholders, support socio-economic growth and build a more positive environmental impact.
 </p>
 <p>
  We bring together more than 30,000 people from over 70 nationalities, coming from five continents. The diversity of our markets, from mature to emerging economies, provides a wide range of attractive opportunities for growth.
 </p>
 <p>
  We nurture our talents. We give opportunities to people across all functions and levels, as well as different geographies, backgrounds and education. We are willing to take a risk on the people we believe in, even if they don&rsquo;t have the perfect experience. We have faith in what every person can be.
 </p>
 <p>
  And although we have so much to be proud of, we always stay humble. We believe the real magic happens &ndash; for us and for you &ndash; when we OPEN UP.
 </p>
 <p>
  <strong>
   AT COCA-COLA HBC, DIVERSITY HELPS US THRIVE
  </strong>
 </p>
 <p>
  Including and celebrating different people and opinions is embedded in our growth story. We are committed to fostering diverse teams that reflect the communities we serve, and to creating an inclusive environment where everyone&rsquo;s unique perspectives are valued and heard. By constantly building a diverse and inclusive workplace, we enrich our decision-making and provide ever more innovative solutions and shared value.
 </p>
</div>


Test Lead

Bechtel

<div><p><b>Requisition ID: 293367</b></p><ul><li><b>
Relocation Authorized: National - Single</b></li><li><b>
Telework Type: Full-Time Office/Project</b></li><li><b>
Work Location: Pecos , TX, Various Work Locations USA</b></li></ul><p></p><div><div><div><h2 class="jobSectionHeader"><b><br>
Extraordinary teams building inspiring projects:</b></h2></div><div><p>
Since 1898, we have helped customers complete more than 25,000 projects in 160 countries on all seven continents that have created jobs, grown economies, improved the resiliency of the world's infrastructure, increased access to energy, resources, and vital services, and made the world a safer, cleaner place.</p><p>
Differentiated by the quality of our people and our relentless drive to deliver the most successful outcomes, we align our capabilities to our customers' objectives to create a lasting positive impact. We serve the Infrastructure; Nuclear, Security &amp; Environmental; Energy; Mining &amp; Metals, and the Manufacturing and Technology markets. Our services span from initial planning and investment, through start-up and operations.</p><p>
Core to Bechtel is our Vision, Values and Commitments. They are what we believe, what customers can expect, and how we deliver. Learn more about our extraordinary teams building inspiring projects in our Impact Report.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Project Overview:</b></h2></div><div><p>
The rapid growth of AI and digitalization is fueling unprecedented demand for data centers that require large, reliable sources of energy. In response to this market trend, the Renewables &amp; Clean Power (R&amp;CP) team have signed an early works contract to build one of the largest gas fired power generation facilities in the U.S.</p><p>
This project is of significant scale and complexity, and our team is helping the customer progress early-stage development, that would lead to the start of full EPC delivery this year.</p><p>
The candidate will locate on a long-term assignment to Pecos, Texas. This position is contingent upon project award.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Summary:</b></h2></div><div><p>
The Environmental Safety &amp; Health (ES&amp;H) Field Lead helps implement and ensure compliance with each component of an Environmental, Safety, and Health program. This involves administrative and field tasks per established industry practices, procedures, and regulatory and Bechtel requirements. The position requires practical application of occupational safety and related disciplines for managing environmental, safety and health aspects of a project or facility. The position reports to the Deputy ES&amp;H Manager. #LI-VB1</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Major Responsibilities:</b></h2></div><div><ul><li>
Coordinates a wide variety of Environmental, Safety, and Health (ES&amp;H) disciplines to facilitate implementation of Bechtel's ES&amp;H program and ES&amp;H Management System, including aiding compliance with Bechtel's ES&amp;H standards, applicable regulatory requirements, and contractual commitments</li><li>
Assists in the development, implementation, and maintenance of programs, systems, and procedures necessary for the safety and health of employees and protection of the environment and communities</li><li>
Maintains ES&amp;H databases, inclusive of incident events, audit/assessment findings, and corrective actions</li><li>
Performs statistical analysis of ES&amp;H data to identify performance trends and contributing factors as part of continuous improvement and makes recommendations accordingly</li><li>
Identifies and coordinates unique software systems and electronic innovation used by ES&amp;H personnel</li><li>
Leads teams in conducting risk assessment, studies, mitigation planning, and monitoring in response to ES&amp;H issues</li><li>
Prepares communications, writes reports, and prepares documents for program execution and records retention</li><li>
Coordinates incident notifications, leads investigations, and prepares incident investigation reports</li><li>
Recommends and implements improvements in processes, procedures, and work activities to minimize hazard potential</li><li>
Participates in and may lead employee training, emergency preparedness, and quality assurance programs</li><li>
Coordinates ES&amp;H recognition programs</li><li>
Researches moderately complex issues and provides regulatory interpretation and technical advice</li><li>
Provides support to ES&amp;H field and office personnel, inclusive of all ES&amp;H discipline</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Education and Experience Requirements:</b></h2></div><div><ul><li>
Requires bachelor's degree (or international equivalent) and 8-10 years of relevant experience or 12-14 years of relevant work experience</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Required Knowledge and Skills:</b></h2></div><div><ul><li>
Ability to research and comprehend organizational and regulatory requirements.</li><li>
Excellent oral and written communication skills.</li><li>
Computer skills for preparing presentations, data management, and report preparation.</li><li>
Adaptable and able to work outdoors in a field environment under various weather conditions.</li><li>
Ability to support multiple work shifts, as needed, and a wide range of tasks.</li><li>
Demonstrated leadership skills and experience in managing a team of Environmental, Safety and Health professionals.</li><li>
Demonstrated ability to apply education, training and experience to solve problems and the communication skills necessary to share those solutions with Construction supervision.</li><li>
Knowledge and experience with ISO 45001 Management System standards</li><li>
Specialized technical skills and knowledge related to applicable safety or health discipline.</li><li>
Broad technical knowledge, science skills, and technical writing abilities.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Total Rewards/Benefits:</b></h2></div><div><p>
For decades, Bechtel has worked to inspire the next generation of employees and beyond! Because our teams face some of the world's toughest challenges, we offer robust benefits to ensure our people thrive. Whether it is advancing careers, delivering programs to enhance our culture, or providing time to recharge, Bechtel has the benefits to build a legacy of sustainable growth. Learn more at Bechtel Total Rewards</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Diverse teams build the extraordinary:</b></h2></div><div><p>
As a global company, Bechtel has long been home to a vibrant multitude of nationalities, cultures, ethnicities, and life experiences. This diversity has made us a more trusted partner, more effective problem solvers and innovators, and a more attractive destination for leading talent.</p><p>
We are committed to being a company where every colleague feels that they belong-where colleagues feel part of &quot;One Team,&quot; respected and rewarded for what they bring, supported in pursuing their goals, invested in our values and purpose, and treated equitably.</p></div></div></div><p></p><p><b><i><br>
Bechtel is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, disability, citizenship status (except as authorized by law), protected veteran status, genetic information, and any other characteristic protected by federal, state or local law. Applicants with a disability, who require a reasonable accommodation for any part of the application or hiring process, may e-mail their request to </i></b><b>acesstmt@bechtel.com</b></p></div>

Field ESH Lead

Premiere Health and Wellness

<p><b>Lead Clinical Research Coordinator Job Description</b></p><p><b>Job Title: Lead Clinical Research Coordinator</b></p><p><b>Reports To: </b>Clinical Research Site Manager</p><p><b>Department: </b>Clinical Operations</p><p><b>Location: </b>On-site (SKYCRNG Network Site)</p><p><b>Position Summary</b></p><p>The <b>Lead Clinical Research Coordinator (Lead CRC)</b> provides operational leadership and oversight of clinical research studies conducted at the site. This role is responsible for ensuring protocol compliance, subject visit execution, investigational product (IP) accountability, regulatory maintenance, and serving as a DEXA technician, while serving as a manager to CRCs. The Lead CRC works closely with the Site Manager to support study start-up, execution, study maintenance, and close-out activities in accordance with ICH-GCP, IRB requirements, sponsor protocols, and SKYCRNG&rsquo;s Standard Operating Procedures (SOPs).</p><p><b>Key Responsibilities</b></p><p><b>Study Operations &amp; Compliance</b></p><ul><li>Maintain and oversee subject visit schedules, ensuring protocol-required visits and procedures are completed accurately and on time.</li><li>Ensure subject visit compliance across all CRCs, including source documentation, protocol adherence, and timely data, imaging, and lab query resolution by CRC staff.</li><li>Oversee and maintain investigational product (IP) accountability, ensuring accurate documentation, storage, reconciliation, and compliance.</li><li>Maintain the regulatory binder, ensuring all essential documents are complete, current, and audit-ready.</li><li>Attend and actively participate in Site Initiation Visits (SIVs) and other required sponsor or CRO meetings.</li></ul><p><b>Data Quality &amp; Query Management</b></p><ul><li>Oversee the resolution of data, lab, and imaging queries, ensuring timely, accurate responses and appropriate follow-up.</li><li>Collaborate with CRCs to identify trends, recurring errors, or training needs related to source quality and visit compliance.</li><li>Provide ongoing subject study status updates to the Site Manager, including enrollment, visit completion, and outstanding issues.</li></ul><p><b>Study Start-Up &amp; Close-Out &amp; Systems Readiness</b></p><ul><li>Work closely with the Site Manager to collect, organize, and submit study start-up documents, including regulatory and training materials.</li><li>Create and maintain study-specific checklists to support efficient study execution and consistent CRC workflows.</li><li>Complete continuing review and study termination IRB submissions in accordance with IRB requirements and established timelines.</li></ul><p><b>Leadership, Mentorship &amp; Team Development</b></p><ul><li>Serve as a manager and subject-matter resource for CRCs, providing guidance on protocol requirements, documentation standards, and best practices.</li><li>Support training, onboarding, and professional development of CRC staff.</li><li>Ensure all site staff have appropriate access to study systems, including EDC, IRT/IXRS, ePRO, imaging platforms, and sponsor portals.</li><li>Monitor and support staff training completion, system access readiness, and protocol-required certifications.</li><li>Promote a culture of compliance, accountability, collaboration, and continuous improvement across the site and SKYCRNG network.</li></ul><p>&middot;</p><p><b>DEXA &amp; Specialized Procedure Oversight</b></p><ul><li>Perform and/or coordinate DEXA scans, including the completion, tracking, and documentation of all outside DEXA scans, as required per protocol.</li></ul><p><b>Qualifications</b></p><p><b>Required</b></p><ul><li>Minimum 3&ndash;5 years of clinical research coordination experience.</li><li>Strong working knowledge of ICH-GCP, IRB requirements, and FDA regulations.</li><li>Proven experience with regulatory binders, IP accountability, and subject visit management.</li><li>Experience working with EDC systems, IRB portals, and sponsor systems.</li><li>Excellent organizational, communication, and leadership skills.</li></ul><p><b>Preferred</b></p><ul><li>Prior experience in a Lead CRC or Senior CRC role.</li><li>Experience with DEXA scans and imaging-based clinical studies.</li><li>Multi-protocol and multi-therapeutic area experience.</li><li>Professional certification (CCRC, CCRP, or equivalent).</li></ul><p><b>Core Competencies</b></p><ul><li>Attention to detail and regulatory compliance</li><li>Leadership and team mentorship</li><li>Time management and prioritization</li><li>Data quality oversight and query resolution</li><li>Cross-functional collaboration</li><li>Audit and inspection readiness</li></ul><p><b>Work Environment</b></p><ul><li>Clinical research site environment</li><li>May require extended hours based on study needs and sponsor visits</li><li>Occasional travel for meetings, monitoring visits, or training, if applicable</li></ul><p><b>SKYCRNG is committed to excellence, integrity, and community-focused research. This role is critical to maintaining our reputation as an audit-ready, enrollment-ready, high-performing clinical research network.</b></p><p>Job Type: Full-time</p><p>Work Location: In person</p>

Clinical Research Coordinator

Aton Health

<p>Department: Research Operations</p><p>Reports To: Senior Manager, Research Operations</p><p>Job Status: Full-Time</p><p>Job Classification: Exempt</p><p>Company Overview</p><p>Aton Health is a clinician-first clinical research company rethinking how evidence is generated in modern healthcare. Instead of treating trials as separate from care, we embed research directly into real-world clinical workflows, helping sponsors and specialty practices accelerate enrollment, improve study execution, and generate high-quality, audit-ready evidence at scale. Our model depends on operational precision and regulatory rigor. We&rsquo;re building a team that takes pride in running studies the right way and where compliance isn&rsquo;t a checkpoint, but a standard embedded in every aspect of execution.</p><p>Position Summary</p><p>The Senior Clinical Research Coordinator is responsible for the end-to-end execution of clinical research within Aton Health&rsquo;s integrated care and decentralized research model.</p><p>Operating from the site perspective, the Senior CRC owns the delivery of 1&ndash;3 concurrent non-interventional, low-risk clinical studies, ensuring high-quality, compliant, and efficient execution across patient care, data collection, and study operations.</p><p>This role serves as the lead clinical research coordinator and study operator, managing sponsor relationships, overseeing distributed vendor teams, and driving study performance across Aton&rsquo;s care-enabled research infrastructure.</p><p>Key Responsibilities</p><p>Study Leadership, Planning &amp; Trial Oversight</p><ul><li>Lead implementation and optimization of decentralized trial tools and workflows</li><li>Lead execution of 1&ndash;3 non-interventional, low-risk clinical studies</li><li>Develop and oversee detailed project plans, including timelines, work instructions, and staff training plans</li><li>Oversee study timelines, enrollment progress, and site performance metrics</li><li>Monitor study progress and proactively address risks, issues, and delays</li><li>Maintain and contribute to study-level tools such as RAID logs, trackers, and internal planning documents</li></ul><p>Sponsor Relations &amp; Stakeholder Management</p><ul><li>Serve as the primary point of contact for sponsors and CRO partners</li><li>Lead sponsor communications, including study updates, issue escalation, and performance reporting</li><li>Maintain effective communication with all stakeholders, including internal teams and external partners</li><li>Coordinate across cross-functional teams to ensure alignment on study execution</li></ul><p>Vendor &amp; Distributed Team Oversight</p><ul><li>Oversee performance and coordination of off-site and vendor staff, including:</li><li>Data managers</li><li>Pre-study validation teams</li><li>Laboratory partners</li><li>Sub-investigators</li><li>Chart abstraction teams</li><li>Ensure vendors meet timelines, quality standards, and protocol requirements</li><li>Coordinate vendor activities and ensure alignment with study deliverables</li></ul><p>Clinical Operations &amp; Participant Management</p><ul><li>Oversee and support participant validation, enrollment, and management</li><li>Ensure research activities are appropriately integrated into clinical care workflows</li><li>Ensure proper execution of informed consent (ICF), HIPAA compliance, and participant protections</li><li>Ensure proper storage, handling, and accountability of study materials</li></ul><p>Data Quality, Documentation &amp; Monitoring Oversight</p><ul><li>Ensure protocol compliance, GCP adherence, and data integrity across all studies</li><li>Review eSource, EDC, eCRFs, and digital data streams for completeness and accuracy</li><li>Ensure accurate and timely data collection, entry, and reporting</li><li>Assist in preparation and review of study-related documentation, including:</li><li>Source documentation</li><li>eCRFs</li><li>Study files and regulatory documents</li><li>Review monitoring reports and ensure timely resolution of findings</li></ul><p>Monitoring, Audits &amp; Inspection Readiness</p><ul><li>Oversee and support site monitoring visits, audits, and inspections</li><li>Ensure continuous inspection readiness across all studies</li><li>Act as the primary site interface during monitoring visits</li><li>Support audit readiness and participate in regulatory inspections</li></ul><p>Safety, Compliance &amp; Issue Management</p><ul><li>Ensure compliance with regulatory, ethical, and protocol requirements</li><li>Oversee adverse event (AE) reporting and protocol deviation management, including follow-up and documentation</li><li>Monitor and resolve study queries and operational issues</li><li>Escalate risks appropriately and implement corrective actions</li></ul><p>Training, Process Development &amp; Continuous Improvement</p><ul><li>Provide training and ongoing support to CRCs, CRAs, and site staff</li><li>Develop and refine study processes, SOPs, and internal workflows</li><li>Contribute to continuous improvement of monitoring, data quality, and operational processes</li><li>Standardize best practices across studies to support scalability</li></ul><p>Qualifications</p><p>Required</p><ul><li>Bachelor&rsquo;s degree in life sciences, nursing, or related field (required)</li><li>3-5 years of clinical research experience, including:</li><li>Senior site-level, CRA, or Lead CRA</li><li>Experience managing multiple studies and competing priorities</li><li>Strong knowledge of ICH-GCP, regulatory, and compliance requirements</li><li>Experience with decentralized or hybrid trials strongly preferred</li></ul><p>Competencies</p><ul><li>Ability to lead cross-functional teams and distributed vendors</li><li>Strong data review, documentation, and compliance capabilities</li><li>Excellent written and verbal communication and stakeholder management skills</li><li>Ability to operate effectively in a non-traditional, fast-evolving model</li><li>Independent judgment and integrity</li><li>Ability to influence without direct authority</li><li>Strong attention to detail</li><li>Risk-based decision making</li><li>Operational pragmatism (balances compliance with business needs)</li></ul><p>Work Environment</p><ul><li>Small, growth-stage organization</li><li>Hands-on role with strategic and tactical responsibilities</li><li>High visibility with executive leadership</li><li>Opportunity to shape quality infrastructure from the ground up</li></ul><p>Physical Demands</p><p>The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.</p><p>While performing the duties of this job, the employee is regularly required to talk or hear. The employee must occasionally lift and or move up to 10 pounds. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.</p><p>AAP/EEO Statement</p><p>The Company is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. The Company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. The Company conforms to the spirit as well as to the letter of all applicable laws and regulations.</p><p>Other Duties</p><p>Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.</p><p>Pay: From $65,000.00 per year</p><p>Benefits:</p><ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Senior Clinical Research Coordinator

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