study lead

Roche

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
<br><br>
Die Position
<br><br>
The role focuses on the responsibilities to ensure leadership and execution of one or more sponsored interventional trials or managed primary data collection non-interventional studies, the effective and efficient delivery of all operational aspects in accordance with the appropriate quality standards including ICH/GCP and GVPs/GPPs.
<br><br>
Your Responsibilities
<br><br>
<ul>
<li>Ensures study adherence to appropriate guidelines (ICH GCP/GVP/GPP), relevant regulations and Roche procedural documents. Ensures study inspection readiness at all times. Ensures the completion and finalization of any corrective and preventive action plans resulting from site audits and inspections</li>
<li>Provides operational input and insights into the development of study protocols, Clinical Study Reports, informed consent form and protocol feasibility questionnaires</li>
<li>Promotes operational excellence. Oversees the delivery and maintenance of essential study plans and systems (e.g. site& country selection and monitoring plan; study tracking systems, clinical supply; vendor oversight plan; RBQM or equivalent risk management activities). Ensures accurate tracking and reporting of study metrics</li>
<li>Chairs Study Management Team meetings and organizes the investigator meetings and study kick-off meetings</li>
<li>Establishes and maintains study budgets and approves invoices, identifies and communicates any issues/variances with study budgets and action plans for resolution</li>
<li>Accountable for all vendor related operational study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Leads vendor selections by reviewing proposals and providing recommendations, reviews and negotiates clinical work orders. Maintains oversight of vendor performance, issues, and their resolution and identifies systematic issues and coordinates any corrective action. Ensures vendors receive appropriate training.</li>
<li>Ensures proper handling of all study close out activities including but not limited to the site close out, final drug accountability, final safety reconciliation and Inspection readiness of Trial Master File documentation.</li>
</ul>
Who you are
<br><br>
<ul>
<li>Strong leadership skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies.</li>
<li>Proven strategic capabilities, organizational awareness and proactive planning with embedded contingencies and risk management mindset.</li>
<li>Clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.</li>
<li>Well-developed written and verbal communication skills demonstrated by an ability to present clear instructions/directions, to motivate your team, negotiate with peers and partners and influence cross functionally.</li>
<li>Excellent problem solving, negotiation and conflict resolution skills</li>
<li>Borderless Collaboration: working closely with other countries/communities/teams, embracing the loop of ‘sharing and learning together’ to co-create Solutions</li>
<li>Budget Management- cost effective management with limited unforeseen cost overruns.</li>
</ul>
Wer wir sind
<br><br>
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
<br><br>
Gemeinsam können wir eine gesündere Zukunft gestalten.
<br><br>
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

Clinical Study Lead

IQVIA

<div>Istanbul, Turkey | Full time | Home-based | R1535388</div>
<br><div><div>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>

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

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><div>
Lead projects from inception to completion, ensuring delivery on time, within budget, and aligned with client expectations.</div></li><li><div>
Champion Mace&rsquo;s Safety First culture, embedding health, safety, and wellbeing into every stage of delivery.</div></li><li><div>
Drive collaboration across clients, consultants, contractors, and stakeholders to achieve seamless project outcomes.</div></li><li><div>
Provide expert guidance and subject matter leadership to strengthen delivery across wider Mace programmes.</div></li><li><div>
Manage design, procurement, and construction programmes, integrating sequencing and staging plans to meet milestones.</div></li><li><div>
Proactively identify risks, issues and constraints; implement mitigation and recovery actions.</div></li><li><div>
Coordinate with engineering, planning, commercial and logistics teams for seamless package execution.</div></li><li><div>
Build trusted relationships with senior stakeholders, influencing and negotiating to secure successful outcomes.</div></li><li><div>
Promote innovation and continuous improvement by applying best practice, digital tools, and sustainability principles.</div></li><li>
Lead and develop project teams, fostering excellence, accountability, and alignment with Mace&rsquo;s strategic priorities.<br>
Works collaboratively towards the common goal of net zero carbon transition, and share responsibility for the proactive identification and management of the associated carbon emissions and reductions during the delivery of work.</li></ul><p><br>
You&rsquo;ll need to have:</p><ul><li><div>
Degree in Construction Management, Civil Engineering, or equivalent.<br>
Proven experience as a Package Lead / Senior Project Manager on large infrastructure or mixed‑use programmes.</div></li><li><div>
Strong background in utilities and infrastructure delivery, ideally including district cooling, chiller plants, generator farms, power, water and wastewater assets.</div></li><li><div>
Demonstrable experience across design management, procurement and site delivery.</div></li><li><div>
Ability to operate effectively on remote or logistically challenged projects in the Middle East.</div></li><li><div>
15+ years plus relevant industry experience.</div></li><li><div>
Middle East project exposure preferred, adaptable to remote environments and evolving demands.</div></li><li><div>
Solid HSE, QA/QC, construction methodology, permits, sequencing, and multidisciplinary coordination skills.</div></li><li><div>
Strong communication and coordination skills across multidisciplinary teams.<br>
Necessary visa criteria for the Kingdom of Saudi Arabia and have relevant work experience working on high-valued projects/programmes for a project management consultancy business, which are required for immigration and client approval.</div></li></ul><p><br>
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

El Seif Engineering Contracting Company

<div><p>Building the Future - One Project at a Time!
</p><p>At El Seif, we embrace and embody our core values of excellence, integrity, and innovation in every aspect of our work from meticulous planning to expert construction, we consistently uphold the highest standards of excellence, ensuring that our projects are delivered with precision and attention to detail. With half a century of diverse experiences across a wide range of industries, ranging from public infrastructure to military and defense applications, we have honed our expertise and gained indispensable insights that enable us to tackle complex challenges and maintain our standard of delivering exceptional results. Our forward-thinking approach sets us apart as a trusted partner in the construction industry. By continuously pushing the boundaries of innovation, we strive to pioneer the future of construction, creating sustainable and impactful solutions that leave a lasting legacy.
</p><p>Excellence, Integrity and, Innovation - every step of the way.</p></div>
<br><div><div>Responsibilities</div>
<div>
<p>The main purpose of the Lead - HSE (Project) job is to ensure compliance with set safety and environmental policies and procedures
</p><ul><li>Support the development of KSA national employees across the team to support corporate objectives, Saudization targets and the knowledge dissemination culture to ensure optimal building of internal capabilities and maximize their performance.
</li><li>Support and conduct the affairs of the team with the highest standards of respect, integrity, accountability, agility, quality, safety and corporate governance.
</li><li>Ensure compliance with Code of Ethics policy and adopting company values across all function&rsquo;s employees and provide leadership to reinforce a strong people culture and ethical business practices.
</li><li>Facilitate the adoption and utilization of systems and ERP in the function.
</li><li>Prepare and Implement project Safety &amp; Emergency Plan/Program.
</li><li>Monitor and ensure HSE orientation to new employees on projects is completed.
</li><li>Reviews method statements and ensure risk assessment is completed.
</li><li>Ensures HSE compliance during site set up or mobilization stage.
</li><li>Ensure and monitor Safety toolbox meetings, HSE awareness sessions &amp; training are being conducted
</li><li>Investigate incidents, conduct root cause analysis and identify &amp; ensure correction &amp; corrective actions are undertaken.
</li><li>Prepare &amp; schedule site emergency drills and make sure being held as planned.
</li><li>Participate &amp; review Hazard Identification, Risk Assessment and compliance with recommended controls to mitigate hazards.
</li><li>Review Material safety Data sheets &amp; ensure its requirements being complied with.
</li><li>Ensure material handling and storage is conducted in an approved manner.
</li><li>Prepare project Lesson Learnt Reports relating to HSE.
</li><li>Conduct planned inspection, identifying potential hazards and ensuring controls are in place.
</li><li>Prepare traffic plan at the site.
</li><li>Monitor waste management and ensure disposal as per safety plan.
</li><li>Identify &amp; ensure field HSE procedures including work permits for hazardous jobs at the site if required.
</li><li>Conduct HSE audits and analyze the trends.
</li><li>Manage the performance of the team</li></ul></div></div>
<br><div><div>Qualifications</div>
<div><ul><li>BA/ BSC/ Diploma in Safety Management or relevant
</li><li>NEBOSH / IOSH Managing Safely / OHSA Certification
</li><li>Minimum 7 years&rsquo; experience in HSE in a comparable sized operation to ESEC
</li><li>Experience in the Middle East is a strong plus
</li><li>Proficient in MS Office Suites
</li><li>Proficiency in written and spoken English (Arabic is a plus)
</li></ul><p>Additional Info:
</p><p>This is a Full-time job offering standard benefits such as paid annual leave, public holidays, living allowances, healthcare coverage, and end of service benefits. We also offer discretionary benefits such as a performance bonus and merit increase along with training and development opportunities if eligible.</p></div></div>

LEAD - HSE

ClinTrial Research, INC

<p><b>Position Summary:</b></p><p>The Clinical Research Coordinator (CRC) is an experienced, independent clinical execution role responsible for managing complex study activities, ensuring protocol compliance and data integrity, and serving as a senior resource within the site team. Reporting to the Site Manager and working closely with the Associate Director, Site Development, the CRC leads the full lifecycle of clinical trial conduct across multiple concurrent studies &mdash; from site activation and patient enrollment through study close-out. The CRC serves as a mentor and functional lead for Junior staff, and partners with Regulatory, Patient Engagement, Commercial Strategy, and Site Operations teams to ensure CTR executes studies with precision and in full compliance with GCP, IRB, and sponsor requirements.</p><p><b>Key Responsibilities:</b></p><p>Patient Enrollment &amp; Study Conduct</p><ul><li>Lead patient screening, eligibility assessment, and enrollment activities across multiple concurrent protocols, exercising independent clinical judgment on complex eligibility determinations.</li><li>Oversee informed consent processes, ensuring full compliance with IRB-approved consent procedures and documenting exceptions or deviations appropriately.</li><li>Perform and/or supervise all study visit activities including dosing, drug administration, drug accountability, specimen collection and shipping, CTMS data entry, and patient record maintenance.</li><li>Monitor study activities for ongoing compliance with protocols, ICH-GCP standards, and applicable regulatory requirements; proactively identify and escalate compliance risks.</li><li>Track and manage enrollment status across assigned studies; document patient dropouts; record, report, and follow up on adverse events and protocol deviations in accordance with sponsor and regulatory requirements.</li><li>Serve as the primary site contact for sponsor representatives and CROs during monitoring visits and routine study communications.</li></ul><p>Data Quality &amp; Regulatory Compliance</p><ul><li>Create, maintain, and quality-review source documents and study records in accordance with GCP, CTR SOPs, and sponsor requirements.</li><li>Build, manage, and audit study data in CTMS (RealTime), ensuring timely, accurate, and complete data entry across all active studies; identify and resolve data discrepancies prior to monitoring visits.</li><li>Adhere to all applicable SOPs, ICH-GCP guidelines, HIPAA requirements, and privacy regulations at all times.</li><li>Lead preparation for internal audits, sponsor monitoring visits, and regulatory inspections; serve as the primary point of contact for on-site monitors and ensure inspection-ready study files are maintained continuously.</li><li>Review and contribute to the development and revision of CTR SOPs and study-specific procedures as requested by the Site Manager or Quality team.</li></ul><p>Study Start-Up &amp; Business Development Support</p><ul><li>Lead or co-lead site activation activities including IRB submissions, protocol training, system setup in CTMS, and regulatory document collection.</li><li>Complete feasibility questionnaires and support pre-award site visits, drawing on protocol-level expertise to provide accurate and competitive assessments.</li><li>Provide clinical and protocol intelligence to the Commercial Strategy and Site Development teams to support feasibility submissions and sponsor engagement.</li><li>Assist with budget and contract review by identifying protocol-driven visit and procedure requirements; escalate scope discrepancies to the Site Manager or CBO.</li></ul><p>Team Leadership &amp; Site Operations</p><ul><li>Serve as a mentor and day-to-day resource for CRC I staff and Research Assistants; provide protocol-specific training, answer procedural questions, and escalate performance concerns to the Site Manager.</li><li>Coordinate with Patient Engagement, Regulatory &amp; Quality, and Site Operations teams to ensure seamless patient scheduling, visit preparation, and study execution.</li><li>Support study close-out activities including final data reconciliation, regulatory binder completion, and sponsor communication.</li><li>Contribute to a culture of quality, accountability, and continuous improvement within the site team.</li></ul><p>Pay: $55,000.00 - $75,000.00 per year</p><p>Benefits:</p><ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Parental leave</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Clinical Research Coordinator

Regeneron

<div>
 Clinical Study Specialist- R46129
 <br/>
 <br/>
 <strong>
  Position Description
  <br/>
  <br/>
 </strong>
 The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
 <br/>
 <br/>
 <strong>
  Roles Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Organizes and delivers analyzable reports and metrics to the clinical study lead
  </li>
  <li>
   Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
  </li>
  <li>
   Collates data for assessments such as feasibility and site selection and reviews site usability database
  </li>
  <li>
   Contributes to review of study documents such as informed consent forms, case report forms
  </li>
  <li>
   Facilitates study document reviews per company standard operating procedures
  </li>
  <li>
   Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
  </li>
  <li>
   Collates materials for training and investigator meetings
  </li>
  <li>
   Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
  </li>
  <li>
   Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
  </li>
  <li>
   Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
  </li>
  <li>
   Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form)
  </li>
  <li>
   Manages and maintains team SharePoint and/or shared drive sites, as needed
  </li>
  <li>
   Communication with sites as directed and maintains site contact information
  </li>
  <li>
   Contributes to line listings review for Blind Data Review Meeting (BDRM)
  </li>
  <li>
   May manage or contribute to oversight of Third-Party Vendors (TPV)
  </li>
  <li>
   Tracks and monitors close out activities ? study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
  </li>
  <li>
   Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
  </li>
  <li>
   Proactively recommends process improvement initiatives for the department
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Attention to details for the ability to track information and deliver on assigned study activities
  </li>
  <li>
   Good communication and interpersonal skills; ability to build relationships internally and externally
  </li>
  <li>
   Ability to be resourceful and to demonstrate problem solving skills
  </li>
  <li>
   Demonstrate the ability to proactively assess information and investigate impact on clinical trials
  </li>
  <li>
   Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
  </li>
  <li>
   Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
  </li>
  <li>
   Basic familiarity with medical terms and clinical drug development
  </li>
  <li>
   Awareness of ICH/GCP
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education &amp; Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Minimum of a Bachelor's degree
  </li>
  <li>
   2 years? industry related work experience in a clinical setting
  </li>
 </ul>
</div>


Temp - Clinical Study Specialist

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>

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