Qureos Mentor

Parexel

<div>Are you passionate about advancing clinical research and making a real difference in patients' lives? Parexel is seeking an experienced Study Start-Up Specialist (SSU Specialist) to join our FSP Clinical Operations team (fully outsourced to work for one of the largest Pharmaceutical company). 
This role offers flexible working arrangements with two days per week at the Sponsor's office in either Istanbul or Ankara. 
Key Responsibilities<ul><li>
Full ownership of country-level start-up activities from post-feasibility to site activation</li><li>
Prepare, Preparation, coordination and tracking of initial regulatory submissions</li><li>
Preparation, coordination and tracking of initial regulatory submissions</li><li>
Responsibility for initial contracts and start-up related budget activities</li><li>
Tracking of import licenses, IMP and study equipment delivery</li><li>
Oversight of ISF preparation and site readiness.</li></ul> 
Essential Qualifications &amp; Experience:<ul><li>
Bachelor's degree in life science or a related discipline</li><li>
Good knowledge of ICH-GCP and relevant local regulations</li><li>
Proven experience in clinical trial start-up activities at country level, with end-to-end involvement from feasibility completion through site activation</li><li>
Basic understanding of the drug development process</li><li>
Strong hands-on experience in preparing, coordinating, and managing initial regulatory submissions</li><li>
Demonstrated ownership of start-up timelines, with the ability to track, manage, and drive site activation milestones</li><li>
Proven ability to identify start-up risks, manage competing priorities, and implement solutions to ensure timelines are met</li><li>
Experience supporting or overseeing study start-up budgets and financial aspects related to activation</li><li>
Good understanding of local regulatory environment and Ministry of Health procedures</li><li>
Solid understanding of Import License processes and regulatory requirements relevant to clinical trials</li><li>
Experience coordinating Investigational Product (IMP) and study equipment delivery to sites Strong knowledge of essential documents and ability to ensure site readiness, including ISF preparation and inspection readiness</li><li>
Fluency in Turkish and English (written and spoken)</li><li>
Good verbal and written communication skills</li><li>
Strong organizational and time management skills.</li></ul>
Why Join Parexel 
Parexel is a leading global clinical research organization with a commitment to advancing clinical research and improving patient outcomes.
We offer:<ul><li>
Opportunity to work on diverse, high-impact clinical trials across multiple therapeutic areas</li><li>
Collaborative and supportive work environment with experienced clinical professionals</li><li>
Professional development and training opportunities</li><li>
Competitive compensation and benefits package</li><li>
Flexible work arrangements</li><li>
Career growth opportunities within a global organization.</li></ul> 
#LI-REMOTE</div>

Study Start-Up Specialist - FSP

<div>Are you passionate about advancing clinical research and making a real difference in patients' lives? Parexel is seeking an experienced Senior Clinical Study Administrator to join our FSP Clinical Operations team (fully outsourced to work for one of the largest Pharmaceutical company) and play a specialized role that bridges clinical administration with regulatory expertise, supporting ongoing studies with a focus on regulatory compliance and documentation excellence.
This is a remote position for candidates based in Istanbul or Ankara.
Key Responsibilities: 
Regulatory Submissions &amp; Maintenance: Lead and manage ongoing regulatory submissions and maintenance activities. Prepare, review, and track regulatory documents for submission to Ethics Committees, IRBs, and Regulatory Authorities. Ensure timely and compliant submission of all required documentation. 
Investigator Site File (ISF) Management: Oversee the setup, population, and maintenance of the ISF with meticulous attention to detail. Ensure all essential documents are properly organized, tracked, and maintained in accordance with ICH-GCP guidelines and local regulatory requirements. Maintain ISF inspection readiness throughout the study lifecycle. 
Budget &amp; Contract Oversight: Manage oversight and follow-up of budget and contract amendments. Support contract preparation at the site level and ensure all contractual obligations are met and documented appropriately. 
Regulatory Compliance &amp; Documentation: Demonstrate solid understanding of local regulatory and Ministry of Health procedures, including ethics and regulatory processes. Ensure all study documentation maintains compliance with sponsor standards, local legislation, and ICH-GCP guidelines. 
Cross-Functional Collaboration: Work closely with CRAs, study teams, and regulatory specialists to ensure seamless coordination between clinical operations and regulatory functions. Serve as a key liaison between the Local Study Team and regulatory authorities. 
Document Management &amp; Quality Control: Contribute to the production and maintenance of study documents, ensuring template and version compliance. Manage layout, language control, and distribution of regulatory and administrative documents. 
What We're Looking For<div> 
Essential Experience: 
<ul><li>Strong involvement in ongoing regulatory submissions and lifecycle management, including amendments and maintenance activities</li><li>Solid knowledge of local regulatory environment, including Ministry of Health procedures and ethics submission processes in T&uuml;rkiye</li><li>Experience in preparing, tracking, and following up on contract and budget amendments</li><li>Focus on regulatory, documentation, and contract activities, with no direct involvement in payment processing</li><li>This role requires a structured and detail-oriented professional with strong regulatory awareness rather than purely administrative support</li><li>Ability to work in a structured, detail-oriented manner with strong emphasis on compliance and regulatory accuracy</li><li>Working knowledge of the clinical study process and ICH-GCP guidelines</li><li>Previous administrative experience in the medical/life science field</li><li>Proficiency in written and spoken Turkish and English.</li></ul></div><div>
Why Join Parexel? 
<ul><li>Work with a global leader in clinical research and regulatory services</li><li>Develop specialized expertise in regulatory submissions and compliance</li><li>Collaborate with experienced clinical teams across multiple therapeutic areas</li><li>Opportunity for professional growth and career advancement</li><li>Competitive compensation and comprehensive benefits package</li><li>Supportive, international work environment.</li></ul></div> 
Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 
#LI-REMOTE</div>

Senior Clinical Study Administrator

<div>Key Accountabilities:
Oversight of Monitoring Responsibilities and Study Conduct<ul><li>
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
</li><li>Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
</li></ul><ul><li>During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
 </li><li>Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation andrecruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level</li><li>
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
</li><li>Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
</li><li>Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
</li><li>Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
</li><li>Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines</li></ul> 
 Skills:
<ul><li>Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
</li><li>Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
 </li><li>Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
</li><li>Global clinical trial experience
</li><li>Must be fluent in English
 </li><li>Significant travel across whole Turkey
</li><li>Valid driver&rsquo;s license and passport required</li></ul> 
Knowledge and Experience:<ul><li>
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
 </li><li>Demonstrated knowledge of global and local regulatory requirements
</li><li>Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
</li><li>Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)</li><li>
Demonstrated ability to support sponsor regulatory interactions/inspections
</li><li>Demonstrated knowledge of the processes around protocol design and feasibility assessment</li></ul><ul><li>
Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery</li><li>
Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation</li></ul> 
Education:
<ul><li>Bachelor&rsquo;s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent</li></ul> 
#LI-REMOTE</div>

Senior Clinical Research Associate I - FSP

<div>Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and &ldquo;first in human&rdquo; trials are the first step in testing these novel treatments in humans. 
At Parexel Glendale Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Then monitor the volunteer participants health status around the clock as per the trial protocol to ensure their safety and wellbeing.
This position is Intermittent at 20 hours per week.
Develop professionally by gaining experience in delivering high-quality research projects in this growing sector.
What you&rsquo;ll do after training is completed (including but not limited):<ul><li>
Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU).</li><li>
Assume responsibility for patient care and study conduct assignments.</li><li>
Ensure that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assess compliance, symptoms, etc. per study protocol. Arrange for pre/post procedure laboratory work to be performed.</li><li>
Ensure that all established timelines relating to areas of responsibility and assigned projects are met.</li><li>
Participate and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives.</li><li>
Assess, monitor, record, and report patient&rsquo;s condition and reaction to drugs and treatments to the appropriate physician.</li><li>
Collect and prepare data. Organize and enter data into case report forms.</li><li>
Enter data into databases when required. Assist physicians in completing flow sheets in medical records and progress notes. Update and maintain the contents of the Clinical Study File.</li><li>
Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.</li><li>
Act as participant advocate in the conduct of clinical studies.</li></ul>
Qualifications<ul><li>
At least 2 years working in a hospital or clinical setting</li><li>
BSN preferred or relevant work experience.</li><li>
Active Registered Nurse License in the state of California</li><li>
Current Basic Life Support (BLS) certification.</li><li>
ACLS certification required within 6 months of start date</li></ul>
Base Pay Range: $40.00 to $47.00 per hour
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel&rsquo;s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.
#LI-SM1</div>

Clinical Research Nurse

<div>Shift: Per Diem/PRN - Day
Location: Baltimore, MD
Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and &ldquo;first in human&rdquo; trials are the first step in testing these novel treatments in humans. 
At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Then monitor the volunteer participants health status around the clock as per the trial protocol to ensure their safety and wellbeing.
Develop professionally by gaining experience in delivering high-quality research projects in this growing sector.
What you&rsquo;ll do after training is completed (including but not limited):<ul><li>
Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU).</li><li>
Assume responsibility for patient care and study conduct assignments.</li><li>
Ensure that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assess compliance, symptoms, etc. per study protocol. Arrange for pre/post procedure laboratory work to be performed.</li><li>
Ensure that all established timelines relating to areas of responsibility and assigned projects are met.</li><li>
Participate and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives.</li><li>
Assess, monitor, record, and report patient&rsquo;s condition and reaction to drugs and treatments to the appropriate physician.</li><li>
Collect and prepare data. Organize and enter data into case report forms.</li><li>
Enter data into databases when required. Assist physicians in completing flow sheets in medical records and progress notes. Update and maintain the contents of the Clinical Study File.</li><li>
Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.</li><li>
Act as participant advocate in the conduct of clinical studies.</li></ul>
Qualifications<ul><li>
At least 2 years working in a hospital or clinical setting</li><li>
BSN preferred or relevant work experience.</li><li>
Active Registered Nurse License in the state of Maryland</li><li>
Current Basic Life Support (BLS) certification.</li><li>
ACLS certification required within 6 months of start date</li></ul>
Base Pay Range: $40.00 to $46.00 per hour
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel&rsquo;s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.
Parexel is dedicated to supporting, developing and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers here at Parexel. The following military career roles align with this position 66G, 66H, 68C, 4NOX1, 46NX, 66S, 66T, 290X.</div>

Clinical Research Nurse PRN/Per Diem