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site specialist ii study start up

ICON plc

<div>Site Specialist II, Study Start Up<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Site Specialist II (Study Start Up Associate II) to join our diverse and dynamic team. As a Site Specialist II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.</div><div></div><div>
What you will be doing</div><ul><li><div>
Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.</div></li></ul><ul><li><div>
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.</div></li></ul><ul><li><div>
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence</div></li></ul><ul><li><div>
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.</div></li></ul><ul><li><div>
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.</div></li></ul><div></div><div>
Your profile</div><ul><li><div>
Bachelor's degree in life sciences or a related field.</div></li></ul><ul><li><div>
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.</div></li></ul><ul><li><div>
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.</div></li></ul><ul><li><div>
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.</div></li></ul><ul><li><div>
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Site Specialist II, Study Start Up

<div>Site Specialist II<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
What you will be doing</div><ul><li><div>
Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.</div></li></ul><ul><li><div>
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.</div></li></ul><ul><li><div>
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence</div></li></ul><ul><li><div>
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.</div></li></ul><ul><li><div>
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.</div></li></ul><div></div><div>
Your profile</div><ul><li><div>
Bachelor's degree in life sciences or a related field.</div></li></ul><ul><li><div>
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.</div></li></ul><ul><li><div>
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.</div></li></ul><ul><li><div>
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.</div></li></ul><ul><li><div>
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Site Specialist II

<div>CRA II<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Clinical Research Associate II Specialist to join our diverse and dynamic team. As a Clinical Research Associate II Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies</div>
What you will be doing<ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li></ul><ul><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li></ul><ul><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li></ul><ul><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li></ul><ul><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul>
Your profile<ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li></ul><ul><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li></ul><ul><li>
In-depth kNwledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li></ul><ul><li>
Strong organizational and communication skills, with attention to detail.</li></ul><ul><li>
Ability to work independently and collaboratively in a fast-paced environment.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

CRA II

Sitero LLC

<div><p>Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.</p>
<p>
This role will involve regulatory work to get the country and sites approved through the Regulatory Authority (RA) and Ethics Committees (ECs), as well as site activities from feasibility through close out visits. The ability to perform both Reg and CRA duties is required.</p><p></p><p><b><br>
Job Title: Senior Clinical Research Associate (Contract)
</b></p><p><b>Location: Turkey (Remote)
</b></p><p><b>Function: Clinical Operations and Regulatory<br>
</b></p><p></p><p><b>ESSENTIAL DUTIES AND RESPONSIBILITIES:</b></p>
<ul>
<li>Primary point of contact for site personnel during life cycle of clinical trial. This includes study start up support, site activation, trial conduct and closeout of a clinical trial.</li>
<li>Provides support to the Global Project Lead and CTM during project start up to ensure timely site selection and feasibility. Assists with collection of essential documents from the site. applications/Approvals required.</li>
<li>Ability to identify protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety.</li>
<li>Familiarity with regulations surrounding conduct of clinical trials in all countries pertinent to your contract</li>
<li>Knowledge and ability to perform throughout the duration of the study any RA submissions, Central EC submission, Local EC submission, and any other country specific submissions required</li>
<li>Conduct Site qualification, site initiation, routine site monitoring close out visits (remote and onsite), Central monitoring in compliance with study protocol and ICH-GCP.</li>
<li>Expert documentation of monitoring priorities/activities via site visit confirmation and follow up letters, monitoring visit reports, and any trial associated logs.</li>
<li>Oversees conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and any potential breeches that can impact data integrity.</li>
<li>Ability to present essential function of CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face to Face meetings.</li>
<li>Assists the Global Project Lead in identification of out-of-scope activities.</li>
<li>Basic understanding of assigned projects scope, milestones and budget and manages site level activities to ensure project deliverables are met.</li>
<li>Provides support to the CTM and Global project lead in negotiation of site budgets and contracts.</li></ul><br>
<p></p>
<p><b>
EDUCATION AND EXPERIENCE REQUIRED:</b></p>
<ul>
<li>5 years of experience independently monitoring clinical drug trials</li>
<li>Completed at least 2 clinical trial application submissions in the past 5 years in each country pertinent to your contract</li>
<li>Rare Disease; Hepatology and Gastrology experience required</li>
<li>Bachelors degree in a life science field required</li></ul><br>
<p></p>
<p><b>
COMPENSATION &amp; BENEFITS:</b></p>
<p>
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.</p><p></p><p><b><br>
EMPLOYMENT TYPE:</b></p>
<p>
Contract; 0.5-0.75 FTE availability required.</p><p></p><p><b><br>
COMMITMENTS:</b></p>
<ul>
<li>5-0.75 FTE availability</li>
<li>Willing to work in shifts as and when needed.</li>
<li>Ability to travel up to 80% for site monitoring and regulatory purposes</li>
<li>Ability to lift 1-50 pounds at varying times</li>
<li>Ability to stand for long durations, kneel, bend, and sit for varying periods of time</li></ul><br>
<p></p>
<p><b>
DISCLAIMER:</b></p>
<p>
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.</p></div>

Senior Clinical Research Associate (Contract)

<div>Clinical Research Associate II<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.</div><div></div><div>
What you will be doing</div><ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li></ul><ul><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li></ul><ul><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li></ul><ul><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li></ul><ul><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul><div><br>
Your profile</div><ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li></ul><ul><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li></ul><ul><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li></ul><ul><li>
Strong organizational and communication skills, with attention to detail.</li></ul><ul><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li><div>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Clinical Research Associate II

CRA 2

PSI CRO

<div><b>Company Description</b><p><br>
PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.</p><b><br>
Job Description</b><p><br>
Take your career to the next level and be involved in study startup processes in T&uuml;rkiye. You will provide direct operational support to project teams, ensure that clinical projects start smoothly and on time and support PSI in developing the local study startup team.</p><p>
Office-based in Ankara or remote</p><ul><li>
Perform study startup activities and support all processes critical for site activation.</li><li>
Collect site documents for IRB/IEC submission and/or IP-RED process.</li><li>
File study-specific documentation in TMF, in accordance with Document management plan.</li><li>
Compile IP-REDs packages assuring high quality.</li><li>
Review study-specific translations, including patient-facing documents.</li><li>
Support site agreement and/or budget negotiations, upon request.</li><li>
Ensure initial distribution of locally obtained clinical study supplies to sites and supervise initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.</li><li>
Identify project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.</li><li>
Develop site-specific startup timelines and is responsible for meeting the site activation targets under supervision.</li></ul><br>
<b>
Qualifications</b><br>
<ul><li>
College/University degree or an equivalent combination of education, training and experience</li><li>
At least 4 years' experience in clinical research</li><li>
At least 3 years of full-scope Study Startup experience in T&uuml;rkiye</li><li>
Excellent knowledge of ICH GCP, local laws and applicable regulations in the region</li><li>
Full working proficiency in English and Turkish</li><li>
Communication and organizational skills</li><li>
Ability to negotiate and build relationships at all levels</li></ul><br>
<b>
Additional Information</b><p><br>
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.</p></div>

Senior Study Startup Specialist

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