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clinical research associate

Bristol Myers Squibb

<div><b>Working with Us</b><br>
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.<br>
<br>
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .<br>
<br>
<b>Job Description</b><ul><li>
Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP</li><li>
Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites</li><li>
Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP</li><li>
Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.</li><li>
Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level.</li><li>
Motivate and influence sites to meet study objectives, including enrollment and retention goals.</li><li>
Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method. Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner</li><li>
Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.</li><li>
Demonstrate understanding and proficiency working with targeted, centralized, remote and riskbased monitoring approaches</li><li>
Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators</li><li>
Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance</li><li>
Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor</li><li>
Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.</li><li>
Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.</li><li>
In specific instances, may support start-up and submission related activities, including ICF reviews and collection of documents to/from site.</li><li>
Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.</li><li>
Support coordination of site activities related to database locks to ensure timelines are met as required locally.</li><li>
Perform timely site closure activities when all required protocol visits and follow-up are completed.</li></ul><b>
Qualifications &amp; Experience</b><br>
<br>
Degree/Certification/Licensure:
<br>
<br>
<ul><li>Bachelor's degree required, preferably within life sciences or equivalent</li></ul><br>
<ul><li>Valid driver's license (as locally required)</li></ul><br>
Experience:<br>
<br>
<ul><li>2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role</li></ul><br>
<ul><li>Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator</li></ul><br>
preferred<br>
<br>
<ul><li>Experience in the drug discovery/development process.</li></ul><br>
Competencies:<br>
<br>
<ul><li>Knowledge and understanding of clinical research processes, regulations and methodology</li></ul><br>
<ul><li>Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management</li></ul><br>
<ul><li>Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (that govern</li></ul><br>
clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities (Analytical thinking/critical thinking skills. Capable of using technology to analyze<br>
<br>
diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions<br>
<br>
(Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies,<br>
<br>
embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic<br>
<br>
environment<br>
<br>
<ul><li>Organization and time management skills</li></ul><br>
<ul><li>Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders</li></ul><br>
<ul><li>Good verbal and written communication skills (both in English and local language)</li></ul><br>
<ul><li>Have a foundational level of disease understanding and awareness (how the protocol fits in current</li></ul><br>
landscape, standard of care, etc.)<br>
<br>
<ul><li>Proven ability to work independently with a high degree of autonomy, proactively managing tasks and</li></ul><br>
seeking opportunities for continuous learning<br>
<br>
<ul><li>Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel,</li></ul><br>
based upon assigned site location and/or geographic territory<br>
<br>
<ul><li>Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to</li></ul><br>
identify and resolve issues, support site performance, and ensure data integrity<br>
<br>
Software that must be used independently and without assistance (e.g., Microsoft Suite)<br>
<br>
<ul><li>Microsoft Suite</li></ul><br>
<ul><li>Clinical Trial Management Systems (CTMS)</li></ul><br>
<ul><li>Electronic Data Capture Systems (eDC)</li></ul><br>
<ul><li>Electronic Trial Master File (eTMF)</li></ul><br>
<ul><li>RBM tools and platforms (e.g., Veeva, Medidata, CluePoints).</li></ul><br>
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
<br>
<br>
<b>Uniquely Interesting Work, Life-changing Careers</b><br>
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.<br>
<br>
<b>On-site Protocol</b><br>
<br>
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
<br>
<br>
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
<br>
<br>
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
<br>
<br>
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
<br>
<br>
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.<br>
<br>
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
<br>
<br>
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</div>

Clinical Research Associate

Parexel

<div><p><b>Key Accountabilities:</b></p><p></p><p><b><br>
Site Management Responsibilities</b></p><ul><li><p>
Contributes to the selection of potential investigators.</p></li><li><p>
In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.</p></li><li><p>
Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.</p></li><li><p>
Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.</p></li><li><p>
Actively participates in Local Study Team (LST) meetings.</p></li><li><p>
Contributes to National Investigators meetings, as applicable.</p></li><li><p>
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.</p></li><li><p>
Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.</p></li><li><p>
Updates CTMS and other systems with data from study sites as per required timelines.</p></li><li><p>
Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</p></li><li><p>
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.</p></li><li><p>
Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.</p></li><li><p>
Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.</p></li><li><p>
Ensures data query resolution in a timely manner.</p></li><li><p>
Works with data management to ensure robust quality of the collected study data.</p></li><li><p>
Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</p></li><li><p>
Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.</p></li><li><p>
Follows up on outstanding actions with study sites to ensure resolution in a timely manner.</p></li><li><p>
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.</p></li><li><p>
Assists site in maintaining inspection ready ISF.</p></li><li><p>
Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).</p></li><li><p>
Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.</p></li><li><p>
 Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.</p></li><li><p>
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.</p></li><li><p>
Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</p></li></ul><p></p><p><b><br>
Compliance with Sponsor Standards</b></p><ul><li><p>
Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).</p></li><li><p>
Ensures compliance with local, national, and regional legislation, as applicable.</p></li><li><p>
Completes timesheets accurately as required</p></li></ul><p></p><p><b><br>
Compliance with Parexel Standards</b></p><ul><li><p>
Complies with required training curriculum.</p></li><li><p>
Completes timesheets accurately as required.</p></li><li><p>
Submits expense reports as required.</p></li><li><p>
Updates CV as required.</p></li><li><p>
Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</p></li></ul><p><b>
Skills (Essential):</b></p><ul><li><p>
Excellent attention to detail.</p></li><li><p>
Good written and verbal communication skills.</p></li><li><p>
Good collaboration and interpersonal skills.</p></li><li><p>
Good negotiation skills.</p></li><li><p>
Proficient in written and spoken English language required.</p></li><li><p>
Fluency in local language(s) required.</p></li></ul><p><b>
Skills (Desirable):</b></p><ul><li><p>
Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.</p></li><li><p>
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.</p></li><li><p>
Good analytical and problem-solving skills.</p></li><li><p>
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.</p></li><li><p>
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.</p></li><li><p>
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):</p></li><li><p>
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.</p></li><li><p>
Good medical knowledge and ability to learn relevant Client Therapeutic Areas.</p></li><li><p>
Basic understanding of the drug development process.</p></li><li><p>
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</p></li></ul><p></p><p><b><br>
Knowledge and Experience (Desirable):</b></p><ul><li><p>
Familiar with risk-based monitoring approach including remote monitoring.</p></li><li><p>
Good cultural awareness.</p></li></ul><p></p><p><b><br>
Education:</b></p><ul><li><p>
Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.</p></li></ul><p><b>
Other:</b></p><ul><li><p>
Ability to travel nationally/internationally as required.</p></li><li><p>
Valid driving license per country requirements, as applicable</p></li></ul><br>
<p></p>
#LI-REMOTE</div>

Senior Clinical Research Associate - FSP

ICON plc

<div>In-House Clinical Research Associate (Site Management)<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 an IHCRA (In-House Clinical Research Associate) to join our diverse and dynamic team. As an IHCRA at ICON, you will play a pivotal role in supporting the execution and management of clinical trials, contributing to the advancement of innovative treatments and therapies.</div><div></div><div>
What you will be doing</div><ul><li><div>
Assisting in the planning, initiation, and execution of clinical trial activities</div></li></ul><ul><li><div>
Conducting site feasibility assessments and participating in site selection processes</div></li></ul><ul><li><div>
Coordinating with investigative sites to ensure compliance with study protocols and regulatory requirements</div></li></ul><ul><li><div>
Monitoring study progress and data collection activities to ensure quality and accuracy</div></li></ul><ul><li><div>
Assisting in the preparation and review of study documentation and reports</div></li></ul><div></div><div>
Your profile</div><ul><li><div>
Bachelor's degree in a relevant field, such as life sciences or healthcare</div></li></ul><ul><li><div>
Previous experience in clinical research or a related field preferred</div></li></ul><ul><li><div>
Strong organizational and communication skills</div></li></ul><ul><li><div>
Ability to work independently and collaboratively in a fast-paced environment</div></li></ul><ul><li><div>
Attention to detail and ability to prioritize tasks effectively</div></li></ul><div></div><div>
#LI-JJ1</div><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>

In-House Clinical Research Associate (Site Management)

<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.
 <br/>
 <br/>
 We are currently seeking an IHCRA (In-House Clinical Research Associate) to join our diverse and dynamic team. As an IHCRA at ICON, you will play a pivotal role in supporting the execution and management of clinical trials, contributing to the advancement of innovative treatments and therapies.
 <br/>
 <br/>
 <strong>
  What You Will Be Doing
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Assisting in the planning, initiation, and execution of clinical trial activities
  </li>
  <li>
   Conducting site feasibility assessments and participating in site selection processes
  </li>
  <li>
   Coordinating with investigative sites to ensure compliance with study protocols and regulatory requirements
  </li>
  <li>
   Monitoring study progress and data collection activities to ensure quality and accuracy
  </li>
  <li>
   Assisting in the preparation and review of study documentation and reports
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Your profile
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor's degree in a relevant field, such as life sciences or healthcare
  </li>
  <li>
   Previous experience in clinical research or a related field preferred
  </li>
  <li>
   Strong organizational and communication skills
  </li>
  <li>
   Ability to work independently and collaboratively in a fast-paced environment
  </li>
  <li>
   Attention to detail and ability to prioritize tasks effectively
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What ICON Can Offer You
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  Our Benefits Examples Include
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Various annual leave entitlements
  </li>
  <li>
   A range of health insurance offerings to suit you and your family&rsquo;s needs.
  </li>
  <li>
   Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  </li>
  <li>
   Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
  </li>
  <li>
   Life assurance
  </li>
  <li>
   Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
   <br/>
   <br/>
  </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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 or submit a request here
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 Are you a current ICON Employee? Please click here to apply
 <br/>
 <br/>
</div>


<div>Sr CRA<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 Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.</div><div></div><div>
What You Will Be Doing:</div><ul><li>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</li><li>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</li><li>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</li><li>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</li><li>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</li></ul><div>
Your Profile:</div><ul><li>
Advanced degree in a relevant field such as life sciences, nursing, or medicine.</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex 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>

Senior CRA

<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 I, Study Start Up (Turkey, Ankara)<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 I (Study Start Up Associate I) to join our diverse and dynamic team. As a Site Specialist I at ICON, you will play a pivotal role in facilitating 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>
Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.</div></li></ul><ul><li><div>
Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.</div></li></ul><ul><li><div>
Maintaining accurate and up-to-date records of regulatory submissions and approvals.</div></li></ul><ul><li><div>
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.</div></li></ul><ul><li><div>
Participating in study start-up meetings and providing input on regulatory requirements and timelines.</div></li></ul><div></div><div>
Your profile</div><ul><li><div>
Bachelor's degree in life sciences or a related field.</div></li><li><div>
Working knowledge of English and local language.</div></li></ul><ul><li><div>
Previous experience in clinical research or regulatory affairs preferred, but not required.</div></li></ul><ul><li><div>
Strong attention to detail and organizational skills.</div></li></ul><ul><li><div>
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.</div></li></ul><ul><li><div>
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.</div></li></ul><div></div><div>
#LI-JJ1</div><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 I, Study Start Up (Turkey, Ankara)

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