senior clinical research associate

ICON plc

<div>Senior Clinical Research Associate<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 Clinical Research Associate

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)

Optimapharm d.o.o.

<p></p><div><p><b>Location: Remote</b></p><p></p><h2 class="jobSectionHeader"><b><br>
Who we are?</b></h2><p>
Optimapharm is a <b>globally operating, leading, mid-sized, full-service CRO</b> aiming to deliver new therapies to improve and save patients&rsquo; lives.</p><p>
Optimapharm&rsquo; s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.</p><p>
With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.</p><p>
As we expand our US Clinical Operations team, we&rsquo;re looking for a <b>Senior CRA</b> who is driven by excellence - a professional committed to responsible oversight, meaningful patient outcomes, and shaping the future of clinical research with purpose and precision.</p><p></p><h2 class="jobSectionHeader"><b><br>
 What do we offer?</b></h2><ul><li>
Working in a successful company that&rsquo;s growing and developing every day</li><li>
Company that supports life balance</li><li>
Company with healthy culture</li><li>
Working with a highly experienced team of clinical research professionals</li><li>
Competitive salary</li><li>
Competitive PTO entitlement</li><li>
Health insurance, including vision and dental plans, to meet your and your family's needs</li><li>
Comprehensive pension plan to maximize savings and prepare confidently for the future</li><li>
Employee engagement programs</li><li>
Well-being initiatives</li><li>
Training and development program</li><li>
Fast-paced career path progression</li></ul><p></p><h2 class="jobSectionHeader"><b><br>
 Who are we looking for?</b></h2><p></p><h3 class="jobSectionHeader"><b><br>
 Qualifications and</b><b> Experience</b></h3><ul><li>
University degree, <b>preferably in medical or life sciences;</b> nursing education or other relevant healthcare college degree</li><li>
At least<b> 3-5</b><b> years </b><b>of independent clinical trial monitoring experience in oncology</b></li><li>
High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research</li><li>
Computer proficiency is mandatory</li><li>
Ability to read, analyze, and interpret common scientific and technical journals</li><li>
Excellent verbal and written communication skills</li><li>
Very good interpersonal and negotiation skills</li><li>
Ability to work independently, pro-active</li><li>
Affinity to work effectively and efficiently in a matrix environment</li><li>
A current, valid driver&rsquo;s license</li></ul><p></p><h3 class="jobSectionHeader"><b><br>
 Your </b><b>responsibilities</b></h3><ul><li>
Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits</li><li>
Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements</li><li>
Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable</li><li>
Identifying and escalating potential risks and identifying retraining opportunities for site personnel</li><li>
Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution</li><li>
Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor</li><li>
Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable</li><li>
Administration of site payments in accordance with relevant project instructions</li></ul><p></p><p><b><br>
By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.</b></p><p>
If you would be interested in joining the Optimapharm team, please <b>send your CV a</b>nd note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.</p><p>
Compensation is competitive and final offers will reflect each candidate&rsquo;s experience, skills, and qualifications.</p><p><b>
Disclaimer</b>: <i>Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.</i></p></div>

Senior Clinical Research Associate - US

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Senior Clinical Research Associate

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Senior Clinical Research Associate - US

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