cra ii

サイネオス・ヘルス

<div><div><div><p><b>Updated:</b> Yesterday<br>
<b>Location:</b> Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey<br>
<b>Job ID:</b> 25107370
</p><div><div>Not ready to apply?<br>
Join our Talent Network
</div></div><div><p><b>Description</b>
</p>CRA II - FSP<p></p><div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.<br>
<br>
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
<br>
<br>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
<br>
<br>
Discover what your 25,000 future colleagues already know:
<br>
<br>
Why Syneos Health<br>
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div><p></p><p><b>
Job Responsibilities</b></p><p></p><ul><li>
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li><li>
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection<br>
Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.</li></ul><p></p><p>
Qualifications:</p><p></p><ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills</li><li>
Ability to manage required travel of up to 75% on a regular basis</li><li>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</li></ul><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.</p><p></p><p>
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</p><p><b>
Summary</b>
</p>Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div></div></div></div><div></div>

CRA II - FSP

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p>
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation<br>
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<br>
<br>
<br>
<br>
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.<br>
<br>
What You&rsquo;ll Do:<br>
<ul><li>Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>Participates in investigator meetings as necessary. Identifies potential
</li><li>investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
</li><li>Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.
</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul><br>
Education and Experience Requirements:
<br>
<ul><li>Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
</li><li>Valid driver's license where applicable.</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
<br>
<br>
Knowledge, Skills and Abilities:
<br>
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexibile and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Good English language and grammar skills</li><li>Good presentation skills</li></ul><br>
Working Conditions and Environment:
<br>
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
</li><li>Exposure to biological fluids with potential exposure to infectious organisms.
</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.
</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul></div><p></p>

CRA II

<div><div><div><p><b>Updated:</b> Yesterday<br>
<b>Location:</b> Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey<br>
<b>Job ID:</b> 25107030
</p><div><div>Not ready to apply?<br>
Join our Talent Network
</div></div><div><p><b>Description</b>
</p>CRA II - Fully Homebased - Open for any City in Turkey - FSO/FSP<p></p><div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.<br>
<br>
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
<br>
<br>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
<br>
<br>
Discover what your 25,000 future colleagues already know:
<br>
<br>
Why Syneos Health<br>
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div><p></p><p><b>
Job Responsibilities</b></p><p></p><ul><li>
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li><li>
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection<br>
Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.</li></ul><p></p><p>
Qualifications:</p><p></p><ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills</li><li>
Ability to manage required travel of up to 75% on a regular basis</li><li>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</li></ul><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.</p><p></p><p>
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</p><p><b>
Summary</b>
</p>Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div></div></div></div><div></div>

CRA II - Fully Homebased - Open for any City in Turkey - FSO/FSP

Atlantic Research Group

<div><p><b>We are building something</b> <b>EPIC.</b></p><div><p>
Evestia Clinical is a biotech-focused global CRO delivering authentic expertise and personalized support. We partner with clients to provide expert guidance through complex clinical trials in specialized areas, including Rare Disease, Oncology, Neurology, and Immunology. Here, you become a vital part of a global team delivering life-changing impact through clinical excellence.</p></div><div><p>
Our foundation is built on principles that define our identity. <b>Innovation</b> drives us to seek new solutions, while <b>Excellence</b> ensures high standards in every project. This is balanced by genuine <b>Care</b>, fostering a supportive culture for both our patients and our people. Above all, we champion <b>Partnership</b>, believing that working together&mdash; with trust and flexibility &mdash;is the key to our collective success.</p><p>
Our approach is agile and personalized, empowering you to find creative solutions. We offer a welcoming culture that values belonging, ensuring you have the environment needed to thrive and grow. If you are ready to change lives worldwide, join our team.</p></div><p></p><p><b>
About the Role</b></p><div><p>
Evestia Clinical is looking Clinical Research Associate (II or Senior) to be responsible for ensuring that the rights and safety of clinical trial participants are protected and that the clinical data obtained are accurate, complete, and verifiable according to source.</p></div><p></p><div><p><b>
What will your job look like?</b></p></div><div><ul><li><p>
Performing all and any visit types while ensuring regulatory and protocol compliance</p></li><li><p>
Participate in all aspects of a clinical trial from development and planning to study closure</p></li><li><p>
Comply with applicable regulations, ICH/GCP and Evestia Clinical or sponsor SOPs to assess the safety and efficacy of investigational products (drugs, biologics or devices)</p></li><li><p>
Maintain key performance metrics in accordance with company standards and timelines, ensuring compliance with established monitoring and reporting expectations</p></li><li><p>
Ensure assigned sites are in compliance with the study protocol objectives</p></li><li><p>
Work in project teams and under supervision, reporting to a Clinical Team Lead and/or Project Manager</p></li><li><p>
Liaise effectively between sponsors, investigators and project teams</p></li><li><p>
Completes all administrative tasks (expense and time reporting) within company guidelines</p></li><li><p>
Perform any other duties as assigned.</p></li></ul><p><b>
What will you need to succeed?</b></p></div><div><ul><li><p>
Substantial previous experience independently monitoring and performing all types of site visits</p></li><li><p>
Ideally Miami based and ability to visit sites regularly in Miami</p></li><li><p>
Understanding the principles of Good Clinical Practice (GCP) and clinical trial regulations</p></li><li><p>
Both written and verbal communication and presentation skills</p></li><li><p>
Understanding of medical terminology and human physiology</p></li><li><p>
Proficiency with information technology (computer skills)</p></li><li><p>
Excellent customer service skills</p></li><li><p>
Demonstrated flexibility and adaptability</p></li><li><p>
Ability to work in a team environment and independently as needed</p></li><li><p>
Ability to travel nationally and internationally as required</p></li><li><p>
Organizational and time management skills, able to prioritize tasks and work within timelines</p></li></ul><p><b>
What we offer you in return?</b></p><p>
We believe that to do your best work, you need the best support. That&rsquo;s why we care deeply about your well-being, personal development, and achieving a true work-life balance. Our comprehensive benefits package is carefully designed to align with our culture and values, ensuring it maximizes your positive experience working here.</p></div><div><p>
Here is a quick look at the benefits you can expect as a valued member of the Evestia Clinical team:</p></div><ul><li><p>
Health Insurance: 99% employer-paid</p></li><li><p>
Dental &amp; Vision Insurance: 100% employer-paid</p></li><li><p>
Short-Term &amp; Long-Term Disability: 100% employer-paid</p></li><li><p>
Life Insurance Policy</p></li><li><p>
401(k) Retirement Plan: 3% employer contribution</p></li><li><p>
Flexible and Hybrid Work Options</p></li><li><p>
Unlimited PTO for salaried staff</p></li><li><p>
12 Corporate Holidays</p></li><li><p>
Employee Assistance Program (EAP)</p></li><li><p>
Wellness Program</p></li><li><p>
Learning &amp; Development Stipend: Increases with tenure</p></li><li><p>
Charitable Match Program</p></li><li><p>
Wednesdays Catered Lunches (In-Office)</p></li></ul><div><p><b>
Ready to Take the Next Step?</b></p></div><div><p>
Does joining Evestia Clinical and making a global impact excite you? Then it's time to apply!</p></div><div><p>
We are eager to meet ambitious candidates. Remember, we hire for potential and passion. Therefore if you feel you're a good fit but don't meet every single requirement, please submit your application anyway. We want to hear from you.</p><p><b>
Our Commitment to Inclusion and Diversity</b></p></div><div><p>
We are deeply proud of our people and the successes we achieve together. We actively seek out and hire individuals with diverse backgrounds, voices, beliefs, and perspectives to join our growing global workforce.</p><p>
At Evestia Clinical, we believe that each person is unique. We celebrate your individuality, knowing that diverse viewpoints fuel Innovation and drive Excellence. We foster true Partnership across our global teams, guided by genuine Care for our colleagues. Our managers are dedicated to upholding this inclusive environment in every aspect of employment&mdash;from hiring and promotion to training and benefits.</p><p>
It's <b>who we are</b>, it's <b>what we do</b>, it's <b>what we care about.</b></p><p><b>
Equal Opportunity &amp; Accessibility</b></p></div><div><p>
Evestia Clinical is an equal opportunity employer committed to diversity in the workplace. We ensure fair treatment of all applicants and employees, without discrimination based on actual or perceived race, color, creed, religion, national origin, age, sex, gender identity or expression, sexual orientation, disability, veteran status, or any other characteristic protected by applicable law.</p></div><div><p>
We are committed to providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Evestia Clinical and require an accommodation or special assistance during the application process, please notify our recruitment team by sending an email with your request to HR@evestiaclinical.com</p></div></div>

Clinical Research Associate (CRA II or Senior) - Miami

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p><div>
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation<br>
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<br>
<br>
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.<br>
<br>
What You&rsquo;ll Do:<br>
<ul><li>Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>Participates in investigator meetings as necessary. Identifies potential</li><li>investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</li><li>Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul><br>
Education and Experience Requirements:<br>
<ul><li>Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.</li><li>Valid driver's license where applicable.</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br>
<br>
Knowledge, Skills and Abilities:<br>
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexibile and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Good English language and grammar skills</li><li>Good presentation skills</li></ul><br>
Working Conditions and Environment:<br>
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.</li><li>Exposure to biological fluids with potential exposure to infectious organisms.</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul></div></div><p></p>

CRA (Level II) - FSP Vaccines - Southeast

ICON plc

<div>Clinical Research Associate, Sponsor Dedicated<p></p><p>
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</p><p></p><p>
As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.</p><p></p><p><b>
What You Will Do:</b></p><p></p><p>
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.<br>
<br>
Key responsibilities include:</p><ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul><p></p><p><b>
Your Profile:</b></p><p></p><p>
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills.<br>
<br>
Required qualifications and experience:</p><ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li><li>
Strong organizational and communication skills, with attention to detail.</li><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul><p></p><p><b>
What ICON can offer you:</b></p><p></p><div><div><div><div><p>
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.</p><p></p><p>
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.</p><p></p><p>
Our benefits examples include:</p><ul><li><p>
Various annual leave entitlements</p></li><li><p>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</p></li><li><p>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>
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.</p></li><li><p>
Life assurance</p></li><li><p>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul></div></div></div></div><p></p><p>
Visit our careers site to read more about the benefits ICON offers.</p><p></p><p>
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.</p><p></p><div><div><div><div><p>
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</p><p></p><div><p>
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.</p></div></div></div></div></div></div><p></p>

Clinical Research Associate, Sponsor Dedicated

<div>Clinical Research Associate<p></p><p>
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</p><p></p><p>
As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.</p><p></p><p><b>
What You Will Do:</b></p><p></p><p>
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.<br>
<br>
Key responsibilities include:</p><ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul><p></p><p><b>
Your Profile:</b></p><p></p><p>
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills.<br>
<br>
Required qualifications and experience:</p><ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li><li>
Strong organizational and communication skills, with attention to detail.</li><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul><p></p><p><b>
What ICON can offer you:</b></p><p></p><div><div><div><div><p>
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.</p><p></p><p>
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.</p><p></p><p>
Our benefits examples include:</p><ul><li><p>
Various annual leave entitlements</p></li><li><p>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</p></li><li><p>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>
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.</p></li><li><p>
Life assurance</p></li><li><p>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul></div></div></div></div><p></p><p>
Visit our careers site to read more about the benefits ICON offers.</p><p></p><p>
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.</p><p></p><div><div><div><div><p>
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</p><p></p><div><p>
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.</p></div></div></div></div></div></div><p></p>

Clinical Research Associate II

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