ICON plc

<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

Fortrea

<div><p>We are recruiting for our <b>sponsor-dedicated</b> business in <b>T&uuml;rkiye</b> and are seeking to hire a <b>CRA </b>on a permanent, full-time contract.</p><p></p><p>
Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.</p><p></p><p>
At Fortrea, you will have autonomy to organize your work and in return, you will be supported and empowered to go beyond the typical CRA role, to really be an expert on your protocols and to own your sites.</p><p></p><h3 class="jobSectionHeader"><b>
Summary of Responsibilities</b></h3><ul><li><p>
Manage all phases of clinical site activity: pre-study, initiation, monitoring, and close-out visits</p></li><li><p>
Ensure protocol compliance, data accuracy, patient safety, and audit readiness</p></li><li><p>
Review source documents, resolve data queries, and oversee SAE reporting and follow-up</p></li><li><p>
Act as primary liaison with sites, vendors, and internal teams</p></li><li><p>
Prepare trip reports and support regulatory submissions, feasibility, and site budget negotiations</p></li><li><p>
Mentor junior staff and support project coordination as assigned</p></li></ul><p></p><h3 class="jobSectionHeader"><b>
Qualifications</b></h3><ul><li><p>
Degree in life sciences or related health profession</p></li><li><p>
Strong knowledge of regulatory requirements and clinical trial processes</p></li><li><p>
Fluent in English and local language (written and verbal)</p></li></ul><h3 class="jobSectionHeader"><b><br>
Experience</b></h3><ul><li><p>
Minimum 1.5 years of clinical on-site monitoring in interventional studies</p></li><li><p>
Skilled in SAE handling, CRF review, and site management</p></li><li><p>
Able to work independently with strong planning and problem-solving skills</p></li><li><p>
Fluent in English and Turkish</p></li></ul><p></p><p>
Learn more about our EEO &amp; Accommodations request here.</p></div>

CRA II - Sponsor Dedicated

<div><p><b>We are currently seeking </b><b>Experienced Oncology </b><b>Sr. CRAs</b><b> residing in East Coast to join our FSP team!</b></p><p></p><p><b>
WHAT YOU WILL DO</b></p><p></p><p>
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.</p><p></p><p><b>
Responsibilities</b>:</p><ul><li>
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -</li><li>
Responsible for all aspects of site management as prescribed in the project plans</li><li>
General On-Site Monitoring</li><li>
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</li><li>
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</li><li>
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data</li><li>
Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested</li><li>
Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs</li><li>
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management</li><li>
Assist with training of new employees, eg. co-monitoring</li><li>
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned</li><li>
Perform other duties as assigned by management</li></ul><p></p><p><b>
Requirements</b></p><ul><li>
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)</li><li>
3+ years of onsite Clinical Monitoring experience</li><li>
Oncology experience</li><li>
Open to major hub locations in the Northeast US</li></ul><p></p><p>
The important thing for us is you are comfortable working in an environment that is:</p><ul><li><b>
Fast paced</b>: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.</li><li><b>
Changing priorities constantly</b> asking you to prioritize and adapt on the spot.</li><li><b>
Teamwork </b>and<b> people skills</b> are essential for the study to run smoothly.</li><li><b>
Technology based</b>. We collect our data directly into an electronic environment.</li></ul><p></p><p><b>
What do you get?</b></p><p></p><p>
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:</p><ul><li>
Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)</li><li>
401(K)</li><li>
Paid time off (PTO) &ndash; Flex Plan</li><li>
Employee recognition awards</li><li>
Multiple ERG&rsquo;s (employee resource groups)</li><li>
Target Pay Range (based on title): $130-140K</li></ul><p></p><p>
#LI - Remote</p><p>
Applications will be accepted on an ongoing basis.</p><p></p><p><i>
Work Environment:</i></p><ul><li><i>
Work is performed in an office environment with exposure to electrical office equipment.</i></li><li><i>
Frequent travel to clients/ site locations with occasional travel both domestic and international.</i></li></ul><p></p><p><i>
Physical Requirements:</i></p><ul><li><i>
Ability to sit for extended periods and operate a vehicle safely.</i></li><li><i>
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</i></li><li><i>
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</i></li><li><i>
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</i></li><li><i>
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</i></li><li><i>
Regular and consistent attendance.</i></li><li><i>
Varied hours may be required.</i></li></ul><p></p><p>
Learn more about our EEO &amp; Accommodations request here.</p></div>

Sr CRA 1 or Sr. CRA 2,FSP - Oncology - East Coast

Syneos Health

<div><p><b>Description</b>
</p>Sr CRA | Sponsor Dedicated | Oncology (Home-Based - Atlanta, GA)<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
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 accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><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 our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><ul><li>
Performs site qualification, site initiation, interim monitoring, site management 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 via review of site source documents and medical records. 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>
Understands project scope, budgets, and timelines for own and others&rsquo; activities in the clinical team; 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 project 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, and may, with supervision, lead, 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>
May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.</li><li>
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close out<br>
Knowledge of local requirements for real world late phase study designs<br>
Chart abstraction activities and data collection<br>
As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff<br>
Identify and communicate out of scope activities to Lead CRA/Project Manager<br>
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations<br>
Identify operational efficiencies and process improvements<br>
Develop country level informed consent forms<br>
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared<br>
Participate in bid defense meetings</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. Basic level of critical thinking skills expected.</li><li>
Ability to manage required travel of up to 75% on a regular basis</li></ul><p></p><p>
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.</p><p></p><p>
Salary Range:</p>
$80,600.00 - $145,000.00<p></p><p>
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.</p><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 job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring.Impact and ContributionIndividual 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. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Sr CRA | Sponsor Dedicated | Oncology (Home-Based - Atlanta, GA)

<div><p><b>Description</b>
</p>CRA II | Sponsor Dedicated | Oncology (Home-Based - Buffalo, NY)<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
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 accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><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 our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><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><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>
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.</p><p></p><p>
Salary Range:</p>
$70,100.00 - $126,100.00<p></p><p>
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.</p><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 ContributionIndividual 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>

CRA II | Sponsor Dedicated | Oncology (Home-Based - Buffalo, NY)

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><p>
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.</p><p></p><h2 class="jobSectionHeader"><b>
Discover Impactful Work:</b></h2><p></p><p>
Our global Clinical Operations colleagues within our PPD&reg; clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and complete high-quality, cost-efficient clinical studies.</p><p></p><h2 class="jobSectionHeader"><b>
A day in the Life:</b></h2><p></p><ul><li>
Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, exciting projects.</li><li>
Have excellent communication and social skills and are looking to work in a collegiate environment where you want to take true ownership for your work.</li><li>
Perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently.</li><li>
Benefit from award winning training programmes that will assist your technical and professional skills and knowledge.</li></ul><p></p><h2 class="jobSectionHeader"><b>
Keys to Success:</b></h2><p></p><h2 class="jobSectionHeader"><b>
Education</b></h2><p></p><ul><li>
University degree in a life-sciences field</li></ul><p></p><h2 class="jobSectionHeader"><b>
Experience</b></h2><p></p><ul><li>
Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation</li></ul><p></p><h2 class="jobSectionHeader"><b>
Knowledge, Skills, Abilities</b></h2><p></p><ul><li>
Demonstrated understanding of ICH-GCP, EU and FDA requirements</li><li>
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>
Exceptional communication, collaboration, organisational and time management skill</li><li>
Fluency in Turkish and English languages</li></ul></div><p></p>

Clinical Research Associate (CRA) - Client-dedicated

<div>Clinical Research Associate -Late Development, Onc/Hem- Northeast Region<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Clinical Research Associate in the Northeast region with Late Phase Onc/Hem experience to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.</div><div></div><div>
What you will be doing</div><ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li></ul><ul><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li></ul><ul><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li></ul><ul><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li></ul><ul><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul><div><br>
Your profile</div><ul><li><div>
Bachelor's degree in a scientific or healthcare-related field.</div></li><li><div>
Minimum of 1.5-2 years of experience as a Clinical Research Associate and Oncology/Hematology experience</div></li><li><div>
Must be located in NY, NJ, PA, NH, CT, RI, ME or MA.</div></li><li><div>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</div></li><li><div>
Strong organizational and communication skills, with attention to detail.</div></li><li><div>
Ability to work independently and collaboratively in a fast-paced environment.</div></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>

CRA II, Late Phase Oncology/Hematology

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