clinical trial monitor

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

Bristol Myers Squibb

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

Clinical Research Associate

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

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

Syneos Health

<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)

Parexel

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

Senior Clinical Research Associate - FSP

Sun City Clinical Trials

<p>We are seeking a board-certified Pulmonologist to provide medical leadership and expertise in pulmonary clinical trials. The physician will be involved in working on studies for new cutting-edge treatments related to respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, pulmonary fibrosis, lung infections, and other pulmonary disorders.</p><p><b>Key Responsibilities:</b></p><ul><li>Provide clinical and scientific input for the development of study protocols and clinical trial design related to pulmonary medicine.</li><li>Oversee and monitor clinical trials involving patients with respiratory diseases to ensure protocol adherence and patient safety.</li><li>Review and assess adverse events, medical queries, and safety data in ongoing studies.</li><li>Collaborate with investigators, clinical operations teams, and regulatory bodies to support site selection, enrollment, and trial conduct.</li><li>Analyze clinical data and contribute to clinical study reports, abstracts, publications, and regulatory submissions.</li><li>Participate in investigator meetings, advisory boards, and external scientific conferences.</li><li>Stay current with medical and scientific developments in pulmonology and clinical research regulations.</li><li>Support medical affairs and business development activities as needed.</li></ul><p><b>Qualifications:</b></p><ul><li>Medical degree (MD or DO) with board certification in Pulmonology or Pulmonary and Critical Care Medicine. (required)</li><li>Valid medical license to practice in Arizona. (required)</li><li>Proven ability to analyze clinical trial data and ensure patient safety.</li><li>Excellent communication and interpersonal skills.</li><li>Ability to work collaboratively in a multidisciplinary environment.</li></ul><p><b>Preferred Qualifications:</b></p><ul><li>Experience as an investigator or sub-investigator in pulmonary clinical trials.</li><li>Familiarity with electronic data capture systems and clinical trial management software.</li><li>Understanding of biostatistics and clinical trial methodology.</li><li>Willingness to travel to clinical trial sites and scientific meetings.</li></ul><p>Job Types: Full-time, Part-time, Contract</p><p>Pay: $100.00 - $250.00 per hour</p><p>Expected hours: No more than 40 per week</p><p>Benefits:</p><ul><li>Flexible schedule</li><li>Health insurance</li><li>Paid time off</li></ul><p>Work Location: In person</p>

Pulmonologist - Physician for Clinical Research

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