site monitor

As a Site Inspector, you will play a crucial role in ensuring the successful implementation of a waterfront development project. Your responsibilities will include overseeing the installation of beach and underwater breakwater structures, which are vital for coastal protection and development. This role offers an exciting opportunity to contribute to a significant infrastructure project and make a lasting impact on the UAE's coastline.
 <div><ul><li>Conduct regular site inspections to monitor progress and ensure compliance with project specifications and safety standards.
</li><li>Coordinate with contractors, engineers, and other stakeholders to resolve any issues or challenges that arise during construction.
</li><li>Review and approve construction drawings, ensuring they meet the required standards and regulations.
</li><li>Maintain accurate records of site activities, including daily reports, photographs, and any relevant documentation.
</li><li>Manage and supervise a team of inspectors, providing guidance and support to ensure efficient and effective inspections.
</li><li>Conduct quality control checks to verify the integrity and durability of installed structures.
</li><li>Collaborate with the project manager to develop and implement inspection schedules and strategies.
</li><li>Stay updated on industry best practices and emerging technologies related to coastal engineering and construction.
</li><li>Provide timely feedback and recommendations to the project team, highlighting any potential risks or areas for improvement.
</li><li>Ensure effective communication and coordination between the site team and the client, keeping them informed of project progress.</li></ul></div>
 <div><ul><li>Bachelor's degree in Civil Engineering, Coastal Engineering, or a related field.
</li><li>Minimum of 7 years of experience in site inspection or construction supervision, preferably in coastal engineering projects.
</li><li>Strong knowledge of construction techniques, materials, and industry standards relevant to waterfront development.
</li><li>Excellent communication and interpersonal skills, with the ability to build positive working relationships.
</li><li>Proficiency in using inspection tools and software, as well as MS Office applications.
</li><li>Ability to work independently and manage multiple tasks in a fast-paced environment.
</li><li>Valid driving license and willingness to travel to the project site as required.
</li><li>Familiarity with UAE construction regulations and safety standards is highly preferred.
</li><li>Excellent problem-solving skills and a proactive approach to identifying and mitigating potential issues.
</li><li>Flexibility to adapt to changing project requirements and work schedules.</li></ul></div>

Site Inspector

ICON Strategic Solutions

<div>
 Clinical Research Associate - Oncology - Texas
 
 
 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.
 
 
 
 What You Will Be Doing
 
 
 
 <ul>
 <li>
 Serve as the primary point of contact between investigational sites and the sponsor
 </li>
 <li>
 Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
 </li>
 <li>
 Ensure site compliance with ICH-GCP, SOPs, and regulations
 </li>
 <li>
 Maintain up-to-date documentation in CTMS and eTMF systems
 </li>
 <li>
 Support and track site staff training and maintain compliance records
 </li>
 <li>
 Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
 </li>
 <li>
 Support subject recruitment and retention efforts at the site level
 </li>
 <li>
 Oversee drug accountability and ensure proper storage, return, or destruction
 </li>
 <li>
 Resolve data queries and drive timely, high-quality data entry
 </li>
 <li>
 Document site progress and escalate risks or issues to the clinical team
 </li>
 <li>
 Assist in tracking site budgets and ensuring timely site payments (as applicable)
 </li>
 <li>
 Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
 
 
 </li>
 </ul>
 
 You Are
 
 
 
 <ul>
 <li>
 A graduate with a Bachelor&rsquo;s degree in Life Sciences or equivalent, or a qualified RN
 </li>
 <li>
 Eligible to work in United States without visa sponsorship
 </li>
 <li>
 A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
 </li>
 <li>
 Experienced monitoring Oncology trials ideally in Heme/ONC
 </li>
 <li>
 Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
 </li>
 <li>
 A clear communicator, problem-solver, and collaborative team player
 </li>
 <li>
 Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Texas near major HUB airports to support efficient regional travel
 
 
 </li>
 </ul>
 
 What ICON Can Offer You
 
 
 
 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.
 
 
 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.
 
 
 
 Our Benefits Examples Include
 
 
 
 <ul>
 <li>
 Various annual leave entitlements
 </li>
 <li>
 A range of health insurance offerings to suit you and your family&rsquo;s needs.
 </li>
 <li>
 Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
 </li>
 <li>
 Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
 </li>
 <li>
 Life assurance
 </li>
 <li>
 Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
 
 
 </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 
 
 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.
 
 
 If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
 
 
 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.
 
 
 Are you a current ICON Employee? Please click here to apply
</div>

Clinical Research Associate

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation 
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. 
 
 
 
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. 
 
What You&rsquo;ll Do: 
<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> 
Education and Experience Requirements:
 
<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.
 
 
Knowledge, Skills and Abilities:
 
<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> 
Working Conditions and Environment:
 
<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>

CRA II

AbbVie

<div>
 
 Company Description
 
 
 
 
 About AbbVie
 
 
 
 AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
 
 
 
 Job Description
 
 
 
 
 These positions are field based / remote in the following locations: CA, WA, OR, IA, MN, IN, OH, FL. Candidates must reside in one of the these states and be willing to travel for site visits.
 
 
 
 
 Purpose
 
 
 
 Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
 
 
 Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
 
 
 Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.
 </li>
 <li>
 Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
 </li>
 <li>
 Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
 </li>
 <li>
 Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
 </li>
 <li>
 Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
 </li>
 <li>
 Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
 </li>
 <li>
 Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
 </li>
 <li>
 Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
 </li>
 <li>
 Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
 </li>
 <li>
 Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 Qualifications
 
 
 
 <ul>
 <li>
 Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
 </li>
 <li>
 Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk&hyphen;based monitoring approach, onsite and offsite monitoring.
 </li>
 <li>
 Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
 </li>
 <li>
 Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
 </li>
 <li>
 Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
 </li>
 <li>
 Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
 </li>
 <li>
 Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
 </li>
 <li>
 Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
 </li>
 <li>
 Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
 </li>
 <li>
 Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
 
 
 </li>
 </ul>
 Additional Information
 
 
 Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
 
 
 <ul>
 <li>
 The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
 </li>
 <li>
 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
 </li>
 <li>
 This job is eligible to participate in our short-term incentive programs.
 
 
 </li>
 </ul>
 Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested,and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to aparticular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion,consistent with applicable law.
 
 
 AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
 
 
 US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
 
 
 US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
 
 
 https://www.abbvie.com/join-us/reasonable-accommodations.html
</div>

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

<div>Company Description 
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
These positions are field based / remote in the following locations: CA, WA, OR, IA, MN, IN, OH, FL. Candidates must reside in one of the these states and be willing to travel for site visits.
Purpose
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. 
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. 
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities<ul><li>
Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.</li><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li><li>
Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li><li>
Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. 
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. 
May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.</li><li>
Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. 
Ensures audit and regulatory inspection readiness at assigned clinical site at all times. 
Manages investigator payments as per executed contract obligations, as applicable.</li></ul> 

Qualifications 
Qualifications<ul><li>
Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).</li><li>
Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li><li>
Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested,and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to aparticular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion,consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
This is a functional service provider (FSP) Clinical Research Associate (CRA) opportunity, you will be dedicated to one sponsor, monitoring seven days a month, 50% onsite and 50% remotely based on business needs. This position is targeted to travel regionally, travel can be national if needed. Ideal candidates will have one to two years of onsite pharmaceutical CRA experience.
Discover Impactful Work
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments. Acts as a site processes specialist, ensuring 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. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
A Day in the Life<ul><li>
Monitors investigator sites with a risk-based monitoring approach: applies root Functions 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 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>
Keys to Success
Education and Experience
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Valid driver's license where applicable.
CRA Level II
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years as a clinical research monitor).
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
Knowledge, Skills, Abilities<ul><li>
Proven clinical monitoring skills, ideal candidates will have monitoring experience with oncology, HIV, respiratory and or vaccine/flu</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-depth investigation 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 flexible 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>
Work Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:<ul><li>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</li><li>
Able to work upright and stationary for typical working hours.</li><li>
Ability to use and learn standard office equipment and technology with proficiency.</li><li>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</li></ul>
Compensation and Benefits
The salary range estimated for this position based in Washington is $66,800.00&ndash;$112,938.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</div>

Clinical Research Associate (Level II) - FSP Vaccines - West Region

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description<div>
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation 
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. 
 
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. 
 
What You&rsquo;ll Do: 
<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> 
Education and Experience Requirements: 
<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. 
 
Knowledge, Skills and Abilities: 
<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> 
Working Conditions and Environment: 
<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>

CRA (Level II) - FSP Vaccines - Southeast

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