clinical research associate

Polaris Pharmaceuticals Inc.

<div>
 
 
 Clinical Research Associate
 
 
 
 
 
 
 
 Location : San Diego, CA (Hybrid 1 day/week)
 
 
 
 
 Reports to : Associate Director Clinical Trial Management
 
 
 
 
 Job Type : Full Time
 
 
 
 
 FLSA : Exempt
 
 
 
 
 
 
 
 Company Overview
 
 
 
 Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company&rsquo;s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications.
 
 
 Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide.
 
 
 
 
 
 
 Job Summary
 
 
 
 We are seeking an in-house Clinical Research Associate with oncology experience to independently monitor and manage clinical sites participating in studies with pegargiminase. No travel requirements are anticipated as all monitoring visits will be conducted remotely. Additional responsibilities will include support for the maintenance of monitoring related documents and trackers.
 
 
 
 
 
 The position will report to the Associate Director Clinical Trial Management and will be hybrid position requiring a minimum of one day per week in the San Diego office.
 
 
 
 
 
 We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible, and willing to take on additional responsibilities as required.
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Support study monitoring startup tasks including the development of plans and manuals, training, reviewing, and approving essential documents, facilitating completion of clinical study agreements and shipment of investigation product.
 </li>
 <li>
 Perform clinical monitoring activities to ensure that the clinical studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and applicable regulatory requirements
 </li>
 <li>
 Independently conduct monitoring visits to ensure accuracy of data entry with source documentation and perform study drug accountability or manage outsourced CRA performing these activities
 </li>
 <li>
 Review clinical site regulatory documents to ensure completeness and retrieve documents for the Trial Master File
 </li>
 <li>
 Maintain the internal Trial Master File and periodically review
 </li>
 <li>
 Support the preparation of project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries as required
 </li>
 <li>
 Monitor and track clinical research progress and provide status update reports
 </li>
 <li>
 Liaise with clinical sites and provide guidance on site/study issues
 </li>
 </ul>
 
 
 
 
 
 Required Qualifications
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree, preferably in science or healthcare
 </li>
 <li>
 Demonstrated clinical research experience with a minimum of 2 years monitoring experience in the biotech/medical diagnostics/pharmaceutical industry, CRO, or in a hospital setting with experience in oncology
 </li>
 <li>
 Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines
 </li>
 <li>
 Excellent written and verbal communication skills
 </li>
 <li>
 Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint
 </li>
 <li>
 Ability to work independently and prioritize multiple projects in a fast-paced environment.
 </li>
 </ul>
 
 
 
 
 
 Physical / Work Environment
 
 
 <ul>
 <li>
 This role is mainly a desk role requiring proper ergonomics.
 </li>
 </ul>
 
 
 
 
 
 Salary Range
 
 
 <ul>
 <li>
 Annual base salary: $80,000 to $110,000
 </li>
 </ul>
 
 
 
 
 
 Equal Employment Opportunity Statement
 
 
 
 Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.
 
 
 
</div>

Clinical Research Associate

Pennington Biomedical Research Center

<div>
 About Us:
 
 
 At the forefront of medical discovery as it relates to understanding the causes of obesity, diabetes, cardiovascular disease, cancer and dementia, Pennington Biomedical Research Center is a campus of Louisiana State University and conducts basic, clinical and population research. The Center includes Basic Science, Clinical Research, and Population and Public Health, enabling both focused research and translational science. Research at Pennington Biomedical is supported broadly by multiple NIH Research Centers, and includes approximately 65 faculty and 20 postdoctoral fellows who comprise a network of 44 laboratories and 13 highly specialized core service facilities. Pennington Biomedical is located within state-of-the-art research facilities on a 222-acre campus in Baton Rouge, Louisiana.
 
 
 
 
 All Job Postings will close at 12:01a.m. CST (1:01a.m. EST) on the specified Closing Date (if designated).
 
 
 
 
 
 If you close the browser or exit your application prior to submitting, the application progress will be saved as a draft. You will be able to access and complete the application through &ldquo;My Draft Applications&rdquo; located on your Candidate Home page.
 
 
 
 Job Posting Title:
 
 
 Clinical Research Associate 1
 
 
 Position Type:
 
 
 Professional / Unclassified
 
 
 Department:
 
 
 LSUPBRC PopSci - Pediatric Obesity and Health Behavior - Project Management (Natalie Malek (00057821))
 
 
 Work Location:
 
 
 LSU - Pennington Biomedical
 
 
 Pay Grade:
 
 
 Professional
 
 
 Job Description:
 
 
 Pennington Biomedical Research Center, a world-renowned academic research institute of Louisiana State University, is seeking a Clinical Research Associate 1 in the Pediatric Obesity and Health Behavior Laboratory.
 
 
 The Clinical Research Associate will conduct clinical trial study visits, including preparation, data collection, and entry. This position will be responsible for coordinating obtaining informed consent, data collection, assessing diet and activity, and administering questionnaires at clinical sites while ensuring high data quality and consistency. Effective communication with participants for scheduling, reminders, screenings, interventions, and follow-ups is essential. Ideal candidates will have a strong educational background, relevant experience, and excellent organizational and communication skills.
 
 
 
 
 Job Responsibilities
 
 
 
 
 <ul>
 <li>
 Conduct Clinical Trial Study Visits: Prepare for and conduct clinical trial study visits, including data collection and entry. Ensure all necessary materials and equipment are ready, accurately collect data during visits, and promptly enter data into the appropriate systems.
 </li>
 <li>
 Perform Clinical Research Data Collection Activities: Carry out various clinical research data collection tasks, such as obtaining informed consent from participants, measuring anthropometrics and body composition, assessing diet and physical activity, and administering questionnaires. Ensure all data is collected accurately and in accordance with study protocols.
 </li>
 <li>
 Coordinate and Implement Data Collection and Intervention Delivery: Assist in the coordination, implementation, and execution of data collection and intervention delivery at clinical sites. Ensure consistency with established strategies, commitments, and goals to maintain high data quality. Monitor and adjust processes as needed to ensure smooth operation.
 </li>
 <li>
 Communicate Effectively with Participants: Maintain clear and effective communication with study participants. This includes scheduling visits, making reminder calls, sending emails, conducting screenings, delivering interventions, and performing follow-ups. Ensure participants are well-informed and supported throughout the study.
 </li>
 <li>
 Enter Clinical Trial Data in REDCap Database: Accurately enter clinical trial data into the REDCap database. Ensure data is entered promptly and correctly, following all relevant guidelines and protocols.
 </li>
 <li>
 Perform Off-Campus Visits: Ensure all activities are performed in accordance with study requirements and maintain high standards of data collection and participant care.
 
 
 </li>
 </ul>
 
 
 Note: Flexible schedule required. This position will require some work after regular hours. Intermittent travel is sometimes required when conducting studies inside and outside of Baton Rouge.
 
 
 
 
 
 Required Qualifications
 
 
 
 <ul>
 <li>
 Bachelor's degree in public health, life sciences, nursing, kinesiology, or a related field.
 </li>
 <li>
 Experience in or familiarity with performing assessments in human subjects.
 </li>
 <li>
 Excellent verbal and written communication skills for effective interaction with study participants, scheduling visits, and conducting follow-ups. Ability to explain complex information clearly and empathetically.
 </li>
 <li>
 Exceptional organizational and time-management skills to handle multiple tasks, coordinate study activities, and ensure data quality. Attention to detail is critical for accurate data collection and entry.
 </li>
 <li>
 Ability to work well in a team and build rapport with participants.
 </li>
 <li>
 Willingness to travel for off-campus visits and adapt to varying study protocols.
 </li>
 <li>
 Strong problem-solving abilities to troubleshoot issues that arise during study visits and data collection.
 
 
 </li>
 </ul>
 
 Pennington Biomedical Research Center seeks to recruit a highly productive workforce with a broad range of backgrounds and perspectives and will provide equal employment opportunities to all employees and prospective employees. Employment decisions shall be based strictly on merit and without regard to religious or political beliefs, sex, race, or any other non-merit factor.
 
 
 
 Additional Job Description:
 
 
 Competencies:
 
 
 None
 
 
 Special Instructions:
 
 
 Interested candidates should include a resume and a list of three (3) professional references to the online application. Professional references should be the name, title, company, and contact information from past employers. Professional references should include current or previous supervisors and/or coworkers. Personal references should not be considered for the reference check process. We will respect the request that we not contact a current employer. However, we will need to contact a prior supervisor if such a request is made.
 
 
 A letter of application/cover letter is recommended but not required. Official transcripts are required prior to hire and are not required at the time of application.
 
 
 Posting Date:
 
 
 April 20, 2026
 
 
 Closing Date (Open Until Filled if No Date Specified):
 
 
 May 25, 2026
 
 
 Additional Position Information:
 
 
 Pennington Biomedical is located within state-of-the-art research facilities on a 222-acre campus in Baton Rouge, Louisiana. For more information, visit PBRC.
 
 
 Questions regarding career opportunities at Pennington Biomedical should be sent to hrm@pbrc.edu.
 
 
 
 Background Check -
 
 An offer of employment is contingent on a satisfactory pre-employment background check.
 
 
 
 Benefits -
 
 Pennington Biomedical Research Center offers outstanding benefits to eligible employees and their dependents including health, life, dental, and vision insurance; flexible spending accounts; retirement options; various leave options; paid holidays; wellness benefits; tuition exemption for qualified positions; training and development opportunities; employee discounts; and more!
 
 
 Positions approved to work outside the State of Louisiana shall be employed through Louisiana State University&rsquo;s partner, nextSource Workforce Solutions, for Employer of Record Services including but not limited to employment, benefits, payroll, and tax compliance. Positions employed through Employer of Record Services will be offered benefits and retirement as applicable through their provider and will not be eligible for State of Louisiana benefits and retirement.
 
 
 Essential Position (Y/N):
 
 
 Pennington Biomedical Research Center/LSU is an Equal Opportunity Employer.
 
 
 Contact Information:
 
 
 Questions or concerns can be directed to PBRC Human Resources at 225-763-2776 or hrm@pbrc.edu.
</div>

Clinical Research Associate 1

ICON plc

<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:<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.
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, 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.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
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.<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>
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>

NSABP Foundation, Inc.

<div><div>Clinical Research Associate</div><div>
This position is located in Pittsburgh, PA. We operate under a hybrid work arrangement - 3 days onsite (Monday, Tuesday and Thursday) and 2 days remote (Wednesday and Friday).</div><div></div><div> 
PURPOSE</div><div>
This role supports breast and colorectal cancer clinical trial operations and the primary deliverables of ensuring accrual to NSABP protocols, data integrity and regulatory compliance. The Clinical Research Associate, Level 3 role is one that includes responsibilities both as an individual contributor and leader. Leadership responsibilities focus online management of study monitors.</div><div>
ESSENTIAL FUNCTIONS</div><div><ul><li>
Actively plans, executes and assesses performance of activities across the life span of study.</li><li>
Ensures timely study start-up. Examples include but are not limited to study timeline start-up development, site selection and Principal Investigator review.</li><li>
Assists with site activation requirements including ICF review, site access to study platforms and other needs as they arise.</li><li>
Facilitates daily or weekly team huddles to assess, plan, review and prioritize activities to ensure timely site activation, accrual, metrics review, compliance with CMP and other study requirements and audit prep.</li><li>
Completes required trainings with appropriate documentation.</li><li>
Develops relationships with site staff and NSABP monitors.</li><li>
Acts as a liaison for NSABP, site staff and external partners.</li><li>
Conducts weekly performance metrics review, identifies gaps and initiates contact with study monitor to review performance as needed. Examples include the number of queries, query resolution, source data verification, protocol deviation reporting and other study specific metrics.</li><li>
Responsible for providing regular metrics assessment to leadership team.</li><li>
Identifies key metrics with poor performance and develops an action plan to remediate the issue.</li><li>
Develops and implements recruitment strategies to ensure accrual targets are met.</li><li>
Ensures site initiation visits, interim monitoring visits and close out visits are compliant with the Clinical Monitoring Plan (CMP).</li><li>
Reviews and approves itineraries to ensure CMP compliance and associated expense reports.</li><li>
Follows Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines.</li><li>
Assists with developing, writing and implementing Study Start-Up Plans, Clinical Monitoring Plans, Roles and Responsibilities grids and other study-specific documents.</li><li>
Collaborates with clinical research organizations and centralized services such as laboratories.</li><li>
Collaborates with data management regarding CRF development and UAT testing.</li><li>
Acts as a resource to sites and investigators.</li><li>
Supports review of SIV and monitoring reports by Clinical Trial Manager to ensure expected quality compliance standards are met. These include compliance with CMP, SOPs, WIs and training requirements.</li><li>
Supports study monitors with resolution of significant site issues.</li><li>
Performs other job-related duties as assigned.</li></ul></div><div></div><div> 
OTHER RESPONSIBILITIES</div><div><ul><li>
Knowledge of randomized clinical trials principles and procedures.</li><li>
Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials.</li><li>
Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management.</li></ul></div><div></div><div> 
EXPERIENCE/SKILLS</div><div><ul><li>
Bachelor&rsquo;s degree required.</li><li>
Prior CRA experience required.</li><li>
Research certification strongly preferred</li><li>
Prior experience at CRO strongly preferred.</li><li>
Familiarity with electronic TMF, EDC and CTMS systems required.</li><li>
Strong verbal, written and organizational skills with a team-oriented approach required.</li><li>
Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.</li><li>
Proficiency in Microsoft Office Suite</li></ul> 
The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.</div></div>

<div>Clinical Research Associate/Senior CRA - East Coast
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
As a CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.
What You Will Do:
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. 
 
Key responsibilities include:<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>
Your Profile:
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</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>
Willingness to travel as required (approximately 60%)</li><li>
Location: East coast</li></ul>
What ICON can offer you:<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.
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, 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.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
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.<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>
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>Clinical Research Associate - California
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
As a CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.
What You Will Do:
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. 
 
Key responsibilities include:<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>
Your Profile:
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</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>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<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.
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, 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.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
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.<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>
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>

RTI LABORATORIES

Job Summary We are seeking a dynamic and detail-oriented Clinical Research Associate (CRA) to join our innovative clinical development team. In this vital role, you will oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory standards and study protocols. Your expertise will drive the successful management of clinical research projects, ensuring data integrity, patient safety, and adherence to all applicable regulations. This position offers an exciting opportunity to contribute to groundbreaking medical advancements while working in a collaborative and fast-paced environment.Responsibilities<ul><li>Coordinate and monitor clinical trials across multiple sites, ensuring adherence to study protocols, FDA regulations, ICH GCP guidelines, and company standards. </li><li>Conduct site qualification visits, initiate visits, routine monitoring visits, and close-out visits to verify compliance and data accuracy. </li><li>Review and verify source documents, case report forms (CRFs), and other trial documentation for completeness and accuracy. </li><li>Provide training and support to site staff on protocol procedures, data collection methods, EMR systems, and regulatory requirements. </li><li>Monitor patient safety by reviewing adverse event reports, ensuring proper documentation, and reporting to relevant authorities as required. </li><li>Manage trial documentation including ethics submissions, informed consent forms, regulatory binders, and audit readiness files. </li><li>Collaborate with cross-functional teams such as clinical operations, data management, laboratory personnel, and medical staff to facilitate smooth trial execution. </li><li>Ensure compliance with HIPAA regulations concerning patient confidentiality and data security. </li><li>Assist in the review of clinical laboratory results, vital signs data, blood sampling procedures (phlebotomy), and other clinical assessments. </li><li>Support statistical analysis activities by coordinating with statisticians using software tools designed for clinical data analysis. </li><li>Maintain detailed records of site communications, monitoring reports, and trial progress for audit purposes.</li></ul>Experience<ul><li>Proven supervising experience in managing clinical trials or overseeing clinical research teams. </li><li>Extensive knowledge of clinical trials management processes from initiation through close-out phases. </li><li>Strong understanding of medical terminology, FDA regulations, ICH GCP guidelines, and CDISC standards for data exchange. </li><li>Hands-on experience with EMR systems and electronic data capture (EDC) platforms for efficient data management. </li><li>Background in nursing or clinical laboratory work (including blood sampling and vital signs measurement) is highly desirable. </li><li>Familiarity with statistical software used in clinical research for data analysis purposes. </li><li>Certification such as ICH GCP certificate from a recognized issuer (including CA) is required; additional certifications in HIPAA compliance or phlebotomy are a plus. </li><li>Excellent analysis skills combined with meticulous attention to detail to ensure high-quality documentation review and compliance management. Join us in advancing medical science through rigorous research practices! We value energetic professionals committed to excellence in clinical development who thrive in collaborative environments dedicated to improving patient outcomes worldwide.</li></ul>Pay: $51,498.23 - $62,019.38 per yearWork Location: In person

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