regional clinical research associate

ICON Strategic Solutions

<div>
 Clinical Research Associate - Oncology - Texas
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  What You Will Be Doing
  <br/>
  <br/>
 </strong>
 <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
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  You Are
  <br/>
  <br/>
 </strong>
 <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
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What ICON Can Offer You
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  Our Benefits Examples Include
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 Are you a current ICON Employee? Please click here to apply
</div>


Clinical Research Associate

Polaris Pharmaceuticals Inc.

<div>
 <p>
  <strong>
   Clinical Research Associate
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Location : San Diego, CA (Hybrid 1 day/week)
  </strong>
 </p>
 <p>
  <strong>
   Reports to : Associate Director Clinical Trial Management
  </strong>
 </p>
 <p>
  <strong>
   Job Type : Full Time
  </strong>
 </p>
 <p>
  <strong>
   FLSA : Exempt
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Company Overview
  </strong>
 </p>
 <p>
  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.
 </p>
 <p>
  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.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Summary
  </strong>
 </p>
 <p>
  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.
 </p>
 <p>
  <br/>
 </p>
 <p>
  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.
 </p>
 <p>
  <br/>
 </p>
 <p>
  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.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <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>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Required Qualifications
  </strong>
 </p>
 <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>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Physical / Work Environment
  </strong>
 </p>
 <ul>
  <li>
   This role is mainly a desk role requiring proper ergonomics.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Salary Range
  </strong>
 </p>
 <ul>
  <li>
   Annual base salary: $80,000 to $110,000
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Equal Employment Opportunity Statement
  </strong>
 </p>
 <p>
  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.
 </p>
 <p>
 </p>
</div>


Medpace

<div>
 <strong>
  Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!
  <br/>
  <br/>
 </strong>
 This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our
 <em>
  PACE&reg;
 </em>
 Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
 <br/>
 <br/>
 <strong>
  WE OFFER THE FOLLOWING
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Competitive travel bonus;
  </li>
  <li>
   Equity/Stock Option program;
  </li>
  <li>
   Training completion and retention bonus
  </li>
  <li>
   Annual merit increases;
  </li>
  <li>
   401K matching;
  </li>
  <li>
   The opportunity to work from home;
  </li>
  <li>
   Flexible work hours across days within a week;
  </li>
  <li>
   Retain airline reward miles and hotel reward points;
  </li>
  <li>
   Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
  </li>
  <li>
   In-house travel agents, reimbursement for airline club, and TSA pre-check;
  </li>
  <li>
   Opportunity for leadership positions &ndash; Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
  </li>
  <li>
   CRA training program (PACE&reg;);
  </li>
  <li>
   Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
  </li>
  <li>
   In-house administrative support for all levels of CRAs; and
  </li>
  <li>
   Opportunities to work with international team of CRAs.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
  </li>
  <li>
   Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
  </li>
  <li>
   Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
  </li>
  <li>
   Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
  </li>
  <li>
   On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
  </li>
  <li>
   Verification that the investigator is enrolling only eligible subjects;
  </li>
  <li>
   Regulatory document review;
  </li>
  <li>
   Medical device and/or investigational product/drug accountability and inventory;
  </li>
  <li>
   Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
  </li>
  <li>
   Assess the clinical research site&rsquo;s patient recruitment and retention success and offering suggestions for improvement; and
  </li>
  <li>
   Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Must have a minimum of a Bachelor&rsquo;s degree in a health or science related field;
  </li>
  <li>
   Experience as a Clinical Research Coordinator (minimum 1 year);
  </li>
  <li>
   Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely
  </li>
  <li>
   Must maintain a valid driver&rsquo;s license and the ability to drive to monitoring sites;
  </li>
  <li>
   Proficient knowledge of Microsoft&reg; Office;
  </li>
  <li>
   Strong communication and presentation skills; and
  </li>
  <li>
   Must be detail-oriented and efficient in time management.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  <br/>
  <br/>
 </strong>
 <strong>
  Medpace Overview
  <br/>
  <br/>
 </strong>
 Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
 <br/>
 <br/>
 <strong>
  Why Medpace?
  <br/>
  <br/>
 </strong>
 People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
 <br/>
 <br/>
 The work we&rsquo;ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
 <br/>
 <br/>
 <strong>
  Medpace Perks
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Flexible work environment
  </li>
  <li>
   Competitive PTO packages &ndash; starting at 20+ days
  </li>
  <li>
   Company-sponsored employee appreciation events
  </li>
  <li>
   Employee health and wellness initiatives
  </li>
  <li>
   Competitive compensation and benefits package
  </li>
  <li>
   Structured career paths with opportunities for professional growth
  </li>
  <li>
   Discounts for local businesses
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Awards
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Named a Top Workplace in 2024 by The Cincinnati Enquirer
  </li>
  <li>
   Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  </li>
  <li>
   Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What To Expect Next
  <br/>
  <br/>
 </strong>
 A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
 <br/>
 <br/>
</div>


Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

ICON plc

<div>Clinical Research Associate - TX - Adverum<p></p><p>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</p><p></p><p>
As a CRA at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.</p><p></p><p><b>
What You Will Do:</b></p><p></p><p>
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.<br>
<br>
Key responsibilities include:</p><ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul><p></p><p><b>
Your Profile:</b></p><p></p><p>
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills.<br>
<br>
Required qualifications and experience:</p><ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li><li>
Strong organizational and communication skills, with attention to detail.</li><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li>
Ophthalmology experience is required</li><li>
Willingness to travel as required (approximately 60%)</li></ul><p></p><p><b>
What ICON can offer you:</b></p><p></p><div><div><div><div><p>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</p><p></p><p>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</p><p></p><p>
Our benefits examples include:</p><ul><li><p>
Various annual leave entitlements</p></li><li><p>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</p></li><li><p>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</p></li><li><p>
Life assurance</p></li><li><p>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul></div></div></div></div><p></p><p>
Visit our careers site to read more about the benefits ICON offers.</p><p></p><p>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</p><p></p><div><div><div><div><p>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</p><p></p><div><p>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</p></div></div></div></div></div></div><p></p>

<div>Clinical Research Associate - California<p></p><p>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</p><p></p><p>
As a CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.</p><p></p><p><b>
What You Will Do:</b></p><p></p><p>
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement.<br>
<br>
Key responsibilities include:</p><ul><li><p>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</p></li><li><p>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</p></li><li><p>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</p></li><li><p>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</p></li><li><p>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</p></li></ul><p></p><p><b>
Your Profile:</b></p><p></p><p>
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others.<br>
<br>
Required qualifications and experience:</p><ul><li><p>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</p></li><li><p>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</p></li><li><p>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</p></li><li><p>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</p></li><li><p>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</p></li><li><p>
Willingness to travel as required (approximately 60%)</p></li></ul><p></p><p><b>
What ICON can offer you:</b></p><p></p><div><div><div><div><p>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</p><p></p><p>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</p><p></p><p>
Our benefits examples include:</p><ul><li><p>
Various annual leave entitlements</p></li><li><p>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</p></li><li><p>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</p></li><li><p>
Life assurance</p></li><li><p>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul></div></div></div></div><p></p><p>
Visit our careers site to read more about the benefits ICON offers.</p><p></p><p>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</p><p></p><div><div><div><div><p>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</p><p></p><div><p>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</p></div></div></div></div></div></div><p></p>

RTI LABORATORIES

<p><b>Job Summary</b>  <br/>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.</p><p><b>Responsibilities</b></p><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><p><b>Experience</b></p><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><p>Pay: $51,498.23 - $62,019.38 per year</p><p>Work Location: In person</p>

University of Nebraska Medical Center

<div><div><h2 class="jobSectionHeader"><b>Requisition Details</b></h2>
<div><div><div>GENERAL REQUISITION INFORMATION
</div><p></p><div><div><div><div><b>EEO Statement:</b></div>
<div>UNMC is an Equal Employment Opportunity Employer, including an equal opportunity employer of protected veterans and individuals with disabilities.</div>
</div><br>
<div><div><b>Location</b></div> <div>Omaha, NE</div>
</div><br>
<div><div><b>Requisition Number:</b></div> <div>Staff_14645</div>
</div><br>
<div><div><b>Department</b></div> <div>Neurological Sciences 50001975
</div></div><br>
<div><div><b>Business Unit</b></div> <div>College of Medicine</div>
</div><br>
<div><div><b>Reg-Temp</b></div> <div>Full-Time Regular</div>
</div><br>
<div><div><b>Work Schedule</b></div> <div>As directed by supervisor</div>
</div><br>
<div><div><b>Remote/Telecommuting</b></div> <div>Hybrid (part-time working on site, part-time working off-site)</div>
</div><br>
<div><div><b>Position Summary</b></div>
<div>The research associate will work with the principal investigator (PI) and the research team to develop, implement, coordinate, and conduct scholarly research projects. The PI&rsquo;s lab focuses on novel investigations of memory and cognitive functions in neurological, medical, and healthy aging populations using neuropsychological, neuroimaging, and eye-tracking methods. The lab is housed in the Department of Neurological Sciences at the University of Nebraska Medical Center in Omaha. Candidates must be independent, responsible, and self-motivated. Additionally, candidates should have prior research experience in an empirical psychology or cognitive neuroscience setting. Anticipated duties include research coordination, project implementation, participant scheduling, data collection, data entry, and general administration. This position will provide an excellent opportunity for exposure to cognitive, transnational, and clinical research, and it will provide possibilities for career development through research experience, scholarly publication, and mentorship by the PI.</div>
</div><br>
<div><div><b>Position Details</b></div>
<div><b>Additional Information</b></div>
</div><br>
<div><div><b>Posting Category</b></div> <div>Research - Non Academic</div>
</div><br>
<div><div><b>Working Title</b></div> <div>Clinical Research Associate I</div>
</div><br>
<div><div><b>Job Title</b></div> <div>Clinical Research Associate L1</div>
</div><br>
<div><div><b>Salary Grade </b></div><div>RA14H</div>
</div><br>
<div><div><b>Appointment Type</b></div> <div>C2 - REG OFF/SERV HRLY</div>
</div><br>
<div><div><b>Salary Range</b></div> <div>$18.221 - $27.356/hourly</div>
</div><br>
<div><div><b>Job Requisition Begin Date</b></div> <div>04/09/2026</div>
</div><br>
<div><div><b>Application Review Date</b></div> <div>04/16/2026</div>
</div><br>
<div><div><b>Review Date Information:</b></div>
<div>Initial application review will begin on the date provided in the field above. Applications received prior to this review date will be considered. Applications received after the review date may be considered.</div>
</div><br>
</div></div></div><div><div>Required and Preferred Qualifications
</div><p></p><div><div><div><div><b>Required Education:</b></div> <div>High School education or equivalent</div>
</div><br>
<div><div><b>If any degree major/training is required, please specify the type. (NOTE: Concentration and minors are not equivalent to a major)</b></div>
<div>(Will consider three years related post high school education/experience)</div>
</div><br>
<div><div><b>Required Experience</b></div> <div>3 years</div>
</div><br>
<div><div><b>If any experience is required, please specify what kind of experience:</b></div>
<div>Experience related to healthcare, laboratory and/or clinical research<br>
<br>
(Will consider three years related post high school education/experience)</div>
</div><br>
<div><div><b>Required License</b></div> <div>No</div>
</div><br>
<div><div><b>If yes, what is the required licensure/certification?</b></div>
</div><br>
<div></div><div><div><b>Required Computer Applications:</b></div> <div>Not Applicable</div>
</div><br>
<div><div><b>Required Other Computer Applications:</b></div>
</div><br>
<div></div><div><div><b>Required Additional Knowledge, Skills and Abilities:</b></div>
<div>1.Ability to work with a multidisciplinary team of researchers is required.<br>
2.Understanding and empathy for participants with neurological (or other medical) disorders and their associated physical, cognitive, visual, and psychological impairments is required.<br>
3.Professionalism, courtesy, and discretion are required in all interactions with research participants, lab members, department staff, and supervisors.</div>
</div><br>
<div><div><b>Preferred Education:</b></div> <div>Bachelor's degree or equivalent</div>
</div><br>
<div><div><b>If any degree/training is preferred, please specify the type:</b></div>
<div>Health, Science or related field.</div>
</div><br>
<div><div><b>Preferred Experience:</b></div>
<div>1. Reasonable (1-3 years) experience in social, cognitive, or health science data collection and/or lab experience is desired.<br>
2. Strong interpersonal, organizational, and written/verbal communication skills are desired.<br>
3. Experience with research participant recruitment and interviewing is desired.<br>
4. Previous experience with general purpose programming languages (e.g., Python, MATLAB), statistical programming languages (e.g., R, SPSS, SAS), and/or stimulus presentation software (e.g., Psychtoolbox, Presentation, ExperimentBuilder, PsychoPy) is desired.<br>
5. Experience and background in administration of neuropsychological or ophthalmological tests is desired.<br>
6. Experience working with elderly and clinical populations is desired.<br>
7. Experience with neuroimaging methods is desired.<br>
8. Experience with eye-tracking methods is desired.</div>
</div><br>
<div><div><b>Preferred License:</b></div> <div>Yes</div>
</div><br>
<div><div><b>If yes, what is the preferred licensure/certification?:</b></div>
<div>valid US driver&rsquo;s license</div>
</div><br>
<div><div><b>Preferred Computer Applications:</b></div> <div>Microsoft Access</div>
</div><br>
<div><div><b>Preferred Other Computer Applications:</b></div> <div>Microsoft Office, UNIX, web development, Python, R, MATLAB, experimental presentation software, or other programming experience.</div>
</div><br>
<div><div><b>Preferred Additional Knowledge, Skills and Abilities:</b></div>
<div>Basic computer literacy is required.</div>
</div><br>
<div><div><b>Email to a Friend</b></div> <div>https://unmc.peopleadmin.com/postings/97338</div></div></div></div></div></div></div></div><p></p>

Clinical Research Associate I

Search 10000+ Regional clinical research associate jobs near you this May. New roles added regularly across leading industries. Apply today.

10000 regional clinical research associate jobs Near Me

Clinical Research Associate

Clinical Research Associate

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate I