regional clinical research associate

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 - 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>

Clinical Research Associate

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

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>

<div>Clinical Research Associate<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 II 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>
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>

Clinical Research Associate II

Bright Uro

<p>About Bright Uro:<br/></p><p>Bright Uro is a fast-growing medical device startup headquartered in Irvine, CA, on a mission to improve the lives of millions affected by lower urinary tract symptoms (LUTS). We develop cutting-edge diagnostic technology that integrates advanced hardware, intuitive software, and powerful data analytics &mdash; enabling clinicians to gain actionable insights while delivering a better patient experience. We're passionate about advancing urologic care through innovation, and we're building a collaborative, dynamic team to bring transformative solutions to life.<br/></p><p>About the Role:<br/></p><p>The Clinical Research Associate I (CRA I) is an exciting entry point into the world of clinical research at Bright Uro, offering hands-on exposure across the full lifecycle of a clinical study &mdash; from site identification and initiation through data collection and study close-out.<br/></p><p>As a CRA I, you'll work at the intersection of science, patient care, and regulatory rigor. You'll collaborate closely with investigational sites, clinicians, and internal teams to ensure studies are conducted with integrity, precision, and compliance. Whether you're providing real-time case coverage support, training site personnel on investigational devices, or contributing to study protocols and publications, your work will directly support the development of technologies that improve patient outcomes.<br/></p><p>This is a largely travel-based position requiring routine on-site presence at clinical study locations throughout the East Coast. This role is ideal for someone who is detail-oriented, thrives in a dynamic environment, and is eager to grow their clinical research career at a company where their contributions truly matter.<br/></p><p>Duties and Responsibilities:<br/></p><p>The Clinical Research Associate I (CRA I) is responsible for assigned aspects of clinical research, in accordance with, applicable Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). The CRA I will perform the following activities as directed:<br/></p><p>Provide real-time clinical research case coverage support, document case observations and provide summary reports as required.<br/>Ensure study procedures are conducted in accordance with the approved protocol, regulatory requirements, and Bright Uro guidelines.<br/>Contribute to clinical research development such as study protocols, monitoring plans, and other related clinical and regulatory documents.<br/>Assist in the management of investigational sites from identification and selection to study closure including engaging with the site to ensure preparedness for clinical research<br/>Advise and train site personnel in the proper study procedures and use of investigational devices, software applications, and/or study-specific tools as appropriate, including enforcing said training and troubleshooting device or procedural issues during cases.<br/>Serve as an additional point of contact between the site and Bright Uro.<br/>Assist in the planning and conduct of meetings (e.g., Investigator, Data and Safety Monitoring Board, Scientific Advisory Board), as well as the preparation of meeting minutes and reports.<br/>Assist or conduct site initiation visits (SIV) and interim monitoring visits (IMVs) such as preparing agendas, checklists, reports, and follow-up letters as appropriate.<br/>Assist in the formulation of instructional materials and training of clinicians, researchers, and other personnel.<br/>Provide continuous data review of source documents and case report forms (CRFs) (i.e., source data verification [SDV]) to ensure the timely, accurate, and complete collection and submission of study data.<br/>Ensure all required study documentation is completed at various stages of the clinical study (e.g., initiation, close-out) and maintain specific records of research activity for Bright Uro (e.g., Trial Master File [TMF]).<br/>Manage study supplies and ensure remaining study supplies are returned to Bright Uro.<br/>Monitor and track participant enrollment and study progress and attend study visits at investigational sites as appropriate.<br/>Monitor study progress to ensure compliance with the protocol requirements, FDA regulations, and Good Clinical Practice (GCP) to identify, address, and resolve issues and problems as they might occur at the investigational site.<br/>Contribute to scientific posters, publications, and other published materials.<br/>Perform other duties or tasks in clinical, research and development, regulatory, sales, marketing, and client services, or as directed by company leadership.<br/></p><p>Education and/or Work Experience Requirements:<br/></p><p>Must have a minimum of a Bachelor's Degree in a relevant science.<br/>Minimum of 2 years of relevant research experience. Experience may include work in a clinical laboratory, clinic, or pharmacy.<br/>Human Subjects Research and GCP in Medical Devices Certifications must be completed within 30 days of hire.<br/></p><p>Required Qualifications:<br/></p><p>Willingness and ability to travel a minimum of 80% of the time.<br/>Must reside near a major U.S. airport in the U.S. Eastern Time Zone.<br/>Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external stakeholders.<br/>High level of personal and professional integrity, a strong work ethic, and the ability to work independently while managing and prioritizing multiple tasks simultaneously.<br/>Strong organizational skills with keen attention to detail and thorough documentation practices.<br/>Computer proficiency (Microsoft Office &ndash; Outlook, Word, Excel, and PowerPoint).<br/></p><p>Nice to Have:<br/></p><p>Prior startup or early-stage company experience.<br/></p>

Clinical Research Associate I (CRA I) - East Coast-Based

University of Alabama

<div><p><b>Pay Grade/Pay Range: </b>Minimum: $21.25 - Midpoint: $26.59 (Hourly N6)</p>
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<p><b>Department/Organization: </b>208122 - Community Med &amp; Population Health</p>
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<p><b>Normal Work Schedule: </b>Varies based on needs of program; some evening and weekend hours required.</p>
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<p><b>Job Summary: </b>The Clinical Research Associate provides research work in support of a clinical research project. Tracks all data related to referrals and usage of community resource and services. Assists with data collection and reporting of program services.</p>
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<p><b>Additional Department Summary: </b>This position is part of the UA research team for the Healthy Brain and Child Development Study (HBCD), and requires working in partnership with The University of Alabama at Birmingham (UAB) and other sites in this large, nation-wide study.<br>
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Provides support services, information, and resources to HBCD participants, based on individual needs. Supports recruitment and retention of study participants. Provides individualized, ongoing guidance, education, and assistance to participants in completing study requirements, prepares participants and completes collection of data via MRI, EEGs, and cognitive and behavioral assessments for young children and their parents. Completes bio-specimen collection, administers and oversees self-completion of specific questionnaires by the participant.<br>
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This position requires a flexible, non-traditional schedule to meet participants&rsquo; scheduling needs and research protocol goals. Support services will require some evening and weekend hours.</p>
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<p><b>Required Minimum Qualifications: </b>High school diploma or GED and four (4) years of clinical research support experience; OR associate's degree and two (2) years of clinical research support experience; OR bachelor's degree and some clinical research support experience.</p>
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<p><b>Additional Required Department Minimum Qualifications:</b> Must have valid U.S. driver's license. Must be at least 19 years of age at time of hire and have an acceptable Motor Vehicle Report that is in compliance with University policies. Applicants under the age of 21 will have some driving restrictions.</p>
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<p><b>Skills and Knowledge: </b>Organized and detail oriented. Excellent communication skills (verbal and written). Ability to work well with others. Working knowledge of standard office software applications, including Microsoft Office, Zoom, Webex and basic data platforms. Ability to maintain strict confidentiality of protected information and the requirement to follow HIPPA regulations at all times. Ability to travel to UAB and other study sites as needed. Ability to work flexible hours.</p>
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<p><b>Preferred Qualifications: </b>Bachelor's degree Psychology, Communicative Disorders, Child Development, or Cognitive Neuroscience strongly preferred. Research experience in developmental psychology, human development, early childhood development, communicative disorders, or cognitive/affective neuroscience, or related background/field.<br>
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Experience with EEG and/or MRI date collection. Experience working in large team settings. Experience providing health/social services support or education for pregnant people, children, and/or young families. Familiarity with West Alabama communities and local resources.</p>
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<p><b>Background Investigation Statement:</b> Prior to hiring, the final candidate(s) must successfully pass a pre-employment background investigation and information obtained from social media and other internet sources. A prior conviction reported as a result of the background investigation DOES NOT automatically disqualify a candidate from consideration for this position. A candidate with a prior conviction or negative behavioral red flags will receive an individualized review of the prior conviction or negative behavioral red flags before a hiring decision is made.</p>
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<div><div><div><div><p><b>Equal Employment Opportunity</b>: The University of Alabama is an Equal Employment/Equal Educational Opportunity Institution. All qualified applicants will receive consideration for employment or volunteer status without regard to any legally protected basis and will not be discriminated against because of their protected status. Applicants and employees of this institution are protected under Federal law from discrimination on several bases. More information is available in the EEOC&rsquo;s <b>Know Your Rights: Workplace discrimination is illegal</b> poster.</p>
The University of Alabama affirms its longstanding commitment to institutional neutrality, free speech, and academic freedom.</div></div></div></div></div>

Clinical Research Associate - Community Medicine and Population Health

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Clinical Research Associate - Community Medicine and Population Health