clinical research management 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

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

ICON plc

<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>

University of Texas at Austin

<div>Job Posting Title:
Clinical Research Associate I
-
Hiring Department:
Department of Psychiatry
-
Position Open To:
All Applicants
-
Weekly Scheduled Hours:
40
-
FLSA Status:
Exempt
-
Earliest Start Date:
Immediately
-
Position Duration:
Expected to Continue Until Sep 01, 2027
-
Location:
AUSTIN, TX
-
Job Details:<h2 class="jobSectionHeader">
General Notes</h2>
This is a grant-funded position with an end date of September 1, 2027, renewable based upon availability of funding, work performance, and progress toward research goals.<h2 class="jobSectionHeader">
Purpose</h2>
The Clinical Research Associate I (CRA I) is responsible for assisting in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data.
The Clinical Research Associate I will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI). This role may coordinate the data collection and operations of multiple concurrent clinical research studies under the guidelines of research protocols, The University of Texas at Austin, and regulatory agency policies.
A successful candidate will possess strong attention to detail; excellent interpersonal, verbal, and written communication skills; the ability to coordinate with subjects, team members, other departments, and external institutions; the ability to multitask in a fast-paced environment while working with a diverse subject population; and the ability to prioritize and complete multiple projects within established deadlines.<h2 class="jobSectionHeader">
Responsibilities</h2>
Site Management &amp; Study Execution<ul><li>
Conduct site initiation, monitoring, and close-out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution.</li><li>
Ensure compliance with study protocols and regulatory requirements.</li><li>
Manage site performance and resolve issues.</li><li>
Administer questionnaires, collect medical history, and perform study procedures.</li><li>
Maintain rapport with participants to support retention and address concerns.</li><li>
Obtain informed consent and ensure participant safety throughout protocol procedures.</li><li>
Coordinate with affiliated departments and external collaborators.</li></ul>
Data Collection &amp; Management<ul><li>
Collect and verify data from clinical sites.</li><li>
Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap).</li><li>
Review and resolve data queries.</li><li>
Assist with manuscript and grant preparation, including opportunities for authorship.</li><li>
Maintain and update study databases and data collection forms.</li></ul>
Regulatory Compliance &amp; Oversight<ul><li>
Ensure adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.</li><li>
Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites.</li><li>
Prepare and maintain regulatory documents.</li><li>
Coordinate with ethics committees to safeguard participant rights.</li><li>
Participate in internal and external audits and protocol reviews.</li></ul>
Participant Recruitment &amp; Retention<ul><li>
Evaluate medical records and perform screenings to identify eligible study participants.</li><li>
Assist in screening and enrolling study participants.</li><li>
Maintain communication with participants to support retention.</li><li>
Address participant concerns and inquiries.</li></ul>
Reporting &amp; Documentation<ul><li>
Prepare study reports and documentation.</li><li>
Maintain accurate records of study activities.</li><li>
Assist in the preparation of manuscripts and publications.</li></ul>
Marginal or Periodic Functions<ul><li>
Conduct literature reviews to support study design and protocol development.</li><li>
Assist in training new site staff and research team members.</li><li>
Participate in internal and external audits.</li><li>
Support development of study protocols and case report forms.</li><li>
Attend conferences and workshops to stay updated on industry trends.</li><li>
Adhere to internal controls and reporting structure.</li><li>
Perform related duties as required.</li></ul>
Knowledge, Skills, and Abilities<ul><li>
Maintain organized records, follow detailed procedures, and double-check work for accuracy.</li><li>
Write clear and concise reports, actively listen, and present information effectively.</li><li>
Analyze information, develop solutions, and implement corrective actions.</li><li>
Collaborate with team members and support team decisions.</li><li>
Prioritize tasks, set realistic deadlines, and manage time effectively.</li></ul><h2 class="jobSectionHeader">
Required Qualifications</h2><ul><li>
Bachelor&rsquo;s degree in life sciences, nursing, or a related field</li><li>
One year of relevant clinical research experience</li><li>
Familiarity with IRB processes and human subjects protection standards</li><li>
Experience with electronic data capture systems (e.g., REDCap)</li></ul>
Relevant education and experience may be substituted as appropriate.<h2 class="jobSectionHeader">
Preferred Qualifications</h2><ul><li>
Master&rsquo;s degree in life sciences, nursing, or a related field with at least two years of clinical research experience, preferably involving pediatric or neurodevelopmental populations</li><li>
Experience with statistical software (e.g., R, SAS, SPSS)</li><li>
Experience presenting research findings or contributing to publications</li><li>
Completion of Human Subjects Protection Training</li><li>
Experience working with children and families affected by neurodevelopmental disorders</li><li>
Strong written and verbal communication skills</li><li>
Ability to abstract data from medical records and manage complex databases</li><li>
Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP)</li></ul><h2 class="jobSectionHeader">
Working Conditions</h2><ul><li>
May work around standard office conditions</li><li>
Repetitive use of a keyboard at a workstation</li><li>
Occasional weekend, overtime, and evening work to meet deadlines</li><li>
Occasional interstate, intrastate, and international travel</li><li>
This position will be assigned on-campus with an expectation to report to work on-site during the scheduled work week.</li></ul><h2 class="jobSectionHeader">
Required Materials</h2><ul><li>
Resume/CV</li><li>
3 work references with their contact information; at least one reference should be from a supervisor</li><li>
Letter of interest</li></ul>
Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.
Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.
-
Employment Eligibility:
Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.
-
Retirement Plan Eligibility:
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.
-
Background Checks:
A criminal history background check will be required for finalist(s) under consideration for this position.
-
Equal Opportunity Employer:
The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.
-
Pay Transparency:
The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor&rsquo;s legal duty to furnish information.
-
Employment Eligibility Verification:
If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.
-
E-Verify:
The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university&rsquo;s company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:<ul><li>
E-Verify Poster (English and Spanish) [PDF]</li><li>
Right to Work Poster (English) [PDF]</li><li>
Right to Work Poster (Spanish) [PDF]</li></ul>
-
Compliance:
Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.
The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.</div>

Clinical Research Associate I

<div>Clinical Research Associate, Sponsor Dedicated
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 II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. 
 
Key responsibilities include:<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>
Your Profile:
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. 
 
Required qualifications and experience:<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>
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>

Clinical Research Associate, Sponsor Dedicated

Cedars-Sinai Medical Center

<div><div><div><div>Job ID 16205
Location California, United States
Job Category Academic / Research
Date posted 04/07/2026</div></div><div> 
<div></div>
</div></div><div><h2 class="jobSectionHeader">Job Description</h2>
Join our team and use your skill with an organization known nationally for excellence in research!
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. 
 
Principal Responsibilities:
Works under the direction of a Clinical Research Coordinator, Research Program Administrator or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs).
Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
 Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Responsible for sample preparation and shipping and maintenance of study supplies and kits
 HIPAA regulations and applicable law.
May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.<h2 class="jobSectionHeader"> 
Qualifications</h2>
Education:
High School Diploma/GED is required.
Bachelor's degree in Science, Sociology, or a related field preferred
Experience and Skills:
One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
</div><div><div><div>Req ID 16205</div>
</div><div><div>Working Title Clinical Research Associate I - Spine Research Team - Dept of Orthopaedics</div>
</div><div><div>Department Dept of Orthopaedics</div>
</div><div><div>Business Entity Cedars-Sinai Medical Center</div>
</div><div><div>Job Category Academic / Research</div>
</div><div><div>Job Specialty Research Studies/ Clin Trial</div>
</div><div><div>Overtime Status NONEXEMPT</div>
</div><div><div>Primary Shift Day</div>
</div><div><div>Shift Duration 8 hour</div>
</div><div><div>Base Pay $24.00 - $32.86</div></div></div></div>
 <div><div><h3 class="jobSectionHeader">Diversity and Inclusion at Cedars-Sinai</h3>
<div>
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve &ndash; because that&rsquo;s what our patients, colleagues and communities deserve Quality Care and Research&mdash;For All, By All.</div>
</div><div><h3 class="jobSectionHeader">Cedars-Sinai is an Equal Employment Opportunity employer.</h3>

Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.

At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.</div></div><div></div>

Bright Uro

About Bright Uro: 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. About the Role: 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. 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. 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. Duties and Responsibilities: 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: Provide real-time clinical research case coverage support, document case observations and provide summary reports as required. Ensure study procedures are conducted in accordance with the approved protocol, regulatory requirements, and Bright Uro guidelines. Contribute to clinical research development such as study protocols, monitoring plans, and other related clinical and regulatory documents. 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 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. Serve as an additional point of contact between the site and Bright Uro. 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. Assist or conduct site initiation visits (SIV) and interim monitoring visits (IMVs) such as preparing agendas, checklists, reports, and follow-up letters as appropriate. Assist in the formulation of instructional materials and training of clinicians, researchers, and other personnel. 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. 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]). Manage study supplies and ensure remaining study supplies are returned to Bright Uro. Monitor and track participant enrollment and study progress and attend study visits at investigational sites as appropriate. 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. Contribute to scientific posters, publications, and other published materials. Perform other duties or tasks in clinical, research and development, regulatory, sales, marketing, and client services, or as directed by company leadership. Education and/or Work Experience Requirements: Must have a minimum of a Bachelor's Degree in a relevant science. Minimum of 2 years of relevant research experience. Experience may include work in a clinical laboratory, clinic, or pharmacy. Human Subjects Research and GCP in Medical Devices Certifications must be completed within 30 days of hire. Required Qualifications: Willingness and ability to travel a minimum of 80% of the time. Must reside near a major U.S. airport in the U.S. Eastern Time Zone. Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external stakeholders. High level of personal and professional integrity, a strong work ethic, and the ability to work independently while managing and prioritizing multiple tasks simultaneously. Strong organizational skills with keen attention to detail and thorough documentation practices. Computer proficiency (Microsoft Office &ndash; Outlook, Word, Excel, and PowerPoint). Nice to Have: Prior startup or early-stage company experience.

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

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