cra i

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

IQVIA

<div>
 
 
 IQVIA Biotech is now hiring for CRA 1 with a minimum of 6 months of on-site monitoring. Must have experience monitoring in oncology solid tumor.
 
 
 
 
 
 IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
 
 
 
 
 Job Overview
 
 
 
 The Clinical Research Associate I (CRA I) plays a key role in supporting the successful conduct of clinical research studies by performing site monitoring and site management activities. In this position, you will ensure that assigned study sites conduct trials in compliance with the protocol, applicable regulations, Good Clinical Practice (GCP), and ICH guidelines. This role is essential in protecting patient safety, ensuring high‑quality clinical data, and maintaining study integrity.
 
 
 
 Key Responsibilities
 
 
 
 As a CRA I, you will conduct various types of monitoring visits&mdash;including site selection, initiation, routine monitoring, and close‑out visits&mdash;to evaluate the quality and integrity of site practices. You will verify that study activities are performed according to regulatory requirements and sponsor expectations, escalating quality concerns as necessary. During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the Investigator Site File (ISF).
 
 
 A central part of this role involves building and maintaining strong communication with investigative sites. You will provide protocol training, set expectations, address site‑level challenges, and support recruitment planning to help sites meet enrollment targets. You will also collaborate closely with internal project teams to ensure cohesive study execution and may contribute to site-level financial processes or start‑up activities based on study needs.
 
 
 Accurate and timely documentation is critical. The CRA I prepare detailed monitoring visit reports, follow‑up letters, and all required study documentation to ensure audit readiness and transparent oversight. The ability to manage multiple tasks, prioritize effectively, and work independently while maintaining productive team relationships is essential for success.
 
 
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree required; a scientific or healthcare discipline is preferred.
 </li>
 <li>
 6 months &ndash;2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
 </li>
 <li>
 Basic knowledge of clinical research regulations (GCP/ICH).
 </li>
 <li>
 Ability to travel as required by the project.
 
 
 </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 
 
 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
 
 
 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
 
 
 The potential base pay range for this role, when annualized, is $71,900.00 - $119,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
</div>

CRA 1, IQVIA Biotech

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
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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.
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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.
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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.
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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.
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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>
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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

Medpace

<div>
 
 Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!
 
 
 
 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
 
 PACE&reg;
 
 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.
 
 
 
 WE OFFER THE FOLLOWING
 
 
 
 <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.
 
 
 </li>
 </ul>
 
 Responsibilities
 
 
 
 <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.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <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.
 
 
 </li>
 </ul>
 
 
 
 
 
 Medpace Overview
 
 
 
 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.
 
 
 
 Why Medpace?
 
 
 
 People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
 
 
 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.
 
 
 
 Medpace Perks
 
 
 
 <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
 
 
 </li>
 </ul>
 
 Awards
 
 
 
 <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
 
 
 </li>
 </ul>
 
 What To Expect Next
 
 
 
 A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
 
 
</div>

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

JPMorganChase

<div>JOB DESCRIPTION 
To fulfill the firm&rsquo;s CRA obligations, CRCP maintains a technology platform which includes a data ecosystem that assembles qualifying activities from across the firm and from external data sources, workflow tools to manage review of those activities, and operational tools to facilitate LOB engagement, strategy, and other CRCP deliverables.
The Program Manager for the CRA Program is responsible for translating CRCP&rsquo;s business requirements into actionable technical solutions &ndash; a combination of steady-state technology deliverables and ground-breaking new development leveraging AI and re-architected technology. This role serves as the primary liaison between CRCP teams, and Corporate Technology Product and Engineering, ensuring that CRA-related technology initiatives are delivered efficiently, accurately, and in compliance with CRA requirements and business standards. The Program Manager gathers proposed prioritization of technology work and is responsible for stakeholder collaboration, requirements management, testing oversight/acceptance.
The ideal candidate will demonstrate strong analytical and communication skills, a deep understanding of agile methodologies and product management, as well as the ability to work collaboratively across business, Product and Technology. They will be proactive in identifying and resolving issues, adept at managing competing priorities, and committed to delivering high-quality solutions that support regulatory requirements and operational excellence.
Responsibilities:<ul><li>
Serve as the primary liaison between CRCP and the Technical Product Manager, ensuring clear and consistent communication of priorities and objectives.</li><li>
Assist with documenting CRCP&rsquo;s technical needs by working closely with stakeholders.</li><li>
Maintain and manage a clear, organized, and prioritized backlog of CRA-related technical needs, ensuring alignment with business goals and regulatory deadlines.</li><li>
Collaborate with the Technical Product Owner to oversee the timely delivery of technology solutions that effectively address CRA business objectives and operational needs.</li><li>
Participate actively in agile ceremonies, including sprint planning and backlog grooming, to represent CRA priorities and ensure business needs are reflected in development activities.</li><li>
Coordinate user acceptance testing (UAT) to assist CRCP with validation of technology solutions.</li><li>
Provide structured feedback to Product and Technology based on testing and user experience and drive continuous improvement of CRA technology solutions.</li></ul>
Qualifications<ul><li>
3+ years of experience in product ownership required, with business analysis and project management, preferably within financial services or regulatory environments, strongly preferred.</li><li>
Familiarity with agile methodologies and product management tools strongly preferred.</li><li>
Understanding of the Community Reinvestment Act and related compliance requirements.</li><li>
Experience working with cross-functional teams, including business, Product and Technology.</li><li>
Excellent communication, documentation, and organizational skills.</li><li>
Familiarity with agile methodologies and product management tools strongly preferred.
</li><li>Bachelor&rsquo;s degree in Information Systems, Business, Finance, or related field is preferred.</li></ul>
ABOUT US 
<div>
<div>JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world&rsquo;s most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.
</div><div>We offer a competitive total rewards package including base salary determined based on the role, experience, skill set and location. Those in eligible roles may receive commission-based pay and/or discretionary incentive compensation, paid in the form of cash and/or forfeitable equity, awarded in recognition of individual achievements and contributions. We also offer a range of benefits and programs to meet employee needs, based on eligibility. These benefits include comprehensive health care coverage, on-site health and wellness centers, a retirement savings plan, backup childcare, tuition reimbursement, mental health support, financial coaching and more. Additional details about total compensation and benefits will be provided during the hiring process.
<div>We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants&rsquo; and employees&rsquo; religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.
JPMorgan Chase &amp; Co. is an Equal Opportunity Employer, including Disability/Veterans 
</div></div></div> 
 
ABOUT THE TEAM 
<div>Our professionals in our Corporate Functions cover a diverse range of areas from finance and risk to human resources and marketing. Our corporate teams are an essential part of our company, ensuring that we&rsquo;re setting our businesses, clients, customers and employees up for success. 
</div><div></div> 
<div>The Corporate Responsibility (CR) department mission is to advance a stronger, more durable and safe financial system and an inclusive economy and society for clients, customers and communities around the world. The department includes sub-departments focused on policy advocacy and lobbying, philanthropy, sustainability, impact finance, community engagement and data analysis and research.</div></div>

Community Reinvestment Act Program Manager

Medasource

<div>
 
 
 Position Overview
 
 
 
 
 Pay:
 
 $70-75 an hour | 40 hour work week
 
 
 
 
 
 The Senior Clinical Research Associate (CRA) will serve as the
 
 primary owner for assigned clinical sites
 
 , overseeing day-to-day site management, monitoring activities, and issue resolution for cardiovascular device studies involving heart pump technology.
 
 
 
 
 
 This role requires a
 
 traditional, hands-on monitoring approach
 
 , including in-depth review of medical records, informed consent documentation, and safety data. The CRA is expected to independently identify risks, guide sites through corrective actions, and escalate thoughtfully when necessary.
 
 
 
 
 
 
 CRA's will be involved cardiovascular studies. Devices which are used in various cardiac procedures.
 
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 1. Site Management &amp; Ownership
 
 <ul>
 <li>
 Serve as the
 
 primary point of contact
 
 for assigned investigational sites
 </li>
 <li>
 Take full ownership of site performance, beyond high-level monitoring
 </li>
 <li>
 Proactively manage:
 </li>
 <li>
 Site questions and protocol clarifications
 </li>
 <li>
 Retraining needs
 </li>
 <li>
 Data quality concerns
 </li>
 <li>
 Monitoring follow-ups
 </li>
 <li>
 Identify issues early and work independently to resolve them before escalating
 </li>
 </ul>
 
 
 
 
 2. Clinical Monitoring (SDV &amp; SDR)
 
 <ul>
 <li>
 Conduct onsite monitoring visits focused on
 
 deep Source Data Verification (SDV)
 
 and
 
 Source Data Review (SDR)
 
 </li>
 <li>
 Review
 
 full medical records
 
 , not just EDC worksheets
 </li>
 <li>
 Ensure:
 </li>
 <li>
 Accurate transcription of source data
 </li>
 <li>
 Protocol compliance
 </li>
 <li>
 Complete and compliant documentation
 </li>
 <li>
 Clearly articulate monitoring logic, including:
 </li>
 <li>
 How informed consent is reviewed
 </li>
 <li>
 How eligibility and endpoint data are verified
 </li>
 </ul>
 
 
 
 
 3. Protocol Compliance &amp; Patient Safety
 
 <ul>
 <li>
 Act as the
 
 first line of defense
 
 to ensure sites:
 </li>
 <li>
 Enroll the correct patient populations
 </li>
 <li>
 Follow protocol requirements precisely
 </li>
 <li>
 Review medical histories and clinical documentation to identify:
 </li>
 <li>
 Adverse events (AEs)
 </li>
 <li>
 Serious adverse events (SAEs)
 </li>
 <li>
 Other safety signals
 </li>
 <li>
 Assist sites in properly documenting and reporting safety events in accordance with protocol and regulatory expectations
 </li>
 </ul>
 
 
 
 
 4. Communication &amp; Team Integration
 
 <ul>
 <li>
 Participate in:
 </li>
 <li>
 Regular study team meetings
 </li>
 <li>
 Project check-ins and updates
 </li>
 <li>
 Maintain
 
 high transparency
 
 by:
 </li>
 <li>
 Copying the internal study team on all site-related communications
 </li>
 <li>
 Providing clear, timely updates on site status, risks, and progress
 </li>
 <li>
 Operate as an embedded team member rather than a siloed monitor
 </li>
 </ul>
 
 
 
 
 5. Office-Based Administrative Responsibilities
 
 
 Approximately
 
 1&ndash;2 weeks per month
 
 are dedicated to office-based work, including:
 
 <ul>
 <li>
 Query review and resolution
 </li>
 <li>
 Site retraining preparation and follow-up
 </li>
 <li>
 Monitoring visit preparation and documentation
 </li>
 <li>
 Follow-up on action items identified during visits
 </li>
 <li>
 Ongoing site relationship management
 </li>
 </ul>
 
 This time is critical to maintaining site quality and continuity between visits.
 
 
 
 
 
 
 Qualifications &amp; Experience
 
 
 
 Required Experience
 
 <ul>
 <li>
 
 5&ndash;10 years
 
 of clinical monitoring experience
 </li>
 <li>
 Previous experience functioning at a
 
 Senior CRA level
 
 </li>
 <li>
 Strong background in
 
 cardiovascular clinical studies
 
 </li>
 </ul>
 
 
 
 
 Preferred Experience
 
 <ul>
 <li>
 
 Medical device trial experience
 
 (highly preferred)
 </li>
 <li>
 Understanding of device-specific regulatory and procedural nuances
 </li>
 <li>
 Experience working:
 </li>
 <li>
 Directly with a sponsor
 
 or
 
 </li>
 <li>
 At a smaller, high-touch CRO
 </li>
 <li>
 Candidates whose background is limited to large, highly automated CRO environments may not be an ideal fit due to differences in monitoring depth and expectations
 </li>
 <li>
 Someone who has worked with us in the past.
 </li>
 </ul>
 
 
 
 
 Core Competencies
 
 <ul>
 <li>
 Strong critical-thinking and problem-solving skills
 </li>
 <li>
 Ability to clearly explain:
 </li>
 <li>
 SDV/SDR methodology
 </li>
 <li>
 Informed consent review process
 </li>
 <li>
 Safety event identification
 </li>
 <li>
 High attention to detail with a patient-safety mindset
 </li>
 <li>
 Strong written and verbal communication skills
 </li>
 <li>
 Comfort operating autonomously with accountability
 </li>
 </ul>
 
 
 
 
 
 Travel &amp; Work Environment
 
 
 <ul>
 <li>
 
 Travel Requirement:
 
 Approximately
 
 60%
 
 </li>
 <li>
 
 Visit Frequency:
 
 </li>
 <li>
 Typically
 
 2 monitoring visits per month
 
 </li>
 <li>
 Occasionally
 
 3 visits per month
 
 </li>
 <li>
 Only
 
 one visit in any given week
 
 </li>
 <li>
 
 Geographic Scope:
 
 </li>
 <li>
 Primary regions include East Coast, South, and Midwest
 </li>
 <li>
 Some sites located in
 
 California and Texas
 
 </li>
 <li>
 Willingness to travel outside a traditional region as business needs arise is required
 </li>
 </ul>
 
 
 
 
 
 Travel &amp; Expense Logistics
 
 
 <ul>
 <li>
 Travel is booked through the
 
 Concur
 
 system
 </li>
 <li>
 CRA uses a
 
 personal credit card
 
 to access preferred corporate rates
 </li>
 </ul>
 
 
</div>

Clinical Research Associate

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