senior cra

Ally Financial

<div><div><div><div><div><div><h3 class="jobSectionHeader"><b>General information
</b></h3></div></div><div><div><div><div>Career area
</div><div>Compliance
</div></div><div><div>City
</div><div>Sandy, UT
</div></div><div><div>Work Location(s)
</div><div>UT, UT
</div></div><div><div>Remote?
</div><div>Yes
</div></div><div><div>Ref #
</div><div>21854
</div></div><div><div>Posted Date
</div><div>03-10-26
</div></div><div><div>Working time
</div><div>Full time
</div></div></div></div></div><div><div><div><h3 class="jobSectionHeader"><b>Ally and Your Career
</b></h3></div></div><div><div><div><div><div>Ally Financial only succeeds when its people do - and that&rsquo;s more than some clich&eacute; people put on job postings. We live this stuff! We see our people as, well, people - with interests, families, friends, dreams, and causes that are all important to them. Our focus is on the health and safety of our teammates as well as work-life balance and diversity and inclusion. From generous benefits to a variety of employee resource groups, we strive to build paths that encourage employees to stretch themselves professionally. We want to help you grow, develop, and learn new things. You&rsquo;re constantly evolving, so shouldn&rsquo;t your opportunities be, too?</div><div></div><div><b><br>
Work Schedule:</b> Ally designates roles as (1) fully on-site, (2) hybrid, or (3) fully remote. Hybrid roles are generally expected to be in the office a certain number of days per week as indicated by your manager. Your hiring manager will discuss this role's specific work requirements with you during the hiring process. All work requirements are subject to change at any time based on leader discretion and/or business need.</div>
</div></div></div></div></div><div><div><div><h3 class="jobSectionHeader"><b>The Opportunity
</b></h3></div></div><div><div><div><div><p>Ally&rsquo;s Community Reinvestment Act (CRA) team is a highly specialized group within the Bank dedicated to positively impacting communities across our assessment area through CRA-qualifying loans, investments, and services. All FDIC-insured banks are required to comply with the CRA. However, at Ally CRA is not just a regulatory requirement; rather, it is a passion shared by the CRA team in managing a $5+ billion portfolio of loans and investments that finance affordable housing, community services, economic development, and neighborhood revitalization.
</p><p>The Manager - CRA Investments will report to the Senior Director/Director &ndash; CRA Investments and assist in managing and monitoring the CRA Investment portfolio, including the underwriting of new investments into small business investment companies (SBICs), community development venture capital (CDVC) funds, and affordable housing and preservation funds</p><p>
At this time, Ally will not sponsor a new applicant for employment authorization for this position.</p>
</div></div></div></div></div><div><div><div><h3 class="jobSectionHeader"><b>The Work Itself
</b></h3></div></div><div><div><div><div><ul><li>Participate in the due diligence, underwriting and closing of various types of Community Development (CD) equity investments by:</li><li><ul><li>
performing research, economic and financial analysis</li><li>
drafting internal investment memos and participating in the internal investment approval process</li><li>
negotiating legal agreements</li><li>
administrative closing of transactions</li></ul></li><li>
Perform ongoing portfolio management and monitoring tasks, including the following:</li><li><ul><li>
managing and reviewing fund reporting documents and monitoring data</li><li>
working with internal stakeholders and external fund managers on regular basis</li><li>
reviewing CRA qualification criteria relevant to each transaction</li><li>
staying up to date on relevant industry and market trends</li><li>
sending and receiving capital to/from investment counterparties (capital calls/distributions)</li></ul></li><li>
Curiously seek areas of improvement and develop efficient ways to reconfigure current processes</li><li>
Participate in Ally Bank&rsquo;s community outreach programs, including volunteer and leadership opportunities with non-profit organizations, to contribute to the Bank&rsquo;s CD service hour requirements</li><li>
Support and prepare materials related to internal meetings, CRA activities, etc.</li><li>
Engage with and represent Ally Bank at industry and trade association groups, requiring occasional travel</li><li>
Assist with any other task as requested by the Senior Director/Director &ndash; CRA Investments or CRA Office<br>
</li></ul>
</div></div></div></div></div><div><div><div><h3 class="jobSectionHeader"><b>The Skills You Bring
</b></h3></div></div><p></p><div><div><div><div><div>Minimum Qualifications:<br>
<ul><li>
7+ years of relevant experience or equivalent combination of education and experience
</li><li>High School Diploma or GED equivalent</li></ul>
Preferred Qualifications:<br>
<ul><li>
5+ years of banking, investment, risk, compliance, general underwriting or CRA experience</li><li>
Strong sense of community and desire to be part of a giving-back culture</li><li>
Strong organizational skills and ability to follow through, and keen attention to detail
</li><li>Thorough investigative and problem-solving skills and meticulous record keeping skills
</li><li>Ability to work both independently and cooperatively on project teams</li><li>
Intermediate proficiency in Excel and other MS Office software</li><li>
SharePoint / MS Teams experience preferred</li></ul><br>
</div></div></div></div></div></div><p></p><div><div><div><h3 class="jobSectionHeader"><b>How We'll Have Your Back
</b></h3></div></div><div><div><div><div>Ally's compensation program offers market-competitive base pay and pay-for-performance incentives (bonuses) based on achieving personal and company goals. Our Total Rewards program includes industry-leading compensation and benefits plus additional incentives that are designed to meet your needs and those of your family so you can get the most out of your career and your life, including:<ul><li><b>
Time Away:</b> Program starts at 20 paid time off days in addition to 11 paid holidays and 8 hours of volunteer time off yearly (time off days are prorated based on start date and program varies based on full or part-time status and management level).</li><li><b>
Planning for the Future:</b> plan for the near and long term with an industry-leading 401K retirement savings plan with matching and company contributions, student loan pay downs and 529 educational save up assistance programs, tuition reimbursement, employee stock purchase plan, and financial learning center and financial coach access.</li><li><b>
Supporting your Health &amp; Well-being:</b> flexible health and insurance options including medical, dental and vision, employee, spouse and child life insurance, short- and long-term disability, pre-tax Health Savings Account with employer contributions, Healthcare FSA, critical illness, accident &amp; hospital indemnity insurance, and a total well-being program that helps you and your family stay on track physically, socially, emotionally, and financially.</li><li><b>
Building a Family:</b> adoption, surrogacy and fertility assistance as well as paid parental and caregiver leave, Dependent Day Care FSA back-up child and adult/elder care days and childcare discounts.</li><li><b>
Work-Life Integration:</b> other benefits including Mentally Fit Employee Assistance Program, subsidized and discounted Weight Watchers&reg; program and other employee discount programs.</li><li><b>
Other compensations:</b> depending on the role for which you are considered, you may be eligible for travel allowances, relocation assistance, a signing bonus and/or equity.</li><li>
To view more detailed information about Ally&rsquo;s Total Rewards, please visit this link: https://www.ally.com/content/dam/pdf/corporate/ally-total-rewards-snapshot.pdf</li></ul><p><b><br>
Who We Are:</b></p><p><br>
Ally Financial is a customer-centric, leading digital financial services company with passionate customer service and innovative financial solutions. We are relentlessly focused on &quot;Doing it Right&quot; and being a trusted financial-services provider to our consumer, commercial, and corporate customers. For more information, visit www.ally.com.</p><p><br>
Ally is an equal opportunity employer committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity or expression, pregnancy status, marital status, military or veteran status, genetic disposition or any other reason protected by law.</p><p><br>
We are committed to working with and providing reasonable accommodation to applicants with physical or mental disabilities. For accommodation requests, email us at hrpolicy@ally.com. Ally will not discriminate against any qualified individual who is capable of performing the essential functions of the job with or without reasonable accommodation.</p>
</div></div><div><div><div><div><b>Base Pay Range</b>: $90000 - $150000 USD</div><div>
An individual's position in the range is determined by the specific role, the scope and responsibilities of the role, work experience, education, certification(s), training, and additional qualifications. We review internal pay, the competitive market, and business environment prior to extending an offer.</div></div>
</div></div><div><div><div>Incentive Compensation: This position is eligible to participate in our annual incentive plan.</div></div></div></div></div></div></div></div></div><div></div>

Manager - CRA Investments

Agilent Technologies

<div><h2 class="jobSectionHeader"><b>Job Description</b></h2><p></p><ul><li><p>
Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits</p></li><li><p>
Trains investigator(s) and site staff on study protocol and all relevant study procedures</p></li><li><p>
Supports study start-up, conduct, and closeout activities. May assist in developing study related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, reviewing informed consent forms, monitoring plan, etc. May coordinate IRB/EC approvals</p></li><li><p>
Functions independently in the field and interacts professionally with all levels of medical and scientific professionals</p></li><li><p>
Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct</p></li><li><p>
Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits. Responsible for implementing and maintaining the effectiveness of the quality system</p></li><li><p>
Collect and review site regulatory and essential documents for accuracy and completion. Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained</p></li><li><p>
Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan. Reviewing all study logs and documentation ensuring audit trail and chain of custody is maintained</p></li><li><p>
Performs Investigation Use Only (IUO) or Research Use Only (RUO) inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused IUO/RUO material as required</p></li><li><p>
 Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings</p></li><li><p>
Maintains accurate and timely communications with sites and ensures records are filed in TMF/ISF</p></li><li><p>
Ensures TMF/ISF is audit ready. Assists with site audit(s) and site quality management activities, as needed. Tracks site progress against contractual agreements</p></li><li><p>
Contribute to organizational and departmental process development, improvement, and implementation</p></li></ul><p><b><br>
In addition to the primary, the Senior CRA will also be expected to take on the following responsibilities:</b></p><p></p><ul><li><p>
Assist and/or develop study-related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, informed consent forms, monitoring plan, etc.</p></li><li><p>
Assist in training new CRA staff by supporting remote monitoring, co-monitoring and/or mentoring</p></li><li><p>
Assist the project management team in identifying risks in study execution at study sites, implement mitigations, monitoring outcomes, and communicate observations</p></li><li><p>
Demonstrate an ability to influence others, especially study site staff, to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process</p></li><li><p>
Demonstrate a high degree of competence in clinical research with prior exposure to all aspects of clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research</p></li><li><p>
May serve as Lead CRA or Lead monitor for assigned studies</p></li><li><p>
Works closely with other assigned CRAs to track monitoring deliverables and metrics in accordance with the study monitoring plan</p></li><li><p>
May actively participate as a member of the cross-functional project team</p></li></ul><p></p><h2 class="jobSectionHeader"><b>
Qualifications</b></h2><p></p><ul><li><p>
Bachelor's degree in biological sciences or medical specialty or higher, or equivalent credentials</p></li><li><p>
For Senior CRA: 5+ years direct clinical research experience at a sponsor, device manufacturer, IVD, companion diagnostics as a CRA/study monitor, or equivalent experience</p></li><li><p>
Experience with Electronic Data Capture (EDC) systems and eTMF systems</p></li><li><p>
Molecular diagnostic, medical device, in vitro diagnostic (IVD), companion diagnostics, oncology and/or pathology experience</p></li><li><p>
Previous experience with Next Generation Sequencing (NGS), lmmunohistochemistry (IHC), and/or pathology</p></li><li><p>
Knowledge of International Council for Harmonisation (ICH)/GCP guidelines, 21 CFR (Code of Federal Regulations) part 812 (lnvestigational Device Exemption) (IDE)), and monitoring procedures/best practices (ICH E6(R2))</p></li><li><p>
Demonstrating strong written and verbal communication skills and presentation skills</p></li><li><p>
Track record demonstrating strong organizational and problem-solving skills</p></li><li><p>
Track record demonstrating a strong work ethic and ability to deliver tasks on time</p></li><li><p>
Proficient with Microsoft Office Suite including automation tools</p></li></ul><p></p><p><b><br>
Additional Details</b></p><p></p>
This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least March 23, 2026 or until the job is no longer posted.<p></p>
The full-time equivalent pay range for this position is $80,800.00 - $151,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations<p></p>
Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.<p></p><h2 class="jobSectionHeader"><b>
Travel Required:
</b></h2>25% of the Time<p></p><h2 class="jobSectionHeader"><b>
Shift:
</b></h2>Day<p></p><h2 class="jobSectionHeader"><b>
Duration:
</b></h2>No End Date<p></p><h2 class="jobSectionHeader"><b>
Job Function:
</b></h2>Medical/Clinical</div>

Senior Clinical Research Associate (CRA)

Abbott

<div><p>Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.</p><p><b>
Clinical Research Associate (CRA)</b></p><p></p><p><b>
Working at Abbott</b></p><p>
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You&rsquo;ll also have access to:</p><ul><li>
Career development with an international company where you can grow the career you dream of.</li><li>
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO</li><li>
An excellent retirement savings plan with high employer contribution</li><li>
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor&rsquo;s degree.</li><li>
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.</li><li>
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.</li></ul><p></p><p><b>
The Opportunity</b></p><p>
Under supervision, the CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155.</p><p></p><p>
This is an on-site position in Alameda, California. This is not a remote position.</p><p></p><p><b>
What You'll Work On</b></p><ul><li>
Under supervision, the incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as assigned by management.</li><li>
Perform study site visits (SQV, SIV, IMV, COV), generate monitoring reports, and track resolution of action items.
</li><li>Assist and conduct clinical monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements.</li><li>
Participate in study start up activities.</li><li>
Assist with shipping study devices and supplies to clinical sites.</li><li>
Perform study device accountability and reconciliation.</li><li>
Assist senior staff in development of study-specific forms and trial-specific monitoring plans.</li><li>
Assist senior staff in study planning, designing case report forms (CRFs), and training of study sites.</li><li>
Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.</li><li>
Perform review of clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/Study Lead as needed.
</li><li>Proactively and effectively communicate the status of clinical studies to management.</li><li>
Participate in the interim and final reviews of study data in preparation of regulatory submissions.</li><li>
May interact with RA/QA in responding to audits and FDA inquiries.</li><li>
Perform any other duties as assigned by management.</li><li>
Must be able to travel 30-40%-, with additional travel as required.</li></ul><p></p><p><b>
Required Qualifications</b></p><ul><li>
BS degree in life sciences required.</li><li>
0-1 years of as a CRA/CRC/CTA experience, or combination of appropriate education and experience.</li><li>
Flexibility in daily activities or Perform any other duties as assigned by management.</li><li>
Proficient with Microsoft Suite</li></ul><p></p><p><b>
Preferred Qualifications</b></p><ul><li>
Experience working on medical device studies and/or in-vitro diagnostics studies preferred.</li><li>
Pharmaceutical background may also be considered.</li><li>
Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs strongly preferred.</li></ul><p></p><p><b>
Apply Now</b></p><p><b>
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: </b>www.abbottbenefits.com</p><p>
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.</p><p>
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.</p><p></p><p><b>
Divisional Information</b></p><p>
Medical Devices</p><p>
General Medical Devices:</p><p>
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ﬁngersticks.</p><p></p><p>
Diabetes</p><p>
We&rsquo;re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We&rsquo;re revolutionizing the way people monitor their glucose levels with our new sensing technology.</p><p></p><p><br>
The base pay for this position is $73,900.00 &ndash; $116,000.00. In specific locations, the pay range may vary from the range posted.</p></div>

Clinical Research Associate

Alira Health

<div><p><b>Are you being referred to one of our roles by a connection in Alira Health? </b>If so, please apply using the referral link emailed to you.</p><p></p><p>
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don&rsquo;t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.</p><p></p><p><b>
Job Description Summary</b></p>
The Lead CRA is an important member of the Alira Health Clinical team. The Lead CRA provides oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. Lead CRAs work closely with the Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.<p></p><p><b>
Job Description</b></p><h2 class="jobSectionHeader"><b>
THE LEAD CLINICAL RESEARCH ASSOCIATE ROLE</b></h2><p></p><h3 class="jobSectionHeader"><b>
ESSENTIAL JOB FUNCTIONS*</b></h3><ul><li><p>
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.</p></li><li><p>
May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor.</p></li><li><p>
Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct.</p></li><li><p>
Exhibits meticulous care in upholding the privacy of all subjects/participants.</p></li><li><p>
Escalates quality issues or trends appropriately per the escalation pathway.</p></li><li><p>
Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols. Confirms IP has been dispensed and administered to participants in compliance with the study protocol. Leverages expertise in GCP, local regulations and Alira Health procedures to ensure IP is properly labeled, relabeled, transported, released, returned or destroyed.</p></li><li><p>
Reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness. Reconciles the ISF with the Trial Master File (TMF), ensuring filing of essential documents in accordance with local guidelines and regulations.</p></li><li><p>
Performs quality checks on regulatory documents per ALCOA+ principles, collecting copies for TMF filing. Supports audit readiness by submitting documents to the TMF, utilizing the filing index and medidata as necessary.</p></li><li><p>
Verification and review of safety events (AE/SAE/UADE/AESI, etc) including reconciliation of concomitant medications and medical history to confirm accurate reporting in accordance with the protocol, local regulations and regulations.</p></li><li><p>
Prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines. Reports detail site-specific concerns, follow-up tasks, corrective actions, protocol deviations and violations, enrollment progress and safety events collected.</p></li><li><p>
Participates in internal, client/sponsor, scientific, and other meetings as required.</p></li><li><p>
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.</p></li><li><p>
Assists in set up/collection of site-specific ethics documents and site contract negotiation.</p></li><li><p>
Provides monthly billing information to finance team as required.</p></li><li><p>
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.</p></li><li><p>
Provides monthly billing information to the finance and project management team, as needed.</p></li><li><p>
Performs CRA training and mentoring to more junior level CRAs.</p></li><li><p>
May co-monitor and perform Evaluation Visits for more junior level CRAs.</p></li><li><p>
Provides guidance, oversight, and feedback to the study team to ensure adherence to project scope, study plans, timelines, and budget requirements.</p></li><li><p>
Oversees Clinical Research Associates (CRAs) to ensure monitoring visits are conducted within the timelines specific in the Clinical Monitoring Plan or adjusted as necessary to align with the project requirements. Monitors site and CRA performance to maintain SDV rates within study goal range, directing CRAs to perform additional visits when thresholds are not met.</p></li><li><p>
Oversees CRAs in the execution of ongoing site management activities, including reviewing Electronic Data Capture (EDC) queries, resolving follow-up items and responding to site staff inquiries in a timely manner.</p></li><li><p>
Can serve as a line manager with direct reports, with accountability for CRA annual performance reviews, continued career progression, Key Performance Indicators (KPIs) and study/site assignments.</p></li><li><p>
Ensure CRAs are working with sites to drive, track and report on subject recruitment in line with project needs and expectations.</p></li><li><p>
Provide protocol and study related training to assigned CRA and establish regular lines of communication to manage ongoing project expectations and issues.</p></li><li><p>
Evaluate the quality and integrity of CRA performance through monitoring visit report review. Review will ensure evidence of adequate CRA oversight and site management per the Clinical Monitoring Plan (CMP), Alira Health SOPs and ICH GCP. Specifically, adequate oversight of IP and accountability, routine review of ISF and audit readiness, clear and adequate reporting of protocol deviations, ensuring resolve of follow-up items in a timely manner and study compliance by the site staff and PI. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.</p></li><li><p>
Evaluate the quality and integrity of CRA performance through metric tracking. Specifically, tracking EDC query resolution and follow-up issue duration. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.</p></li><li><p>
Maintains oversight and accountability of monitoring visit reports, ensuring CRAs submit the draft, and the report is finalized within the Alira Health SOP and CMP timelines. Responsible for tracking study specific metrics, sharing with the Project Manager and escalating to the Director of Clinical Monitoring as needed.</p></li><li><p>
Consistently reviews monitoring visit reports within the Alira Health SOP and CMP timelines.</p></li><li><p>
Works closely with Project Managers, CRAs and Data Management to resolve CRF queries on discrepant data.</p></li><li><p>
Collaborates with development, maintenance and training of the Clinical Trial Management System (CTMS) and Trial Master File (TMF).</p></li><li><p>
Prepares for, attends and presents during Investigator Meetings.</p></li><li><p>
Conducts project specific CRA meetings and trainings.</p></li><li><p>
May be mentored and assigned Project Management, or other operational tasks, under the supervision of an experienced team member.</p></li><li><p>
Assists in resourcing planning for upcoming and ongoing clinical trials.</p></li><li><p>
Can support hiring potential new employees.</p></li><li><p>
Can be responsible for CRA new hire training and onboarding.</p></li><li><p>
Can conduct review of CRA timesheet reporting.</p></li><li><p>
May participate and present in bid defense meetings.</p></li><li><p>
May participate in audits and associated meetings, including preparation at study sites as needed.</p></li><li><p>
Collaborates with study team members for project execution and performs additional duties and tasks as assigned.</p></li></ul><h2 class="jobSectionHeader"><b>
PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES</b></h2><ul><li><p>
Dedicated and results oriented with a bachelor&rsquo;s degree in a relevant field (sciences, nursing, medical preferred).</p></li><li><p>
Preferred 7+ years&rsquo; experience in the clinical research or health industry fields. Clinical monitoring experience required in the pharmaceutical, biotech, medtech or CRO industries. People and study management experience required.</p></li><li><p>
Expertise in data management, site management and monitoring, including proficiency in clinical trial software and tools.</p></li><li><p>
Committed to quality with a proven track record of being thorough and detail-oriented in ensuring protocol adherence and data integrity.</p></li><li><p>
Excels in organizational and time management skills, enabling effective multitasking in fast-paced environments while managing priorities, organizing time efficiently, and solving complex problems.</p></li><li><p>
Possess strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills to drive successful trial outcomes.</p></li><li><p>
Willing and able to travel up to 85% to support site visits and project needs.</p></li><li><p>
Professional, trustworthy, and disciplined self-starter who thrives in collaborative team settings, fostering a positive and productive atmosphere.</p></li><li><p>
In-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.</p></li><li><p>
Skilled at establishing and maintaining positive relationships with sponsors, investigative sites, and cross-functional project teams to facilitate seamless communication and achieve study milestones.</p></li><li><p>
Experience in people and study management.</p></li><li><p>
Strong command of English, and the local language as necessary, both written and verbal.</p></li></ul><p></p><h2 class="jobSectionHeader"><b>
WORKING CONDITIONS/PHYSICAL DEMANDS</b></h2><p>
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.</p><p></p><p>
Compensation: $130,000 - 155,000 commensurate with experience</p><p></p><p><b>
Languages</b></p>
English<p></p><p><b>
Education</b></p>
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy<p></p><p><b>
Contract Type</b></p>
Regular</div>

Lead Clinical Research Associate

IQVIA

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  <strong>
   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.
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  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.
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 <strong>
  Job Overview
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 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.
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  Key Responsibilities
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 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).
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 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.
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 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.
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  Qualifications
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   Bachelor&rsquo;s degree required; a scientific or healthcare discipline is preferred.
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   6 months &ndash;2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
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   Basic knowledge of clinical research regulations (GCP/ICH).
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   Ability to travel as required by the project.
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  </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
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 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
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 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.
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 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.
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CRA 1, IQVIA Biotech

FIRST UTAH BANK

<ul><li><ul><li><b>Job Tracking ID</b>: 512729-909310</li>
<li><b>Job Location</b>: Salt Lake City, UT
<br>
Salt Lake City</li>
<li><b>Job Level</b>: Mid Career</li>
<li><b>Level of Education</b>: BA/BS</li>
<li><b>Job Type</b>: Full-Time/Regular</li>
</ul></li><li><ul><li><b>Date Updated</b>: March 19, 2026</li>
<li><b>Years of Experience</b>: 2 - 5 Years</li>
<li><b>Starting Date</b>: ASAP</li>
<li><b>Reports to*</b>: Audit &amp; Compliance Officer</li></ul></li></ul>
<br><p></p><div><div><div><p>The Risk and Audit Specialist provides critical execution support across the Bank&rsquo;s independent risk management and oversight functions. This role reports to the Internal Audit Manager and is primarily responsible for executing the Bank&rsquo;s audit program, while also assisting with the monitoring and surveillance activities of the Compliance and BSA/AML areas. Pay will depend on experience, skills, education, etc. ($60,000 to $100,000/yr is the range).</p>
<p>
<b>Preservation of the Three Lines of Defense</b></p>
<p>
To maintain the integrity of the Bank&rsquo;s governance framework, this role operates under strict protocols:</p>
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<ul><li>First Line (Operations): The employee will have no decision-making authority over Bank operations or lending.</li></ul>
<ul><li>Second Line (Compliance, BSA/AML): The employee will assist in monitoring and surveillance of risk.</li></ul>
<ul><li>Third Line (Internal Audit): the employee will provide independent testing. Crucially, the employee will not audit any specific second line processes.</li></ul></div>
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<b>Internal Audit Support</b></p>
<ul>
<li>Assist in planning, executing, and documenting internal audits across all bank departments and processes.</li>
<li>Prepare audit workpapers, testing documentation, and preliminary findings reports.</li>
<li>Conduct testing of internal controls, including transaction sampling and substantive testing procedures.</li>
<li>Review and evaluate operational processes for efficiency, effectiveness, and compliance with established policies.</li>
<li>Document audit procedures, observations, and recommendations in accordance with professional standards.</li>
<li>Track and monitor management action plans resulting from audit findings.</li>
<li>Assist in preparing audit reports for senior management and the Board Audit Committee</li>
<li>Maintain organized audit files and documentation in compliance with retention policies.</li>
<li>Assist in the preparation and compilation of the Bank&rsquo;s Internal Audit Risk Assessment and Internal Audit Plan</li>
<li>Perform follow-up reviews to verify implementation of corrective actions.</li>
<li>Research and stay current on banking regulations, industry standards, and audit best practices.</li>
<li>Review Bank policies as compared to internal audit workpapers ensuring that all information maintained by the Internal Audit Department is current and accurate</li>
<li>Compile and verify general ledger certifications each quarter-end and on two random dates in a 12-month period</li>
<li>Verify accuracy of paper general ledger transaction tickets, verify daily branch balancing and report results of surprise cash counts, and other recurring internal audit tasks.</li>
<li>Assist with special projects and investigations as directed by the Internal Audit Manager.</li></ul>
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<b>Compliance and Regulatory Oversight | BSA/AML and OFAC Monitoring</b></p>
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<li>Serve as either the primary or back-up to daily tasks including cash monitoring, CTR filings, SAR filings, 314(a) processing, and OFAC suspect match reviews.</li>
<li>Support BSA/AML monitoring activities, including reviewing alerts and investigating suspicious activity.</li>
<li>Support the Bank&rsquo;s CRA program including completion of CRA service hours, assistance with CRA service hours, lending and investment tracking.</li>
<li>Assist in conducting compliance reviews and testing of BSA/AML program components.</li>
<li>Help maintain compliance documentation, policies, and procedures manuals.</li>
<li>Support regulatory examination preparation and coordination.</li>
<li>Assist with regulatory change management activities and impact assessments.</li>
<li>Conduct periodic reviews of bank operations for compliance with applicable regulations.</li>
<li>Support compliance training completion across the organization.</li>
<li>Support Customer Identification Program (CIP) and Customer Due Diligence (CDD) processes</li>
<li>Support compliance testing and documentation</li></ul>
</div></div><div><div><h2 class="jobSectionHeader"><b>Experience and Skills:</b></h2>
<p><b>Qualifications</b></p>
<ul>
<li>Bachelor's degree in Finance, Accounting, or a related field. Equivalent experience accepted.</li>
<li>Three to five years in banking, specifically within audit, compliance, or risk management.</li>
<li>Professional auditor certification (CIA - Certified Internal Auditor) highly preferred.
<ul><li>CAFP - Certified AML and Fraud Professional and CRCM - Certified Regulatory Compliance Manager if these areas become a major part of the position.</li></ul></li>
<li>Strong understanding of internal control frameworks and audit methodologies.</li>
<li>Familiarity with data analytics tools.</li>
<li>Knowledge of current banking industry trends and emerging technologies.</li>
<li>Ability to remain objective and maintain confidentiality.</li>
<li>Excellent analytical, problem-solving, and decision-making skills.</li>
<li>Strong leadership, communication, and interpersonal skills.</li></ul>
</div></div><div><div><h2 class="jobSectionHeader"><b>Benefits</b></h2>
<p>Medical, Dental, and Vision coverage (Bank pays 75% of Medical and Dental premiums). Company-paid Life Insurance and Disability. Paid Leave, Maternity/Paternity Leave, Company Parties/Activities, Tuition Reimbursement, etc.</p>
<p>
 fmlaen.pdf (FMLA Poster)</p>
<p>
Polygraph Protection Act employee rights</p>
<p>
Know Your Rights: Workplace discrimination is illegal</p></div></div></div><p></p>

Bank Risk and Audit Analyst

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