ICON plc

<div>Sr CRA<div></div><div>
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</div><div></div><div>
We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.</div><div></div><div>
What You Will Be Doing:</div><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><div>
Your Profile:</div><ul><li>
Advanced degree in a relevant field such as life sciences, nursing, or medicine.</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><div>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><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.</div><div></div><div>
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.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
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.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
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><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><div></div><div><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></div><div></div>

Senior CRA

<div>Senior Clinical Research Associate, US, Remote, Northeast Region<div></div><div>
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</div><div></div><div>
We are currently seeking a Senior Clinical Research Associate (CRA) in the Northeast region to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. Ideal locations would be: Northern NJ, New York Metro or CT.</div><div></div><div>
What You Will Be Doing:</div><ul><li><div>
Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness</div></li><li>
Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites</li><li>
Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trials</li><li>
May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs</li><li>
Promptly document monitoring activities and submit/approve visit reports</li><li>
Manage site essential document collection and TMF reconciliation with site files</li><li>
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals</li><li>
Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution</li><li>
Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans</li><li>
Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations</li><li>
Support sites during regulatory inspections</li><li>
Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities</li><li>
Lead site engagement initiatives and foster relationships with key Oncology sites and networks</li></ul><div>
Your Profile:</div><ul><li>
Bachelor&rsquo;s degree (scientific field preferred)</li><li>
3+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits</li><li>
1+ years early development trial experience preferred</li><li>
Solid tumor clinical trial experience is preferred</li><li>
Experience utilizing Veeva CTMS for report writing is required</li><li>
Demonstrated experience developing/maintaining site relationships and securing compliance</li><li>
Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology</li><li>
Experience collaborating with sites from initial engagement through close-out phases</li><li>
Experience activating sites</li><li>
Experience training site staff</li><li>
Experience supporting sites and/or sponsors in regulatory inspections</li><li>
Experience working within an FSP (or in-house) monitoring model is preferred</li><li>
Willing to travel up to 50% domestically</li><li>
Reside in Northeast Region USA</li></ul><div></div><div>
 <i>Pay Range ( 110,520.00 USD - 138,150.00 USD)</i></div><div></div><div>
What ICON can offer you:</div><div></div><div><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.</div><div></div><div>
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.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
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.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
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><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><div></div><div><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></div><div></div>

Evermore Bank

<p><b>Role and Responsibilities </b></p><p>The Compliance, BSA, OFAC &amp; CRA Officer reports directly to the Board of Directors of Evermore Bank, with an internal administrative reporting line to the CFO.</p><p>The Compliance, BSA, OFAC &amp; CRA Officer works with senior management, the Audit Committee, and the Board of Directors to establish the framework to identify, assess, monitor and control all aspects of the Bank&rsquo;s compliance initiatives including the responsibility of administrating and maintaining the Bank&rsquo;s BSA/AML policies and procedures to ensure the Bank follows all applicable laws and regulations.</p><p><i>The Compliance, BSA, OFAC &amp; CRA Officer:</i></p><ul><li>Ensures that Evermore Bank&rsquo;s compliance risks are adequately identified, assessed, monitored and controlled in conjunction with the business unit(s) and any associated control function.</li><li>Aligns annual compliance plans with business strategies and goals.</li><li>Develops, initiates, maintains, and revises policies and procedures for the Bank&rsquo;s Compliance, CRA, and BSA Programs.</li><li>Monitors the performance of the Compliance, CRA, and BSA Programs, and related activities on a continuing basis, taking appropriate steps to improve their effectiveness.</li><li>Performs the Bank&rsquo;s Compliance and BSA/AML Risk Assessments.</li><li>Responsible for developing an effective compliance training program, including appropriate introductory training for new employees, as well as ongoing training for all Bank associates and the Board pf Directors.</li><li>Acts as an independent review and evaluation body to ensure that compliance Issues/concerns within the organization are being appropriately evaluated, investigated, and resolved.</li><li>Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues and provides general guidance on how to avoid similar situations in the future.</li><li>Ensures proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.</li><li>Monitors and report all complaints to senior management and the Board of Directors on a regular basis.</li><li>Provides reports on a regular basis to keep the Board of Directors and senior management informed of the operation and progress of compliance efforts.</li><li>Reviews all advertising/marketing and development of new products and services to ensure compliance with all regulatory requirements including but not limited to Fair Lending, UDAAP and Truth in Savings, etc.</li><li>Responsible for the overall operations and staff within the Compliance and BSA/AML Departments.</li><li>Provides guidance on all compliance and BSA/AML matters to all associates throughout the Bank.</li><li>Validates BSA/AML methodology rules, thresholds, and risk scoring in the Bank&rsquo;s transaction monitoring system.</li><li>Reviews and approves all SARs prior to filing, ensuring accuracy and conformity to FinCEN guidance.</li><li>Reviews CTRs for accuracy and conformity to FinCEN guidance.</li><li>Reviews resolution of all FinCEN 314(a) requests and possible OFAC matches.</li><li>Provides final approval of all possible OFAC matches including the responsibility of contacting OFAC to report any Blocked/Rejected transactions.</li><li>Stays abreast of industry trends by leading and/or attending seminars, training sessions, and workshops, as necessary to develop and ensure compliance with banking regulations and industry standards for financial institutions.</li><li>Executes other duties and projects, as assigned by the President &amp; CEO, CFO, Audit Committee, and/or the Board of Directors.</li></ul><p><i>Qualifications and Education Requirements </i></p><ul><li>Bachelor&rsquo;s Degree and demonstrated a minimum of 10 years relevant experience in Compliance and BSA/AML in a commercial banking organization managing and delivering best practice investigative and proactive compliance service in or for a banking organization with significant activity in Miami and Latin America or equivalent combination of education and experience.</li><li>Strong knowledge of financial institution compliance with the ability to set compliance strategy, analyze multiple complex business and regulatory issues and implement new compliance policies and procedures</li><li>Comprehensive knowledge of Compliance and BSA/AML regulations, sufficient to interpret and analyze complex concepts.</li><li>Comprehensive management and leadership skills and the ability to coordinate a wide range of different compliance initiatives that the compliance department manages on behalf of the Bank.</li><li>Demonstrated leadership skills, excellent interpersonal skills, and proven problem-solving ability.</li><li>ACAMS certification preferred.</li><li>Team-building and effective communications skills are critical requirements, as is the ability to make decisions in a dynamic environment.</li><li>Well-developed and demonstrated facilitation, persuasion, presentation, and project management skills.</li><li>Knowledge of interrelationships amongst Bank functions.</li><li>Demonstrated ability to champion and support operational efforts.</li><li>Ability to effectively collaborate with others and accept challenging assignments.</li></ul><p><i>Preferred Skills </i></p><p>Ability to work under pressure and make decisions according to established guidelines; work unsupervised and accomplish tasks accurately and on a timely basis; prioritize work; strong organization skills. Travel may be required. Must be able to work with Microsoft Word, Excel, and Outlook. Ability to read, write and speak fluently in English is required and in Spanish is preferred.</p><p>Job Type: Full-time</p><p>Benefits:</p><ul><li>401(k)</li><li>Dental insurance</li><li>Employee assistance program</li><li>Health insurance</li><li>Life insurance</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Compliance, BSA, OFAC & CRA Officer

Syneos Health

<div><p><b>Description</b>
</p>CRA II - NEU &amp; IMN Studies - FSP - Istanbul<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><div><b>
CRA II</b><b> - Neurology &amp; Immunology </b><b>Studies - FSP</b><br>
<ul><li><b>Homebased but based in Istanbul</b></li></ul></div><ul><li>
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes<br>
Conducts Source Document Review of appropriate site source documents and medical records<br>
Verifies required clinical data entered in the case report form (CRF) is accurate and complete<br>
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines<br>
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture<br>
Verifies site compliance with electronic data capture requirements</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li><li>
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:<br>
Site support throughout the study lifecycle from site identification through close-out<br>
Knowledge of local requirements for real world late phase study designs<br>
Chart Abstraction activities and data collection<br>
Collaboration with Sponsor affiliates, medical science liaisons and local country staff</li></ul><p></p><p>
Qualifications:</p><p></p><ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills</li><li>
Ability to manage required travel of up to 75% on a regular basis</li><li>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</li></ul><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.</p><p></p><p>
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</p><p><b>
Summary</b>
</p>Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.</div>

CRA II - NEU & IMN Studies - FSP - Istanbul

<div><p><b>Description</b>
</p>Sr.CRA in KSA - Single Sponsor - CKD<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><ul><li>
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records<br>
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines<br>
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li></ul><p></p><p>
Qualifications:</p><ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.</li><li>
Ability to manage required travel of up to 75% on a regular basis</li></ul><p></p><p>
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.</p><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.</p><p></p><p>
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</p><p><b>
Summary</b>
</p>Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs.</div>

Sr.CRA in KSA - Single Sponsor - CKD

Old National Bank

<div>Overview:
<div>
Old National Bank has been serving clients and communities since 1834. With over $70 billion in total assets, we are a regional powerhouse deeply rooted in the communities we serve. As a trusted partner, we thrive on helping our clients achieve their goals and dreams, and we are committed to social responsibility and investing in our communities through volunteering and charitable giving.</div><div></div><div><i><br>
We continually seek highly motivated and talented individuals as our people are critical to our success. In return, we offer competitive compensation with our salary and incentive program, in addition to medical, dental, and vision insurance. 401K, continuing education opportunities and an employee assistance program are also included in our benefit suite. Old National also offers a variety of </i><i>Impact Network Groups</i><i> led by team members who are passionate about driving engagement, creating awareness of diverse backgrounds and experiences, and building inclusion across the organization. We offer a unique opportunity to join a growing, community and client-focused company that is firmly rooted in its core values.</i></div>
Responsibilities:
<div>
The CRA Compliance Reporting Analyst is responsible for supporting the Bank&rsquo;s Community Reinvestment Act (CRA) program through data analysis, reporting, and documentation. This role plays a key part in ensuring the Bank meets regulatory requirements by maintaining accurate CRA data, preparing reports, and supporting internal and external CRA-related audits and examinations. The analyst will collaborate with internal stakeholders to ensure timely and accurate CRA performance tracking and reporting.</div><div></div><div><b><br>
Salary Range</b></div><div>
The annual salary range for this position is $51,700.00 - $101,500.00. The base salary indicated for this position reflects the compensation range applicable to all levels of the role across the United States. Actual salary offers within this range may vary based on a number of factors, including the specific responsibilities of the position, the candidate&rsquo;s relevant skills and professional experience, educational qualifications, and geographic location.</div><div></div><div><b><br>
Key Accountabilities</b></div><ul><li>
Maintain and manage CRA-related data systems and tools to ensure accurate tracking of community development lending, investments, and services.</li><li>
Prepare and distribute recurring CRA performance reports for internal stakeholders, including senior leadership and governance committees.</li><li>
Support the development, tracking, and reporting of Community Growth Plan (CGP) objectives by analyzing performance data, drafting periodic updates, and collaborating with stakeholders.</li><li>
Assist in the preparation of regulatory reports and public file disclosures in accordance with CRA requirements.</li><li>
Support the CRA Compliance Manager in responding to examiner and auditor requests during CRA evaluations.</li><li>
Conduct peer analysis and benchmarking using CRA data tools and public data sources.</li><li>
Collaborate with business units to validate CRA-eligible activities and ensure proper documentation is retained.</li><li>
Monitor and communicate changes in CRA regulatory requirements that may impact reporting or data collection.</li><li>
Assist in the development and delivery of CRA-related training materials focused on data integrity and reporting.</li><li>
Serve as a back-up to assist CRA Compliance Analysts with completing community development lending, investment, and service reviews as needed.</li></ul><div><b>
Key Competencies for Position</b></div><p><b>
Analytical Thinking: </b>Ability to analyze complex data sets, identify trends, and present findings in a clear and actionable format.</p><p></p><p><b><br>
Attention to Detail: </b>Ensures accuracy in data entry, reporting, and documentation to support CRA compliance.</p><p></p><p><b><br>
Communication: </b>Effectively communicates technical and regulatory information to both technical and non-technical audiences.</p><p></p><p><b><br>
Collaboration: </b>Works closely with CRA Compliance Manager, CRA Compliance Analysts, and business line partners to support CRA goals.</p><p><br>
</p><p><b>Technical Proficiency: </b>Proficient in Microsoft Excel and other data tools; experience with CRA software platforms (RATA Comply, Kadince)</p><div></div><div><b><br>
Qualifications and Education Requirements</b></div><ul><li>
Bachelor&rsquo;s degree in Business, Finance, Economics, or related field.</li><li>
3+ years of experience in CRA compliance, regulatory reporting, or financial services analytics.</li><li>
Technical knowledge of CRA banking laws, regulations and regulatory expectations and the ability to accurately evaluate CRA eligibility for bank activities.
</li><li>General analytical and technical skills, including the ability to use CRA analytical tools, reporting tools and systems to evaluate CRA performance. Intermediate to advanced Microsoft Office skills, particularly Excel.
</li><li>Excellent written and verbal communication skills.</li><li>
General working knowledge of banking products and services covered by CRA and CRA related investment vehicles.</li><li>
A solid understanding of FFIEC large bank examinations and CRA regulatory expectations.</li><li>
Willingness to travel up to 10% to visit staff and stakeholders in other locations.</li></ul><div><b>
Key Measures of Success/Key Deliverables:</b></div><ul><li>
Timely and accurate CRA performance reporting.</li><li>
Positive feedback from internal stakeholders on data quality and reporting support.</li><li>
Demonstrated understanding of CRA requirements and ability to apply them to reporting processes.</li><li>
Achievement of the Bank&rsquo;s desired CRA performance rating and positive examiner feedback on the overall CRA program.</li><li>
Proactive communication of regulatory changes and ability to implement those changes in a timely manner.</li><li>
Ability to complete tasks independently and collaborate with team members on various projects and initiatives.</li></ul><p><b>
Old National is proud to be an equal opportunity employer focused on fostering an inclusive workplace and committed to hiring a workforce comprised of diverse backgrounds, cultures and thinking styles.</b></p><p></p><p><br>
As such, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, status as a qualified individual with disability, sexual orientation, gender identity or any other characteristic protected by law.</p><p></p><p><i><br>
We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have an agreement signed by the Director of Talent Acquisition, SVP to fill a specific position.</i></p><div>
 <b><i>Our culture is firmly rooted in our core values.
</i></b></div><div><b><i>We are optimistic. We are collaborative. We are inclusive. We are agile. We are ethical.
</i></b></div><div><b><i>We are Old National Bank.
</i></b></div><div><b><i>Join our team!</i></b></div></div>

Compliance Reporting Analyst

Shelby State Bank

<b>Position Description:</b><br>
Responsible for strategic direction of compliance, fair lending and CRA activities. Contributes to planning, budgeting, organizing, executing and evaluating of all risk management activity including audit and compliance.
<br><br>
In consultation with Senior Management, develop short-term and long-term goals for the Banks compliance and fair lending functions and reporting to Board Audit Committee.
<br><br>
Report results, recommendations, management responses, and monitor status of actions to the Audit Committee.
<br><br>
Serve as a management contributor to the Boards Audit Committee.
<br><br>
Manage / coordinate the banks management Compliance Committee.
<br><br>
Coordinate the external compliance reviews, assisting third parties as liaison with staff and management.
<br><br>
Understand organizations assets, liabilities, cash flow, insurance coverage, tax status, and financial objectives so can be a resource to help in the development of appropriate regulatory compliance, CRA, and fair lending strategies to achieve financial results with appropriate risk level.
<br><br>
Develop, implement, and ensure compliance with policies established for fair lending and CRA activities and proper training with the Board and employees.
<br><br>
Communicate policies and practices and oversee training to assure adequate understanding of risk and compliance with policies and regulations.
<br><br>
Develop risk assessments in coordination with department management and third-party audit / compliance vendors.
<br><br>
Maintain fair lending risk assessments and CRA community impact documentation.
<br><br>
Oversee HMDA / CRA data collection and reporting.
<br><br>
Coordination with marketing to ensure proper printed materials are in compliance.
<br><br>
Facilitate coordination of consumer complaints.
<br><br>
Maintain knowledge of the Banks regulatory environment and compliance issues.
<br><br>
Oversee the banks online compliance training program.
<br><br>
Additional responsibilities as assigned.
<br><br>
Be familiar with and comply with the provisions of the AML/CFT and USA PATRIOT Act as they relate to the functions of this position. Assist where need with required reporting related to those acts and reports any observed violations or potential violations of those acts to a supervisor or other appropriate bank officer.
<br><br>
Be familiar with and comply with all federal and state banking regulations as applicable.

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