senior research associate

ICON plc

<div>Senior CRA<p></p><p>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</p><p></p><div><div>
Job Advert Posting</div></div><div><div><div><div><div><div><div><div><div><p>
We are currently seeking a <b>Contractor Senior Clinical Research Associate </b>to join our diverse and dynamic team. <b>This will be for a 6 month contract. As a Clinical Research Associate at ICON</b>, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.</p><p></p><p><b>
What you will be doing</b></p><ul><li><p>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</p></li><li><p>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</p></li><li><p>
Collaborating with investigators and site staff to facilitate smooth study conduct.</p></li><li><p>
Performing data review and resolution of queries to maintain high-quality clinical data.</p></li><li><p>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</p></li></ul><p></p><p><b>
Your profile</b></p><ul><li><p>
Bachelor&rsquo;s degree in a scientific or health-related field or an equivalent combination of education and clinical research experience, particularly in a study coordinator or nursing role</p></li><li><p>
Minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate.</p></li><li><p>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</p></li><li><p>
Strong organizational and communication skills, with attention to detail.</p></li><li><p>
Ability to work independently and collaboratively in a fast-paced environment.</p></li><li><p>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</p></li></ul><p></p><p>
#LI-Remote #LI-ZH1</p></div></div></div></div></div></div></div></div></div><p></p><p><b>
What ICON can offer you:</b></p><p></p><div><div><div><div><p>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</p><p></p><p>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</p><p></p><p>
Our benefits examples include:</p><ul><li><p>
Various annual leave entitlements</p></li><li><p>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</p></li><li><p>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</p></li><li><p>
Life assurance</p></li><li><p>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul></div></div></div></div><p></p><p>
Visit our careers site to read more about the benefits ICON offers.</p><p></p><p>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</p><p></p><div><div><div><div><p>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</p><p></p><div><p>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</p></div></div></div></div></div></div><p></p>

Senior Clinical Research Associate

<div>Senior CRA / CRA II - Home-Based (US)<p></p><p>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</p><p></p><p>
As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.</p><p></p><p><b>
What You Will Do:</b></p><p></p><p>
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement.<br>
<br>
Key responsibilities include:</p><ul><li>
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><p></p><p><b>
Your Profile:</b></p><p></p><p>
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others.<br>
<br>
Required qualifications and experience:</p><ul><li>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</li><li>
Willingness to travel as required (approximately 60%)<p><br>
#LI-LB1 #LI-REMOTE</p></li></ul><p></p><p><b>
What ICON can offer you:</b></p><p></p><div><div><div><div><p>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</p><p></p><p>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</p><p></p><p>
Our benefits examples include:</p><ul><li><p>
Various annual leave entitlements</p></li><li><p>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</p></li><li><p>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</p></li><li><p>
Life assurance</p></li><li><p>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul></div></div></div></div><p></p><p>
Visit our careers site to read more about the benefits ICON offers.</p><p></p><p>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</p><p></p><div><div><div><div><p>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</p><p></p><div><p>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</p></div></div></div></div></div></div><p></p>

Clinova Clinical Trials

<p>About the Role</p><p>We are seeking an experienced Senior Clinical Research Associate (CRA) to join our growing clinical operations team. In this role, you will be responsible for ensuring the quality and integrity of clinical trial data across multiple sites, from study initiation through close-out. You will serve as a key liaison between the sponsor, investigative sites, and internal study teams, driving compliance with ICH/GCP guidelines, applicable regulations, and study-specific protocols.</p><p>Key Responsibilities</p><p><b>Site Management &amp; Monitoring</b></p><ul><li>Perform Site Qualification Visits (SQV), Site Initiation Visits (SIV), routine on-site monitoring visits, remote monitoring visits, and Site Close-Out Visits (COV)</li><li>Conduct Source Document Verification (SDV) and source data review in accordance with the monitoring plan</li><li>Apply risk-based monitoring (RBM) principles to prioritize and optimize monitoring activities</li><li>Manage 5&ndash;8 site visits per month, balancing on-site and remote monitoring responsibilities</li><li>Identify, document, and resolve protocol deviations, data discrepancies, and site issues in a timely manner</li><li>Ensure investigational product accountability, storage, and handling compliance at all sites</li></ul><p><b>Reporting &amp; Documentation</b></p><ul><li>Author clear, accurate, and timely trip reports and follow-up letters following each monitoring visit</li><li>Maintain and update site files, monitoring logs, and CTMS records in accordance with ICH E6(R3) GCP guidelines</li><li>Track and report key performance indicators (KPIs) and key quality indicators (KQIs) at the site and study level</li><li>Document findings, action items, and site escalations, ensuring appropriate follow-through to resolution</li></ul><p><b>Collaboration &amp; Communication</b></p><ul><li>Attend and contribute to study team meetings, investigator meetings, and sponsor teleconferences</li><li>Serve as the primary point of contact for assigned investigative sites, maintaining strong professional relationships</li><li>Collaborate cross-functionally with data management, regulatory affairs, pharmacovigilance, and biostatistics teams</li><li>Escalate critical site issues and patient safety concerns to the Clinical Project Manager and/or Sponsor in a timely manner</li></ul><p><b>Training &amp; Compliance</b></p><ul><li>Complete and maintain current GCP training (ICH E6(R3)) and all required study-specific training</li><li>Ensure investigative site staff are adequately trained on protocol requirements and amendments</li><li>Support audit and inspection readiness at assigned sites</li></ul><p>Qualifications</p><p><b>Required</b></p><ul><li>Bachelor's degree in a life science, nursing, or a related health/scientific field (required)</li><li>Minimum 5 years of clinical site monitoring experience as a CRA (field and/or in-house)</li><li>Demonstrated experience across Phase I&ndash;III clinical trials</li><li>Strong working knowledge of ICH/GCP guidelines, FDA regulations, and clinical trial operations</li><li>Proficiency with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS)</li><li>Experience with risk-based monitoring (RBM) strategies and oversight tools</li><li>Familiarity with KPI/KQI frameworks and data-driven site oversight</li><li>Excellent written and verbal communication skills with the ability to author professional monitoring reports</li><li>Ability to travel regionally up to 60% of the time</li></ul><p><b>Preferred</b></p><ul><li>Advanced degree (Master's, MBA, or equivalent) in a relevant field</li><li>Experience in specialized therapeutic areas such as dermatology, oncology, or rare diseases</li><li>Remote monitoring and centralized data review experience</li><li>Familiarity with Veeva Vault, Medidata Rave, or comparable eTMF/EDC platforms</li><li>Previous CRO or sponsor-side experience</li></ul><p>What We Offer</p><ul><li>Competitive compensation and a comprehensive benefits package</li><li>Remote-first work environment with a collaborative and inclusive team culture</li><li>Ongoing professional development and GCP training opportunities</li><li>Exposure to diverse therapeutic areas and global study teams</li><li>A mission-driven organization committed to advancing patient health through high-quality research</li></ul><p>Pay: $125,000.00 - $155,000.00 per year</p><p>Benefits:</p><ul><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Flexible spending account</li><li>Health insurance</li><li>Paid time off</li><li>Parental leave</li><li>Vision insurance</li></ul><p>Work Location: Remote</p>

AtriCure, Inc.

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
<br><br>
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
<br><br>
<b>POSITION SUMMARY:</b><br>
The Senior Clinical Research Associate (Sr. CRA) at AtriCure plays a vital role in the Clinical Affairs department, independently managing and overseeing site management and/or monitoring activities during clinical trial execution. This position requires a high level of autonomy and leadership, providing guidance to junior team members and ensuring compliance with regulatory standards and protocols. The Sr. CRA is instrumental in maintaining the integrity of clinical data and adapting to evolving study needs.
<br><br>
<b>ESSENTIAL FUNCTIONS OF THE POSITION:</b><br>
Site Management
<br><ul>
<li>Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.</li>
<li>Conduct Site Qualification, Initiation, Interim and Close-Out training visits.</li>
<li>Facilitate required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.</li>
</ul>
Site Communications
<br><ul>
<li>Act as the primary point of contact for site communications and inquiries.</li>
<li>Liaise with clinical study management, field personnel, and CROs, addressing moderately complex protocol or study related issues as necessary.</li>
</ul>
Compliance
<br><ul>
<li>Ensure clinical study sites adhere to assigned protocols and regulatory standards, independently reviewing individual site compliance and addressing issues with study management.</li>
</ul>
Data Management
<br><ul>
<li>Review and analyze data for accuracy and completeness.</li>
<li>Lead the creation, management, and resolution of data queries for assigned sites</li>
<li>Support development of data cleaning reports and metrics in collaboration with data and operations management teams.</li>
</ul>
Monitoring
<br><ul>
<li>Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.</li>
<li>Assist in reviewing peer interim monitoring visit (IMV) reports.</li>
</ul>
Safety
<br><ul>
<li>Manage the processing of product complaints and adverse events, collaborating with safety specialists to gather materials for CEC meetings.</li>
</ul>
Study Management
<br><ul>
<li>Draft study-related materials, such as patient brochures and recruitment tools.</li>
<li>Support the coordination of activities with study-specific committees, vendor services, and core labs.</li>
</ul>
Leadership and Development
<br><ul>
<li>Provide mentorship and guidance to junior team members, fostering a collaborative environment.</li>
<li>Engage in continuous professional development and contribute to strategic project management activities.</li>
</ul>
Other Duties
<br><ul>
<li>Ensure appropriate translations for study documents and engage in global process improvement initiatives.</li>
<li>Mentor less experienced clinical team members and participate in core team activities.</li>
<li>Contribute to departmental SOPs and work instructions, driving revisions as necessary.</li>
</ul>
<b>ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:</b><br>
<ul>
<li>Regular and predictable work performance</li>
<li>Ability to work under fast-paced conditions</li>
<li>Ability to make decisions and use good judgement</li>
<li>Ability to prioritize various duties and multitask as required</li>
<li>Ability to successfully work with others</li>
<li>Additional duties as assigned</li>
</ul>
<b>BASIC QUALIFICATIONS:</b><br>
<ul>
<li>Bachelor’s degree with a minimum of 5 years of clinical research experience.</li>
<li>Strong leadership, organizational, and communication skills with the ability to work independently and as part of a team.</li>
<li>Proficiency in Microsoft Office Suite and familiarity with clinical data management systems.</li>
<li>Willingness to travel between 10-75% of the time.</li>
</ul>
<b>OTHER REQUIREMENTS:</b><br>
<ul>
<li>Ability to regularly walk, sit, or stand as needed</li>
<li>Ability to occasionally bend and push/pull as needed</li>
</ul>
#LI-KN1
<br><br>
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Novartis

<div><div><h3 class="jobSectionHeader"><b>Summary
</b></h3><div>This is a remote position where candidates must be located near an airport (Texas, Louisiana, Arkansas, Oklahoma or New Mexico are highly desirable locations). The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials within the country. The Senior CRA is responsible for delivering data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs.<br>
<br>
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel.</div>
</div><div><h3 class="jobSectionHeader"><b>About the Role
</b></h3><div><p><b>LI:#Remote</b></p><p><b>
Internal job title:</b> CRA II</p><p><b>
Location</b>: Remote (Texas, Louisiana, Arkansas, Oklahoma or New Mexico)</p><p></p><p><b>
Job description</b></p><p><b>
Key responsibilities: </b>Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis)</p><ul><li>
Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries</li><li>
Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures</li><li>
Facilitates the preparation and collection of site and country level documents</li><li>
Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required ensuring thorough documentation in Monitoring Visit Reports</li><li>
Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.</li><li>
Accountable for continuously updating all relevant electronic systems to perform job functions</li><li>
Takes on the responsibility as SME (Subject Matter Expert) as needed</li><li>
Monitors studies as per current legislations, ICH/GCP and Novartis standards</li><li>
Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.</li><li>
Identifies, resolves &amp; escalates issues appropriately</li><li>
Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry</li><li>
Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities</li><li>
Partners with SSU CRA to ensure seamless transition of site responsibility</li></ul><p></p><p><b>
Essential Requirements:
</b></p><ul><li>Minimum of 3 years&rsquo; experience in site monitoring</li><li>
BS/BA degree. Scientific, Healthcare or other related field.</li><li>
Excellent knowledge of the drug development process specifically clinical trial/research</li><li>
Knowledge of international standards (GCP/ICH, FDA, EMEA)</li><li>
Ability to manage multiple priorities and manage time efficiently.</li><li>
Excellent Site management capabilities with demonstrated negotiating and problem-solving skills</li><li>
Strong communicator and presentation skills (oral and written)</li><li>
Fluent in both written and spoken English</li></ul><p></p><p><b>
Desirable Requirements</b>:</p><ul><li>
RLT, CAR T or Oncology experience a plus!</li></ul><p></p><p>
The salary for this position is expected to range between $108,500 and $201,500 per year.</p><p>
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.</p><p>
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.</p><p>
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.</p><p></p><p><b>
Driving is an Essential Function of this Role:</b> Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver&rsquo;s license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.</p><p></p><p><b>
COVID-19 Vaccine Policy</b> (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers&rsquo; (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.</p></div>
</div><div><div><p><b>Why Novartis:</b> Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture</p><p><b>
Benefits and Rewards:</b> Learn about all the ways we&rsquo;ll help you thrive personally and professionally.<br>
Read our handbook (PDF 30 MB)</p></div>
</div><div><p><b>EEO Statement:</b></p><p>
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.</p><p><b>
Accessibility &amp; Reasonable Accommodations</b></p><p>
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.</p></div></div>
<br><div><div>Division
<div>Development
</div></div><div>Business Unit
<div>Development
</div></div><div>Location
<div>USA
</div></div><div>State
<div>Field, US
</div></div><div>Site
<div>Field Non-Sales (USA)
</div></div><div>Company / Legal Entity
<div>U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
</div></div><div>Functional Area
<div>Research &amp; Development
</div></div><div>Job Type
<div>Full time
</div></div><div>Employment Type
<div>Regular
</div></div><div>Shift Work
<div>No</div></div></div><div></div>

Senior Clinical Research Associate (CRA)

St. Jude Children's Research Hospital

<div>The Senior Clinical Research Associate-RN is responsible for performing data abstraction, collection, and entry to support clinical research. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data and reports to the collaborating research organization or study sponsor.<p></p><p>
We are seeking a highly motivated and experienced Senior Clinical Research Associate-RN to support a growing portfolio of clinical research studies in the Department of Infectious Diseases. This role is critical to ensuring the successful start-up, execution, and ongoing management of multiple investigator-initiated and collaborative trials.</p><p></p><p>
The ideal candidate will bring strong project management capabilities, clinical research experience, and the ability to work across multidisciplinary teams. This position offers the opportunity to play a key leadership role in advancing innovative research initiatives that impact patient care and outcomes.</p><p><b><i>
This postition will work primarily on campus.</i></b></p><p></p><p><b>
Key Responsibilities</b></p><ul><li><p>
Lead and manage study start-up activities for multiple clinical trials, including regulatory coordination, site activation, and operational planning</p></li><li><p>
Oversee and support enrollment-based studies across multiple principal investigators, including studies conducted at partner institutions</p></li><li><p>
Coordinate day-to-day study operations to ensure timelines, milestones, and compliance requirements are met</p></li><li><p>
Serve as a central point of contact for study teams, sponsors, and collaborators</p></li><li><p>
Provide hands-on clinical research support as needed, including serving as a research nurse and assisting with study visits</p></li><li><p>
Ensure appropriate staffing and coverage for study visits, including those requiring multiple research nurses</p></li><li><p>
Mentor and provide oversight to research nursing staff, supporting their development in both clinical and project management competencies</p></li><li><p>
Collaborate with data management, quality assurance, and regulatory teams to ensure high-quality study execution</p></li><li><p>
Support both pre-activation and post-activation phases of clinical trials, including studies recruiting from community-based settings</p></li></ul><p></p><p><b>
Job Responsibilities:</b></p><ul><li><p>
Support project management (lead/monitor planning and delivery) for institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study.</p></li><li><p>
Act as site study coordinator for complex, large multi-site and/or multidisciplinary clinical trials.</p></li><li><p>
Maintain and share essential study documents (e.g., investigator files, case report forms) as required.</p></li><li><p>
Assist with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g., CPSRMC and IRB) as applicable.</p></li><li><p>
Assist in the development of ongoing review of departmental/divisional standard operating procedures. and ensure compliance in execution of assigned tasks.</p></li><li><p>
Oversee quality of data abstraction, collection, and entry to support clinical research of study team members.</p></li><li><p>
(As applicable) Provide patient care, education, and management (e.g., routine test conduct; assistance in clinical procedures; medication instruction, monitoring, and documentation; patient care coordination; education on protocol activities).</p></li><li><p>
Perform other duties as assigned to meet the goals and objectives of the department and institution.</p></li><li><p>
Maintains regular and predictable attendance.</p></li></ul><p></p><p><b>
Minimum Education and/or Training:</b></p><ul><li><p>
Bachelor's degree in Nursing required.</p><ul><li><p>
Master's degree preferred.</p></li></ul></li></ul><p></p><p><b>
Minimum Experience:</b></p><ul><li><p>
Minimum Requirement: 4+ years of experience in carrying out research preferably in healthcare settings.</p><ul><li><p>
Experience Exception: Master's degree and 2+ years of experience.</p></li></ul></li><li><p>
Experience managing cross-functional communication, including liaison between site and study teams.</p></li><li><p>
Experience with documentation and tracking systems/processes.</p></li><li><p>
Proven performance in earlier role.</p></li></ul><p></p><p><b>
Preferred Skills/Experience:</b></p><ul><li><p>
Several years of clinical research experience, with demonstrated involvement in study start-up and trial management.</p></li><li><p>
Strong project management and organizational skills, with the ability to manage multiple studies simultaneously.</p></li><li><p>
Experience working with investigator-initiated trials and multi-site studies preferred.</p></li><li><p>
Phlebotomy skills strongly preferred.</p></li><li><p>
Excellent communication, leadership, and problem-solving abilities.</p></li></ul><p></p><p><b>
Licensure, Registration and/or Certification Required by Law:</b></p><ul><li><p>
(LC: RN-TN) Must possess a current Tennessee State Board of Nursing license if primary residence is Tennessee or a Nurse Licensure Non-Compact state.</p></li><li><p>
(LC: RN-MISS, RN-ARK or RN-KY) Must possess a current State Board of Nursing license in the state of primary residence if the state is a Nurse Licensure Compact state.</p></li></ul><p></p><p><b>
Compensation</b></p>
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $78,000 - $139,360 per year for the role of Senior Clinical Research Associate RN - Department of Infectious Diseases.<p></p><p>
Explore our exceptional benefits!</p><p></p><div><p>
St. Jude is an Equal Opportunity Employer</p></div><p></p><p><b>
No Search Firms</b></p><p>
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.</p></div>

Senior Clinical Research Associate RN - Department of Infectious Diseases

Community Health Center, Inc.

<div><p><b>Job Description Summary:</b></p><p></p><p><b>
Job Description:</b></p><p>
The Senior Research &amp; Evaluation Associate is a masters or higher-level research professional responsible for quantitative data analysis of Weitzman Institute research projects. The Senior Research &amp; Evaluation Associate is expected to work with the principal investigators, project managers, and project-related stakeholders to plan, measure, and analyze simple and complex data sets. The position is expected to employ advanced data analytic skills to ensure research goals are met, including support for grant and manuscript preparation. Furthermore, this position will be responsible for helping build staff capacity in research methodology and data analysis and designing and implementing new research projects.</p><p><b>
I. JOB RESPONSIBILITIES</b></p><ul><li>
Contribute to the design, planning, implementation, and management of a host of studies (e.g., observational, experimental, qualitative)</li><li>
Develop detailed protocols for conducting research, including data collection processes and instruments</li><li>
Clean, transform, manage, and analyze data from a variety of sources (e.g., surveys, electronic health records)</li><li>
Perform statistical analyses (e.g., descriptive statistics, correlations, t-tests, regression, factor analysis, mixed-effects modeling, sample and effect size calculation, and other types of statistical modeling) under the direction of research leads</li><li>
Lead the preparation of reports, manuscripts, and presentations for scientific and lay audiences</li><li>
Contribute to grant and contract proposals to governmental (e.g., NIH, CDC) and nongovernmental funding sources</li><li>
Other duties as assigned</li></ul><p><b>
II. REQUIRED QUALIFICATIONS</b></p><p>
Master&rsquo;s-level or higher training in a health-related field (preferably in a quantitative discipline) and 3-5 years of post-graduate work experience in research.</p><p></p><p>
Knowledge, Skills, &amp; Experience:</p><ul><li>
Research and analysis<ul><li>
Proven experience developing and conducting surveys and establishing measures to assess research questions</li><li>
Demonstrated knowledge and experience analyzing and reporting data to scientific and community-based audiences</li></ul></li><li>
Proposals and Manuscripts<ul><li>
Strong track record supporting grant proposals</li><li>
Clear, concise writing, communication, and presentation skills</li><li>
First author on at least one article published in a peer-reviewed journal preferred</li></ul></li><li>
Software<ul><li>
Proficiency with SPSS and R, ideally conducting analyses as an analyst for a minimum of three years</li><li>
Proficiency with Microsoft Office products, specifically Excel</li></ul></li><li>
Management<ul><li>
Strong interpersonal, organizational, time-management and prioritization skills; ability to multi-task and a keen attention to detail</li></ul></li><li>
Other<ul><li>
Exceptionally self-motivated and directed</li><li>
Preference for and experience with working on a fully remote team</li><li>
Willingness to pitch in at any level, from taking meeting notes and cleaning survey data to presenting at national conferences</li></ul></li></ul><p></p><p>
This Position is available for remote work.</p><p></p><p><b>
Organization Information:</b></p><p>
The Moses/Weitzman Health System is a global leader addressing challenges faced by organizations caring for the poor and diverse populations, and is home to programs focusing on education, research, and process improvement support for safety net providers. The system delivers primary care to more than 150,000 patients in Connecticut, and extends access to specialty care for more than 2.5 million individuals across the U.S. It is a national accrediting body for organizations training advanced practice providers, and offers accredited education and training for Medical Assistants in multiple states. As an incubator for new ideas in areas including social justice, the environment, and social determinants of health, the MWHS is addressing challenges faced by providers caring for underserved communities, creating innovative and impactful initiatives led by nationally and internationally recognized experts. As it forges pathways into the future of primary care, the MWHS honors Lillian Reba Moses (1924-2012), a granddaughter of slaves, and Gerard (Gerry) Weitzman (1938-1999), whose ancestors escaped pogroms in Eastern Europe. Their vision and commitment to justice and equity in healthcare is the foundation upon which the Moses/Weitzman Health System was built.</p><p></p><p><b>
Time Type:</b></p>
Full time</div>

Research and Evaluation Associate- Remote

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Senior Clinical Research Associate RN - Department of Infectious Diseases

Research and Evaluation Associate- Remote