clinical research associate

Novotech

<div><p><b>Role Summary<br>
</b></p><p><br>
The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.<br>
<br>
</p><p><b>Key Responsibilities<br>
</b><br>
</p><ul><li>CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials
</li><li>Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
</li><li>Provide mentorship to junior staff and can also provide support to the line manager or project manager as per request.
</li><li>Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
</li><li>In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
</li><li>In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials. &bull; Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
</li><li>Monitoring of investigational sites as per ICH GCP &sect;5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co monitoring visits. Visits can be conducted either onsite or remote as per CMP.
<ul><li>Ensure the rights &amp; wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly.
</li><li>Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
</li>Ensure all study drug is appropriately stored, dispensed, accounted<br>
<li>
<br>
</li></ul></li></ul><p><b>Qualifications<br>
</b><br>
</p><div>Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
<br>
<ul><li>At least 2-3 years of Clinical Research Associate experience in the Clinical industry.<br>
</li></ul></div><p>Salary Band - $70,000 &ndash; 115,000 Salary offered will be based on candidates experience level.<br>
<br>
</p><p>Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.<br>
<br>
</p><p>Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.<br>
<br>
</p><p>We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.<br>
<br>
</p><p>We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.</p></div><p></p>

Clinical Research Associate

RTI LABORATORIES

<p><b>Job Summary</b>  <br/>We are seeking a dynamic and detail-oriented Clinical Research Associate (CRA) to join our innovative clinical development team. In this vital role, you will oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory standards and study protocols. Your expertise will drive the successful management of clinical research projects, ensuring data integrity, patient safety, and adherence to all applicable regulations. This position offers an exciting opportunity to contribute to groundbreaking medical advancements while working in a collaborative and fast-paced environment.</p><p><b>Responsibilities</b></p><ul><li>Coordinate and monitor clinical trials across multiple sites, ensuring adherence to study protocols, FDA regulations, ICH GCP guidelines, and company standards.  </li><li>Conduct site qualification visits, initiate visits, routine monitoring visits, and close-out visits to verify compliance and data accuracy.  </li><li>Review and verify source documents, case report forms (CRFs), and other trial documentation for completeness and accuracy.  </li><li>Provide training and support to site staff on protocol procedures, data collection methods, EMR systems, and regulatory requirements.  </li><li>Monitor patient safety by reviewing adverse event reports, ensuring proper documentation, and reporting to relevant authorities as required.  </li><li>Manage trial documentation including ethics submissions, informed consent forms, regulatory binders, and audit readiness files.  </li><li>Collaborate with cross-functional teams such as clinical operations, data management, laboratory personnel, and medical staff to facilitate smooth trial execution.  </li><li>Ensure compliance with HIPAA regulations concerning patient confidentiality and data security.  </li><li>Assist in the review of clinical laboratory results, vital signs data, blood sampling procedures (phlebotomy), and other clinical assessments.  </li><li>Support statistical analysis activities by coordinating with statisticians using software tools designed for clinical data analysis.  </li><li>Maintain detailed records of site communications, monitoring reports, and trial progress for audit purposes.</li></ul><p><b>Experience</b></p><ul><li>Proven supervising experience in managing clinical trials or overseeing clinical research teams.  </li><li>Extensive knowledge of clinical trials management processes from initiation through close-out phases.  </li><li>Strong understanding of medical terminology, FDA regulations, ICH GCP guidelines, and CDISC standards for data exchange.  </li><li>Hands-on experience with EMR systems and electronic data capture (EDC) platforms for efficient data management.  </li><li>Background in nursing or clinical laboratory work (including blood sampling and vital signs measurement) is highly desirable.  </li><li>Familiarity with statistical software used in clinical research for data analysis purposes.  </li><li>Certification such as ICH GCP certificate from a recognized issuer (including CA) is required; additional certifications in HIPAA compliance or phlebotomy are a plus.  </li><li>Excellent analysis skills combined with meticulous attention to detail to ensure high-quality documentation review and compliance management. Join us in advancing medical science through rigorous research practices! We value energetic professionals committed to excellence in clinical development who thrive in collaborative environments dedicated to improving patient outcomes worldwide.</li></ul><p>Pay: $51,498.23 - $62,019.38 per year</p><p>Work Location: In person</p>

ICON plc

<div>CRA II- Adverum East coast<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>
Job Advert Posting</p><p>
We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, 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>Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul><p><b><br>
Your profile
</b></p><ul><li>Bachelor's degree in a scientific or healthcare-related field.</li><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li><li>
Strong organizational and communication skills, with attention to detail.</li><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li>
Experience in ophthalmology or gene therapy studies</li><li>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</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><p></p><p>
Salary Range</p>
$91,336.00-$114,170.00<p></p><p>
Bonus, Com, Stock, Benefits &amp; Disclaimer verbiage:</p><p>
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.</p></div><p></p>

<div>Clinical Research Associate - California<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 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><p>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</p></li><li><p>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</p></li><li><p>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</p></li><li><p>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</p></li><li><p>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</p></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><p>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</p></li><li><p>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</p></li><li><p>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</p></li><li><p>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</p></li><li><p>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</p></li><li><p>
Willingness to travel as required (approximately 60%)</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>

Alliance for Clinical Trials in Oncology

<div>
 <p>
  The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
 </p>
 <p>
  In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.
 </p>
 <p>
  The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS. The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.
 </p>
 <p>
  Benefits of working at the Alliance for Clinical Trials in Oncology Foundation{{:}}
 </p>
 <ul>
  <li>
   8 weeks of paid time off (including PTO, sick, and holidays) during year one
  </li>
  <li>
   Medical, Dental &amp; Vision plans with a 100% employer-paid option for employees
  </li>
  <li>
   Tuition reimbursement stipends
  </li>
  <li>
   Continuing Education
  </li>
  <li>
   3% employer match for retirement investments
  </li>
  <li>
   Annual Employee Performance Bonus Program
  </li>
  <li>
   Annual Cost of Living Adjustment
  </li>
  <li>
   50% commuter reimbursement
  </li>
  <li>
   Healthy Work/Life balance and flexibility
   <br/>
  </li>
 </ul>
 <p>
  <strong>
   ROLE AND RESPONSIBILITIES
  </strong>
 </p>
 <p>
  &bull; Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.
 </p>
 <p>
  &bull; Send, track, and review study-specific and global feasibility questionnaires.
 </p>
 <p>
  &bull; Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.
 </p>
 <p>
  &bull; Track training information and issue trainings for sites and contacts.
 </p>
 <p>
  &bull; Collection of essential documents related to study start-up and review IP release packages.
 </p>
 <p>
  &bull; Prepare for and execute Investigator meetings and other site training programs.
 </p>
 <p>
  &bull; Assist with creation of start-up plans and templates.
 </p>
 <p>
  &bull; Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations.
 </p>
 <p>
  &bull; Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
 </p>
 <p>
  &bull; Accurately enter and manage data within the Clinical Trial Management System (CTMS) by{{:}} tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.
 </p>
 <p>
  &bull; Participate in co-monitoring activities.
 </p>
 <p>
  &bull; Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
 </p>
 <p>
  &bull; Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team
 </p>
 <p>
  &bull; Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
 </p>
 <p>
  &bull; Other related duties as assigned to meet departmental and company objectives.
  <br/>
  <br/>
 </p>
 <strong>
  Requirements
  <br/>
  <br/>
 </strong>
 <p>
  <strong>
   QUALIFICATIONS AND EDUCATION REQUIREMENTS
  </strong>
 </p>
 <p>
  &bull; A minimum of a BA/BS degree is required.
 </p>
 <p>
  &bull; Degree in a health or science major preferred.
 </p>
 <p>
  &bull; 2 - 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
 </p>
 <p>
  &bull; Working knowledge of clinical monitoring responsibilities and procedures.
 </p>
 <p>
  &bull; Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
 </p>
 <p>
  &bull; Proficient in Microsoft Office Suite, especially Word and Excel.
 </p>
 <p>
  <strong>
   PREFERRED SKILLS
  </strong>
 </p>
 <p>
  &bull; Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.
 </p>
 <p>
  &bull; Strong interpersonal, written, and verbal communication skills.
 </p>
 <p>
  &bull; Flexible and adaptable to a small business workplace environment.
 </p>
</div>


Impulse Dynamics

<div><div><b>Clinical Research Associate</b></div>
<div><b>Marlton, NJ</b></div>
<div></div><div><b>Hope is Here!</b></div>
<div>Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company&rsquo;s Optimizer&reg; Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany.</div>
<div></div><div>The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines. Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics. In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers.</div>
<div></div><div><b>How You&rsquo;ll Add Value</b></div>
<ul><li>Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, and electronic or binder preparation for distribution.</li>
<li>Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review</li>
<li>Prepare CST meeting minutes.</li>
<li>Act as a resource for the clinical sites and research monitors for the trial.</li>
<li>Assist with training of site staff who are working on the study.</li>
<li>Collect regulatory documentation and ensure accuracy. Record the receipt of all key study documentation and contact site regarding missing records.</li>
<li>Review various study-related tracking systems to determine and report the status of clinical trial documents.</li>
<li>Collect outstanding documents by contacting the clinical trial sites or working with the field monitors.</li>
<li>Send notifications to the clinical trial sites regarding their IRB renewal dates.</li>
<li>Maintain and audit all study-related files in compliance with department standard operating procedures.</li>
<li>Assist with the follow-up and resolution of noted observations on audit and monitoring reports.</li>
<li>Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories.</li>
<li>Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies.</li>
<li>Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, and Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings.</li>
<li>Review and approve Site Qualification Reports for new clinical trial sites</li>
<li>Train users on the EDC/case report forms and other systems that may be used (<i>i.e.,</i> electronic regulatory Binders).</li>
<li>Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement. Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment.</li>
</ul><div><b>What You&rsquo;re Bringing with You</b></div>
<ul><li>1-2 years of clinical research experience with a bachelor&rsquo;s degree and/or</li>
<li>4 years of clinical research experience with professional certification (CCRP, ACRP)</li>
<li>Experience with communicating with hospital administrators, research nurses, and study coordinators.</li>
<li>Working knowledge of FDA regulations, Good Clinical Practices (GCPs), and all applicable state, local, and federal regulatory requirements.</li>
<li>Experience with IBM EDC, ClinPlus CTMS, Florence e-Binders, Egnyte, and/or other eRegulatory solutions.</li>
<li>Medical device and/or heart failure clinical trials experience preferred.</li>
<li>Bachelor&rsquo;s degree in life sciences or related field preferred or equivalent work experience.</li>
</ul>
<div></div><div><b>Our commitment to you</b></div>
<div>Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that&rsquo;s enjoyable, thorough, and fair. That&rsquo;s our way of inspiring the innovative brightest minds.</div>
<div></div><div>Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere&mdash;we strive to foster an inclusive culture built around the diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.</div><br>
<div>
</div><div><div>Annual Base Salary Range: $ 60,000 - $ 75,000</div><br>
<div></div>
<ul><li>Full Coverage Medical Benefits &ndash; Employee + family contribution is 100% covered by Impulse Dynamics.</li>
<li>Paid Vacation, floating holidays, and sick time.</li>
<li>Paid Holidays</li>
<li>401k Match (up to 6%)</li>
<li>Annual bonus eligibility</li></ul><br>
<div><br>
<i>Unless specifically indicated communicated otherwise in writing, all employees are &ldquo;at-will&rdquo; employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described </i><i>compensation</i><i> and benefits constitute a promise to continue them for the duration of an employee&rsquo;s employment.</i></div></div><br>
<div></div><div><b>Equal Opportunity Employer Statement</b>:</div>
<div>Impulse Dynamics is an equal opportunity employer.</div>
<div></div><div>Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.</div></div><div></div>

Neuralink

<div>
 <p>
  <strong>
   About Neuralink:
  </strong>
 </p>
 <p>
  We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
 </p>
 <p>
  <strong>
   Team Description:
  </strong>
 </p>
 <p>
  The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what&rsquo;s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink&rsquo;s BCI technology for use in people!
 </p>
 <p>
  <strong>
   Job Description and Responsibilities:
  </strong>
 </p>
 <p>
  As a Clinical Research Associate, you'll play a crucial role in pioneering groundbreaking clinical studies. Your work will directly contribute to the planning, execution, and success of innovative trials, from the initial phases of study setup to hands-on clinical monitoring and site management. You'll be visiting sites both in-person and remotely to ensure protocol and regulatory compliance, tackle safety event management, and maintain essential documentation. Collaborating closely with a passionate, cross-functional team, as well as external partners, you'll be at the forefront of Neuralink's mission to push the boundaries of what&rsquo;s possible in clinical research. Additional job responsibilities will include:
  <br/>
 </p>
 <ul>
  <li>
   Conduct site initiation, interim monitoring, and close-out visits (remote and on-site)
  </li>
  <li>
   Ensure clinical studies are conducted in accordance with protocol, GCP, ISO 14155, and applicable regulatory requirements (e.g., 21 CFR Part 812)
  </li>
  <li>
   Verify the accuracy, completeness, and consistency of clinical trial data through source data verification (SDV) and source data review (SDR)
  </li>
  <li>
   Monitor participant safety by reviewing adverse events (AEs), serious adverse events (SAEs), and device deficiencies for completeness and timeliness
  </li>
  <li>
   Ensure sites maintain adequate regulatory documentation, including Investigator Site Files (ISF), informed consent forms, and essential documents
  </li>
  <li>
   Track site performance, enrollment, and data quality metrics; proactively identify risks and implement mitigation strategies
  </li>
  <li>
   Support site training on protocol, investigational device use, and study procedures
  </li>
  <li>
   Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, and Quality teams
  </li>
  <li>
   Ensure timely resolution of data queries and protocol deviations
  </li>
  <li>
   Prepare and maintain monitoring reports and follow-up letters in accordance with timelines
  </li>
  <li>
   Support audit and inspection readiness at the site level
  </li>
 </ul>
 <p>
  <strong>
   Required Qualifications:
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree in life sciences, engineering, or related field
  </li>
  <li>
   5+ years of clinical research experience (device experience strongly preferred)
  </li>
  <li>
   Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulations
  </li>
  <li>
   Experience with electronic data capture (EDC) systems and clinical trial documentation
  </li>
  <li>
   Strong understanding of clinical trial processes, including monitoring and site management
  </li>
  <li>
   Excellent communication, organization, and problem-solving skills
  </li>
  <li>
   Ability to work independently in a fast-paced, evolving environment
  </li>
  <li>
   Up to 30% travel (domestic and occasional international)
  </li>
 </ul>
 <p>
  <strong>
   Preferred Qualifications:
  </strong>
  <strong>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   Experience in neuromodulation, implantable devices, or other Class III medical devices
  </li>
  <li>
   Experience supporting IDE or PMA clinical studies
  </li>
  <li>
   Familiarity with risk-based monitoring approaches
  </li>
  <li>
   Exposure to early feasibility or first-in-human studies
  </li>
  <li>
   Exposure to market approval studies
  </li>
  <li>
   Willingness and ability to travel up to 30&ndash;50% (domestic and occasional international)
  </li>
 </ul>
 <p>
  Expected Compensation:The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees&rsquo; success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
 </p>
 <p>
  Base Salary Range:: $89,000 USD - $148,000 USD
 </p>
 <p>
  <strong>
   What We Offer:
  </strong>
 </p>
 <p>
  Full-time employees are eligible for the following benefits listed below.
 </p>
 <ul>
  <li>
   An opportunity to change the world and work with some of the smartest and most talented experts from different fields
  </li>
  <li>
   Growth potential; we rapidly advance team members who have an outsized impact
  </li>
  <li>
   Excellent medical, dental, and vision insurance through a PPO plan
  </li>
  <li>
   Paid holidays
  </li>
  <li>
   Commuter benefits
  </li>
  <li>
   Meals provided
  </li>
  <li>
   Equity (RSUs)
   <em>
    *Temporary Employees &amp; Interns excluded
   </em>
  </li>
  <li>
   401(k) plan
   <em>
    *Interns initially excluded until they work 1,000 hours
   </em>
  </li>
  <li>
   Parental leave
   <em>
    *Temporary Employees &amp; Interns excluded
   </em>
  </li>
  <li>
   Flexible time off
   <em>
    *Temporary Employees &amp; Interns excluded
   </em>
  </li>
 </ul>
</div>


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