clinical research associate

Venesco, LLC

<div>Description:
<p><b>
Clinical Research Associate</b></p><p>
Venesco LLC is seeking a <b>Clinical Research Associate</b> (CRA) to provide clinical monitoring and oversight support to ensure studies are conducted in compliance with protocols, Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and sponsor requirements.</p>
Requirements:
<p><b>
Duties and Responsibilities</b></p><ul><li>
Conduct site qualification, initiation, monitoring, and closeout visits.</li><li>
Perform source data verification (SDV).</li><li>
Review informed consent documentation and study records.</li><li>
Evaluate protocol compliance and identify deviations.</li><li>
Review regulatory binders and essential documents.</li><li>
Generate clinical monitoring reports and follow-up letters.</li><li>
Support site training and communication activities.</li><li>
Track and assist with CAPA implementation.</li><li>
Support audit and inspection readiness.</li><li>
Maintain study documentation and monitoring files.</li></ul><p><b>
Minimum Qualifications</b></p><ul><li>
Bachelor's degree in Life Sciences, Nursing, Public Health, or related discipline.</li><li>
Minimum 3 years of clinical monitoring experience.</li><li>
Knowledge of FDA regulations, ICH-GCP, and clinical research practices.</li><li>
Strong written and verbal communication skills.</li><li>
Ability to travel CONUS and OCONUS.</li></ul><p>
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.</p><p>
For more information on Venesco, LLC., visit https://venesco.com.</p></div>

Clinical Research Associate

ICON plc

<div>Clinical Research Associate - Miami, FL<br>
<br>
<p>ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.</p><br>
<br>
<p>As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.</p><br>
<br>
<p>As a CRA II at ICON, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. This position is sponsor dedicated supporting our client monitoring cardio and obesity trials. Must be located in Miami, FL.</p>
<p></p><p><b>What You Will Do:
</b></p><p></p><p>You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.
<br>
<br>
Key responsibilities include:</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></p><p><b>Your Profile:
</b></p><p></p><p>You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills.
<br>
<br>
Required qualifications and experience:</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>Willingness to travel as required (approximately 60%)</li><br>
</ul><br>
<p>Employment with ICON is contingent upon having the legal right to work in the country where the role is based.</p><br>
<br>
<p><b>Rewards &amp; Benefits
</b></p><p>ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.</p><br>
<br>
<p>Benefits may include:</p>
<ul><li>Competitive base salary and performance related incentives</li>
<li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li>
<li>Retirement and pension plans</li>
<li>Life assurance and disability coverage</li>
<li>Employee assistance programmes and wellbeing resources</li>
<li>Learning and development opportunities through structured training and career pathways</li><br>
</ul><br>
<p>Benefits may vary depending on role and location.</p><br>
<br>
<p>Visit our careers site to read more about the benefits ICON offers.</p><br>
<br>
<p><b>Inclusion and Accessibility
</b></p><p>ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.</p><br>
<br>
<p>If you require reasonable accommodations during the recruitment process, please let us know or submit a <b>request </b>.</p>
<p></p><p>Are you a current ICON Employee?</p></div>

RQM+

<div><p>RQM+ is <i>The</i> MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients &mdash; faster, safer, better.</p>
<p>We don&rsquo;t make MedTech. We make MedTech happen.</p>
<p>Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.</p>
<p><b>Job Summary:</b></p>
<p>The Clinical Research Associate II (CRA II) participates in the preparation and execution of pre-market to post market clinical trials. Oversees the progress of clinical investigations by conducting site qualification, initiation, interim and close out visits to clinical sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by RQM+ and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.</p>
<p><b>Primary Responsibilities:</b></p>
<ul><li>Collaborates with the start-up department to coordinate activities with assigned sites in preparation for the initiation of the study.</li>
<li>Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.</li>
<li>Works with start-up, project team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.</li>
<li>Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities.</li>
<li>Trains site staff on the EDC system.</li>
<li>Assists in resolving any issues to ensure compliance with site file audits in conjunction with eTMF.</li>
<li>Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.</li>
<li>Performs validation of source documentation as required by sponsor and prepares monitoring reports and letters per the timelines defined in RQM+ SOPs by using approved templates and reports.</li>
<li>Documents accountability, stability and storage conditions of investigational and commercial product inventory as required by sponsor.</li>
<li>Ensures return of unused study product to designated location or verifies destruction as required.</li>
<li>Reviews the quality and integrity of the clinical data through in-house review of electronic CRF data and on-site or remote source verification.
</li><li>Works with sites to resolve data queries.</li>
<li>Serves as primary contact between RQM+, sponsor and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.</li>
<li>Performs study close-out visits per the study specific Clinical Monitoring Plan including final study product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.</li>
<li>Assists with, and attends, Investigator Meetings for assigned studies.</li>
<li>Authorized to request site audits due to data integrity concerns.</li>
<li>Attends study-related, company, departmental, and external meetings, as required.</li>
<li>Ensures internal and study-related trainings are completed per RQM+ process and/or study timelines, including updating the study level trial management system.</li>
<li>Ensures all study deliverables are completed per RQM+ and study timelines.</li>
<li>Serves as mentor for junior staff and those new to the company and/or study.</li>
<li>Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate</li>
<li>Performs other duties, as requested</li>
</ul>
<p><b>Education/Work Experience/Requirements:</b></p>
<ul><li>Bachelor's Degree in scientific discipline or health care preferred.</li>
<li>Requires at least 2 years of on-site monitoring experience.</li>
<li>In-house or remote monitoring experience preferred.</li>
<li>Equivalent combination of education, training and experience considered</li>
<li>In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Clinical Trial Regulation, Good Clinical Practice (ICH-GCP) guidelines and international standards like ISO 14155. MedTech regulations and active experience preferred.</li>
<li>Strong therapeutic and protocol knowledge as provided in company training.</li>
<li>Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required.</li>
<li>Written and verbal communication skills including command of English language.</li>
<li>Organizational and pragmatic problem-solving skills</li>
<li>Effective time and financial management skills</li>
<li>Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff and sites.</li>
<li>Ability to act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate</li>
<li>Ability to travel up to 60-75%</li>
</ul>
<p><b>Behaviors: </b>Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity &amp; Trust, Interpersonal Savvy, Planning</p>
<p><b>Supervisory Responsibilities: </b>This position does not have supervisory responsibilities.</p>
<p><b>Work Environment &amp; Physical Requirements:</b> This role involves regular travel to client and partner sites, which may include varying office and facility environments. The employee should be able to travel independently, navigate different facility types, and occasionally lift or carry items up to 20 lbs. (e.g., equipment, materials, luggage).</p>
<p>These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know &mdash; we're happy to discuss options.</p>
<p>Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!</p>
<p>We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.</p>
<p><b>Job Opportunity Verification</b></p>
<p>At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:</p>
<p>All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers</p>
<p>Every candidate going through the interview process will participate in a voice and/or video interview.</p>
<p>Exercise caution with unsolicited job offers or requests for sensitive information.</p></div>

Clinical Research Associate II

Natera

<div><p><b>POSITION SUMMARY:</b></p>
<p><b>
The Senior Clinical Research Associate is</b> responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion. This position will perform required job duties with guidance from Clinical Trial Managers to ensure that trial timelines, costs, and quality metrics are met, and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements helps design and execute clinical research activities.</p><br>
<p></p>
<p><b>
PRIMARY RESPONSIBILITIES:</b></p>
<ul>
<li><p>Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations</p>
</li>
<li><p>Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required</p>
</li>
<li><p>Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight</p>
</li>
<li><p>Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC</p>
</li>
<li><p>Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements</p>
</li>
<li><p>Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
</p></li><li><p>Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues</p>
</li>
<li><p>Monitor and track clinical trial progress, provide status updates to stakeholders</p>
</li>
<li><p>Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies</p>
</li>
<li><p>Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where Natera functions as a Clinical Research Site.</p>
</li>
<li><p>Update Clinical Department SOPs with guidance from CTM and/or Director</p>
</li>
<li><p>Partner with other research and development groups at Natera to achieve deliverables</p>
</li>
<li><p>Perform other duties as assigned</p>
</li>
<li><p>This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.</p>
</li>
<li><p>Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP.</p>
</li>
<li><p>Must maintain a current status on Natera training requirements including General Policies, Procedure Compliance, and security training</p>
</li>
<li><p>Employee must pass post offer criminal background check<br>
</p></li></ul><p></p><p><b>QUALIFICATIONS:</b></p>
<ul>
<li><p>BA/BS degree in life sciences, related field, or equivalent</p>
</li>
<li><p>Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields</p></li></ul><br>
<p>
</p><p><b>KNOWLEDGE, SKILLS AND ABILITIES:</b></p>
<ul>
<li><p>Experience with clinical EDC systems,</p>
</li>
<li><p>Familiarity with the organization and structure of the Trial Master File (TMF)</p>
</li>
<li><p>Familiarity with bio sample management, sample processing, and biobanking best practices</p>
</li>
<li><p>Competency in SOPs, ICH-GCP, FDA Regulations</p>
</li>
<li><p>Proficiency in MS Word, Excel and PowerPoint</p>
</li>
<li><p>Demonstrated ability to work independently and lead projects</p>
</li>
<li><p>Demonstrated analytical skills and ability to identify complicated problems and propose solutions</p>
</li>
<li><p>Strong interpersonal skills and communication skills (both written and oral)</p>
</li>
<li><p>Excellent writing skills</p>
</li>
<li><p>Detail oriented, with solid organization and time management skills</p></li></ul><br>
<p>
</p><div><p><b>OUR OPPORTUNITY</b></p>
<p>
Natera&trade; is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.</p>
<p>
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.</p>
<p><b>
WHAT WE OFFER</b></p>
<p>
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!</p>
<p>
For more information, visit www.natera.com.</p>
<p>
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.</p>
<p>
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.</p>
<p><i>
If you are based in California, we encourage you to read this important information for California residents.</i></p>
<p>
Link: https://www.natera.com/notice-of-data-collection-california-residents/</p>
<p>
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.</p>
<div>
For more information:<br>
<ul><li>BBB announcement on job scams</li><li>FBI Cyber Crime resource page</li></ul></div></div></div>

Senior Clinical Research Associate

Protagonist Therapeutics

<div><div><b>Onsite Clinical Research Associate</b></div>
<div></div><div><b>Job Summary</b></div>
<ul><li>Support ongoing trials and/or set-up and manage new trials.</li>
<li>Contributions include:
<ul><li>study planning and start-up,</li>
<li>project, site and vendor management</li>
<li>oversight of study site monitoring and performance</li>
<li>clinical operations input into the general clinical development of Protagonist compounds.</li>
</ul></li></ul><div><div><b><i>Must be willing to be onsite 5 days a week.</i></b></div>
</div>
<div></div><div><b>Skills &amp; Attributes</b></div>
<div><br>
Clinical trial experience that includes international Phase 1-2 trials, involving CROs from study set-up through to completion. Experience with Gastrointestinal, hematology and/or orphan drug trials preferred. High level of appreciation and understanding of the feasibility, regulatory and start-up processes, together along with on-site monitoring and site management. Good overall understanding of the major areas within clinical development. Excellent communication and interpersonal skills, along with attention to detail and critical thinking skills. Strong written and spoken English. Ability to collaborate, problem solve and work in a small dynamic organization with minimal supervision, to achieve personal and collective goals.</div>
<div><br>
<b>Experience Required</b></div>
<div>2+ years as a CRA within Biotech/Pharma or CRO</div>
<div></div><div><b>Education Required</b><br>
Bachelors Degree<br>
</div><div><b>Travel Required</b><br>
Yes, up to 10%</div>
<div></div><div><b>Core Responsibilities</b></div>
<ul><li>Serves as the internal primary site operations lead, working with the Project Manager and CROs to achieve efficient study set-up and initiation, ongoing data monitoring all the way through successful study execution and site close-out.</li>
<li>Oversight of the site feasibility activities leading to site selection, activation and routine monitoring activities to ensure ongoing data integrity and quality.</li>
<li>Develops and reviews integrated site plans/timelines and reports weekly progress including risks and mitigations</li>
<li>Develops contingency plans for site performance, with regards to recruitment, data quality etc.</li>
<li>Helps ensure the trial stays within the contracted site management scope, progress, timelines and budget.</li>
<li>Presents site management strategy and status/metrics at project meetings.</li>
<li>Monitors and reports on CRO CRA resource utilization, and analyzes expected vs. actual performance</li>
<li>Implements and leverages best monitoring practices</li>
<li>Experience and proficiency with Good Clinical Practices (cGCP) and compliance with Protagonist SOPs</li>
<li>Works closely and effectively with other cross-functional teams to identify best practices and process improvements.</li>
<li>Proficiency with MS Office computer software</li>
<li>Other duties and assignments as requested for the overall performance of the function and Company.</li>
</ul><div>The base pay range for this position at commencement of employment is expected to be between $125K and $135K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.</div>
<div></div><div>Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE&trade; (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc.,a Johnson &amp; Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson &amp; Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson &amp; Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.</div>
<div></div><div>More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.</div></div><div></div>

On-site Clinical Research Associate

IQVIA

<div>
 <em>
  <strong>
   IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring and will also consider CRA 1 candidates with a minimum of 6 months on-site monitoring experience. Must have experience monitoring in oncology solid tumor.
   <br/>
   <br/>
  </strong>
 </em>
 <em>
  IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
  <br/>
  <br/>
 </em>
 <strong>
  Job Overview
  <br/>
  <br/>
 </strong>
 We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Conduct all types of site visits&mdash;selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
  </li>
  <li>
   Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
  </li>
  <li>
   Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
  </li>
  <li>
   Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
  </li>
  <li>
   Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
  </li>
  <li>
   Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
  </li>
  <li>
   Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
  </li>
  <li>
   Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
  </li>
  <li>
   Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in life sciences or health-related field (or equivalent experience).
  </li>
  <li>
   Requires at least 1 year of on-site monitoring experience.
  </li>
  <li>
   Strong understanding of GCP, ICH guidelines, and regulatory requirements.
  </li>
  <li>
   Ability to travel as required by the project.
   <br/>
   <br/>
  </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 <br/>
 <br/>
 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
 <br/>
 <br/>
 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
 <br/>
 <br/>
 The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
</div>


Clinical Research Associate, IQVIA Biotech

Penumbra

<div><div><b>General Summary</b></div>
<div>The Field Clinical Research Associate III participates in the designing and executing of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This position works with confidential patient and company data, and interfaces with a variety of internal and external stakeholders. This opportunity is open to qualified applicants across the US. Regretfully, sponsorship is not available for this position.</div><br>
<div></div>
<div></div>
<div><b>Specific Duties and Responsibilities</b></div>
<ul><li>Serve as the site manager, ensuring data entry and query resolution within a timely manner, as well as ensure the overall high-quality data is reported and audit readiness at the clinical site. *</li></ul>
<ul><li>Participates in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring, and final close out visits. *</li></ul>
<ul><li>Monitors, onsite and remotely, ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting. *</li></ul>
<ul><li>Prepares and participates in presentation of protocols and other study conduct requirements at study initiation visits, including training at investigational sites when needed. *</li></ul>
<ul><li>Manages device accountability, inventory, and distribution, with some oversight responsibilities of device complaint/malfunction processing and tracking. *</li></ul>
<ul><li>Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra trial master file, and for audit readiness. *</li></ul>
<ul><li>Conducts site visits as necessary. Acting as a company liaison, works with clinical sites to resolve any site related issues quickly and effectively. *</li></ul>
<ul><li>Assists Clinical team with the development, approval, and distribution of study-related documents including Case Report Forms (CRF&rsquo;s), study protocols, study manuals, and other study tools to investigational sites and review committees. *</li></ul>
<ul><li>Drafts informed consents with minimal supervision from Clinical Management. *</li></ul>
<ul><li>Provides mentoring to junior staff regarding protocols, site management/monitoring, etc.*</li></ul>
<ul><li>Participates in maintaining project timeline and preparing routine operations reports. *</li></ul>
<ul><li>Collaborates in the development and/or maintenance of Clinical infrastructure such as</li></ul>
<div>the drafting or reviewing of SOP&rsquo;s and Work Instructions. *</div>
<ul><li>Adhere to the Company&rsquo;s Quality Management System (QMS) as well as domestic and</li></ul>
<div>global quality system regulations, standards, and procedures. *</div>
<ul><li>Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *</li></ul>
<ul><li>Ensure other members of the department follow the QMS, regulations, standards, and procedures. *</li></ul>
<ul><li>Perform other work-related duties as assigned. *</li></ul>
<ul><li><i>Indicates an essential function of the role</i></li></ul><br>
<div></div>
<div></div>
<div><b>Position Qualifications</b></div>
<div><b>Minimum education and experience:</b></div>
<ul><li>Bachelor&rsquo;s degree required, with a major in Biological sciences or a health-related field (e.g., Biology, chemistry, Biochemistry, nursing, Biomedical or Veterinary Sciences) with 5+ years of experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required, and 2+ years of clinical monitoring experience required or equivalent combination of education and experience.</li></ul>
<div></div>
<div><b>Additional qualifications:</b></div>
<ul><li>Strong knowledge of medical terminology required.</li></ul>
<ul><li>Strong knowledge of laws, regulations, standards and guidance governing the conduct of clinical studies preferred.</li></ul>
<ul><li>Excellent verbal, written, and interpersonal communication skills.</li></ul>
<ul><li>Strong organizational and problem-solving skills with ability to prioritize assignments while handling various projects simultaneously; keen attention to detail.</li></ul>
<ul><li>Advanced level of competence in Word, Excel, PowerPoint or equivalent programs.</li></ul>
<ul><li>Ability to work on teams and with multiple projects.</li></ul>
<ul><li>Ability to provide guidance and mentoring to junior Clinical staff.</li></ul><br>
<div></div>
<div></div>
<div><b>Working Conditions</b></div>
<ul><li>General office, laboratory, and hospital environments.</li></ul>
<ul><li>Approximately 40-60% travel to research laboratories or hospitals, conferences and /or other Penumbra affiliated facilities.</li></ul>
<ul><li>Potential exposure to blood-borne pathogens and other potentially infectious materials.</li></ul>
<ul><li>The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.</li></ul><br>
<div></div>
<div></div>
<div><b>Annual Base Salary Range: $113,000 - $140,000</b></div>
<div>This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range<i>.
</i></div><div>We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</div><br>
<div></div>
<div></div>
<div><b>What We Offer</b></div>
<ul><li>A collaborative teamwork environment where learning is constant, and performance is rewarded.</li></ul>
<ul><li>The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.</li></ul>
<ul><li>A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&amp;D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).</li></ul>
<div></div>
<div>Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.</div>
<div></div>
<div>Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.</div>
<div></div>
<div>If you reside in the State of California, please also refer to <b>Penumbra's Privacy Notice for California Residents.</b></div>
<div></div>
<div>For additional information on Penumbra&rsquo;s commitment to being an equal opportunity employer, please see <b>Penumbra's AAP Policy Statement.</b></div></div>

Field CRA III (Field Clinical Research Associate III )

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