clinical trial associate

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>

Clinical Research Associate

Planet Pharma

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <strong>
  The Opportunity:
 </strong>
 Clinical Trial Assistant I
 <br/>
 <br/>
 This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant I (CTA I), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting into the Director (D) you will play a critical role in ensuring trials and studies align with all applicable standards.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guideline
  </li>
  <li>
   Assist in the development, review, distribution, and archiving of study specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
  </li>
  <li>
   Will lead the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
  </li>
  <li>
   Assist project team(s) with sample management and generate trial progress tracking systems.
  </li>
  <li>
   Tracks and prepare study-specific information utilizing databases, trackers, and other study tools.
  </li>
  <li>
   Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
  </li>
  <li>
   Gather investigator and site information to support study start-up, maintenance, and close-out activities.
  </li>
  <li>
   Assist in contacting investigator sites to provide study specific information.
  </li>
  <li>
   May serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
  </li>
  <li>
   Work with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
  </li>
  <li>
   Liaise with Clinical Supply and other cross functional teams with processing shipments, returns, and assists with in-house drug, specimen, and ancillary supply reconciliation.
  </li>
  <li>
   Support other clinical operations activities as appropriate.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required Skills, Experience And Education
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in biological sciences or health-related field required.
  </li>
  <li>
   1-3 years relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
  </li>
  <li>
   Has knowledge of GCP ICH Guidelines .
  </li>
  <li>
   Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  </li>
  <li>
   Excellent written/verbal communication and interpersonal skills.
  </li>
  <li>
   Demonstrate proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  </li>
  <li>
   Travel may be required (~10%).
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
  </li>
  <li>
   Oncology experience preferred.
  </li>
  <li>
   Attention to detail.
   <br/>
  </li>
 </ul>
 The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
 <br/>
</div>


Clinical Trial Assistant I - CTA

Alcanza Clinical Research

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
<br>
<br>
The <b>Business Development Associate </b>provides support to the Business Development (BD) team. Responsible for developing and fostering business in conjunction with a focus on lead generation for the Business Development Team by supporting and growing the company pipeline.</div><h3 class="jobSectionHeader"><b><br>
Key Responsibilities</b></h3><div><b><br>
Essential Job Duties:</b></div><ul>
<li>Follow up on outstanding pipeline leads</li>
<li>Communicate daily with Sponsors and CRO&rsquo;s for trial pipeline progression</li>
<li>Aid in scheduling pre-site qualification visits, facilitating communication between Sponsors/CRO and site&rsquo;s</li>
<li>Disseminate protocol information and feasibility questionnaire, if available, to site and PI in preparation for all pre-site qualification visits</li>
<li>Update all site activity and enrollment pages post PSV, focusing on any recruitment and financial projection changes</li>
<li>Follow up on awarded trials to leverage network multi &ndash; site awards</li>
<li>Notify the network of all awarded trials</li>
<li>Identify potential investigators at sites who will be submitted for the clinical research trial in conjunction with the Business Development Team.</li>
<li>Review the available study details such as protocol or protocol synopsis for study submissions.</li>
<li>Contact potential investigators/clinical site leaders to discuss study details and protocol to assess the onboarding of the proposed study.</li>
<li>File emails and relevant documents into CRM.</li>
<li>Enter required data points into CRM for trials/site activity and enrollment.</li>
<li>Assist in management of strategizing placement of clinical trials at the sites for prioritization.</li>
<li>Assist in study selection activities at current sites as needed with the assistance of the CROs and sponsors engagement.</li>
<li>Keep Sponsor/CRO notes and updated account information in company databases.</li>
<li>Attend and successfully complete all company training programs; participate in webinars as needed.</li>
<li>Participate in team, department, client, &amp; other meetings as needed.</li>
<li>Communicate and work with clients and all stakeholders (internal &amp; external) in a timely and professional manner.</li>
<li>Maintain confidentiality of patients, customers, and company information.</li>
<li>Perform all other duties as requested or assigned.</li>
<li>Up to 10% travel may be required</li></ul><br>
<h3 class="jobSectionHeader"><b>
Skills, Knowledge and Expertise</b></h3><div><br>
<b>
Minimum Qualifications</b>: An associate&rsquo;s degree AND 1+ years of clinical research or sales experience, OR an equivalent combination of education and experience, is required. Bi-lingual (English / Spanish) proficiency is a plus.<br>
</div><div><b>Required Skills:</b></div><ul>
<li>Proficiency with computer applications such as Microsoft applications, email, web applications, and the ability to type proficiently (40+ wpm).</li>
<li>Strong organizational and time management skills</li>
<li>Must possess exceptional attention to detail.</li>
<li>Well-developed written and verbal communication skills.</li>
<li>Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.</li>
<li>Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.</li>
<li>Must be professional, respectful of others, self-motivated, and have a strong work ethic.</li>
<li>Must possess a high degree of integrity and dependability.</li>
<li>Ability to work under minimal supervision, identify problems and implement solutions.</li>
<li>Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.</li></ul><br>
<h3 class="jobSectionHeader"><b>
Benefits</b></h3><br>
<ul>
<li>
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.</li>
<li>Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.</li></ul><br>
<h3 class="jobSectionHeader"><b>
About Alcanza Clinical Research</b></h3><div>
Alcanza Clinical Research (&ldquo;Alcanza&rdquo;) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.
<br>
<br>
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
<br>
<br>
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
<br>
<br>
<b>Alcanza Clinical Research is an Equal Opportunity Employer</b> that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.</div></div>

Business Development Associate (Clinical Research)

Cedars-Sinai Medical Center

<p></p><div><div><div><div><p><b>Job ID</b> 16205</p>
<p><b>Location</b> California, United States
</p><p><b>Job Category</b> Academic / Research
</p><p><b>Date posted</b> 04/07/2026</p></div></div><p></p><div><br>
<div></div>
</div></div><div><h2 class="jobSectionHeader"><b>Job Description</b></h2><p><b>
Join our team and use your skill with an organization known nationally for excellence in research!</b></p><p>
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.<br>
<br>
<b>Principal Responsibilities:</b></p><p>
Works under the direction of a Clinical Research Coordinator, Research Program Administrator or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.</p><p>
Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.</p><p>
Completes Case Report Forms (CRFs).</p><p>
Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.</p><p>
 Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.</p><p>
Responsible for sample preparation and shipping and maintenance of study supplies and kits</p><p>
 HIPAA regulations and applicable law.</p><p>
May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.</p><h2 class="jobSectionHeader"><b><br>
Qualifications</b></h2><p><b>
Education:</b></p><p>
High School Diploma/GED is required.</p><p>
Bachelor's degree in Science, Sociology, or a related field preferred</p><p><b>
Experience and Skills:</b></p><p>
One (1) year of clinical research related experience is preferred.</p><p>
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.</p><p>
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.</p>
</div><div><div><div><b>Req ID</b> 16205</div>
</div><div><div><b>Working Title</b> Clinical Research Associate I - Spine Research Team - Dept of Orthopaedics</div>
</div><div><div><b>Department</b> Dept of Orthopaedics</div>
</div><div><div><b>Business Entity</b> Cedars-Sinai Medical Center</div>
</div><div><div><b>Job Category</b> Academic / Research</div>
</div><div><div><b>Job Specialty</b> Research Studies/ Clin Trial</div>
</div><p></p><div><div><b>Overtime Status</b> NONEXEMPT</div>
</div><div><div><b>Primary Shift</b> Day</div>
</div><div><div><b>Shift Duration</b> 8 hour</div>
</div><div><div><b>Base Pay</b> $24.00 - $32.86</div></div></div></div><p></p>
<br><div><div><h3 class="jobSectionHeader"><b>Diversity and Inclusion at Cedars-Sinai</b></h3>
<div>
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve &ndash; because that&rsquo;s what our patients, colleagues and communities deserve <b>Quality Care and Research&mdash;For All, By All</b>.</div>
</div><div><h3 class="jobSectionHeader"><b>Cedars-Sinai is an Equal Employment Opportunity employer.</b></h3>
<p>
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at <b>Applicant_Accommodation@cshs.org</b> and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.</p>
<p>
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.</p>
<p>
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.</p></div></div><div></div>

Clinical Research Associate I

Bright Uro

<p>About Bright Uro:<br/></p><p>Bright Uro is a fast-growing medical device startup headquartered in Irvine, CA, on a mission to improve the lives of millions affected by lower urinary tract symptoms (LUTS). We develop cutting-edge diagnostic technology that integrates advanced hardware, intuitive software, and powerful data analytics &mdash; enabling clinicians to gain actionable insights while delivering a better patient experience. We're passionate about advancing urologic care through innovation, and we're building a collaborative, dynamic team to bring transformative solutions to life.<br/></p><p>About the Role:<br/></p><p>The Clinical Research Associate I (CRA I) is an exciting entry point into the world of clinical research at Bright Uro, offering hands-on exposure across the full lifecycle of a clinical study &mdash; from site identification and initiation through data collection and study close-out.<br/></p><p>As a CRA I, you'll work at the intersection of science, patient care, and regulatory rigor. You'll collaborate closely with investigational sites, clinicians, and internal teams to ensure studies are conducted with integrity, precision, and compliance. Whether you're providing real-time case coverage support, training site personnel on investigational devices, or contributing to study protocols and publications, your work will directly support the development of technologies that improve patient outcomes.<br/></p><p>This is a largely travel-based position requiring routine on-site presence at clinical study locations throughout the East Coast. This role is ideal for someone who is detail-oriented, thrives in a dynamic environment, and is eager to grow their clinical research career at a company where their contributions truly matter.<br/></p><p>Duties and Responsibilities:<br/></p><p>The Clinical Research Associate I (CRA I) is responsible for assigned aspects of clinical research, in accordance with, applicable Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). The CRA I will perform the following activities as directed:<br/></p><p>Provide real-time clinical research case coverage support, document case observations and provide summary reports as required.<br/>Ensure study procedures are conducted in accordance with the approved protocol, regulatory requirements, and Bright Uro guidelines.<br/>Contribute to clinical research development such as study protocols, monitoring plans, and other related clinical and regulatory documents.<br/>Assist in the management of investigational sites from identification and selection to study closure including engaging with the site to ensure preparedness for clinical research<br/>Advise and train site personnel in the proper study procedures and use of investigational devices, software applications, and/or study-specific tools as appropriate, including enforcing said training and troubleshooting device or procedural issues during cases.<br/>Serve as an additional point of contact between the site and Bright Uro.<br/>Assist in the planning and conduct of meetings (e.g., Investigator, Data and Safety Monitoring Board, Scientific Advisory Board), as well as the preparation of meeting minutes and reports.<br/>Assist or conduct site initiation visits (SIV) and interim monitoring visits (IMVs) such as preparing agendas, checklists, reports, and follow-up letters as appropriate.<br/>Assist in the formulation of instructional materials and training of clinicians, researchers, and other personnel.<br/>Provide continuous data review of source documents and case report forms (CRFs) (i.e., source data verification [SDV]) to ensure the timely, accurate, and complete collection and submission of study data.<br/>Ensure all required study documentation is completed at various stages of the clinical study (e.g., initiation, close-out) and maintain specific records of research activity for Bright Uro (e.g., Trial Master File [TMF]).<br/>Manage study supplies and ensure remaining study supplies are returned to Bright Uro.<br/>Monitor and track participant enrollment and study progress and attend study visits at investigational sites as appropriate.<br/>Monitor study progress to ensure compliance with the protocol requirements, FDA regulations, and Good Clinical Practice (GCP) to identify, address, and resolve issues and problems as they might occur at the investigational site.<br/>Contribute to scientific posters, publications, and other published materials.<br/>Perform other duties or tasks in clinical, research and development, regulatory, sales, marketing, and client services, or as directed by company leadership.<br/></p><p>Education and/or Work Experience Requirements:<br/></p><p>Must have a minimum of a Bachelor's Degree in a relevant science.<br/>Minimum of 2 years of relevant research experience. Experience may include work in a clinical laboratory, clinic, or pharmacy.<br/>Human Subjects Research and GCP in Medical Devices Certifications must be completed within 30 days of hire.<br/></p><p>Required Qualifications:<br/></p><p>Willingness and ability to travel a minimum of 80% of the time.<br/>Must reside near a major U.S. airport in the U.S. Eastern Time Zone.<br/>Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external stakeholders.<br/>High level of personal and professional integrity, a strong work ethic, and the ability to work independently while managing and prioritizing multiple tasks simultaneously.<br/>Strong organizational skills with keen attention to detail and thorough documentation practices.<br/>Computer proficiency (Microsoft Office &ndash; Outlook, Word, Excel, and PowerPoint).<br/></p><p>Nice to Have:<br/></p><p>Prior startup or early-stage company experience.<br/></p>

Clinical Research Associate I (CRA I) - East Coast-Based

<p></p><div><div><div><div><p><b>Job ID</b> 15988</p>
<p><b>Location</b> California, United States
</p><p><b>Job Category</b> Academic / Research
</p><p><b>Date posted</b> 04/07/2026</p></div></div><p></p><div><br>
<div></div>
</div></div><div><h2 class="jobSectionHeader"><b>Job Description</b></h2><p><b>
Join our team and use your skill with an organization known nationally for excellence in research!</b></p><p>
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.<br>
<br>
<b>Principal Responsibilities:</b></p><p>
Works under the direction of a Clinical Research Coordinator, Research Program Administrator or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.</p><p>
Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.</p><p>
Completes Case Report Forms (CRFs).</p><p>
Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.</p><p>
 Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.</p><p>
Responsible for sample preparation and shipping and maintenance of study supplies and kits</p><p>
 HIPAA regulations and applicable law.</p><p>
May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.</p><h2 class="jobSectionHeader"><b><br>
Qualifications</b></h2><p><b>
Education:</b></p><p>
High School Diploma/GED is required.</p><p>
Bachelor's degree in Science, Sociology, or a related field preferred</p><p><b>
Experience and Skills:</b></p><p>
One (1) year of clinical research related experience is preferred.</p><p>
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.</p><p>
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.</p>
</div><div><div><div><b>Req ID</b> 15988</div>
</div><div><div><b>Working Title</b> Clinical Research Associate I, Per diem - Spine Research Team - Dept of Orthopaedics</div>
</div><div><div><b>Department</b> Dept of Orthopaedics</div>
</div><div><div><b>Business Entity</b> Cedars-Sinai Medical Center</div>
</div><div><div><b>Job Category</b> Academic / Research</div>
</div><div><div><b>Job Specialty</b> Research Studies/ Clin Trial</div>
</div><p></p><div><div><b>Overtime Status</b> NONEXEMPT</div>
</div><div><div><b>Primary Shift</b> Day</div>
</div><div><div><b>Shift Duration</b> 8 hour</div>
</div><div><div><b>Base Pay</b> $24.00 - $32.86</div></div></div></div><p></p>
<br><div><div><h3 class="jobSectionHeader"><b>Diversity and Inclusion at Cedars-Sinai</b></h3>
<div>
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve &ndash; because that&rsquo;s what our patients, colleagues and communities deserve <b>Quality Care and Research&mdash;For All, By All</b>.</div>
</div><div><h3 class="jobSectionHeader"><b>Cedars-Sinai is an Equal Employment Opportunity employer.</b></h3>
<p>
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at <b>Applicant_Accommodation@cshs.org</b> and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.</p>
<p>
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.</p>
<p>
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.</p></div></div><div></div>

Clinical Research Associate I, Per diem

Zymeworks Inc

<div><p><b>Company Description</b><br>
Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company&rsquo;s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera&reg; (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines.<i> </i>We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore.</p><p></p><p><b><br>
Why Work With Us</b></p><p>
Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.</p><p><br>
This role will be located in either Vancouver, BC or Bellevue, WA or New York, or Singapore and is hybrid with a minimum of 3 days per week onsite.</p><p><b><br>
What You'll Do</b></p><ul><li>
With appropriate supervision, manages the design and implementation of study protocols for a clinical development program, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues. Oversees project-related education of investigators, study site personnel, and study staff.</li><li>
Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the asset.</li><li>
Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.</li><li>
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area</li><li>
Support database design and contribute to case report form (CRF) completion guidelines</li><li>
Educate internal study team members, clinical sites on protocol requirements.</li><li>
Collaborate with the Clinical Trial Manager (CTM) to support study start-up, conduct, and close-out activities</li><li>
Provide scientific input into vendor scope of work (SOW), contracts, and study charters</li><li>
Partner with vendors to ensure delivery of high-quality data and scientific integrity of services</li><li>
Perform ongoing clinical data review, including protocol deviations, to ensure data quality, accuracy, and scientific validity</li><li>
Identify data trends, summarize findings, and escalate clinical or medical concerns to the Medical Monitor as appropriate</li><li>
Review MedDRA and WHODRUG coding to ensure consistency and accuracy</li><li>
Represent Clinical Development on cross-functional study teams and at internal or external meetings</li><li>
May be asked to contribute to regulatory responses and discussions.</li><li>
Contribute to continuous improvement of clinical processes and study execution</li><li>
Perform other duties as assigned</li></ul><p><b>
What You'll Bring</b></p><ul><li>
Advanced degree in life sciences or a clinical field (e.g., RN, NP/ARNP, PharmD, Physician Assistant, PhD, MD, or equivalent) required</li><li>
Minimum of 2+ years of relevant experience in the biopharmaceutical industry or a comparable clinical research setting preferred</li><li>
Oncology experience strongly preferred</li><li>
Strong ability to interpret and analyze clinical data with a focus on scientific rigor</li><li>
Solid understanding of clinical development processes, GCP, and regulatory requirements</li><li>
Proficiency in medical terminology</li><li>
Demonstrated ability to assimilate complex scientific information quickly</li><li>
Excellent analytical, problem-solving, and critical thinking skills</li><li>
Strong written and verbal communication skills, with the ability to clearly convey scientific information</li><li>
Highly collaborative with the ability to work effectively in cross-functional teams</li><li>
Strong organizational skills, attention to detail, and commitment to data accuracy</li><li>
Ability to manage multiple priorities in a fast-paced environment and adapt to changing needs</li><li>
Proficiency with Microsoft Office Suite</li></ul><p><b>
Total Rewards</b></p><p>
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.</p><p><br>
The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate&rsquo;s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).</p><p></p><p><br>
Our total rewards package that includes:</p><ul><li>
Industry leading vacation and paid time off</li><li>
Exceptional medical, dental and vision benefits by country</li><li>
Zymelife health and wellness benefits</li><li>
Matching RRSP / 401K / Pension program</li><li>
Employee Share Purchase Program</li><li>
Employee Equity Program</li><li>
Paid time off to volunteer in your community</li></ul><p></p><p><br>
This role is not eligible for relocation or immigration support.</p><p></p><p><br>
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.</p><p></p><p><b><br>
NOTE TO AGENCIES:</b> Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.</p><b><br>
The pay range for this role is:</b><br>
93,750 - 143,750 CAD per year(CA)<br>
97,500 - 149,500 USD per year(US)</div>

Clinical Scientist

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