clinical trial associate

Minerva Research Solutions

<div><p><b>JOB DESCRIPTION:</b><br>
<br>
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.</p><p>
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements.<br>
<br>
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.<br>
<br>
Minerva Research Solution is looking for dynamic individuals with a passion for ensuring the highest standards in clinical trial data quality assurance. As a key player in our team, you will play a crucial role in maintaining the integrity and accuracy of clinical trial data.</p><p><b>
Responsibilities:</b></p><ul><li>
Perform comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.</li><li>
Ensure data is recorded under sponsor protocol, GCP guidelines, industry guidelines, and agency regulations.</li><li>
Perform quality control checks; identify and track source documentation errors and non-conformances with requirements.</li><li>
Provide ongoing compliance support including but not limited to:</li><li>
Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans.</li><li>
Collaborating with the Clinical Team to share audit/inspection observations for lessons learned across protocol, and/or program, and working with appropriate groups to implement Corrective Action Plans (CAPAs).</li><li>
Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities.</li><li>
Assist in preparing for all Sponsor and FDA audits.</li><li>
Assist in conducting internal audits to review key processes.</li><li>
Provide appropriate support to assigned cross-functional workgroups.</li><li>
Establishes effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement.</li><li>
Query resolution and data entry and questionnaire preparation regarding the respective studies.</li><li>
Other related Quality Assurance projects as assigned.</li><li>
The QA Associate will report to the Quality Assurance Lead</li></ul><p><b>
Knowledge, Education, and Experience:</b></p><ul><li>
Qualified Profession with strong medical background (Pharm-D, MBBS, BDS etc) with a keen interest in Clinical Research are strongly encouraged to apply.</li><li>
In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials.</li><li>
Knowledge of IRB requirements.</li><li>
1+ years in work related to Quality Control / Quality Assurance area in clinical research will preferred..</li><li>
Experience including external clinical/regulatory and document auditing will be a plus</li></ul><p><b>
Skills and Abilities:</b></p><ul><li>
Good communication skills (interpersonal, written, verbal)</li><li>
Strong attention to detail and good time management skills</li><li>
Flexible attitude concerning work assignments</li><li>
Ability to manage multiple and varied tasks in a fast-moving environment</li><li>
Ability to interact professionally at all levels within the organization.</li><li>
Knowledge of the HIPAA Privacy Act and its application to clinical research.</li></ul><b>
Benefits:</b><ul><li>
Competitive salary and performance-based bonuses.</li><li>
Medical health insurance coverage.</li><li>
Employees Old-age benefits coverage.</li><li>
Flexible work hours and remote work options.</li><li>
Professional learning and development support.</li><li>
Generous vacation and paid time off.</li><li>
Employee assistance programs for mental health.</li><li>
Company-sponsored events and team-building activities.</li><li>
Diverse, professional, and inclusive work environment.</li><li>
Opportunities for career growth.</li><li>
Cutting-edge technology and tools.</li><li>
Family-friendly policies, including parental leave.</li><li>
Commuter benefits or transportation assistance.</li><li>
Social responsibility and community involvement programs.</li></ul><b>
Openings:</b><p>
04 positions<br>
Full-time<br>
On-site job<br>
<br>
<b>Work Schedule Timings:</b><br>
Monday to Friday<br>
Evening Shift (06 PM to 02 AM)<br>
(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)</p><p>
</p><p>AjYqzsoJFy</p></div>

Clinical Trials Quality Assurance Associate (Night)

CTI Clinical Trial and Consulting

<div><div><b>Clinical Research Associate (level dependent on experience)</b><br>
<br>
<b>Job Purpose/Summary</b></div>
<div><br>
As a CRA you will be responsible for the successful conduct of clinical trials and serve as the main contact for the investigative site by representing CTI in a professional manner.</div>
<div></div><div><b>What You&rsquo;ll Do</b></div>
<ul><li>Conduct evaluation, initiation, monitoring and close out visits</li>
<li>Assist with regulatory and study start-up activities including contract and budget negotiations</li>
<li>Ensure clinical data integrity and meet study timelines</li>
<li>Provide ongoing updates and support to project management</li>
<li>Attend global project meetings including investigator meetings and global team teleconferences</li>
<li>Complete assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.</li>
</ul><div><b>What You Bring</b></div>
<ul><li>2 - 3 years of clinical research experience as a CRA or related profession</li>
<li>Life science background</li>
<li>Excellent knowledge in ICH-GCP and regulatory requirement</li>
<li>Fluent in English</li>
</ul><div><b>Why CTI?</b></div>
<div>At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.</div>
<div></div><div>For that reason, we treat our team members with the respect they deserve, and our numbers show it:</div>
<ul><li>We support career progression &ndash; We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward</li>
<li>We value education and training &ndash; We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department</li>
<li>We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.</li>
<li>Our culture is unparalleled &ndash; We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry</li>
<li>We think globally and act locally &ndash; With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.</li>
<li>We are looking toward the future &ndash; We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs</li>
<li>Our work makes a difference &ndash; We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market</li>
</ul><div><div><div><div>Are you interested? Then we look forward to your electronic application, with a tabular CV in English.<br>
<br>
<b>CTI Clinical Trial and Consulting Services</b><br>
<br>
Filipa Magalh&atilde;es<br>
<br>
www.ctifacts.com</div></div></div></div></div>

Clinical Research Associate (level dependent on experience)

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

ICON plc

<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>

Clinical Research Associate

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