clinical research associate

Alameda Health System

<div><div><div><p><b>SUMMARY: </b>Under direction of the Manager of Grants &amp; Special Projects, the Clinical Research Associate coordinates all aspects of clinical trials within the assigned unit.at the Adult Immunology Clinic, Highland Campus. In consultation with providers and other clinical personnel, is responsible for selecting, implementing and monitoring clinical trials, educating, and when appropriate, enrolling patients into the various programs. Performs related duties as required.</p>
<p><b>DUTIES &amp; ESSENTIAL JOB FUNCTIONS:</b> NOTE:<b> </b>The following are the duties performed by employees in this classification. However, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification.</p>
<p>CLINICAL TRIALS:<b> </b>Responsible for assisting in the selection and administration of appropriate clinical research trials by reviewing studies, adhering to federal regulations and ICH Guidelines, with an emphasis on good clinical practice and clinical Safety Data Management. Administers informed consent, enrollment of participants into clinical trials.</p>
<p>INSTITUTIONAL REVIEW BOARD (IRB): Acts as departmental representative at Institutional Review Board&rsquo;s Human Subject Committee meetings. Presents all new research projects to the committee. Modifies, renews and closes out all appropriate research projects. Reports all serious adverse events and protocol violations. Submits drug and/or device safety reports to the IRB.</p>
<p>REGULATORY: Organizes research team and meets as needed. Maintains current CVs and licenses for all study investigators. Updates regulatory binders for each research study. Provides central protocol and drug information to departments. Educates hospital personnel regarding protocols and screening requirements. Reports serious adverse events to study sponsor and FDA, when appropriate. Ensures compliance with all federal and state laws regarding research and confidentiality. In collaboration with nursing staff, assures that operations are in compliance with external guidelines, statutory and accreditation parameters including JCAHO, Title 22, HCFA, OSHA, and other laws/regulations</p>
<p>PRESENTATION AND PUBLICATIONS: Assists investigators in the preparation of manuscripts and the design of posters and oral presentations for annual conventions, conferences and trainings, when appropriate. Performs searches through existing medical literature.</p>
<p>ADMINISTRATIVE/FISCAL: Organizes research team (nurses, co-investigators) and meets with team, as needed. Maintains current CVs and licenses for all sub investigators and binders for each protocol. Acts as the point person for budgetary and administrative issues. When appropriate, prepares and negotiates study budget. Monitors and accounts for all study related income and expenses. Requests and administers patient compensation and petty cash. Provides scheduled accounting of research funds to department directors. Interacts with AHS staff in a professional and courteous manner. Supervises research personnel to ensure compliance with protocols. Obtains, interview, and directly supervise research department volunteers and medical students on research elective rotations.</p>
<p><b>MINIMUM QUALIFICATIONS:</b></p>
<p>Education: Bachelor&rsquo;s Degree (180 quarter units or 120 semester units) with major coursework in health and human sciences, biology or a field related to the work. (Additional experience as outlined below may be substituted for the education on a year-to-year basis.)</p>
<p>Minimum Experience: Possess experience and expertise in medical research. Experience and expertise can be gained by &ldquo;hands-on experience&rdquo; in a medical or scientific setting, as a graduate or medical student or other medically trained individual. Typically equal to the equivalent of two years of full-time experience as a Clinical Research Associate or equivalent level position at a public hospital, medical center or HMO.</p>
<p>Required Licenses/Certifications: BLS - Basic Life Support Certification issued by AHA-American Heart Association.</p></div><br>
</div><br>
Location: Alameda Health System &middot; HGH Opioid Use Disorder Grant<br>
Schedule: Full Time, Day</div>

Clinical Research Associate

Grifols

<div></div><div><div><div><div><div><p>Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.</p></div></div><div><br>
<div></div>
</div><br>
</div></div><p><b>Position Summary</b></p>
<p>
The Clinical Research Associate 4 (CRA 4) provides advanced oversight and leadership in the execution of clinical trials. This role ensures adherence to ICH/GCP guidelines, regulatory requirements, company SOPs, and study protocols while guiding the successful management of U.S. clinical studies or designated components of larger global programs. As an experienced clinical operations professional, the CRA 4 leads cross‑functional collaboration, manages CROs and vendors, and supports the development of key study documents and processes.</p><br>
<p></p>
<p>
The Clinical Research Associate 4 may provide guidance and oversight for the successful management of all aspects of smaller U.S. studies and/or work with study manager to provide oversight and guidance of specific areas of larger studies.</p><br>
<p></p>
<p><b>
Key Responsibilities</b></p>
<p>
Study Oversight &amp; Execution</p>
<ul>
<li><div><ul><li>Provide leadership and oversight for all operational aspects of assigned clinical studies.</li>
<li>Draft and coordinate review of protocols, informed consent forms, case report forms, monitoring plans, and investigator brochures.</li>
<li>Maintain study timelines and ensure milestones are met.</li>
<li>Lead meetings and conference calls with CROs, vendors, and cross‑functional teams.</li>
<li>Manage CROs and vendors, including performance oversight and issue resolution.</li>
<li>Contribute to development of site and study budgets, RFPs, and vendor selection.</li></ul></div></li><br>
</ul>
<p></p><p>Monitoring &amp; Site Management</p>
<ul>
<li><div><ul><li>Monitor and/or co‑monitor clinical sites as needed to ensure study integrity and compliance.</li>
<li>Train CRO staff, vendors, investigators, and study coordinators on study requirements.</li>
<li>Review data listings and support preparation of interim and final clinical study reports.</li>
<li>Ensure proper documentation, including monitoring reports, follow‑up letters, and site correspondence.</li></ul></div></li><br>
</ul>
<p></p><p>Cross‑Functional Collaboration</p>
<ul>
<li><div><ul><li>Serve as a functional lead interacting with data management, safety, regulatory, and other internal groups.</li>
<li>Support risk management planning and contribute to continuous improvement of study processes.</li></ul></div></li><br>
</ul>
<p></p><p>Documentation &amp; Quality</p>
<ul>
<li><div><ul><li>Ensure high‑quality documentation and adherence to regulatory and SOP requirements.</li>
<li>Support audit and inspection readiness activities.</li>
<li>Oversee distribution and tracking of study drug and clinical supplies.</li></ul></div></li><br>
</ul>
<p></p><p><b>Required Knowledge, Skills, and Abilities</b></p>
<ul>
<li>Advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and ICH/GCP.</li>
<li>Strong verbal and written communication skills.</li>
<li>Ability to train and mentor junior CRAs and external partners.</li>
<li>Ability to work independently and collaboratively across functions.</li>
<li>Strong decision‑making, prioritization, and organizational skills.</li>
<li>Proficiency with MS Office Suite, EDC systems, and CTMS platforms.</li>
<li>Willingness and ability to travel.</li></ul><br>
<p></p>
<p><b>
Education Requirements</b></p>
<ul>
<li>Associate&rsquo;s degree in a life science field required.</li>
<li>Bachelor&rsquo;s degree in a life science field preferred.</li></ul><br>
<p></p>
<p><b>
Experience Requirements</b></p>
<ul>
<li>Typically requires <b>8 years of experience in clinical research</b>, including:
<ul><li>Minimum <b>3 years of field monitoring experience</b>
</li><li>Minimum <b>4 years in a lead CRA role</b></li><br>
</ul>
</li></ul><div></div><p><b>Occupational Demands</b></p>
<p>
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.</p><br>
<p></p><p>Third Party Agency and Recruiter Notice:</p>
<p>
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.</p><br>
<p></p>
<p><b>
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.</b></p><br>
<p></p>
<p></p>
<p><b>Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters</b></p><br>
<p></p>
<p>
Learn more about Grifols</p></div><p></p>

Clinical Research Associate 4

ICON Strategic Solutions

<div>
 Clinical Research Associate (Start Up) - Oncology - Pennsylvania
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  What will you be doing?
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Works on multiple trials within the Oncology Therapeutic area - Start up focus
  </li>
  <li>
   Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
  </li>
  <li>
   Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
  </li>
  <li>
   Build strong relationships with site personnel to facilitate a smooth onboarding process.
  </li>
  <li>
   Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
  </li>
  <li>
   Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
  </li>
  <li>
   Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
  </li>
  <li>
   Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
  </li>
  <li>
   Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
  </li>
  <li>
   Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
  </li>
  <li>
   Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
  </li>
  <li>
   Maintain precise documentation to ensure readiness for inspections.
  </li>
  <li>
   Support sites during the activation phase until they achieve &ldquo;Green Light&rdquo; status for site opening.
  </li>
  <li>
   Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
  </li>
  <li>
   Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What do you need to have?
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
  </li>
  <li>
   Must be located in Pennsylvania, near a major airport.
  </li>
  <li>
   Must have 2 -3 years&rsquo; experience in monitoring pharmaceutical industry clinical trials
  </li>
  <li>
   Have a minimum of 1-3 years' experience monitoring oncology clinical trials
  </li>
  <li>
   Analytical/risk-based monitoring experience is an asset
  </li>
  <li>
   Ability to actively drive patient recruitment strategies at assigned sites
  </li>
  <li>
   Ability to partner closely with investigator and site staff to meet all of our study timelines
  </li>
  <li>
   Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
  </li>
  <li>
   Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
  </li>
  <li>
   Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
  </li>
  <li>
   To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What ICON Can Offer You
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  Our Benefits Examples Include
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Various annual leave entitlements
  </li>
  <li>
   A range of health insurance offerings to suit you and your family&rsquo;s needs.
  </li>
  <li>
   Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  </li>
  <li>
   Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
  </li>
  <li>
   Life assurance
  </li>
  <li>
   Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
   <br/>
   <br/>
  </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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 or submit a request here
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 Are you a current ICON Employee? Please click here to apply
</div>


AbbVie

<div><b>Company Description</b><p><b><br>
About AbbVie</b></p><p>
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.</p><b><br>
Job Description</b><br>
<ul><li>
Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.</li><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li><li>
Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li><li>
Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.<br>
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.<br>
May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.</li><li>
Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.<br>
Ensures audit and regulatory inspection readiness at assigned clinical site at all times.<br>
Manages investigator payments as per executed contract obligations, as applicable.</li><li><b>This is a remote position. Candidates must be based in TN and be willing to travel for site visits.</b></li></ul><b><br>
Qualifications</b><br>
<ul><li>
Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical,<br>
Scientific, Nursing, Pharmacy).</li><li>
Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li><li>
Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul><br>
<b>
Additional Information</b><p><br>
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
</p><ul><li><p>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</p></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</p></li><li><p>This job is eligible to participate in our short-term incentive programs.
</p></li></ul><p>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.</p><div></div><p>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.</p><p>
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><p>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p>
https://www.abbvie.com/join-us/reasonable-accommodations.html</p></div>

Clinical Research Associate II

ImmunityBio, Inc.

<div>
 <strong>
  Company Overview
  <br/>
  <br/>
 </strong>
 ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient&rsquo;s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient&rsquo;s immune system and treat the host rather than just the disease.
 <br/>
 <br/>
 Why ImmunityBio?
 <br/>
 <br/>
 <ul>
  <li>
   ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
  </li>
  <li>
   Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
  </li>
  <li>
   Work with a collaborative team with the ability to work across different areas of the company.
  </li>
  <li>
   Ability to join a growing company with professional development opportunities.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Position Summary
  <br/>
  <br/>
 </strong>
 The Clinical Research Associate I will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.
 <br/>
 <br/>
 <strong>
  Essential Functions
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
  </li>
  <li>
   Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
  </li>
  <li>
   Communicate scientific rationale for assigned studies to team members and clinical sites
  </li>
  <li>
   Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
  </li>
  <li>
   Create/edit, distribute and collect site feasibility questionnaires
  </li>
  <li>
   Oversee and support collection of essential documents during study start-up
  </li>
  <li>
   Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
  </li>
  <li>
   Collect study and site metrics and maintain study trackers, as needed
  </li>
  <li>
   Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
  </li>
  <li>
   Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
  </li>
  <li>
   Partner with field CRAs and CTAs to resolve issues identified during site visits
  </li>
  <li>
   Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions
  </li>
  <li>
   Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
  </li>
  <li>
   Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
  </li>
  <li>
   Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors
  </li>
  <li>
   Conduct remote monitoring tasks including reconciliation of site investigational product accountability
  </li>
  <li>
   Provide data listings and compile clinical study report documents to support medical writing activities
  </li>
  <li>
   Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
  </li>
  <li>
   Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.
  </li>
  <li>
   Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education &amp; Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in a clinical research, science, or health-related field with 2 years of experience in a clinical research setting; or a high school diploma with 3 years of experience in a clinical research setting required
  </li>
  <li>
   2 years of experience as a Clinical Research Coordinator, Clinical Trial Associate or In-House Clinical Research Associate strongly preferred
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Knowledge, Skills, &amp; Abilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
  </li>
  <li>
   Excellent written/oral communication skills
  </li>
  <li>
   Strong organizational and multi-tasking skills
  </li>
  <li>
   Maintain corporate confidentiality at all times
  </li>
  <li>
   Ability to set priorities and independent decision making
  </li>
  <li>
   Ability to work independently as well as in teams
  </li>
  <li>
   Strong oral and written communication skills
  </li>
  <li>
   Outgoing and confident demeanor
  </li>
  <li>
   Independent thinker and persuasive communicator
  </li>
  <li>
   Detail oriented, with solid organization and time management skills
  </li>
  <li>
   Completes projects with reliability and minimal guidance
  </li>
  <li>
   Knowledge of drug development process
  </li>
  <li>
   Computer literacy: EDC, eTMF, CTMS, etc.
  </li>
  <li>
   Working knowledge of ICH E6, and the Code of Federal Regulations
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Working Environment / Physical Environment
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   This position works remotely with ability to work flexible hours for various time zones
  </li>
  <li>
   Must be able to travel up to 75% of the time based on study requirement.
   <br/>
   <br/>
  </li>
 </ul>
 This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate&rsquo;s qualifications, prior experience as well as geographic location.
 <br/>
 <br/>
 $103,900 (entry-level qualifications) to $114,300 (highly experienced) annually
 <br/>
 <br/>
 The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
 <br/>
 <br/>
 ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
 <br/>
 <br/>
 <ul>
  <li>
   Health and Financial Wellness Programs
  </li>
  <li>
   Employer Assistance Program (EAP)
  </li>
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   Company Paid and Voluntary Life/AD&amp;D, Short-Term and Long-Term Disability
  </li>
  <li>
   Healthcare and Dependent Care Flexible Spending Accounts
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   401(k) Retirement Plan with Company Match
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   529 Education Savings Program
  </li>
  <li>
   Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  </li>
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   Paid Time Off (PTO) includes: 11 Holidays
  </li>
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   Exempt Employees are eligible for Unlimited PTO
  </li>
  <li>
   Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
  </li>
  <li>
   We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
   <br/>
   <br/>
  </li>
 </ul>
 At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
</div>


Clinical Research Associate I, Field Monitor

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p><p>
Join Thermo Fisher Scientific Inc. as a Sr. Clinical Research Associate based in Saudi Arabia and be part of an outstanding team! This is an outstanding opportunity to contribute to groundbreaking research and support scientific advancements in an ambitious and collaborative environment.</p><p><br>
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.</p><p></p><p>
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate, you'll conduct on-site or remote visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites and client company personnel. You may assist the project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.</p><p></p><p><b><br>
Key Responsibilities</b></p><ul><li>
Support the Clinical Operations team in the region with the CRO setup and obtention of required licenses.</li><li>
Support study teams as a Subject Matter Expert on different aspects of feasibility, submissions, contract negotiations and startup activities (e.g., Tracking RFPs, Site identification, Advice during EC/RA Submissions).</li><li>
Participate with the local team to customize monitoring plans, operational procedures and tools to ensure accurate approach and adherence to local regulations.</li><li>
Collaborate with cross-functional teams to successfully implement study plans and resolve any issues that arise.</li><li>
Strictly maintain all documentation and records according to company and regulatory standards.</li><li>
Provide guidance and mentorship to junior CRAs, encouraging a culture of inclusion and continuous improvement.</li></ul><p></p><p><b>
What You&rsquo;ll Do:</b></p><ul><li>
Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable</li><li>
Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Lead.</li><li>
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.</li><li>
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</li><li>
Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements &amp; share potential solutions for improvements.</li><li>
Performs additional tasks as assigned by Clinical Lead or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).</li><li>
Provides trial status tracking and progress update reports to the Clinical Lead as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.</li><li>
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>
Responds to company, client and applicable regulatory requirements/audits/inspections federal regulatory requirements/audits.</li><li>
Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner</li></ul><p><b><br>
Education and Experience Requirements:</b></p><ul><li>
Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years as a clinical research monitor).</li><li>
Valid driver's license</li></ul><p></p><p>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.</p><p></p><p><b>
Qualifications</b></p><ul><li>
Proven experience in clinical research, with a minimum of 5 years of experience as a CRA.</li><li>
Comprehensive knowledge of ICH-GCP guidelines and regulatory requirements.</li><li>
Strong analytical skills and attention to detail to determine and address any discrepancies.</li><li>
Outstanding communication and organizational skills to prioritize effectively.</li><li>
Ability to work independently and as part of a collaborative team.</li><li>
Location: Based in Saudi Arabia</li><li>
Languages: Fluent in Arabic and English</li></ul><p><br>
Why Join Us</p><p>
At Thermo Fisher Scientific, we compete at the highest levels to drive innovation and excellence. You'll be part of a team that values diverse perspectives and strives for flawless execution in everything we do. Your contributions will help us make a tangible impact on global health and well-being. Start your story with us today!</p></div><p></p>

Senior Clinical Research Associate (Sr CRA)

ICON plc

<div>US, Senior Clinical Research Associate, Sponsor Dedicated<div></div><div>
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</div><div></div><div>
We are currently seeking a Senior Clinical Research Associate in the Midwest Region to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a key role in early-phase clinical trials, working closely with Clinical Operations leadership and study teams. This is not a narrowly defined, process-heavy role. You will have the opportunity to contribute broadly, problem-solve in real time, and help shape how Phase I studies are executed.</div><div></div><div>
What You Will Be Doing:</div><ul><li><div>
Hands-on involvement across Phase I study start-up, conduct, and close-out</div></li><li><div>
Monitor Phase I clinical trials (on-site and remote)</div></li><li><div>
Support study start-up, site activation, and ongoing site management</div></li><li><div>
Autonomy to manage sites and priorities in a dynamic environment</div></li><li><div>
Exposure to complex early-phase activities and decision-making</div></li><li><div>
Ensure protocol compliance, data integrity, and GCP adherence</div></li><li><div>
Proactively identify and resolve site and study-level issues</div></li><li><div>
Partner closely with Clinical Operations and cross-functional teams</div></li></ul><div>
Your Profile:</div><ul><li><div>
Bachelor's degree in a scientific or healthcare-related field.</div></li><li><div>
Minimum of 2 years of experience as a Clinical Research Associate for a biotech, pharmaceutical company or CRO</div></li><li><div>
Previous CRA experience with Phase I / early-phase trials required</div></li><li><div>
Are comfortable pivoting and working in evolving environments</div></li><li><div>
Strong knowledge of GCP and early-phase clinical trial conduct</div></li><li><div>
Ability to manage multiple priorities independently</div></li><li><div>
Strong communication, adaptability, and problem-solving skills</div></li><li><div>
Are motivated by learning, growth, and visible impact</div></li><li><div>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
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.</div><div></div><div>
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.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
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.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
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.</div><div></div><div><div><div><div><div>
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</div><div></div><div><div>
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.</div></div></div></div></div></div></div><div></div>

US, Senior Clinical Research Associate, Sponsor Dedicated

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Senior Clinical Research Associate (Sr CRA)

US, Senior Clinical Research Associate, Sponsor Dedicated