ClinChoice is seeking an experienced Freelance Clinical Research Associate (CRA) to monitor a Phase I oncology trial. This is a full-time (1.0 FTE), remote position for a U.S.-based CRA, with approximately 70% travel to investigative sites. Opened to 1099 independent contractors. Experience in monitoring Phase I oncology trials, including CAR T studies, is required. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. Main Job Tasks and Responsibilities: - Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned. - Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites. - May act as Feasibility Associate. - Train site staff in all study procedures. - Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF). - Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data. - Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site. - Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues. - Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project. - Act as the main contact person for the site to ensure close follow up. - Provide general support to the Clinical Research Division on quality control of clinical data. - Address appropriate team members about any issues that can jeopardize the conduct of the clinical projects assigned in a timely manner. - Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial. - Develop training material and give training in collaboration with the Training & Qualification Management Unit. - May assist with contract negotiation with sites on study budget after appropriate training. - Assist with the preparation of the study, including CRF design/development, write CRF instructions and organize the study files and documents to ensure good start-up of the investigation sites. - May support the submission process in the project including submission requirements, timelines, informed consent development, etc. Education, Experience and Skills: - University Degree in scientific, medical or paramedical disciplines. - Eight (8) years (at least) of experience as a CRA. - Advanced oncology experience required, including experience with Phase 1 oncology trials. - Experience monitoring CAR T studies is required. - Proven experience as a CRA, performing on-site monitoring activities. - Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements. - Fluent in English. - Proficiency in Microsoft Office (e.g., Word, Excel, Outlook). - Willingness to travel 70% of the time. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Clinical Research Associate, CRA, Freelance, Permanent, CRO, Contract Research Organization, Outsourced, Outsourcing, Oncology, Monitoring, Phase I Oncology Trials, Senior CRA, Oncology Clinical Trials, Early Phase Trials, Investigative Site Monitoring, On-site Monitoring, Remote Monitoring, 1.0 FTE, 70% Travel, 1099, Independent Contractor, GCP (Good Clinical Practice), ICH Guidelines, FDA Regulations, Regulatory Compliance, Clinical Trial Operations, Source Data Verification (SDV), Case Report Forms (CRFs), Data Query Resolution, Safety Reporting (AE, SAE, SUSAR), Investigational Product (IP) Management, Site Initiation Visits (SIV), Site Selection Visits (SSV), Close-Out Visits (COV), Feasibility Assessment, Site Management, Study Start-Up, Clinical Data Quality Control, Monitoring Visit Reports, Investigator Study File (ISF), Trial Master File (TMF), Clinical Study Documentation, Site Training, Study Budget Negotiation, Informed Consent Development, Submission Support, 8+ Years CRA Experience, Advanced Oncology Experience, Phase I Oncology Monitoring, Early-Phase Oncology Trials, CRO Experience, U.S.-Based CRA #LI-VH #LI-Remote #Freelance Clinical Research Associate # Contract

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor) as part of the Clinical Operations team based Remotely. Role Overview We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support. The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross-functional study teams. Key Responsibilities Clinical Trial Operations Support - Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums. - Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance with ICH-GCP and applicable regulatory requirements. Documentation & TMF Management - Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence. - Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs. End-to-End Trial Coordination - Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities. Regulatory & Compliance Support - Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents. - Maintain working knowledge of applicable regulations and standards to support ongoing study compliance. Meeting & Communication Coordination - Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings. - Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion. Tracking, Reporting & Data Support - Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones. - Prepare and maintain study status reports and trackers for internal and external stakeholders. - Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management. Site & Vendor Support - Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication. - Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues. Problem Solving & Continuous Improvement - Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate. - Contribute to the development and continuous improvement of clinical operations processes and best practices. Training & Mentorship - Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building. Requirements - Bachelor’s degree in life sciences, clinical research, or a related field. - Relevant certifications (e.g., CRC, CRA) are a plus. - Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role. - Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities. - Oncology trial experience required; cell therapy and/or CAR-T experience strongly preferred. - Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes. - Proficiency with CTMS, eTMF, and EDC systems. - Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment. - Strong written and verbal communication skills. - Detail-oriented with strong analytical and problem-solving skills. - Ability to work independently and collaboratively within cross-functional teams. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms. #Li-JR1 #Li-Remote #Li-Contract Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. For information related to our privacy notice, please review: Legend Biotech Privacy Notice.

Specialty Networks creates clinical & economic value for independent specialty providers & partners in urology, gastroenterology & rheumatology. The purpose of this organization at Cardinal Health is to help independent specialty providers improve patient outcomes by getting each patient to the right care at the right time. Specialty Networks works with over 11,500 providers across 1,500+ independent specialty physician practices and groups. This individual will be responsible for the management and oversight of member accounts utilizing a proprietary data analytics tool for patient identification in urologic disease states. They will focus on helping private practice urology groups with the analysis of patient data, patient identification, data registry and report production to present to physician groups. This Clinical Analyst will also be responsible for teaching member accounts on best practices for data analysis and collection within the tool itself to ensure end-user success. Location: This position is remote and can be based anywhere within the United States. Candidates must be able to work within EST or CST business hours. Responsibilities - Helping private practice urology groups with the analysis of patient data, patient identification, data registry and report production to present to physician groups. - Management and oversight of member accounts utilizing a proprietary data analytics tool for patient identification in urologic disease states. - Teaching member accounts (external stakeholders) on best practices for data analysis and collection within the tool itself to ensure end-user success. Qualifications - Experience working either as a Medical Assistant (5+ years in Urology), or as an RN (with 3+ years of work experience), highly preferred yet neither are required - Data entry experience in a production environment, or specifically in a laboratory/healthcare setting is preferred but not required - Teaching experience is a plus - Attention to detail and the ability to communicate effectively with stakeholders internally and externally, required Anticipated Pay Range $68,500 - $88,000 Bonus Eligible - No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. - Medical, dental and vision coverage - Paid time off plan - Health savings account (HSA) - 401k savings plan - Access to wages before pay day with myFlexPay - Flexible spending accounts (FSAs) - Short- and long-term disability coverage - Work-Life resources - Paid parental leave - Healthy lifestyle programs Application window anticipated to close: 03/27/26 * if interested in opportunity, please submit application as soon as possible. ** The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: The Clinical Trial Associate (CTA) provides operational and administrative support to clinical trials throughout their lifecycle, ensuring consistency with applicable regulatory guidelines (ICH-GCP, SOPs) and facilitates smooth execution of trial activities. Study management activities may include maintenance of information databases and trial tracking reports, coordination of clinical trial documentation and general support to ensure the successful and timely execution of clinical activities and deliverables. Key Responsibilities: - Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout - Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations - Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams - Set up, organize and maintain study files and shared spaces in accordance with study requirements - Coordinate and track study training - Manage study sample and supply tracking and support interactions with vendors as needed - Support the Study Management team with specific projects - Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-related issues - Perform routine quality checks on trial level documents to ensure completeness and accuracy - Supports the timely, complete and compliant archiving in the TMF - Participate in company, departmental and project team meetings including Investigator Meetings - May assist with basic financial and budget tracking activities related to the clinical trial. Requirements: - BS/BA degree or degree in healthcare field required - 1+ years experience supporting clinical operations activities in sponsor company or 2 years experience experience supporting clinical operations activities in a CRO environment - Basic knowledge of drug development and clinical operations processes - Foundational knowledge of clinical trial process and supports study activities in accordance with ICH-GCP and Code of Federal regulations - Foundational experience with eTMF systems and basic knowledge of essential documents to file study documents accurately with guidance - Effective written and verbal communication skills, with the ability to work collaboratively within study teams - Strong organization and interpersonal skills - Strong attention to detail - Able to prioritize and manage multiple tasks with competing deadlines - High sense of urgency and commitment to excellence in the successful execution of deliverables - Demonstrates ability to identify issues and escalate appropriately to support timeline adherence - Proficient with MS Office Suite (Excel, Word, PowerPoint) and project tracking tools #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.