Role Description 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. - 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. Qualifications - 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. Company Description 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 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. - 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. - We recognize diversity and inclusivity as our strength and celebrate it.

The Study Design Specialist is responsible for creating comprehensive study builds from start to finish in the CRIO platform. This includes developing eSource from protocols and eCRFs, conducting post-build quality control reviews, and configuring budgets in our finance module. This individual will be considered an industry expert on the CRIO eSource and Finance modules. Responsibilities: - Utilize protocols, eCRF guidelines, pharmacy manuals, lab manuals, and other source documents to produce comprehensive builds for clients. - Interpret Clinical Trial Agreements and budgets for configuration in the CRIO finance module. - Design visit schedules and procedures for CTMS-only studies. - Complete client-requested edits and customizations. - Provide quality control reviews of client-built eSource and budget templates. - Manage complex trials to ensure all data is captured appropriately. - Modify standard templates to comply with protocol requirements. - Complete assignments on time. - Mentor and train current and new CRIO employees. Preferred Qualifications: - Experience with eSource, budget, and QC design in CRIO or other eSource/CTMS systems. - BS in medical or sciences field. - Experience as a Research Coordinator, Site Director, or Source Designer is a plus. Other Qualifications: - At least 1 year of healthcare experience. - Ability to interpret clinical trial protocols, source documents, and clinical trial agreements. - Knowledge of medical terminology and procedures. - Experience tracking study financials. - Strong people skills. - Detail-oriented with solid time management skills. - Well-organized, capable of establishing priorities, and executing tasks efficiently. Join us at CRIO and be part of a dynamic team dedicated to revolutionizing the clinical research industry. Apply today to embark on a rewarding career journey! Location & Travel: This position is fully remote. You can work anywhere in the US with the expectation of being available based on EST time zone. Benefits & Perks: - Work from anywhere - Unlimited PTO - 401k company match - Healthcare - Dental - Vision (Company Paid 100%) - Life insurance - Professional development - Work From Home Expense Reimbursement Equal Employment Opportunity: CRIO is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are made based on qualifications, merit, and business need without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other basis protected by federal, state, or local law. Disability Accommodation Statement: We are committed to providing reasonable accommodations to individuals with disabilities in the application and interview process. If you require accommodation to participate in the application process, please contact Human Resources to request assistance. Salary Range: $60,000 --- $70,000

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving the execution of Lilly clinical trials through exceptional investigator engagement and site performance management. This role is pivotal in ensuring Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight. CRLs combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies in existing and new therapeutic areas. They serve as trusted partners to investigators—building strong, enduring relationships that improve return on enrollment and position Lilly as the sponsor of choice. CRLs partner closely with internal Lilly teams (including Clinical Development and Medical Affairs) to ensure that insights from the field shape development strategies and that development strategies are delivered with operational excellence and scientific clarity. Where applicable the CRL may also represent Investigator Engagement with Regulatory and External Bodies and help shape the country-level clinical trial landscape. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Clinical Investigator Management - Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout - Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements - Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas - Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives - Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc - Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct Clinical Trial Management - Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery - Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones - Drive inspection readiness as a continuous discipline across sites - Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality - Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization - Provide oversight and quality assurance for vendor monitoring, escalating risks proactively - Where applicable, lead end-to-end management of Post-Marketing Safety Studies in compliance with local regulations Business Management and Engagement - Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize Lilly trials - Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner - Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity - Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution - Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel - Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer - Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships Country / Regulatory Engagement (where applicable) - Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations in countries/territory - Influence the clinical trial ecosystem to improve regulatory agility and operational feasibility - Ensure that local requirements are translated into compliant, efficient trial execution and that Lilly’s internal processes reflect evolving country landscapes - Partner with leadership to identify and align regional initiatives and contribute to enterprise-wide clinical development success Minimum Qualification Requirements: - Bachelor’s degree or equivalent; strong preference for scientific, clinical, or health-related fields - Minimum 5 years of experience in clinical research or pharmaceutical industry with experience directly interacting with or working with HCPs and clinical sites - Minimum 2 years of relevant clinical or deep therapeutic area experience in Oncology - Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position - Currently reside in or be willing to relocate to our designated region Other Information/Additional Preferences: - Advanced degree in a scientific or clinical field (PharmD, PhD, MD, or MSc preferred) - Excellent understanding of GCP, clinical development and operations, and trial lifecycle - Demonstrated understanding of the therapeutic landscape and standards of care, with the ability to apply this knowledge to decision making - Proven ability to build credibility and influence HCP community through scientific acumen and relationship strength - Strategic approach with demonstrated success in delivering results in complex, fast-paced environments - Data-driven decision-making skills; ability to interpret and act on performance and operational metrics - Excellent communication, negotiation, and organizational skills - Deep therapeutic area knowledge and familiarity with local clinical research ecosystems - Experience directly influencing clinical site performance and driving enrollment success - Track record of delivering or exceeding performance targets in a collaborative matrix environment - Experience working with regulators or national bodies in support of clinical trial delivery - English fluency and proficiency in local language(s) as needed Travel Requirements: - Willingness to travel extensively (60-80%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Clinical Study Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’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 We are currently seeking a Clinical Associate to join our diverse and dynamic team. Working as a Clinical Study Associate exclusively assigned to a Pharmaceutical Company, you will perform tasks related to planning and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. You will provide support for critical day to day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with CTA Managers. You will collaborate with Clinical Operations Study Managers, study teams, and CROs to support clinical study activities, as defined by the clinical trial operating model. What you will be doing - Review study documentation. - Support Risk-Based monitoring. - Attend key team meetings. - Support inspection readiness and clinical trial systems. - Support vendor contract administration. - Support study close-out activities. Your profile - Bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field. - 1-2 years experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry. - Strong organizational and time management skills, with the ability to prioritize tasks and manage competing priorities effectively. - Strong attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance. - Excellent communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships. - Strong regulatory knowledge. - Fluent English. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. 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. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - 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’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’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. 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply