Clinical research coordinator jobs in Owensboro, KY - 340 jobs

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. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary The Clinical Research Scientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans. Key Responsibilities 1. Business & Customer Support Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups. Lead data analyses and health outcomes research to address customer questions. Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners. Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements. Support training of sales, medical, and patient support teams. Lead definition of Patient Journey and contribute clinical perspective to patient programs. Participate in relevant professional and industry associations. 2. Scientific Exchange & Data Dissemination Ensure compliance with global and local regulations governing scientific communication. Address unsolicited scientific inquiries in alignment with medical governance standards. Support scientific meetings, advisory boards, symposia, and other expert engagements. Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts. Build and maintain relationships with key opinion leaders and scientific societies. Represent the company at medical congresses and support scientific booth activities. Contribute to data analyses, publication development, and Clinical Trial Registry reporting. 3. Clinical Planning Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams. Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements. Maintain up‑to‑date understanding of clinical and competitive data. Provide regional clinical insights to inform development plans and study protocols. 4. Clinical Research Execution Review and approve informed consent documents to ensure accurate risk communication. Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out. Support investigator/site training and address study‑related medical questions. Oversee local safety monitoring and adverse event follow‑up. Review investigator‑initiated trial (IIT) proposals as needed. Ensure global alignment of Phase 3b/4 and applicable early‑phase studies. 5. Regulatory Support Contribute to development and review of local labeling and labeling changes. Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities. Participate in risk management planning with global and local teams. 6. Scientific & Professional Development Stay informed on therapeutic area trends, market changes, and competitive landscape. Provide scientific training to clinical study teams and act as a protocol subject‑matter expert. Represent the organization at medical congresses and contribute to medical budget planning. Seek opportunities for external scientific engagement. 7. Leadership & Collaboration Set and pursue professional development goals and support growth of colleagues and direct reports. Contribute to recruitment, diversity, and retention efforts when applicable. Participate in committees, Six Sigma initiatives, and cross‑functional projects. Model leadership behaviors and serve as an ambassador for patients and the company. Basic Qualifications An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience Additional Preferences Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information) Ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders 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 (******************************************************** 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), en Able (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 $177,000 - $308,000 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

Department: MED-Impact Institute Salary/Grade: RES/ Hiring: HIV Implementation Science Coordination Initiative Project Director (Clinical Research Associate), Institute for Sexual and Gender Minority Health and Wellbeing Program Description: Implementation science (IS) is a relatively new field with exciting opportunities for growth and innovation focused on methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine healthcare and public health settings. The HIV Implementation Science Coordination Initiative (ISCI) is the national coordinating and technical support center for Centers for AIDS Research/AIDS Research Centers research-practice partnerships funded as part of the Ending the HIV Epidemic plan. ISCI provides high-quality IS coordination, consultation and data management for NIH-funded Ending the HIV Epidemic (EHE) implementation research teams and creates opportunities to share generalizable knowledge to help end the HIV epidemic in the United States. ICI identifies and disseminates best practices in HIV implementation research, while providing training, and resources to support academic researchers and practice-based partners. Position Description: The Project Director will lead project and personnel management for ISCI, overseeing complex multi-investigator projects across multiple institutions and supervising several research staff. This role involves developing and managing project plans with defined timelines, deliverables, and resources, while identifying opportunities for growth, assessing potential impacts, and collaborating with cross-functional teams to implement innovative solutions. The ideal candidate is an experienced leader with expertise in project management of complex, multi-investigator projects across multiple institutions, experience supervising multiple staff, strong written and oral communication skills, effective time management capabilities, and ability to work independently. The average target hiring range for this position will be between $80,000 - $95,000 per year. Final offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Duties and Responsibilities: Project and Personnel Management * Develops and implements comprehensive project plans, including timelines and deliverables. * Assists in the development and execution of new initiatives, leads strategic planning efforts to ensure alignment with project goals and objectives. * Identifies opportunities for project growth, assesses potential impacts, and collaborates with cross-functional teams to implement innovative solutions. * Leads and coordinates multiple teams, ensuring effective communication and collaboration across the project. * Trains, directs, assigns duties to, and supervises research staff and/or fellows. * Allocates and manages project resources, including personnel, budget, and materials, to ensure optimal project performance. * Acts as the primary contact for stakeholders (sponsoring agencies and collaborators), providing regular updates on project progress and addressing any issues or concerns. * Maintains project documentation, including project plans, progress reports, and final reports. * Ensures that all project activities adhere to quality standards and regulatory requirements. * Evaluates project outcomes and processes to identify areas for improvement and implement best practices. Administration * Analyzes, evaluates and interprets data to determine relevance to research. * Prepares results and may lead and co-author scientific papers for presentation and publication and disseminate information via seminars, lectures, etc. * Creates data for use in grant submission and develops new proposals for research including obtaining financial support. * Ensures that all study documents associated with current local, state, and federal regulatory guidelines, requirements, laws and research protocols are completed in a timely manner. Finance * May create and/or manage research study budget which may include deciding on and approving expenditures of funds based on budget. * Monitors accounts. * Ensures appropriate allocation and compliance. Miscellaneous * Performs other duties as assigned. Position Details: This is a full-time position based on the Chicago campus of Northwestern University. Minimum Qualifications (Education, experience, and any other certifications or clearances) * Master's or doctoral degree in social/behavioral science (e.g., psychology, sociology, anthropology), public health, humanities, or related field * At least 5 years of experience with managing complex projects that involve multiple principal investigators, sites, institutions, and/or public health practice settings. * Experience in project management and supervising multiple staff is required. * Experience using project management software. * Experience using Microsoft Office 365 and basic computer programs (e.g., Teams, Sharepoint, OneNote, Word, Excel, PowerPoint, Adobe, Google, etc.) * Must complete NU's IRB CITI training before interacting with any participants and must re-certify every 3 years. Minimum Competencies (Skills, knowledge, and abilities) * Strong project coordination skills and the ability to prioritize tasks. * Demonstrated attention to detail and ability to adhere to instructions/procedures. * Good communication skills; demonstrated effective spoken and written communication. * Good time management skills; efficient and resourceful in problem-solving. * Demonstrated ability to take ownership of the work, possessing initiative, good follow-through; ability to work without supervision. Preferred Competencies (Skills, knowledge, and abilities) * Familiarity with implementation science concepts (e.g., models and frameworks, determinants, outcomes, strategies, study designs). * Familiarity with HIV prevention and care research To apply: Applicants should email application materials to ********************* with the subject line "ISCI Project Director." Applications should include a CV and cover letter explaining fit with this position; relevant work or educational experiences, including experiences with research topic areas, and the names of two references who will be contacted only for finalists. Consideration of applications will begin immediately and continue until the position is filled. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Chicago, Illinois (IL). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Clinical Research Associate: * 2-4 years performing on-site monitoring and hands on experience with EDC Systems * Experience with Oncology is highly advantageous * Organization to perform monitoring duties across multiple sites is a must Compensation for the Clinical Research Associate: * Salary Range: $100,000-$120,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Position Overview This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team. Essential Duties Include, but are not limited to, the following: Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies. Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships. Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates. Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams. Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements. Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies. Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team. Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate. Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management. Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members. Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study. Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members. Communicate project specific information to/from trial sites through teleconferences, newsletters, etc. Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis. Document monitoring activities in monitoring visit reports and follow-up letters. Communicate serious issues to appropriate parties, in a timely manner. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. Participate in Investigator Meetings, and other study trainings and meetings as required. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work designated schedule. Ability to work nights and/or weekends, as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 50% of working time away from work location may include overnight/weekend travel. Minimum Qualifications Bachelor's Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience. Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience. 4+ years clinical research monitoring experience or equivalent experience. No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability. Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems. Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively. Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices. Meticulousness with a focus on accuracy and precision in all tasks and activities. Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy. Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred Qualifications Experience or knowledge in In Vitro Diagnostics (IVD). Certifications related to clinical research. Working knowledge of the FDA submission process including IDE, PMA, and 510(k). Strong on-site monitoring experience in clinical trials, including: Site initiation. Routine monitoring visits. Site closeout. Knowledge of electronic trial master file (eTMF) systems and document management processes. This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish. #LI-JH1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Job DescriptionAbout Hematogenix Want a job with greater meaning and higher purpose? Every day Hematogenix employees are warriors fighting a noble and global war on cancer. Helping patients every day, and helping partners every day - with our diagnostic and research services. Hematogenix is looking for talented and highly motivated individuals to join our team. We offer a competitive benefit package and career development opportunities to help you achieve your highest professional and personal goals. We are eager to show you all we have to offer and how you can grow with us. Hematogenix is a specialized contract research organization and clinical laboratory with a global presence. Our team of board-certified clinical, anatomic and research pathologists work in conjunction with top scientists from around the world to provide quality testing, consultation, and guidance for all aspects of the company's pharma and diagnostic services. Job Purpose: The Clinical Study Coordinator supports the successful delivery of clinical trial projects via operational/day-to-day management of workflows. Deliver excellent customer service to project stakeholders (e.g., clients, clinical sites). *Please note that this position requires you to be onsite at our Illinois, USA location. Accountabilities/Work Activities: Study Initiation Possess strong working knowledge of company capability's and how it typically aligns with clients' objectives and timelines. Comfortable developing and maintaining relationships with various project stakeholders where needed (external and internal) Planning & Design Contribute, when necessary, operational insights that will impact project scope. Assist the Project Managers with creation of study specific laboratory binders and regulatory documents. Executing Attend in-house initiation meetings with all project personnel in order to understand individual contributions of all, as well as overall study objectives and timelines. Provide guidance to Pharma Accessioning Team regarding query generation. Create and send clearly written data clarification messages to ensure outstanding queries are resolved in a timely fashion according to Communication and Escalation Plan established with each Sponsor. Maintain study tracking spreadsheets/documents in real time if applicable. Communicate effectively (verbal and written) when interacting with external stakeholders (e.g., CRAs, SCs, PIs, etc.) Interact effectively with all in-house project personnel and provide clear communication on status of cases (query resolution) or specific requests (e.g., expedited testing requests Perform data entry if needed and/or manage data entry needs of projects to ensure daily/weekly completion occurs. Process sample repatriations and maintain associated documentation. Monitoring & Controlling Participate in regular internal meetings with Project Manager to feed in views of project personnel, outline operational challenges, and learn of wider project progress. Participate in regular conference calls with clients. Provide support to Project Manager during client monitoring visits. Ensure project supplies and day-to-day resources are always appropriately used in an effort to reduce waste and increase efficiency. Study Closing Contribute to internal project closing meetings in order to share best practice. Provide QC support to Project Manager during close out visits. Experience and Education Bachelor of Science degree or similar degree related to the role 1-2 years' experience in Clinical Laboratory Science Skills and Qualifications Knowledge of GCP/CAP/CLIA and global clinical research industry Must be able to communicate effectively and persuasively, both verbally and in writing, with all levels of in-house Hematogenix personnel and other project stakeholders (e.g., CRAs, site officials) Working experience with laboratory information systems Personal computer skills (Microsoft Word, Excel, Power Point, etc.) Ability to ambulate throughout the office and laboratory. Benefits we Offer: Medical Dental Vison Life 401k PTO Competitive Salary Contact Information: ********************; ******************* Hematogenix provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team in Greenfield, IN. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career. In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery. Essential Job Duties: Writes Study Protocols, Methods and Reports With minimal support and guidance, drafts protocols, methods, amendments, and reports; utilizing sources such as Documentum, Toxicology protocols and client supplied information Reviews study activities for compliance against protocol/SOW, Standard Operating Procedure (SOP), Policies, and regulatory agency guidelines. With support, assists Scientist with report preparation, including table and figure preparation; compiles analytical information from operations teams. Under direction of Scientist, supports with Quality Assurance Unit (QAU) audits of study documents, drafts responses as applicable, and follows up with appropriate personnel to ensure that all responses and/or necessary document/raw data clarifications are completed within specified timelines. Reviews client comments in protocol, method drafts and reports with Scientist, works with them to determine appropriate responses; addresses comments under guidance of Scientist to ensure all necessary document/data clarifications are completed in a timely manner. Supports report production processes through finalization Assists with archiving of study related materials Drives/Maintains Study and Client Communications Efficiently communicate and serve as a secondary to support the Scientist with client contact on assigned studies. Proactively communicates and interacts with study team, other departments, and clients as applicable. Attends and engages in pre-initiation and other internal study-related meetings, and attends conference calls; takes and distributes meeting minutes / action items, as appropriate. Support PM's and Scientists with preparing for and attends routine client visits. With support manages data transfer to clients as requested. Drives/Contributes to Process Improvement/Adherence Participates in the development and maintenance of standard report/table formats as needed. Participates in the development and maintenance of standard protocol, method and Sample Analysis Plan (SAP) formats as needed. Identifies opportunities to increase the efficiency of daily/routine procedures and reporting methods; provides input on and assists with implementation of new technologies, system changes, and enhancements. Study/Timeline Management With support plans, prioritizes, and manages own workload and multiple responsibilities. With support uses project tracking systems, as appropriate. Manages standard projects and study designs, and drives to increase study load over time. Maintains well-documented, organized, and up-to-date study files, including real-time study schedule updates, as applicable. Demonstrates active engagement with study progress/timelines. Actively promotes a team environment; identifies and escalates any activities that do not promote a team environment. Other related duties as assigned Minimum Required: Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education Ability to learn/utilize word processing software, database, spreadsheet, and specialized software Excellent communication and interpersonal skills Excellent attention to detail Ability to prioritize, organize, and manage time Application Window - 1/21 thru 1/31/2026 Pay Range: $24 - $25 per hour All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

The University of Evansville is seeking a dedicated and knowledgeable Institutional Equity & Deputy Title IX Coordinator to assist in advancing the university's commitment to equity, fairness, and compliance with Title IX and related regulations. This full-time position will support the Associate Director of Institutional Equity and Title IX Coordinator in managing and resolving complaints of inequitable treatment, including discrimination, harassment, and sexual misconduct. Key Responsibilities: * Complaint Management: Assist in the intake, assessment, investigation, and resolution of complaints related to discrimination, harassment, and sexual misconduct to ensure timely and equitable processes. * Training & Education: Develop, implement, and evaluate training programs for campus constituencies, helping them understand their rights, resources, and responsibilities under university policies. * System Administration: Enhance the capacity of the Office of Institutional Equity by optimizing the university's student conduct software system. * Funding Opportunities: Identify and pursue external funding opportunities to expand the reach and impact of institutional equity services. * Collaboration & Representation: Collaborate with internal and external stakeholders, representing the office in various university committees and meetings, including Sexual Assault Response Team, CARE Team, Clery Committee, and Gender Equity Committee. Qualifications: * Education: Bachelor's degree required. Master's degree in student affairs, social work, counseling, criminology, sociology, or a related field preferred. * Experience: * Working with individuals impacted by trauma (required). * Investigating harassment, discrimination, or sexual misconduct allegations (preferred). * Legal Knowledge: Familiarity with Title VI, Title VII, Title IX, VAWA, Campus SaVE, Clery, ADA, EEOC, and related laws (preferred). * Skills: Strong communication, analytical, and critical thinking skills. Experience in grant writing and program evaluation is a plus. * Technical Proficiency: Proficient in Microsoft Office Suite and adept at managing student conduct systems. How to Apply: Interested candidates should complete an application for employment at ********************************************************************* The University of Evansville expects all members of its community to treat each other with respect and civility. Harassing behaviors directed towards any member of our community will not be tolerated. As part of its commitment to non-discrimination, the University specifically prohibits harassment based on any other characteristics set forth in its nondiscrimination statement as follows: including race, color, gender, gender identity and expression, sexual orientation, creed or religion, national origin, age, disability, veteran status and all federally protected groups/classes. Any form of harassment undermines the mission of the University and negatively impacts the University community as a whole. The University of Evansville participates in the E-Verify program.

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. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues. Roles and Responsibilities of the Position: Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical Research Scientist will apply scientific and clinical training and expertise to described roles. Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Reporting of adverse events as mandated by corporate patient safety. Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies. Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed. Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions. Minimum Requirements: An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty). 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology. Additional Preferences: Breast cancer disease area knowledge. Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team. Proven track record to bring out the best in others on a cross-functional international team. Leading by influence. Proven track record to interact externally and internally to support a global scientific and business strategy. Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel. Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator. Strong communication, both written and oral. Ability to multi-task and shift priorities rapidly to meet target dates. 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 (******************************************************** 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), en Able (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 $151,500 - $259,600 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

Department: MED-Cancer Center Salary/Grade: EXS/8 Target hiring range for this position will be between be Salary range is as be $70,017-$87,814 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Job Summary: Coordinates clinical research studies, performing a variety of tasks and activities. Recruits, screens, selects, determines eligibility, and enrolls study participants and ensures subjects follow the research protocol. Develops study-related documents. Applies expertise, knowledge, and skills to a broad range of different types of clinical studies, navigates resources, and identifies issues needing escalation. Contributes to development of new team and unit processes, procedures, staff, and tools. * Note: Not all aspects of the job are covered by this job description. Specific Responsibilities: * Schedules logistics, determines workflows, and secures resources for clinical research trials * Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional. Recruits, screens, and enrolls trial participants, collects information, and answers varied questions under supervision of a medically licensed professional. * Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy) * Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols * Identifies work unit resources needs and manages supply and equipment inventory levels * Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues * Performs quality checks * Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training. Contributes to the development of protocols * May assist with training of staff Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Bachelor's degree in relevant area of study required * 5 years' experience working with patients and families in clinical settings required or equivalent * Knowledge of biology, chemistry, mathematics, or medicine gained through education or prior work experience required * Experience with records management, data utilization and resource management required * Must demonstrate sound clinical judgement, critical thinking, cultural sensitivity, and complex problem-solving capabilities Excellent verbal and written communication skills required Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career. In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery. Candidates given best consideration will have the following skills/experience: Proficient in Microsoft Excel and Microsoft Word Highly Organized Works Well Independently Ability to Multi-task Effectively and Navigate Various Systems Schedule: Core hours are 9:00am-3:00pm with flexibility on start and end times around core hours. Essential Duties: Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information. Reviews study compliance against protocol, SOP, and regulatory agency guidelines. Learns to serves as the primary contact in communication and interaction with other departments and clients as applicable. Updates and maintains project tracking systems as appropriate. Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required. Learns to manage increasingly complex projects and study designs and/or increased study load. Responsible for report preparation, including table and figure preparation. Assists in evaluating data for reports. Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable. Reviews QAU report audits and submits audit responses for approval as appropriate. Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed. Responsible for report production through finalization, including archival of data as appropriate. Assists with routine client visits as requested. Manages data transfer to clients as requested. Assists SD/PI in monitoring study phases. Performs other related duties as assigned. Minimum Required: Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education Ability to learn/utilize word processing software, database, spreadsheet, and specialized software Excellent communication and interpersonal skills Excellent attention to detail Ability to prioritize, organize, and manage time Pay Range: $23.00 - $25.00 Application Window: 1/21/26 thru 1/24/26 All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

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. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary The Clinical Research Scientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans. Key Responsibilities 1. Business & Customer Support Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups. Lead data analyses and health outcomes research to address customer questions. Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners. Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements. Support training of sales, medical, and patient support teams. Lead definition of Patient Journey and contribute clinical perspective to patient programs. Participate in relevant professional and industry associations. 2. Scientific Exchange & Data Dissemination Ensure compliance with global and local regulations governing scientific communication. Address unsolicited scientific inquiries in alignment with medical governance standards. Support scientific meetings, advisory boards, symposia, and other expert engagements. Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts. Build and maintain relationships with key opinion leaders and scientific societies. Represent the company at medical congresses and support scientific booth activities. Contribute to data analyses, publication development, and Clinical Trial Registry reporting. 3. Clinical Planning Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams. Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements. Maintain up‑to‑date understanding of clinical and competitive data. Provide regional clinical insights to inform development plans and study protocols. 4. Clinical Research Execution Review and approve informed consent documents to ensure accurate risk communication. Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out. Support investigator/site training and address study‑related medical questions. Oversee local safety monitoring and adverse event follow‑up. Review investigator‑initiated trial (IIT) proposals as needed. Ensure global alignment of Phase 3b/4 and applicable early‑phase studies. 5. Regulatory Support Contribute to development and review of local labeling and labeling changes. Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities. Participate in risk management planning with global and local teams. 6. Scientific & Professional Development Stay informed on therapeutic area trends, market changes, and competitive landscape. Provide scientific training to clinical study teams and act as a protocol subject‑matter expert. Represent the organization at medical congresses and contribute to medical budget planning. Seek opportunities for external scientific engagement. 7. Leadership & Collaboration Set and pursue professional development goals and support growth of colleagues and direct reports. Contribute to recruitment, diversity, and retention efforts when applicable. Participate in committees, Six Sigma initiatives, and cross‑functional projects. Model leadership behaviors and serve as an ambassador for patients and the company. Basic Qualifications An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience Additional Preferences Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information) Ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders 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 (******************************************************** 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), en Able (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 $177,000 - $308,000 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

Department: MED-Physical Med & Rehab Salary/Grade: NEX/13 Target hiring range for this position will be between $50,000-$65,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Job Summary: Coordinates & completes the day to day administrative & technical activities involved in a single complex, large, nationwide or multiple moderately complex concurrent biomedical &/or social-behavioral research study(ies) involving multiple sites& /or longitudinal assessments/ interventions. Ensures that all activities are completed by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Specific Responsibilities: Technical * Participates in the planning & conduct of research studies. * Reviews project & protocol & recommends strategies to expedite study. * Recruits & retains participants. * Obtains informed consent. * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates &/or process responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. * Monitors & maintains systems for effective participant and data flow for studies. * Designs & constructs experimental stimuli. * Performs physical function assessment. Administration * Manages study databases which may include ensuring that data is collected & entered correctly. * Reviews & analyzes data. * Creates computer models, graphs, reports & summaries for use in publications, professional journals, & grant applications. * Writes portions of grant applications. * Co-authors scientific papers for presentation & publication. * Researches & obtains funding. * Creates & maintains study manuals regarding operating, safety, and etc. procedures. * Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner. Finance * May process payments for research participants per study protocol. * Creates lab financial plan & budget/audit expenses. * Obtains sales quotes for lab equipment & supplies. * Reviews & adjusts expenses to decrease costs. * Oversees repair & maintenance of all lab equipment & ensures that lab supplies are ready & available when necessary. * Administers budget including negotiating with grant sponsors. * Maintains & reconciles expenditures & balances in regard to research accounts & budgets. Supervision * Trains, directs, assigns duties to & may supervise research staff, students, residents &/or fellows. * Acts as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 4 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-GY2

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. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues. Roles and Responsibilities of the Position: Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical Research Scientist will apply scientific and clinical training and expertise to described roles. Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Reporting of adverse events as mandated by corporate patient safety. Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies. Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed. Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions. Minimum Requirements: An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty). 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology. Additional Preferences: Breast cancer disease area knowledge. Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team. Proven track record to bring out the best in others on a cross-functional international team. Leading by influence. Proven track record to interact externally and internally to support a global scientific and business strategy. Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel. Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator. Strong communication, both written and oral. Ability to multi-task and shift priorities rapidly to meet target dates. 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 (******************************************************** 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), en Able (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 $151,500 - $259,600 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

Department: MED-Cardiology Salary/Grade: NEX/11 We are seeking a candidate who can serve in a data project management capacity, with particular emphasis on data project coordination. The ideal candidate will have prior experience managing the lifecycle of data projects-from planning and collection through analysis and reporting-and can work independently to keep multiple data streams organized and on schedule. Candidates with experience in data analysis are preferred. Job Summary: Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Please note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters. Specific Responsibilities: Technical * Participates in the planning & conduct of research study including participant recruitment and retention. * Obtains informed consent * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. Administration * Collects, records, reviews & summarizes research data. * Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. * Writes portions of grant applications & co-author scientific papers. * Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Finance * May process payments for research participants per study protocol. * Works with industry representatives to negotiate tentative grant funding. * Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget. Supervision * May provide work direction &/or train other research staff to interview/test participants. * May act as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Target hiring range for this position will be between $19.89 - 27.97 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-JP1

Department: MED-General Internal Salary/Grade: NEX/11 Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Specific Responsibilities: Technical * Participates in the planning & conduct of research study including participant recruitment and retention. * Obtains informed consent * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. Administration * Collects, records, reviews & summarizes research data. * Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. * Writes portions of grant applications & co-author scientific papers. * Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Finance * May process payments for research participants per study protocol. * Works with industry representatives to negotiate tentative grant funding. * Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget. Supervision * May provide work direction &/or train other research staff to interview/test participants. * May act as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Target hiring range for this position will be between $19.89 - 27.97 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-JP1

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. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements PharmD, PhD in health/medical/scientific (for example, in Pharmacology, physiology, microbiology) 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered 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 (******************************************************** 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), en Able (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 $177,000 - $338,800 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

Department: MED-Infectious Disease Salary/Grade: NEX/11 Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Please note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters. Specific Responsibilities: Technical * Participates in the planning & conduct of research study including participant recruitment and retention. * Obtains informed consent * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. Administration * Collects, records, reviews & summarizes research data. * Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. * Writes portions of grant applications & co-author scientific papers. * Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Finance * May process payments for research participants per study protocol. * Works with industry representatives to negotiate tentative grant funding. * Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget. Supervision * May provide work direction &/or train other research staff to interview/test participants. * May act as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Target hiring range for this position will be between $19.89 - 27.97 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-JP1

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. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered 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 (******************************************************** 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), en Able (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 $177,000 - $338,800 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