Clinical research coordinator jobs in Anderson, IN - 38 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. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. Demonstrate compliance with procedures and be accountable for compliance of team members. Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management. Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. Collaborate with Global Patient Safety on risk management planning. Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. Partake in data analysis, scientific dissemination, and preparation of final study reports. Analyze and contextualize clinical data to support decision-making and portfolio strategy. Contribute to strategy and innovation through cross-functional working groups. Support planning and execution of symposia, advisory boards, and other external engagements. Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development Stay current with medical literature and scientific developments in breast oncology. Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. Provide scientific consultation to medical affairs, health outcomes, and commercial teams. Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience 3+ years of clinical research scientist experience/clinical trial experience Leadership experience Additional Information/Preferences: Direct Line Leadership experience Breast cancer disease state knowledge/experience An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. Strong communication, interpersonal, teamwork, organizational, and negotiation skills Demonstrated ability to influence others (both cross-functionally and within the function) to build 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 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

Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Responsibilities** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). + Support adoption of new technology or clinical applications through advocacy and evidence. + Participate in customer presentations regarding use of Interventional products for institution research purposes. + Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. + Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. + Grow technology leadership mindshare through joint scientific presentations and publications. + Install/upgrade research equipment and software & prototypes + Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures + Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. + Study new technology concepts and leverage expertise to move initiatives forward. Note: + No sponsorship available for this role now or in the future to work in the United States.. **Qualifications** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. + 3+ years of experience in Interventional healthcare industry or research. + Knowledge of Interventional procedures, anatomies, clinical practice. + Excellent written and verbal communication skills. + Excellent customer relationship management and collaboration skills. + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( + Quality, Compliance, and Continuous Improvement focus **Desired Characteristics** + 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. \#LI-BR3 \#LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. **Additional Information** GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** No

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. **Position Overview:** The **Development Clinical Research Scientist** (CRS) in the **Breast Cancer Franchise** will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. **Primary Responsibilities** + Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. + Demonstrate compliance with procedures and be accountable for compliance of team members. + Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. + Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management. + Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. + Collaborate with Global Patient Safety on risk management planning. + Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. + Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. + Partake in data analysis, scientific dissemination, and preparation of final study reports. + Analyze and contextualize clinical data to support decision-making and portfolio strategy. + Contribute to strategy and innovation through cross-functional working groups. + Support planning and execution of symposia, advisory boards, and other external engagements. + Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. + Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. **Scientific & Technical Expertise and Development** + Stay current with medical literature and scientific developments in breast oncology. + Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. + Provide scientific consultation to medical affairs, health outcomes, and commercial teams. + Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. **Leadership & Professional Development** + Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. + Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. **Basic qualifications:** + PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience + 3+ years of clinical research scientist experience/clinical trial experience + Leadership experience **Additional Information/Preferences:** + Direct Line Leadership experience Breast cancer disease state knowledge/experience + An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) + Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. + Strong communication, interpersonal, teamwork, organizational, and negotiation skills + Demonstrated ability to influence others (both cross-functionally and within the function) to build 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 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

Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Duties include but not limited to: Ability to understand and follow institutional SOPs. Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Assist with planning and creation of appropriate recruitment materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Attend Investigator meetings as required. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Assist in the creation and review of source documents. Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Study Management Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Patient Coordination Prescreen study candidates Obtain informed consent per Care Access Research SOP Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Bilingual in Spanish-preferred How We Work Together Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, IN clinic. Travel: Regularly planned travel within the region will be required as part of the role. Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

**PXL FSP - Join an organization shaping smarter, faster clinical development** PXL FSP is seeking a detail‑oriented and proactive **Feasibility Study Manager** to support the delivery of high‑quality global feasibility assessments. This role is ideal for someone who thrives in a fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible. **Key Responsibilities** **Survey Design & Configuration** + Transform draft feasibility questionnaires into an electronic survey platform with clear, intuitive formatting. + Apply branching logic, conditional pathways, and scoring algorithms in alignment with the Feasibility Lead's specifications. + Build survey reporting templates directly within the platform or through external systems as needed. **Site & Investigator Readiness** + Perform quality checks on potential investigators before survey deployment. + Support verification of available CDAs prior to launch. + Upload targeted site and investigator lists into the survey management system, ensuring accuracy and completeness. **Survey Management & Execution** + Lead survey launch activities and oversee ongoing monitoring, including: + Delegating surveys appropriately + Tracking and reconciling survey status + Ensuring thorough documentation of site notes and survey details + Identifying and consolidating invalid contact information + Conduct proactive research to update missing or incorrect contact details, ensuring seamless engagement and response tracking. + Monitor country‑level response metrics to support early risk identification and mitigation planning. **Site Identification Strategy** + Execute the agreed site‑identification strategy, including application of priority site designations. + Implement the communication plan using approved study summaries, templates, and designated system email origins. + Facilitate timely revisions to survey content, scoring, and site/country lists as needed throughout survey duration. + Track CDA negotiation status for participating sites and communicate internal updates. **Close‑Out Activities** + Oversee survey closure, including final site notifications and completion of assigned wrap‑up tasks. **Minimum Qualifications** + **Education:** Bachelor's degree or equivalent. + **Experience:** 3-5 years of relevant industry experience (clinical research, feasibility, site engagement, project coordination, or related areas). \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Senior Research Scientist, Non-Clinical Safety & Toxicology We are seeking an experienced non-clinical toxicology / safety scientist to join the Global Non-Clinical Development team in Global Clinical Development. As the Senior Research Scientist, Non-Clinical Safety & Toxicology you will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution at all phases of global veterinary pharmaceutical drug/product and feed additive research and development, product safety assessments, and support for marketed products. This role applies toxicology and immunology expertise to assess safety risks across the full product lifecycle, from early development through commercialization. Responsibilities include evaluating potential safety concerns related to product design, manufacturing changes, deviations, or consumer complaints that could impact animal safety or end-user health. The role involves preparing Product Safety Assessments (PSAs) for products in development, production, or on the market, and compiling medical and toxicological data to assess potential health risks for consumers and end users. Your Responsibilities: Independently design, organize, monitor, report, and resolve issues related to outsourced in vitro and in vivo safety/toxicology studies, utilizing external CROs and/or consultants as needed. These studies may involve typical rodent and non-rodent species. Target animal safety evaluations may include companion animals (dogs and cats) as well as food-producing animals (e.g., cattle, pigs, chickens). Conduct literature reviews and author expert reports, position papers, safety and hazard/risk assessments, and other strategic scientific, technical, or medical evaluations to address safety considerations for veterinary drugs (small molecules and biologics), feed additives, excipients, E&L substances, impurities, or other chemicals. Provide internal expert guidance, including expert statements, health-based exposure limits (e.g., PDEs, OELs), and target safety assessments. Engage with regulatory agencies to address safety concerns for both products in development and marketed products, including preparing and submitting documentation and delivering formal presentations. Collaborate closely with colleagues in Manufacturing, Quality, Human Food Safety, ADME/PK, and Environmental Safety to accomplish multidisciplinary non-clinical objectives for projects and products. Proactively participate in global, cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing) within a matrix organization to drive project success. Maintain technical and professional expertise by staying current with scientific developments and sharing relevant insights and best practices within the organization. What You Need to Succeed (Minimum Qualifications): Education: DVM and/or PhD (preferred) in toxicology or another relevant biomedical science discipline (e.g., veterinary medicine, biology, chemistry) with at least 5 years of industry experience in non-clinical safety, or a Master's degree with at least 7 years of relevant experience. Experience: Demonstrated ability to apply toxicology and risk assessment principles aligned with global regulations and guidance. Experience in non-clinical veterinary drug development, including target safety assessments, in silico predictions, and safety evaluations throughout product life cycles. Strong background in large molecule, biologics, vaccine, and antibody development, as well as using in vitro/in vivo data and literature to support product development and registration. Top 2 skills: A strong, collaborative team-player with expertise in toxicology and immunology with strong risk assessment capabilities. Highly skilled in cross-functional collaboration, regulatory strategy, and effective communication of complex scientific concepts. What Will Give You a Competitive Edge (Preferred Qualifications): Board certification as a toxicologist (ERT, DABT, or equivalent). Immunological background, especially related to monoclonal antibodies and emerging platform technologies for indications like dermatology or pain. Deep understanding of US, European, and international veterinary drug development, as well as agribusiness practices for companion and farm animals. Strong working knowledge of GLP regulations and experience with in silico toxicity prediction tools. Ability to manage complex projects independently, with strong organizational and time management skills. Excellent written and verbal communication skills in English. Additional Information: Travel: Up to 30% annually (domestic and international) Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (Soon to be Indianapolis, Indiana NEW HQ October 2025) Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Senior Clinical Research Associate (home based) (Level dependent on experience) To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Clinical Project Manager needs 5+ years experience Clinical Project Manager requires: Onsite Clinical Project management MS Project, SAP, IMPACT etc. Accurately forecast and track direct expenses for clinical budgets Document key team information and clinical decisions in Chorus custom tracking and communication database Manage clinical operational risks and their impact to the timelines and budgets of clinical studies, including critical path activities Select and manage external network of vendors to ensure on time and on budget clinical project deliverables Establish and manage Clinical vendor expectations, performance, and delivery Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward Partner with regulatory and medical to ensure safety management and monitoring processes are implemented Provide input into molecule development, clinical regulatory and safety strategy Manage global cross-functional communication and escalations to ensure alignment on delivery and execution Utilize clinical operations process knowledge to drive decision making. Participate in review of clinical database specifications and utilization

About IHI At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families. What You Will Do As a Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols. The Opportunity Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator. Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI. Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits. Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol. Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors. Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Participate in internal quality assurance; review monitor reports for trends across studies. Requirements Minimum Associate's degree in related field required. Minimum 1 year of related experience required. Valid Indiana Driver's license and automobile insurance required. All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role. Benefits IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics. IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. Innovative Hematology, Inc. is an Equal Opportunity Employer.

**Details** + **Department: Cardiac Services - Cardiology Research** + **Schedule: Full Time Day - Monday - Friday 8am/5pm** + **Hospital: Ascension St. Vincent** **Benefits** Paid time off (PTO) Various health insurance options & wellness plans Retirement benefits including employer match plans Long-term & short-term disability Employee assistance programs (EAP) Parental leave & adoption assistance Tuition reimbursement Ways to give back to your community _Benefit options and eligibility vary by position. Compensation varies based on factors including, but not limited to, experience, skills, education, performance, location and salary range at the time of the offer._ **Responsibilities** Lead clinical research projects via study protocols and provide direct patient care for study participants. + Assist with the preparation, submission and management of internal/external compliance documentation at all stages of the research project. + Assist with the selection, education, testing, and monitoring of research project participants. Follow protocols and collaborate with other healthcare providers to ensure continuity of participant care. + Document patient care and study results using appropriate formats and systems. Communicate patient/study results on an on-going basis to research team. + Participate in quality assurance/improvement initiatives. Ensure compliance with applicable standards of care and regulatory requirements. **Requirements** Licensure / Certification / Registration: + Registered Nurse credentialed from the Indiana Board of Nursing obtained prior to hire date or job transfer date required. Education: + Diploma from an accredited school/college of nursing OR Required professional licensure at time of hire. **Additional Preferences** Ascension St. Vincent is looking for an **RN** - **Clinical Trial Research Coordinator.** Minimum requirements: The right candidate will have their **Indiana RN** license with Cardiology experience and Clinical Trial Research experience. **The areas of research include (but are not limited to) heart failure, pulmonary hypertension, VAD/transplant, and atrial fibrillation. This role is both administrative and patient facing.** This is a great opportunity for the right person with the perfect mixture of Cardiology & Clinical Trial Research! If you enjoy helping patients - This position will allow you to be part of something that provides options when the patient feels they have none left. Rewarding Cardiology position with great benefits, no weekends, and front loaded PTO. **Why Join Our Team** Ascension St. Vincent in Indiana has been providing rewarding careers in healthcare for over 148 years. With 24 hospitals throughout the greater Indianapolis and Evansville areas, Ascension St. Vincent offers careers in a wide range of services including acute and long-term care, bariatrics, cancer care, cardiovascular services, emergency services, neuroscience, orthopedics, pediatric services, primary and urgent care, women's health services and more. Ascension is a leading non-profit, faith-based national health system made up of over 134,000 associates and 2,600 sites of care, including more than 140 hospitals and 40 senior living communities in 19 states. Our Mission, Vision and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make a positive impact in their community. Ascension careers are more than jobs; they are opportunities to enhance your life and the lives of the people around you. **Equal Employment Opportunity Employer** Ascension provides Equal Employment Opportunities (EEO) to all associates and applicants for employment without regard to race, color, religion, sex/gender, sexual orientation, gender identity or expression, pregnancy, childbirth, and related medical conditions, lactation, breastfeeding, national origin, citizenship, age, disability, genetic information, veteran status, marital status, all as defined by applicable law, and any other legally protected status or characteristic in accordance with applicable federal, state and local laws. For further information, view the EEO Know Your Rights (English) (****************************************************************************************** poster or EEO Know Your Rights (Spanish) (******************************************************************************************** poster. As a military friendly organization, Ascension promotes career flexibility and offers many benefits to help support the well-being of our military families, spouses, veterans and reservists. Our associates are empowered to apply their military experience and unique perspective to their civilian career with Ascension. Pay Non-Discrimination Notice (*********************************************************************************************** Please note that Ascension will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Ascension will not solicit money or banking information from applicants. **E-Verify Statement** This employer participates in the Electronic Employment Verification Program. Please click the E-Verify link below for more information. E-Verify (********************************************** Contents/E-Verify\_Participation\_Poster\_ES.pdf)

Job Description About IHI At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families. What You Will Do As a Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols. The Opportunity Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator. Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI. Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits. Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol. Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors. Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Participate in internal quality assurance; review monitor reports for trends across studies. Requirements Minimum Associate's degree in related field required. Minimum 1 year of related experience required. Valid Indiana Driver's license and automobile insurance required. All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role. Benefits IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics. IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. Innovative Hematology, Inc. is an Equal Opportunity Employer.

The primary purpose of this role is to coordinate and oversee the daily activities associated with all research trials at a research farm. This position works closely with research scientists and associates to support trial execution, contribute ideas for research advancement, and ensure all operational needs are met for current and upcoming studies. The role is approximately 30% office-based and 70% barn-based. Key Responsibilities: Oversee daily tasks for all active research projects, including walking barns each day and caring for animals when a barn caretaker is unavailable. Record and enter daily weights and feed data into Excel spreadsheets and upload information to the corporate website. Prepare research trial diets and operate computerized feed systems. Lead team members in recording accurate pig and feed weights to ensure precise feed consumption data. Support general production activities within a grow/finish swine operation, including vaccinating, administering treatments, recording observations, monitoring ventilation, operating light equipment, and occasional power washing. Additional Responsibilities: Maintain accurate, detailed documentation for all research activities. Support ongoing research initiatives and contribute to continuous improvement of trial processes. Promote and maintain a safe, secure, and biosecure working environment. Typical Work Environment: Farm-based environment with exposure to livestock, farm equipment, and varying weather conditions (hot, cold, humid, etc.). Requires flexibility to work weekends, holidays, and extended hours as research demands. Minimum Qualifications: Bachelor's degree in Animal Science, Agriculture, or a related field, or equivalent professional experience. 1-2 years of experience working with livestock preferred. 1+ year of experience conducting research preferred. Education & Training: Bachelor's degree in Animal Science, Agriculture, or a relevant field, or equivalent professional experience. Relevant Experience: 1-2 years of livestock experience preferred. 1+ year of research experience preferred. Technical Skills: Proficiency in Microsoft Office applications, especially Excel. Ability to effectively use the company email system (Outlook). Working knowledge of research trial protocols and best practices. Basic understanding of animal nutrition principles. Ability to operate farm equipment and technology systems (ex., Fancom feed system). Non-Technical Skills: Strong interpersonal and communication skills. Excellent time management and multi-tasking abilities. High attention to detail and accuracy. Ability to work collaboratively in a team environment. Licenses/Certifications: None required. Physical Requirements: Ability to lift 50 lbs. or more regularly. Good body flexibility including frequent bending, twisting, and repetitive movements. Mobility and stamina to endure manual labor, included extended periods of standing, and working with livestock. Ability to work in farm environments with exposure to varying temperatures and seasonal conditions. Safety Requirements: Adhere to all company safety procedures and regulations. Wear appropriate personal protective equipment (PPE). Strictly follow all biosecurity protocols.

This position provides research project support to requesting department to ensure timelines and effectiveness in activation and completion of needed research projects. Responsible for routine to moderately complex project coordination / project management as well as communication and documentation as required by the research departments. **Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings** We are committed to offering flexible work options where approved and stated in the job posting. However, we are currently not considering candidates who reside or plan to reside in the following states: **California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, and Washington** **Essential Functions** + **Research Support and Administration:** Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources. + **Project Planning & Execution:** Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed. + **Budget & Scope Management:** Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing. + **Study Requirements & Compliance:** Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements. + **Quality Assurance & Documentation:** Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices. + **Study Lifecycle Management:** Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator. + **Medicare Coverage Analysis:** Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review. + **Auditing & Risk Management:** Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations. **Skills** + Budgeting + Financial negotiation + Attention to detail + Multitasking + Clear written and verbal communication + Task Prioritization + Process Improvement + Critical thinking + Collaboration + Research **Physical Requirements** + Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues. + Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately. + Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands. + Expected to bend, lift, and carry patient files, documents, equipment, and supplies. + Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment. + For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles. **Physical Requirements:** **Minimum Qualifications** + Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment. + Demonstrated experience working in a collaborative team environment. + Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications. + Ability and willingness to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required. + Clinical licensure, experience or certification may be required due to grant funding requirements. · Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified. + Two (2) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **OR** + Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **Preferred Qualifications** + Experience in clinical research setting, including relevant study management experience. · Experience in a healthcare or hospital setting. **Location:** Intermountain Health Intermountain Medical Center **Work City:** Murray **Work State:** Utah **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $27.65 - $43.55 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.

Who is Rendevor Dialysis? We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians. Our Mission To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need. What s In It For You? Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees. We offer an extremely generous package including: Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data) Fantastic employee benefit package Employer contribution to H.S.A. F.S.A. tax savings benefits A 4% dollar-for-dollar company match to the 401k plan with immediate vesting A generous PTO accrual program A PTO cash-out provision Tuition reimbursement program Employee referral bonus program Robust employee recognition and appreciation program Quality employee training and development programs Several holidays paid at time and a half Annual holiday gift bags for all employees Comprehensive Medical Benefits Vision Dental STD/LTD/Voluntary Life Accident, Critical Illness and Hospital Indemnity Plans Pet Insurance Discounted auto and home insurance Discounted legal services program Employer-paid life insurance for 1x employee salary Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members Complimentary year-long weight loss program Health & Wellness Program with gift card giveaways What You ll Do: The Clinical Coordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the Clinical Coordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments. The Clinical Coordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel. The Clinical Coordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc. As required by the Regional Director, the Clinical Coordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements. Reports to the Regional Director as assigned. This dialysis unit is located in: Plainfield, IN, within Plainfield Correctional Facility This dialysis unit operates: Monday - Saturday from 5:00 am - 4:30 pm As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.) Minimum Qualifications Education and Experience Graduation from an Accredited Nursing School or Equivalent Current RN License for Indiana & current CPR certification (or within three months of hire) One year of Hemodialysis RN experience is required Previous management experience preferred Required Skills and Competencies Ability to read, write, speak, understand and satisfactorily communicate in English. Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc. Ability to quickly learn a variety of technical systems and equipment Essential Duties and Responsibilities: Leadership In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures. Leads, coaches, and guides other clinical teammates, depending on unit size. May be required to monitor clinical teammate in-servicing and skills checks. Delegates tasks as necessary to maximize time and efficiency. Holds team huddles to discuss unit goals and objectives and delivers pertinent corporate communication. Ensures company policies and procedures are maintained for continuity across the company. Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team. Participates in onboarding, training, and educating new hires. Ensures teammates have been properly in-serviced and checked off on skills. Staffing Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc. Maintains contact with PRN bench staff, coordinating requirements for needed schedules Facilitates staff development, training, and monthly education. Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed. Participates in employee appreciation events and planning, based on provided budget from Regional Director. In coordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates. Communicates staffing needs with RD and Talent Partner. Depending on unit size, may be required to participate in interviews and candidate selection. Encourages employee referrals and may be asked to contact referrals provided by staff. Clinical Delivers safe and effective patient care of all treatment modalities Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards. Actively participates in patient education, and ensures teammates follow same protocols. Takes ownership of lab collections and documentation. Applies critical thinking and time management skills. Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care. Depending on unit size and requirements, may be involved with patient care review meetings. Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies. Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request. Takes ownership of unit safety, cleanliness, and infection control As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc. Monitors and assures that the patients receive adequate medical attention while in the dialysis unit. Maintains the integrity of all protected health information. Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same. Supervises medical records to ensure complete documentation. Engages in constant learning and research of dialysis practices. Continuous Quality Improvement/Quality Assurance & Performance Improvemen Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed. Assists or may be responsible for the monthly completion of the Rendevor Application requirements. Ensures adequate resources for supporting the CQI/QAPI process as applicable. Communication (internal and external) Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc. May be required to attend and participate in facility meetings. Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications. Maintains an open-door policy to communicate with teammates. Maintains professionalism and privacy of confident information. Payroll Records both arrival and departure time via ADP s time and attendance system, following the guidelines outlined by Human Resources. Assists new hires in accessing the time system and demonstrates proper log in/out procedures. If assigned, approves timesheets of unit teammates in ADP. Accounting Timely and accurate review and submission of treatment rosters within two days of month end. Inventory/Supplies Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule. Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand. Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department. Business Development Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties. Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor. General Promotes and implements the Company s mission, vision, and core values. Displays excellent and professional written/verbal communication skills. Always maintains a professional demeanor; keeps an open door policy. Operates with a high level of responsiveness in providing information and deliverables to supervisors. Demonstrates a high degree of self-motivation and willingness to improve. Openly receives and promptly acts upon any feedback from supervisors, peers, clients. Volunteers to assist colleagues when necessary and assist with various projects as assigned. Reports any incidents to Regional Director. Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements. Must maintain RN license, CPR and a clean background. Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications. Adheres to all company and departmental policies and procedures. Maintains regular and predictable attendance and punctuality. Other duties as assigned. Supervision: This position will report to the Regional Director. This position will supervise clinical team members. Background Check: The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made. Work Environment: This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.) Rendevor Dialysis is an Equal-Opportunity Employer.

Who is Rendevor Dialysis? We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians. Our Mission To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need. Whats In It For You? Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees. We offer an extremely generous package including: Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data) * Fantastic employee benefit package * Employer contribution to H.S.A. * F.S.A. tax savings benefits * A 4% dollar-for-dollar company match to the 401k plan with immediate vesting * A generous PTO accrual program * A PTO cash-out provision * Tuition reimbursement program * Employee referral bonus program * Robust employee recognition and appreciation program * Quality employee training and development programs * Several holidays paid at time and a half * Annual holiday gift bags for all employees * Comprehensive Medical Benefits * Vision * Dental * STD/LTD/Voluntary Life * Accident, Critical Illness and Hospital Indemnity Plans * Pet Insurance * Discounted auto and home insurance * Discounted legal services program * Employer-paid life insurance for 1x employee salary * Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members * Complimentary year-long weight loss program * Health & Wellness Program with gift card giveaways What Youll Do: * The Clinical Coordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the Clinical Coordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments. * The Clinical Coordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel. * The Clinical Coordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc. * As required by the Regional Director, the Clinical Coordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements. * Reports to the Regional Director as assigned. This dialysis unit is located in: * Plainfield, IN, within Plainfield Correctional Facility This dialysis unit operates: * Monday - Saturday from 5:00 am - 4:30 pm As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.) Minimum Qualifications Education and Experience * Graduation from an Accredited Nursing School or Equivalent * Current RN License for Indiana & current CPR certification (or within three months of hire) * One year of Hemodialysis RN experience is required * Previous management experience preferred Required Skills and Competencies * Ability to read, write, speak, understand and satisfactorily communicate in English. * Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc. * Ability to quickly learn a variety of technical systems and equipment Essential Duties and Responsibilities: Leadership * In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures. * Leads, coaches, and guides other clinical teammates, depending on unit size. * May be required to monitor clinical teammate in-servicing and skills checks. * Delegates tasks as necessary to maximize time and efficiency. * Holds team huddles to discuss unit goals and objectives and delivers pertinent corporate communication. * Ensures company policies and procedures are maintained for continuity across the company. * Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team. * Participates in onboarding, training, and educating new hires. * Ensures teammates have been properly in-serviced and checked off on skills. Staffing * Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc. * Maintains contact with PRN bench staff, coordinating requirements for needed schedules * Facilitates staff development, training, and monthly education. * Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed. * Participates in employee appreciation events and planning, based on provided budget from Regional Director. * In coordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates. * Communicates staffing needs with RD and Talent Partner. * Depending on unit size, may be required to participate in interviews and candidate selection. * Encourages employee referrals and may be asked to contact referrals provided by staff. Clinical * Delivers safe and effective patient care of all treatment modalities * Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards. * Actively participates in patient education, and ensures teammates follow same protocols. * Takes ownership of lab collections and documentation. * Applies critical thinking and time management skills. * Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care. * Depending on unit size and requirements, may be involved with patient care review meetings. * Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies. * Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request. * Takes ownership of unit safety, cleanliness, and infection control * As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc. * Monitors and assures that the patients receive adequate medical attention while in the dialysis unit. * Maintains the integrity of all protected health information. * Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same. * Supervises medical records to ensure complete documentation. * Engages in constant learning and research of dialysis practices. Continuous Quality Improvement/Quality Assurance & Performance Improvemen * Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed. * Assists or may be responsible for the monthly completion of the Rendevor Application requirements. * Ensures adequate resources for supporting the CQI/QAPI process as applicable. Communication (internal and external) * Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc. * May be required to attend and participate in facility meetings. * Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications. * Maintains an open-door policy to communicate with teammates. * Maintains professionalism and privacy of confident information. Payroll * Records both arrival and departure time via ADPs time and attendance system, following the guidelines outlined by Human Resources. * Assists new hires in accessing the time system and demonstrates proper log in/out procedures. * If assigned, approves timesheets of unit teammates in ADP. Accounting * Timely and accurate review and submission of treatment rosters within two days of month end. Inventory/Supplies * Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule. * Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand. * Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department. Business Development * Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties. * Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor. General * Promotes and implements the Companys mission, vision, and core values. * Displays excellent and professional written/verbal communication skills. * Always maintains a professional demeanor; keeps an open door policy. * Operates with a high level of responsiveness in providing information and deliverables to supervisors. * Demonstrates a high degree of self-motivation and willingness to improve. * Openly receives and promptly acts upon any feedback from supervisors, peers, clients. * Volunteers to assist colleagues when necessary and assist with various projects as assigned. * Reports any incidents to Regional Director. * Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements. * Must maintain RN license, CPR and a clean background. * Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications. * Adheres to all company and departmental policies and procedures. * Maintains regular and predictable attendance and punctuality. * Other duties as assigned. Supervision: * This position will report to the Regional Director. * This position will supervise clinical team members. Background Check: The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made. Work Environment: This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.) Rendevor Dialysis is an Equal-Opportunity Employer.

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. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. Demonstrate compliance with procedures and be accountable for compliance of team members. Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management. Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. Collaborate with Global Patient Safety on risk management planning. Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. Partake in data analysis, scientific dissemination, and preparation of final study reports. Analyze and contextualize clinical data to support decision-making and portfolio strategy. Contribute to strategy and innovation through cross-functional working groups. Support planning and execution of symposia, advisory boards, and other external engagements. Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development Stay current with medical literature and scientific developments in breast oncology. Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. Provide scientific consultation to medical affairs, health outcomes, and commercial teams. Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience 3+ years of clinical research scientist experience/clinical trial experience Leadership experience Additional Information/Preferences: Direct Line Leadership experience Breast cancer disease state knowledge/experience An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. Strong communication, interpersonal, teamwork, organizational, and negotiation skills Demonstrated ability to influence others (both cross-functionally and within the function) to build 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 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

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Duties include but not limited to: * Ability to understand and follow institutional SOPs. * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Assist with planning and creation of appropriate recruitment materials * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Attend Investigator meetings as required. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Assist in the creation and review of source documents. * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) * Study Management * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Communicate clearly verbally and in writing. * Patient Coordination * Prescreen study candidates * Obtain informed consent per Care Access Research SOP * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Bilingual in Spanish-preferred How We Work Together * Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, IN clinic. * Travel: Regularly planned travel within the region will be required as part of the role. * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

About IHI At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families. What You Will Do As a Research Nurse Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols. The Opportunity Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator. Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI. Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits. Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol. Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors. Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Participate in internal quality assurance; review monitor reports for trends across studies. Requirements Minimum Associate's degree in Nursing. Bachelor's preferred RN or LPN license in the state of Indiana required Minimum 5 years of related experience Experience in pharmaceutical sponsored studies required Valid Indiana Driver's license and automobile insurance All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role Benefits IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics. IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. Innovative Hematology, Inc. is an Equal Opportunity Employer.

Job Description About IHI At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families. What You Will Do As a Research Nurse Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols. The Opportunity Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator. Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI. Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits. Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol. Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors. Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Participate in internal quality assurance; review monitor reports for trends across studies. Requirements Minimum Associate's degree in Nursing. Bachelor's preferred RN or LPN license in the state of Indiana required Minimum 5 years of related experience Experience in pharmaceutical sponsored studies required Valid Indiana Driver's license and automobile insurance All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role Benefits IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics. IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. Innovative Hematology, Inc. is an Equal Opportunity Employer.