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  • Clinical Research Scientist - Breast Cancer Franchise

    Eli Lilly and Company 4.6company rating

    Clinical research associate job in Indianapolis, IN

    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 comply 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. Supervise and participate 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. Participate 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 strategic planning 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 or equivalent experience in Health-related field with 10+ years' industry experience 3+ years of clinical research scientist experience/clinical trial experience Direct Line Leadership experience Additional Information/Preferences: 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. Proven 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
    $177k-308k yearly Auto-Apply 24d ago
  • Clinical Research Scientist Interventional Solutions

    GE Healthcare 4.8company rating

    Clinical research associate job in Indianapolis, IN

    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
    $97.6k-146.4k yearly 60d+ ago
  • Senior Clinical Research Associate (level dependent on experience)

    CTI Clinical Trial Services 3.7company rating

    Clinical research associate job in Indianapolis, IN

    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
    $62k-97k yearly est. 60d+ ago
  • Research Scientist - Clinical

    Lilly 4.3company rating

    Clinical research associate job in Indianapolis, IN

    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. **Clinical Research Scientist - Medical Affairs Allergy, Immunology BU** Purpose: The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly's R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly's medications. Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The application of scientific and clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral member of the medical affairs team. The Medical Affairs CRS supports the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s). The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local and global business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The global team CRS is responsible for collaborating with the global development teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Business/ customer support (pre and post launch support) + Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers) + Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts. + Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan. + Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, giving clinical input and insight to develop payer partnership programs and defend the product value. + Support business-to-business and business-to-government activities as medical expert. + Contribute actively on an ongoing basis to the strategic planning for currently marketed brands. + By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. + Support training of sales representatives, and other medical representatives. + Become familiar with market archetypes and potential influence on the medical interventions for the product. + Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. + Become patient advocate, as well as a medical expert supporting identification of Clinical Care Gaps (CCGs). + Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service). + Understand and apply knowledge of customer insights to all customer-related activities. + Participate in local or national trade associations as appropriate. Scientific Data Dissemination/Exchange + Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. + Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. + Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals. + Support medical information associates in preparation and review of medical letters and other medical information materials. + Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff. + Prepare or review scientific information in response to customer questions or media requests. + Provide follow-up to information requested by health care professionals as per global SOPs. + Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). + Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis. + Develop and maintain appropriate collaborations and relationships with relevant professional societies. + Support the design of customer research as medical expert. + Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). + Support efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications. + Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning + Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams. + Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes). + Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. + Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design. Clinical Research/Trial Execution and Support + Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects. + Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). + Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. + Participate in investigator identification and selection, in conjunction with clinical teams. + Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. + Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel. + Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. + Review lIT proposals and publications, as requested. + Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams. + Understand and actively address the scientific information needs of all investigators and personnel. + Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. Regulatory Support Activities + Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists. + Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective. + Participate in advisory committees. + Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS). Scientific / Technical Expertise and continued development + Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years). + Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. + Responsible for the scientific training of the clinical study team. + Acts as scientific consultant and protocol expert for clinical study team members and others in medical. + Explore and take advantage of opportunities for extramural scientific experiences. + Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities + Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget. + Use knowledge of specific disease states and available treatments to provide scientific and medical input, contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality. + Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable. + Collaborate proactively and productively with all alliance, business, and vendor partners. + Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness. + Actively participate in recruitment, diversity, and retention and hiring efforts as applicable. + Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management. + Model the leadership behaviors. + Be an ambassador of both patients and the Lilly Brand. Minimum Qualification Requirements: + PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience + Clinical trial experience in drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Other Information/Additional Preferences: + Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills. + Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills. + Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. + Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. + Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: + Therapeutic area directors, managers, or project managers + Product directors, managers, and associates of the brand + Clinical research staff + Statisticians + Scientific communication associates + Medical information associates + Medical liaisons + Global patient outcomes research consultants/research scientists and health outcomes liaisons + Regulatory directors, scientists, and associates + Sales representatives + Legal counsel + Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. + Corporate or regional patient safety physician(s) External Contacts + Scientific and clinical experts, thought leaders + Lilly clinical investigators + Practicing physicians/prescribers + Regulatory agency personnel + Professional association staff and leaders + Disease advocates and lay organizations focused on relevant health issues + Formulary representatives (private and government) Demonstrates the following competencies Making Business Decisions with data - Harnesses the power of data and analytics to solve problems, make good decisions and measure results. **Job-Based Skills:** + Defines the problem or decision to be made within context of strategy or goals/objectives. + Identifies relevant sources and validates accuracy of data. + Analyzes and synthesizes data and identifies trends. + Draws conclusions and makes timely, well-informed decisions. + Engages data and analytics colleagues appropriately when needed. Scientific/Information Exchange - **Maximizes engagement with key customers and colleagues through the integration of personal and/or non-personal channels when collaborating, discussing, and sharing science/information.** **Job-Based Skills:** + Identifies challenges, information gaps, education needs, and delivery preferences. + Creates an engaging narrative. + Generates content with the channel(s) and medium(s) in mind. + Adjusts style and tone to meet the unique needs of each audience. + Uses preferred channel(s) to deliver at the time of need. + Measures knowledge gained. Technical/Functional Expertise - Leads with technical and functional expertise. **Job-Based Skills:** + Establishes appropriate scientific and medical subject matter expertise (e.g., disease states, therapeutic landscapes, drug development processes, portfolio, etc.). + Maintains relevant knowledge of the healthcare landscape (e.g., health, payer, and regulatory systems and processes) and environment (e.g., HCP experience models and patient flow maps, value/accountable care, and population health landscape, etc.). + Understands the advancements in technology that are influencing area of expertise and function (i.e., real-world clinical practice, AI techniques, tools and platforms). + Develops appropriate knowledge of activities that can be used to influence and deliver on organizational purpose (i.e., shape clinical practice, systems, tools and platforms). + Masters individual workstream tools and processes. Strategic Agility - Defines and commits to an initial strategy or approach; monitors effectiveness; and adapts based on new information and/or insights. **Job-Based Skills:** + Develops an actionable strategy or approach-involving colleagues and engaging stakeholders appropriately. + Creates a clearly defined measurement plan with key metrics and triggers. + Monitors progression and impact against key metrics. + Identifies opportunities to improve. + Reassesses strategy/approach and pivots when appropriate. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 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
    $73k-118k yearly est. 7d ago
  • Clinical Research Manager

    Pharmavise Corporation

    Clinical research associate job in Indianapolis, IN

    Job Description . The Clinical Research Manager (CRM) is responsible for the strategic and operational oversight of clinical trials conducted across various phases. This role ensures that studies are executed in compliance with regulatory requirements, GCP/ICH guidelines, and internal SOPs. The CRM manages cross-functional teams, monitors timelines and budgets, and acts as the primary liaison between investigators, CROs, vendors, and internal stakeholders. Key Responsibilities: Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases. Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities. Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards. Develop and maintain project timelines, budgets, and resource plans. Supervise and mentor Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators. Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports. Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing. Manage vendor and CRO relationships, including contract negotiations and performance monitoring. Track and report on study metrics and provide regular updates to senior leadership. Oversee the preparation and conduct of audits and regulatory inspections. Minimum Qualifications: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (Master's or Ph.D. preferred). Minimum of 5-7 years of experience in clinical research, including 2+ years in a managerial or supervisory role. In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements. Proven experience managing Phase I-IV trials across multiple therapeutic areas. Strong project management, leadership, and team coordination skills. Excellent written and verbal communication abilities. Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms). Ability to travel up to 20% as needed. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at ************ or through their website at dhs.gov/e-verify.
    $65k-100k yearly est. 22d ago
  • Clinical Project Manager

    Global Channel Management

    Clinical research associate job in Indianapolis, IN

    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
    $78k-115k yearly est. 60d+ ago
  • Clinical Operations Specialist

    Storypoint

    Clinical research associate job in Indianapolis, IN

    Job Description Clinical Operations Specialist CommonSail Investment Group/StoryPoint Group 80%+ Travel Required Between: Indiana, Iowa, Illinois, Wisconsin, Tennessee. Territory subject to expand as needed. LPN or RN License Required The Clinical Operations Specialist oversees clinical and wellness operations across multiple senior living communities. This role supports Wellness Leaders in maintaining compliance, delivering quality care, and building strong teams. It requires frequent travel, strong leadership, and expertise in nursing standards and state regulations, while also promoting company culture and collaboration across community and regional teams. Required Experience Proven leadership and supervisory experience in healthcare settings. Passion and compassion for working with the senior population, particularly those affected by Alzheimer's and dementia. Strong communication skills, with the ability to present to groups and collaborate across multiple teams. Problem-solving skills with the ability to navigate and resolve complex, variable situations. Familiarity with compliance and regulatory frameworks in senior living or healthcare. Ability to travel extensively and adapt to changing schedules and priorities. Primary Responsibilities Compact LPN or RN License in the state(s) of practice required Travel between communities 80%+ of the time; flexibility in scheduling is essential. Support, coach, and mentor Wellness Leaders to effectively lead their teams and uphold company standards. Ensure communities are in compliance with all state-specific regulations and company policies. Actively participate in the Excellence Review rotation to ensure quality and compliance benchmarks are met. Promote and nurture our 1440 Mission and company culture across all communities. Ensure consistent application and adherence to Board of Nursing standards and internal Standard Operating Procedures (SOPs). Oversee training attendance and participation in ongoing initiatives, huddles, and trainings. Monitor performance metrics and provide accountability for Wellness Leaders in achieving operational and clinical goals. Coordinate/support in coverage during leadership vacancies in wellness departments. Participate in care conferences as needed Collaborate with community leaders and regional partners to problem-solve and address resident needs. Lead the development, delivery, and evaluation of training for new and current Wellness Leaders. Interview and hire wellness leadership within approved staffing budgets. Stay current on licensure and continuing education requirements. General Working Conditions This position entails standing for long periods of time. While performing the duties of this job, the employee is required to communicate effectively with others, sit, stand, walk and use hands to handle keyboard, telephone, paper, files, and other equipment and objects. The employee is occasionally required to reach with hands and arms. This position requires the ability to review detailed documents and read computer screens. The employee will occasionally lift and/or move up to 25 pounds. The work environment requires appropriate interaction with others. The noise level in the work environment is moderate. Occasional travel to different locations may be required. This classification description is intended to indicate the general kinds of tasks and levels of work difficulty that are required of positions given this title and should not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct and control the work of the employees under her/his supervision. The use of a particular expression or illustration describing duties shall not exclude other duties not mentioned that are of a similar kind or level of difficulty. Equal Opportunity Employer #SPIND
    $60k-104k yearly est. 8d ago
  • Clinical Operations Specialist

    Cspring

    Clinical research associate job in Indianapolis, IN

    At CSpring, we believe operational precision supports the systems that keep communities healthy. We're seeking a detail-oriented Clinical Operations Specialist to support our team in the design, programming, and maintenance of Prior Authorization systems, with a focus on RxAuth. This full-time role is ideal for someone with a strong technical aptitude, clinical understanding, and a passion for improving the accuracy and efficiency of pharmacy benefits systems. If you're someone who enjoys structured work, rigorous testing, and collaborating with internal teams to optimize healthcare operations-this could be a perfect fit. Why You'll Love Working Here Mission-Driven Impact - Your work will help ensure patients receive timely and accurate prescription approvals. Operational Excellence - Be part of a team that values consistency, detail, and process improvements. People-First Culture - We support your development, work-life balance, and career goals. Collaborative Support - Join a team where your insights and suggestions directly shape better outcomes. What You'll Do Program, test, and maintain clinical protocols and prompt schedules in RxAuth. Build and manage requirement schedules, PA (Prior Authorization) details, and GPI (Generic Product Identifier) lists per client specifications. Perform QA reviews and ensure clinical accuracy across all RxAuth programming and client configurations. Track and document all programming processes for standardization and repeatability. Support system-wide enhancements and suggest improvements to RxAuth and related PA applications. Conduct system testing to validate prompt behavior and protocol logic before deployment. Attend client or internal meetings to share progress updates, escalate concerns, and align on priorities. Stay current on RxAuth and other benefit design configurations across active and future clients. Execute special projects and research assignments as directed by management. Requirements High school diploma or equivalent 2+ years of relevant experience in a healthcare or pharmacy-related environment Proficiency with Microsoft Excel and Outlook Strong technical aptitude Strong organizational skills with attention to detail and process documentation Preferred Qualifications Associate's degree or higher in a related field Certified Pharmacy Technician (CPhT) or equivalent clinical certification/license Prior experience with PBM or health insurance operations Familiarity with RxAuth and other prior authorization systems Hands-on experience with system configuration, QA testing, or application setup At CSpring, we unlock potential-through people and through data. If you're ready to help improve clinical operations and system accuracy in a mission-driven environment, we'd love to work with you. Apply today to shape the future of pharmacy benefit management.
    $60k-104k yearly est. 60d+ ago
  • Clinical Project Manager I

    Azenta

    Clinical research associate job in Plainfield, IN

    Azenta Inc.At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and IntegrityJob TitleClinical Project Manager IJob Description How You'll Add Value The Clinical Project Manager within the Project Management Organization (PMO) is expected to provide project management support to internal team members, as well as customers, to deliver Azenta Life Sciences solutions to clients, partners, and alliances. Under guidance from the Director, Clinical Program Management, the Clinical Project Manager is expected to gain an in-depth understanding of the key clients and become an expert in Azenta Life Sciences services. What You'll Do Serve as the primary client contact for assigned projects and establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements. Able to act efficiently in an environment with dynamic timelines and priorities. Accountable for the monitoring and reporting of performance metrics. Create required project plans. Implement and monitor progress against project plans and revise as necessary. Monitor project schedule and scope to ensure both remain on track. Project support may include kit provision and logistics, sample management, lab services support, relocation services, training, management, or support of alliances/ partnerships. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Azenta Life Sciences and client requirements. Participate in pre-sale discussion and client meetings as required. Actively participate in Azenta Life Sciences development through continuous process improvement, quality, and productivity. Mentor Client Coordinator as needed. Managing queries and resolutions. What You Will Bring Associate's or Bachelor's degree in science or related field with a minimum of 2 years of experience in a regulated industry environment. OR High School Diploma or plus a minimum of 5 years of experience in a regulated industry environment. Strong organizational skills and attention to detail. Excellent verbal and written communication skills; presentation skills, ability to engage in effective problem-solving conversations. Demonstrated ability to complete long-range projects as assigned. Demonstrated ability to prioritize work, customers, internal and external demands. Your Working Conditions: General office setting. The Employee may occasionally work in an area with potentially infectious materials. The Employee will be responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated. If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at ********************* for assistance. Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status. United States Base Compensation: $60,000.00 - $75,000.00 The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications), qualifications, performance, and geographic location, among other relevant business or organizational needs.
    $60k-75k yearly Auto-Apply 60d+ ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Indianapolis, IN

    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: ********************************
    $60k-90k yearly 23d ago
  • Clinical Research Coordinator

    Indiana Hemophilia & Thrombosis Center 4.3company rating

    Clinical research associate job in Indianapolis, IN

    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.
    $47k-67k yearly est. Auto-Apply 60d+ ago
  • Dr. Baessler's Clinic Roomer (Certified Medical Assistant)

    Beacon Orthopaedic Partners MSO LLC

    Clinical research associate job in Fishers, IN

    Job Description The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner. Type: Full Time Location: Fishers, IN office Travel Required: 1 day a week to Zionsville, IN and Fishers, IN Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record. Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic. Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary. Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients. Prepares exam and treatment rooms with necessary instruments based on physician and patient needs. Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary. Places a high priority on and maintains strict confidentiality in all situations. Participates in professional development activities and maintains applicable professional affiliations and certifications as required. Attends and participates in required organizational meetings and committees as requested. Perform additional related duties as assigned. Education, Experience, and Certification/License Requirements: Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification. Working Conditions/Physical Requirements: Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.
    $32k-45k yearly est. 16d ago
  • Clinical Research Coordinator II

    Dm Clinical Research Group

    Clinical research associate job in Indianapolis, IN

    Job Details Indianapolis - Indianapolis, INClinical Research Coordinator II The Clinical Research Coordinator II will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff 2Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required; Bachelor's degree preferred Foreign Medical Graduates preferred Experience: At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
    $40k-59k yearly est. 56d ago
  • Clinical Research Assistant- Medical Assistant - Urology of Indiana

    U.S. Urology Partners

    Clinical research associate job in Carmel, IN

    The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. What You'll Be Doing Administratively and clinically coordinates a team to effectively conduct a minimum of six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results. Schedule, plan, and participate in study monitoring visits and address any potential queries or deviations in accordance with the study contract. Acts as a liaison between the sponsor and the research department. In collaboration with the Clinical Manager advises treating physicians on clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion, and judgment to include or exclude potential subjects based on trial criteria. Acts as a study resource for patients and families. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation. Ensures subjects understanding and willingness to continue participation as well as conduct study-specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients with all treatment option information within their scope of practice such as pamphlets and protocol direction. Dispenses study medications in accordance with protocol requirements within his/her scope of practice. Performs investigative product accountability for accurate compliance. Collects, processes, and ships blood/urine specimens at scheduled times. Supervisors scheduling of research patient visits and procedures consistent with protocol requirements. Performs study-specific procedures, including but not limited to ECGs, vital signs, height, weight, injections, etc. within his/her scope of practice. Collect, compile, and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups. Responsible for the reporting of and follow-up on adverse events and serious adverse events per study protocol. Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance. Contacts outside health care providers and communicates with subjects to obtain follow-up information. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Ensures filing and maintenance of all regulatory documents. Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. Maintains required continuing education hours required for certifications. Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). Maintains a high level of patient confidentiality. Performs all other duties as assigned. What We Expect from You Associate's or Bachelor's Degree from an accredited college or university. Good Clinical Practice (GCP) Certificate International Air Transport Association (IATA) Certificate CCRC certification through an accredited organization (ACRP/SoCRA) is required 2-3 years of related Research Experience Preferred. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Travel Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected. Benefits We Offer: Medical Dental Vision Health Savings Account Life Insurance Paid Time Off 401K plus Company Match of up to 4% Accident and Critical Illness Coverage Long-Term and Short-Term Disability Employee Assistance Program What We are Offer You At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters” Compassion Make Someone's Day Collaboration Achieve Possibilities Together Respect Treat people with dignity Accountability Do the right thing Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more. About US Urology Partners U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy. U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.
    $32k-45k yearly est. Auto-Apply 26d ago
  • Research Coordinator

    Microbial Discovery Group

    Clinical research associate job in Frankfort, IN

    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.
    $42k-61k yearly est. Auto-Apply 17d ago
  • Clinical Coordinator

    Allergy Partners 4.1company rating

    Clinical research associate job in Indianapolis, IN

    Job Details 54-07-Indianapolis - Indianpolis, IN 54 C Indy - Indianapolis, IN; 54-01-Avon - Avon, IN; 54-02-Shadeland - Indianapolis, INDescription JOB SUMMARY: coordinates patient care with physician, assists physician with assessment, gives medication pursuant to physician order and assists with administrative duties that further patient care. Responsibilities include, but are not limited to, the following: Clinical Support Greets patient and escorts them from the waiting room to exam rooms; prepares patients for exam or treatment; takes vital signs. Provides assistance to physician when requested. Performs Spirometry and other breathing tests as ordered. Prepares and maintains supplies and equipment for treatments, including sterilization. Performs patient education when appropriate. Completes appropriate documentation in patients medical record. Calls in prescriptions as ordered by physician or nurse practitioner. Performs allergy prick testing and/or intradermal testing as ordered by physician. Administers allergy injections to shot patients as set forth on physician approved schedule. Monitors patients medical status for possible adverse reaction following receipt of allergy injection. Maintains emergency equipment, including oxygen, code kit, suction, etc. Answers patient-related telephone calls and respond according to clinical protocol. Follows up to obtain referrals and insurance authorization as requested and needed. Maintains clinical supply stock and medication samples. Other Maintains patient confidentiality; complies with HIPAA and compliance guidelines established by the practice. Maintains detailed knowledge of practice management and other computer software as it relates to job functions. Attends CPR, OSHA, HIPAA, and OIG training programs as required. Attends all regular meetings. Performs all other tasks and projects assigned by the Manager. Qualifications EDUCATIONAL REQUIREMENTS: High school degree required Registered Nurse License required QUALIFICATIONS AND EXPERIENCE: At least one year of experience in clinical assisting Comfortable using email and interacting with Internet applications Knowledge of practice management and word processing software Good communication skills Neat, professional appearance
    $48k-61k yearly est. 60d+ ago
  • Research Scientist - Clinical

    Eli Lilly and Company 4.6company rating

    Clinical research associate job in Indianapolis, IN

    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. Clinical Research Scientist - Medical Affairs Allergy, Immunology BU Purpose: The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly's R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly's medications. Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The application of scientific and clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral member of the medical affairs team. The Medical Affairs CRS supports the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s). The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local and global business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The global team CRS is responsible for collaborating with the global development teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Business/ customer support (pre and post launch support) Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers) Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts. Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan. Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, giving clinical input and insight to develop payer partnership programs and defend the product value. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for currently marketed brands. By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. Support training of sales representatives, and other medical representatives. Become familiar with market archetypes and potential influence on the medical interventions for the product. Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert supporting identification of Clinical Care Gaps (CCGs). Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service). Understand and apply knowledge of customer insights to all customer-related activities. Participate in local or national trade associations as appropriate. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff. Prepare or review scientific information in response to customer questions or media requests. Provide follow-up to information requested by health care professionals as per global SOPs. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Support the design of customer research as medical expert. Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Support efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams. Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes). Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design. Clinical Research/Trial Execution and Support Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects. Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel. Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Review lIT proposals and publications, as requested. Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. Regulatory Support Activities Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists. Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective. Participate in advisory committees. Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS). Scientific / Technical Expertise and continued development Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years). Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. Responsible for the scientific training of the clinical study team. Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Explore and take advantage of opportunities for extramural scientific experiences. Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget. Use knowledge of specific disease states and available treatments to provide scientific and medical input, contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality. Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable. Collaborate proactively and productively with all alliance, business, and vendor partners. Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness. Actively participate in recruitment, diversity, and retention and hiring efforts as applicable. Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management. Model the leadership behaviors. Be an ambassador of both patients and the Lilly Brand. Minimum Qualification Requirements: PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience Clinical trial experience in drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Other Information/Additional Preferences: Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills. Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills. Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders Disease advocates and lay organizations focused on relevant health issues Formulary representatives (private and government) Demonstrates the following competencies Making Business Decisions with data - Harnesses the power of data and analytics to solve problems, make good decisions and measure results. Job-Based Skills: Defines the problem or decision to be made within context of strategy or goals/objectives. Identifies relevant sources and validates accuracy of data. Analyzes and synthesizes data and identifies trends. Draws conclusions and makes timely, well-informed decisions. Engages data and analytics colleagues appropriately when needed. Scientific/Information Exchange - Maximizes engagement with key customers and colleagues through the integration of personal and/or non-personal channels when collaborating, discussing, and sharing science/information. Job-Based Skills: Identifies challenges, information gaps, education needs, and delivery preferences. Creates an engaging narrative. Generates content with the channel(s) and medium(s) in mind. Adjusts style and tone to meet the unique needs of each audience. Uses preferred channel(s) to deliver at the time of need. Measures knowledge gained. Technical/Functional Expertise - Leads with technical and functional expertise. Job-Based Skills: Establishes appropriate scientific and medical subject matter expertise (e.g., disease states, therapeutic landscapes, drug development processes, portfolio, etc.). Maintains relevant knowledge of the healthcare landscape (e.g., health, payer, and regulatory systems and processes) and environment (e.g., HCP experience models and patient flow maps, value/accountable care, and population health landscape, etc.). Understands the advancements in technology that are influencing area of expertise and function (i.e., real-world clinical practice, AI techniques, tools and platforms). Develops appropriate knowledge of activities that can be used to influence and deliver on organizational purpose (i.e., shape clinical practice, systems, tools and platforms). Masters individual workstream tools and processes. Strategic Agility - Defines and commits to an initial strategy or approach; monitors effectiveness; and adapts based on new information and/or insights. Job-Based Skills: Develops an actionable strategy or approach-involving colleagues and engaging stakeholders appropriately. Creates a clearly defined measurement plan with key metrics and triggers. Monitors progression and impact against key metrics. Identifies opportunities to improve. Reassesses strategy/approach and pivots when appropriate. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 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
    $151.5k-244.2k yearly Auto-Apply 8d ago
  • Clinical Project Manager

    Pharmavise Corporation

    Clinical research associate job in Indianapolis, IN

    Job Description . The Clinical Project Manager (CPM) is responsible for leading and managing all aspects of clinical trials from initiation through closeout. This includes ensuring that clinical projects are conducted in compliance with applicable regulatory requirements, company SOPs, timelines, and budget. The CPM will serve as the primary point of contact for cross-functional teams, vendors, and sponsors (if applicable), ensuring streamlined communication and timely issue resolution throughout the project lifecycle. Key Responsibilities: Develop, manage, and oversee clinical trial project plans including timelines, milestones, budgets, and resource allocation. Serve as the primary liaison between internal teams, clinical research sites, CROs, vendors, and external partners. Lead cross-functional team meetings and coordinate study activities such as site selection, study start-up, monitoring, and close-out. Ensure adherence to GCP, ICH guidelines, regulatory standards, and company SOPs throughout study conduct. Monitor progress against timelines and budget; proactively identify risks and implement mitigation strategies. Oversee vendor performance and manage contract deliverables for CROs, central labs, data management providers, etc. Track clinical trial metrics and prepare regular status reports for internal leadership and/or sponsors. Support regulatory and audit readiness, including contributing to study documentation and inspection preparation. Participate in protocol development, CRF design, and review of key trial documents (e.g., ICF, SAP, CSR). Minimum Qualifications: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (Master's or PMP certification a plus). Minimum of 5 years of experience in clinical research, including 2+ years in a project management role. Strong understanding of GCP, ICH guidelines, and clinical trial regulatory requirements. Proven ability to manage multi-site and/or global studies across various phases (Phase I-IV). Excellent organizational, problem-solving, and leadership skills. Strong interpersonal and written communication skills. Proficiency with clinical trial management systems (CTMS), MS Project, and Microsoft Office Suite. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at ************ or through their website at dhs.gov/e-verify.
    $78k-115k yearly est. 21d ago
  • Dr. Baessler's Clinic Roomer (Certified Medical Assistant)

    Beacon Orthopaedic Partners MSO LLC

    Clinical research associate job in Zionsville, IN

    Job Description The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner. Type: Full Time Location: Fishers, IN office Travel Required: 1 day a week to Zionsville, IN and Fishers, IN Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record. Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic. Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary. Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients. Prepares exam and treatment rooms with necessary instruments based on physician and patient needs. Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary. Places a high priority on and maintains strict confidentiality in all situations. Participates in professional development activities and maintains applicable professional affiliations and certifications as required. Attends and participates in required organizational meetings and committees as requested. Perform additional related duties as assigned. Education, Experience, and Certification/License Requirements: Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification. Working Conditions/Physical Requirements: Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.
    $31k-45k yearly est. 16d ago
  • Dr. Baessler's Clinic Roomer (Certified Medical Assistant)

    Beacon Orthopaedic Partners MSO LLC

    Clinical research associate job in Anderson, IN

    Job Description The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner. Type: Full Time Location: Fishers, IN office Travel Required: 1 day a week to Zionsville, IN and Fishers, IN Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record. Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic. Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary. Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients. Prepares exam and treatment rooms with necessary instruments based on physician and patient needs. Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary. Places a high priority on and maintains strict confidentiality in all situations. Participates in professional development activities and maintains applicable professional affiliations and certifications as required. Attends and participates in required organizational meetings and committees as requested. Perform additional related duties as assigned. Education, Experience, and Certification/License Requirements: Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification. Working Conditions/Physical Requirements: Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.
    $32k-45k yearly est. 16d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Fishers, IN?

The average clinical research associate in Fishers, IN earns between $42,000 and $104,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Fishers, IN

$66,000
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