Clinical research associate jobs in Louisville, KY

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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. Collaborating with investigators and site staff to facilitate smooth study conduct. Performing data review and resolution of queries to maintain high-quality clinical data. Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile Bachelor's degree in a scientific or healthcare-related field. Minimum of 2 years of experience as a Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills, with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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

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

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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.

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: ********************************

The Clinical Scribe's primary duty is to accurately and completely document the details of the office visit as dictated by the provider into the electronic medical record. The clinical scribe may also perform various patient-oriented tasks under the supervision of a nurse or physician as assigned. Employee must maintain a positive relationship with patients, family members, other department visitors, and fellow employees; performs some technical and clerical procedures associated with routine office visits. PREFERRED QUALIFICATIONS: Formal training which will probably be indicated by a high school diploma or equivalent; Medical Terminology; typing skills at least 55 wpm; experienced with computers/data entry; experience working with the public; ability to maintain composure when confronted with fast-paced and stressful situations; pleasant attitude; neat appearance; excellent communication skills; PHYSICAL GUIDELINES: Physical guidelines include the ability to move, traverse, position self, remain in a stationary position and negotiate steps for up to eight hours per day; lift, move and transport patients and materials; manual dexterity and motor coordination; articulate speech; read and understand medical information; visual acuity and ability to distinguish colors. NOTE: This document is intended to describe the general nature and level of work performed. It is not intended to act as an exhaustive list of all duties, skills, and responsibilities required of personnel. Attendance is an essential function of the job. LEXINGTON CLINIC IS AN EQUAL OPPORTUNITY EMPLOYER (EOE)

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

TITLE: Vice Provost for Research Administration, Innovation, and Sponsored Programs DIVISION: Division of Academic and Student Affairs DEPARTMENT: Office of Sponsored Programs REPORTS TO: Vice President and Provost CLASSIFICATION: Staff-12 months STANDARD WORK HOURS: 37.5 hours per week EMPLOYMENT STATUS: Full-Time EMPLOYMENT CLASSIFICATION: Exempt JOB SUMMARY: Kentucky State University (KSU) seeks an innovative and experienced leader to serve as the Vice Provost for Research Administration, Innovation, and Sponsored Programs. Reporting directly to the Vice President and Provost, the Vice Provost will provide strategic direction and oversight for research administration, innovation initiatives, and sponsored programs to support the university's mission of academic excellence and community engagement. The ideal candidate will possess a strong background in research administration, grant management, innovation management, and partnership development, with a commitment to fostering a culture of research excellence and innovation across the institution. ESSENTIAL JOB FUNCTIONS: * Strategic Leadership: Develop and implement strategic plans and initiatives to enhance research administration, innovation, and sponsored programs at KSU, aligning with the university's mission, goals, and priorities. * Research Administration: Provide leadership and oversight for research administration functions, including proposal development, grant management, compliance, and reporting, to support faculty research endeavors and maximize external funding opportunities. * Innovation and Technology Transfer: Promote a culture of innovation and entrepreneurship by facilitating technology transfer, commercialization activities, and startup incubation programs in collaboration with faculty, students, industry partners, and regional stakeholders. * Sponsored Programs Management: Oversee the administration of sponsored programs, contracts, and grants, ensuring compliance with federal, state, and institutional regulations and policies, and providing support and guidance to faculty and staff throughout the grant lifecycle. * Partnership Development: Cultivate and maintain strategic partnerships with industry, government agencies, foundations, and other external stakeholders to enhance research collaborations, secure funding, and promote technology transfer, innovation, and economic development. * Interdisciplinary Collaboration: Foster interdisciplinary collaborations and partnerships among faculty, students, and external stakeholders to address complex societal challenges and advance knowledge in key research areas. * Ethics and Compliance: Ensure adherence to ethical standards, integrity, and compliance with all relevant regulations, policies, and best practices governing research, innovation, and sponsored programs activities. * Budget Oversight: Manage budgetary resources allocated to research administration, innovation, and sponsored programs, ensuring effective stewardship, accountability, and alignment with institutional priorities. * Faculty Development: Provide professional development opportunities, training, and support to faculty members to enhance their research capabilities, grant writing skills, and success in securing external funding. * Data Analysis and Reporting: Collect, analyze, and report data on research productivity, sponsored funding, innovation outcomes, and other relevant metrics to inform decision-making, demonstrate institutional impact, and support accreditation and assessment efforts. KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: * Research Administration: Comprehensive understanding of research administration practices, including grant proposal development, budget management, compliance, and reporting. * Sponsored Programs Management: Familiarity with the policies, regulations, and best practices governing sponsored programs, contracts, and grants at the federal, state, and institutional levels. * Innovation and Entrepreneurship: Knowledge of innovation ecosystems, technology transfer processes, intellectual property rights, and entrepreneurship support programs in academia. * Higher Education Administration: Understanding of the structure, policies, and procedures of higher education institutions, including research administration and academic governance. * Funding Landscape: Awareness of funding opportunities available from government agencies, foundations, industry partners, and other sources to support research and innovation activities. * Grant Writing: Proficiency in preparing competitive grant proposals, including conceptualization, writing, budget development, and submission. * Partnership Development: Skill in cultivating and maintaining strategic partnerships with external stakeholders, including industry, government agencies, and foundations. * Project Management: Ability to effectively manage multiple projects, set priorities, allocate resources, and meet deadlines within a complex organizational environment. * Communication: Strong verbal and written communication skills with the ability to convey complex information clearly and effectively to diverse audiences. * Negotiation: Skill in negotiating contracts, agreements, and other arrangements with external collaborators and funding agencies. * Data Analysis: Capacity to collect, analyze, and interpret data to inform decision-making, assess performance, and measure the impact of research and sponsored programs. * Leadership: Ability to provide visionary leadership, inspire others, and foster a collaborative and inclusive work environment conducive to innovation and excellence. * Ethical Decision-Making: Commitment to upholding ethical standards, integrity, and compliance with all relevant regulations and policies governing research and sponsored programs activities. * Strategic Thinking: Capacity to develop and implement strategic plans and initiatives to advance research, innovation, and sponsored programs in alignment with institutional goals and priorities. * Problem-Solving: Ability to identify challenges, develop innovative solutions, and adapt to changing circumstances in a dynamic higher education environment. * Interdisciplinary Collaboration: Aptitude for fostering interdisciplinary collaborations and partnerships to address complex societal challenges and advance knowledge across academic disciplines. * Change Management: Ability to lead organizational change, inspire innovation, and promote a culture of continuous improvement and adaptability. * Team Leadership: Skill in motivating and empowering teams, delegating responsibilities, and fostering a culture of teamwork, trust, and accountability. By possessing these essential knowledge, skills, and abilities, a Vice Provost for Research Administration, Innovation, and Sponsored Programs at Kentucky State University will be well-equipped to provide strategic leadership and drive excellence in research, innovation, and sponsored programs to advance the university's mission and impact. SUPERVISORY RESPONSIBILITY: This position does have supervisory responsibility. * The Vice Provost for Research Administration, Innovation, and Sponsored Programs at Kentucky State University will have supervisory responsibility over a diverse range of functions and personnel to effectively lead and manage the research, innovation, and sponsored programs portfolio. The supervisory responsibilities may include: * Research Administration Team: Overseeing a team of research administrators responsible for assisting faculty members in grant proposal development, budget preparation, compliance management, and pre- and post-award administration. * Innovation and Entrepreneurship Staff: Directing staff members involved in technology transfer, commercialization activities, startup incubation programs, and entrepreneurship support services to promote innovation and industry collaboration. * Sponsored Programs Office: Managing the Sponsored Programs Office, which may include grants and contracts specialists, compliance officers, and administrative staff responsible for pre-award and post-award administration of sponsored projects. * Interdisciplinary Research Centers/Institutes: Providing oversight to interdisciplinary research centers, institutes, or initiatives focused on specific research areas or thematic priorities, including staffing, budget management, and strategic direction. * Faculty Development Programs: Leading faculty development initiatives aimed at enhancing research capabilities, grant writing skills, and success in securing external funding, which may involve coordinating workshops, seminars, and mentoring programs. * Ethics and Compliance Personnel: Collaborating with ethics and compliance officers to ensure adherence to ethical standards, integrity, and compliance with federal, state, and institutional regulations governing research, innovation, and sponsored programs. * External Partnerships and Collaborations: Coordinating with external partners, industry stakeholders, government agencies, and foundations to facilitate research collaborations, secure funding opportunities, and promote technology transfer and innovation. * Budget and Resource Allocation: Managing budgetary resources allocated to research administration, innovation, and sponsored programs, including personnel, operations, and strategic investments to support institutional priorities and objectives. * Performance Evaluation and Professional Development: Conducting performance evaluations, providing feedback, and facilitating professional development opportunities for staff members to enhance their skills, competencies, and career advancement within the organization. * Strategic Leadership and Vision: Providing visionary leadership, strategic direction, and guidance to the entire team to align research, innovation, and sponsored programs activities with institutional goals, values, and priorities. * By effectively supervising and leading these key areas and personnel, the Vice Provost for Research Administration, Innovation, and Sponsored Programs at Kentucky State University will play a crucial role in advancing the university's research enterprise, promoting innovation, and fostering a culture of excellence and collaboration across the institution. WORKING CONDITIONS AND PHYSICAL EFFORT: * Ability to sit at a workstation for extended periods * Occasional ability to lift, carry, and put away parcels weighing up to 20 pounds * Normal physical mobility, which includes movement from place to place * Normal physical strength to handle routine office materials and tools * Normal endurance * Periodic travel, including airline travel and overnight stays, may be required. OTHER DUTIES: In addition to the core responsibilities and supervisory duties, the Vice Provost for Research Administration, Innovation, and Sponsored Programs at Kentucky State University may be assigned other duties as needed to support the university's research, innovation, and sponsored programs agenda. These additional duties may include: * Strategic Planning: Participating in the development and implementation of strategic plans, goals, and initiatives related to research, innovation, and sponsored programs in collaboration with senior leadership, faculty, and stakeholders. * Policy Development: Collaborating with institutional leadership, faculty governance bodies, and regulatory compliance offices to develop and revise policies, procedures, and guidelines related to research administration, innovation, and sponsored programs. * Grant Review and Evaluation: Participating in grant review committees or advisory panels to evaluate grant proposals, provide feedback to applicants, and make funding recommendations based on merit, alignment with institutional priorities, and strategic goals. * External Representation: Representing the university at conferences, meetings, and events related to research, innovation, and sponsored programs to enhance visibility, network with stakeholders, and promote collaboration opportunities. * Faculty Recruitment and Retention: Collaborating with academic departments and recruitment committees to attract and retain talented faculty members engaged in research and innovation activities, including negotiating startup packages and research support. * Research Compliance Oversight: Providing oversight and guidance on research compliance matters, including human subjects research, animal care and use, biosafety, export controls, and conflict of interest disclosures. * Resource Development: Identifying and pursuing opportunities to secure external funding sources, philanthropic support, and corporate partnerships to support research, innovation, and sponsored programs initiatives. * Technology Transfer and Licensing: Facilitating technology transfer activities, intellectual property management, and licensing agreements to commercialize university inventions and innovations for societal impact and economic development. * Community Engagement: Collaborating with community organizations, government agencies, and industry partners to foster mutually beneficial partnerships, address community needs, and promote the university's role as a driver of regional innovation and economic growth. * Data Analytics and Reporting: Analyzing data on research productivity, funding trends, innovation outcomes, and impact metrics to inform decision-making, strategic planning, and institutional reporting requirements. * Faculty Awards and Recognition: Administering faculty awards, honors, and recognition programs to celebrate research excellence, innovation, and scholarly achievements within the university community. * Continuous Improvement: Identifying opportunities for process improvements, operational efficiencies, and organizational effectiveness in research administration, innovation management, and sponsored programs operations. These additional duties may vary depending on Kentucky State University's evolving needs, priorities, and strategic direction and the broader landscape of research, innovation, and sponsored programs in higher education. The Vice Provost for Research Administration, Innovation, and Sponsored Programs will be critical in advancing the university's mission and impact through effective leadership, collaboration, and strategic initiatives. QUALIFICATIONS: The ideal candidate will possess the following qualifications: * A terminal degree (Ph.D., Ed.D., or equivalent) in a relevant field from an accredited institution. * Substantial experience (at least 7 years) in research administration, grant management, innovation management, sponsored programs, or related roles within higher education or research-intensive organizations. * Demonstrated success in securing external funding through grant writing, proposal development, and sponsored programs management. * Strong leadership, communication, and interpersonal skills with the ability to effectively collaborate with diverse stakeholders. * Knowledge of federal regulations, compliance requirements, and ethical standards governing research, sponsored programs, and innovation activities. * Experience in promoting interdisciplinary collaborations, technology transfer, and entrepreneurship initiatives. * A commitment to diversity, equity, and inclusion in all aspects of research, innovation, and sponsored programs. Licensing and Certifications: The ideal candidate will possess the following qualifications and membership in either the Research Administrators Certification Council, the Society of Research Administrators International, or the National Grants Management Association. Kentucky State University recognizes that an individual, through experience and testing, has the fundamental knowledge necessary to be a professional research or sponsored programs administrator. 1. Certified Research Administrator (CRA): Offered by the Research Administrators Certification Council (RACC) or the Society of Research Administrators International (SRAI), the CRA certification demonstrates expertise in research administration, including grants and contracts management, compliance, and ethics. 2. Certified Grants Management Specialist (CGMS): Provided by the National Grants Management Association (NGMA), the CGMS certification validates proficiency in grants management practices, policies, and regulations. 3. Certified Pre-Award Administrator (CPRA): Offered by the Research Administrators Certification Council (RACC), the CPRA certification demonstrates expertise in pre-award administration, including research partnership and funding, project development and proposal submission, budget design and development, compliance and ethics. 4. Certified Financial Research Administrator (CFRA): Offered by the Research Administrators Certification Council (RACC), the CFRA certification demonstrates expertise in financial research administration, including governing framework, project costs, fiscal and reporting compliance. Applicants must be authorized to work for any employer in the United States. At this time, Kentucky State University is unable to sponsor or take over the sponsorship of an employment visa KENTUCKY STATE UNIVERSITY is an Equal Opportunity Employer The functions, qualifications, knowledge/skills, and physical requirements listed in this job description represent the essential duties of the job, which the incumbent must be able to perform either with or without reasonable accommodation. The Job Functions listed do not necessarily include all activities that the individual may perform.

Baptist Health is looking for a Clinical Research Coordinator I to join their team in Lexington. Under limited supervision, the Clinical Research Coordinator I (CRC) coordinates patient care in compliance with local, state and federal guidelines and regulations through IRB approved protocol requirements. The CRC uses their developing and/or basic knowledge of clinical trial research along with their hospital experience to work collaboratively with individuals associated with the care and treatment of the patient. It is the expectation the CRC will utilize day-to-day experience and collaborations with senior staff to broaden their knowledge base and capabilities. They will seek out opportunities to build their knowledge of the organization, research processes and scope of work. They will understand the guidelines, regulations, and policies associated with conducting clinical trial research and use that insight to evaluate and resolve problems or seek out guidance. The CRC collaborates with the investigators, research staff and other departmental stakeholders to conduct clinical trial coordination per protocol. Through clear documentation, the CRC will define any changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study intervention. The CRC works collaboratively with individuals associated with the care and treatment of the patient. Qualifications: Technical Diploma or Degree/certification must be in biology, public health, pharmacy, or health related field. 3 years' experience. Previous experience in oncology clinical research or as a clinical trial coordinator. Proficient with a computer including navigating websites, electronic data systems, electronic medical records, Excel, Word, PowerPoint. Work Experience Relevant Work Experience Education If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now! Baptist Health is an Equal Employment Opportunity employer.

Job Description About IHI At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families. What You Will Do As a 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.

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.

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

The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Job Title: Clinical Research Assistant Location: GHP New Albany/Louisville Reports To: Manager, Clinical Research Job Summary: The Clinical Research Assistant, under the guidance and supervision of the Clinical Research Manager and Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Impact Research policies, and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information for study patients according to protocols, and for protecting the health, safety, and welfare of research participants. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities Key Responsibilities Assist in the implementation of clinical research studies. Recruit, screen, and enroll study participants. Coordinate and schedule study visits and follow-ups. Collect, process, and manage biological samples. Maintain accurate and detailed records of research activities. Communicate with research participants and address their concerns. Ensure compliance with regulatory and ethical standards. Assist in the preparation of study-related documents and reports. Monitor study progress and report any adverse events or protocol deviations. Coordinate with clinical research coordinators, other departments and staff involved in the study. Other duties as assigned General Adopt the Impact Research culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers. Incorporate a leadership mindset to your role. Comply with Impact Research procedures, policies, and regulations relevant to your role. Successfully completes all Impact Research training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.) Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws. Computer skills - good working knowledge of MS office. Ability to communicate effectively with others, both verbally and in writing. Proven ability to manage time, meet deadlines and prioritize. Able to maintain standards and professionalism during periods of fluctuating workloads. Provide professional service to direct customers of Impact Research in all interactions. Build effective working relationships with other team members. Manage daily tasks to ensure business needs are consistently met. Education and Qualifications High School Diploma or equivalent required. Previous experience in clinical research or healthcare setting preferred Associate's or Bachelor's degree in a relevant field preferred Basic understanding of clinical research principles and methodologies. Strong organizational and time management skills. Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or willingness to learn and demonstrate proficiency within three months of hire Ability to work independently and as part of a team. Ability to follow protocols and guidelines closely. Basic knowledge of medical terminology. Ability to handle sensitive and confidential information. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to speak and hear. Understand/comprehend English as well as read/follow written English instructions. This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening. Work Environment This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stoop as necessary. This position requires the ability to occasionally lift office products and supplies up to 20 pounds. This job operates in a professional office environment. This role routinely uses standard office equipment. This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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. Accommodations Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non essential or essential functions of this job. All accommodations will be investigated on an individual basis with the needs of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary: The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities. Responsibilities Duties/Responsibilities: Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed Prepare source document charts, copy and/or file medical records and study related documents as required. Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems. Other duties as assigned Qualifications Education/Experience: High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications: Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities: Sit or stand for long periods of time Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

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.

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.