Clinical research associate jobs in Louisville, KY - 114 jobs

Job Description . We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities. Key Responsibilities: Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring. Act as the primary liaison between internal study teams and external third-party organizations (TPOs). Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data. Manage and track clinical queries to ensure timely resolution. Collaborate with internal teams to align clinical research processes and operational strategies. Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements. Minimum Qualifications: Bachelor's degree in a relevant field. 6+ years of experience in clinical research or a related industry. Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant. 3+ years of experience in project management or a related role. Prior experience in pharmaceutical, diagnostics, or CRO environments. Strong organizational skills with attention to detail. Ability to effectively communicate with diverse stakeholders. Proficiency in Microsoft Excel for data tracking and reporting. Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms. Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases. Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements. 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.

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

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. O Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues. Roles and Responsibilities of the Position: Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical Research Scientist will apply scientific and clinical training and expertise to described roles. Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Reporting of adverse events as mandated by corporate patient safety. Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies. Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed. Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions. Minimum Requirements: An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty). 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology. Additional Preferences: Breast cancer disease area knowledge. Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team. Proven track record to bring out the best in others on a cross-functional international team. Leading by influence. Proven track record to interact externally and internally to support a global scientific and business strategy. Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel. Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator. Strong communication, both written and oral. Ability to multi-task and shift priorities rapidly to meet target dates. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $259,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#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.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Clinical Research Coordinator I DEPARTMENT: Global Project Delivery *This role is a per-diem contract opportunity* Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America. The Role: Ora's Clinical Research Coordinator I (CRC I) has close relationships with the subjects who participate in our clinical trials located regionally, domestically, and at times, internationally. You will travel with a team of other CRCs to clinical sites as assigned to conduct world-class research using proprietary methodologies. Once onsite, our CRC I's will administrate various technician-based tasks by collecting, recording, and organizing subject and research information during clinical research study visits while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRC I's will partner with tenured Clinical Research Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators. What You'll Do: Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators Performs patient screening, recruitment, and enrollment Perform clinical skills identified in the SOP at study visits Participate in various parallel and compounding trainings to continue advancement of required clinic skills Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property Remain compliant and timely with SOP, ICH-GCP and regulations Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy. Prompt submission of work availability on a monthly basis Enter data into electronic database and resolves data queries Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business. What We Look For: Experience needed for the Role: Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting Additional Skills & Attributes: Previous experience as a research coordinator is strongly preferred Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications is strongly preferred Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician is preferred This role requires a flexible schedule, including weekend availability, and the ability to travel domestically as needed A team player attitude with a strong interest in clinical studies and enjoy interacting with patients Competencies and Personal Traits: What We Do: Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. How We Do It: IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth. Why We Do It: Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see. Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Our Privacy Policy | Ora (oraclinical.com)

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 to 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 (US Full Time Employees) 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: ********************************

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 Coordinator Location: GHP New Albany/Louisville Reports To: Manager, Clinical Research Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities Key Responsibilities * Administratively and clinically manage industry sponsored clinical trials. * Adhere to Research SOP's, Good Clinical Practices, and the study protocols. * Assist in patient recruitment by performing detailed chart reviews and patient interviews. * Discuss study protocols with patients and verify the informed consent documentation. * Review medical history of patients against inclusion/exclusion criteria of studies. * Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations. * Schedule all patient research visits and procedures consistent with protocol requirements. * Dispense study medication, collect vital signs, and perform ECGs. * Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. * Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy. * Function in a clinical role by conducting clinical research studies. * Monitor patients and provide information to the medical staff and other staff members to assure optimal outcomes. * Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients. * Maintain compliance of protocols and regulatory guidelines for studies performed in the research area. * Act as a resource for other staff members regarding investigational issues or guidelines. * Coordinate the availability and distribution of medications for patients in a timely manner. * Perform phlebotomy for lab work as required and complete all necessary forms. * Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved. * Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures. * Assist the principal investigator and research manager with various administrative tasks associated with the day-to-day operations of research studies and projects. * Plan and coordinate with the research manager the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity. * Plan, implement, and maintain data collection and analysis systems in support of the research protocol. * Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies. * Facilitate assigned clinical trials from start to finish. * Screen participants for all studies independently. * Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. * Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required. * Adhere to infection control/safety guidelines and confidentiality policies. Core Competencies * Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized. 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. * Provide professional service to direct customers of One GI 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. * Associate or Bachelor's degree preferred. * One (1) year previous experience in clinical research for pharmaceutical phase II or III trials required. * Previous GI trials experience preferred. * Clinical experience in an office or hospital setting. * Must maintain current licensure and/or certification. * Basic Life Support certification required. * Knowledge of medical terminology, anatomy, physiology, and pathophysiology. * Familiarity with health care systems, regulations, policies, and functions. * Understanding of clinical research documentation standards. * Knowledge of equipment, supplies, and materials needed for medical treatment. * Understanding of basic laboratory procedures including phlebotomy, preparation, and screening. * Working knowledge of industry standards and regulatory requirements relevant to clinical drug trials. Nurse Coordinator Requirements * Active Registered Nurse license required * Ability to be licensed in multiple states required * Experience with intravenous infusions preferred 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.

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar 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.

Zoom Group serves over 200 adults with developmental disabilities through various programs including Employment Services and Adult Day Training. Our mission is to empower, educate, and employ individuals of all abilities while promoting diversity and respect in our community. Summary We are seeking a dedicated Clinic Coordinator to join our team in [City, State]. In this role, you will play a vital part in enhancing the lives of individuals with developmental disabilities by ensuring efficient clinic operations and providing exceptional patient care. Your contributions will directly support our mission of empowerment and inclusion. Responsibilities Coordinate daily clinic operations to ensure smooth workflow. Manage patient scheduling and maintain accurate medical records. Ensure compliance with HIPAA regulations and maintain confidentiality. Assist healthcare professionals in delivering high-quality patient care. Oversee medical documentation processes for accuracy and completeness. Collaborate with team members to promote a supportive environment for clients. Provide training and guidance to staff on clinic procedures. Monitor inventory of medical supplies and equipment. Qualifications Proven experience in a healthcare or clinical setting. Strong knowledge of medical terminology, documentation, and records management. Familiarity with HIPAA regulations is essential. Excellent organizational skills and attention to detail. Ability to communicate effectively with diverse populations. Experience in patient care or nursing is preferred. Knowledge of physiology and anatomy is a plus. Call-To-ActionIf you are passionate about making a difference in the lives of individuals with developmental disabilities, we invite you to apply today and be part of our empowering mission! Job Type: Full-time License/Certification: LPN/RN (Required) Work Location: In person

Baptist Health Medical Group Clinical Coordinator Surgical Associates (Hosp) St. Matthews area Full Time/First Shift The Clinical Coordinator is responsible for ensuring efficient patient flow through a combination of appropriate clinical staff scheduling and working directly with providers - providing patient care within the scope of certification and training. Principal Duties and Responsibilities Handles patient call backs and prescriptions refills within the scope of the certification for this position Administers medication and injections as directed by the provider. Prepares in advance for the provider's clinic to run smoothly by checking the schedule and the patient record to make sure all documents are available for provider viewing Performs in-office lab testing such as glucose testing, strep screens, pregnancy tests, urinalysis, and HgbA1c as directed by the provider. Perform sterilization on instruments used for minor procedures/surgeries. Oversees quarterly OSHA safety meetings. Coordinates staffing to ensure adequate coverage in the clinical area. Monitors clinical staff performance and conducts annual competency evaluations in conjunction with the Practice Manager. Checks expiration dates on supplies and samples; orders supplies as needed to maintain adequate inventory. Interviews and recommends hiring of new clinical employees in conjunction with Practice Manager. Holds regular clinical staff meeting. Attends all required safety training programs and can describe his/her responsibilities related to general safety, department/service safety, specific job-related hazards, and national patient safety goals. Minimum Education, Experience, Training, and Licensures/Certifications/Registrations Required: Graduate of an accredited Medical Assisting Program; School of Nursing and or health related field. Must have an MA certification from an approved institution (AAMA, AMT, NAHP, NCCT) or LPN, RN license. 5 years' experience in direct patient interaction in a physician office setting. Supervisory experience preferred. Phlebotomy experience required. BLS certification (must be obtained within 90 days of hire). Computer skills preferred. Clinical Coordinator, Communication, Clinical Care 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.

The Research Assistant supports the execution of clinical research studies by performing administrative, technical, and participant-focused tasks under the supervision of the Clinical Research Coordinator and Principal Investigator. This role plays a critical part in ensuring high-quality data collection, regulatory compliance, and participant safety. The Research Assistant works collaboratively with the clinical team to facilitate study activities in accordance with Good Clinical Practice (GCP) guidelines, study protocols, and institutional policies. Key Responsibilities Study Support & Coordination Assist in preparing study materials, source documents, and regulatory binders. Support participant screening, recruitment, and scheduling in accordance with study protocols. Maintain accurate participant logs and assist in tracking enrollment progress. Ensure study areas, supplies, and equipment are organized and ready for study visits. Data & Documentation Accurately record data from source documents into electronic case report forms (eCRFs) or databases. Maintain confidentiality and integrity of participant data in compliance with HIPAA and institutional standards. Assist in resolving data queries and ensuring timely data entry. Support document management, filing, and archiving according to regulatory requirements. Participant Interaction Greet and assist study participants during visits to ensure a positive experience. Prepare consent materials and provide administrative support during the informed consent process. Escort participants to appropriate testing areas and assist clinical staff with noninvasive study procedures as directed. Regulatory & Compliance Follow Good Clinical Practice (GCP) and institutional policies at all times. Support compliance with IRB, sponsor, and regulatory agency requirements. Participate in site audits, monitoring visits, and internal quality reviews as needed. Team Collaboration Work closely with Clinical Research Coordinators, Principal Investigators, and site teams to ensure timely completion of study milestones. Participate in team meetings, training, and continuing education to stay current with study and regulatory updates. Contribute to process improvements and operational efficiency initiatives. Qualifications Associate or bachelor s degree in a health sciences, biology, psychology, or related field preferred. Previous experience in healthcare or research setting is strongly preferred. Familiarity with clinical trials, GCP, HIPAA, and human subjects research regulations are desirable. Strong organizational, communication, and time management skills. Ability to work accurately in a fast-paced environment with strong attention to detail. Proficiency with Microsoft Office and data entry systems; experience with EDC or CTMS systems a plus. Core Competencies Accuracy and Attention to Detail Professionalism and Confidentiality Team Collaboration Adaptability and Initiative Ethical Conduct and Compliance Awareness Physical Requirements Ability to sit or stand for extended periods. May require occasional lifting of study materials (up to 25 lbs). Ability to interact with participants and staff in clinical and office settings.

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.

Job Title: Clinical Research AssistantJob Description We are seeking a dedicated Clinical Research Assistant to join our dynamic team in a lab setting. The primary responsibility of this role is to process blood samples in accordance with strict research protocols. This position is integral in ensuring that samples are processed, stored, and shipped correctly, sometimes requiring specific temperatures and labeling methods. The role operates in a fast-paced environment and is not patient-facing. Responsibilities * Process blood samples according to research protocols. * Ensure samples are stored and shipped per specific protocol requirements. * Maintain accurate labeling and documentation of specimens. * Work efficiently in a fast-paced laboratory environment. * Coordinate with other Clinical Research Assistants to ensure timely processing. Essential Skills * Experience in laboratory or healthcare settings, particularly in sample processing (1-2 years required). * Proficiency in specimen processing and labeling. * High School Diploma. Additional Skills & Qualifications * Research experience is a plus. * Experience in clinical trials and oncology is advantageous. Work Environment The position is based in a laboratory alongside two other Clinical Research Assistants. The environment is fast-paced and requires strong organizational skills to manage multiple tasks and ensure timely processing of samples according to protocols. The standard work hours are 8:00-5:00, with occasional extended hours needed to accommodate patient visits. The schedule offers flexibility, allowing for compensation of hours worked by leaving early on another day. Job Type & Location This is a Contract to Hire position based out of Indianapolis, IN. Pay and Benefits The pay range for this position is $18.00 - $20.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Indianapolis,IN. Application Deadline This position is anticipated to close on Jan 23, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.