Clinical research coordinator jobs in Louisville, KY - 111 jobs

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. Demonstrate compliance with procedures and be accountable for compliance of team members. Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management. Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. Collaborate with Global Patient Safety on risk management planning. Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. Partake in data analysis, scientific dissemination, and preparation of final study reports. Analyze and contextualize clinical data to support decision-making and portfolio strategy. Contribute to strategy and innovation through cross-functional working groups. Support planning and execution of symposia, advisory boards, and other external engagements. Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development Stay current with medical literature and scientific developments in breast oncology. Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. Provide scientific consultation to medical affairs, health outcomes, and commercial teams. Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience 3+ years of clinical research scientist experience/clinical trial experience Leadership experience Additional Information/Preferences: Direct Line Leadership experience Breast cancer disease state knowledge/experience An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. Strong communication, interpersonal, teamwork, organizational, and negotiation skills Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

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.

Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly 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: ********************************

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)

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. 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 patient 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 providing 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 completes 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 director with various administrative tasks associated with the day-to-day operations of research studies and projects. * Plan and coordinate with the research director 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 trial 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, Self-motivated General * Adopt the One GI 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 One GI procedures, policies, and regulations relevant to your role. * Successfully completes all One GI 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 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. * Associates degree in a clinical or scientific related discipline required. * Bachelor's degree preferred. * One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required. * Previous GI trials experience preferred. * Clinical experience in an office or hospital setting. * Research experience or equivalent. * 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 trails. * Registered Nurse with five (5) years experience required. * BSN preferable. * Membership in local, state and national societies is encouraged. * Understanding of Code of Federal Regulations for Human Subjects. * Certified in GCP's and HSP. * Periodic local travel to other practice locations on an as-needed basis. * Phlebotomy experience preferred. 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 requiredto 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 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 anytime 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 theneeds 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.

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.

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

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job Description 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.

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD) and other neurodevelopmental disorders. The Center is seeking a Research Coordinator I to implement a portfolio of clinical research trials and projects related to ASD. The Clinical Research Coordinator I will work under the supervision of the Senior Clinical Research Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinical research including the development, initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines. Job Summary Summary Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions -Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met. -Recruiting patients for clinical trials, conducts phone interviews. -Verifies the accuracy of study forms and updates them per protocol. -Prepares data for analysis and data entry. -Documents patient visits and procedures. -Assists with regulatory binders and QA/QC Procedures. -Assists with interviewing study subjects. -Assists with study regulator submissions. Qualifications Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities - Careful attention to detail and good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - Computer literacy. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Remote Type Onsite Work Location 1 Maguire Road Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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

We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures. Key Responsibilities: Coordinate day-to-day clinical research activities to ensure study protocols are followed. Recruit, screen, and enroll study participants. Obtain informed consent and ensure ethical conduct in all study interactions. Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples). Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs). Maintain accurate and timely documentation in case report forms and electronic databases. Communicate with sponsors, monitors, and IRBs regarding study progress and compliance. Schedule participant visits and follow-ups; ensure visit windows are met. Ensure proper storage, handling, and accountability of investigational products, if applicable. Maintain regulatory documents and assist with IRB submissions. Qualifications: Bachelor's degree in a health-related field required. At least 1 2 years of experience in clinical research preferred. Phlebotomy certification or MA certification preferred. Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Excellent organizational skills and attention to detail. Strong interpersonal and communication skills. Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms). Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications: Experience working in clinical trials, especially in a hospital or academic setting. Familiarity with IRB processes and clinical trial documentation. Bilingual skills (depending on patient population) may be a plus. Job Type: Full-time Work Location: In person Schedule: 8 hour shift Monday to Friday Weekends as needed

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.

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.

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

Engage with us for your next career opportunity. Right Here. Job Type: Regular Scheduled Hours: 40 💙 Why You'll Love Working with St. Elizabeth Healthcare At St. Elizabeth Healthcare, every role supports our mission to provide comprehensive and compassionate care to the communities we serve. For more than 160 years, St. Elizabeth Healthcare has been a trusted provider of quality care across Kentucky, Indiana, and Ohio. We're guided by our mission to improve the health of the communities we serve and by our values of excellence, integrity, compassion, and teamwork. Our associates are the heart of everything we do. 🌟 Benefits That Support You We invest in you - personally and professionally. Enjoy: - Competitive pay and comprehensive health coverage within the first 30 days. - Generous paid time off and flexible work schedules - Retirement savings with employer match - Tuition reimbursement and professional development opportunities - Wellness, mental health, and recognition programs - Career advancement through mentorship and internal mobility Job Summary: Coordinate clinical research studies for the principal investigators and coordinates and promotes research program within St. Elizabeth and the community. Responsible for networking with physicians to open studies, educating staff about current studies, educating clients about studies and obtaining informed consents. Responsibilities include screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, and protocol specific requirements. Responsibilities also include data collection and submission as well as Regulatory compliance. Demonstrate respect, dignity, kindness and empathy in each encounter with all patients, families, visitors and other employees regardless of cultural background. Job Description: Coordinate clinical research studies conducted by the principal investigator. Has a thorough understanding of the protocols. Educate and provide in-service to associates in the Medical Center that will be affected by the study. Network with physicians to open new studies at St. Elizabeth and to promote the research program within the community. Work directly with principal investigator to design appropriate recruitment strategies, communication plan, and patient safety monitoring plan. Conducts research studies according to Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA) regulations and guidelines. Follows Good Clinical Practices, Good Laboratory Practices, St. Elizabeth Healthcare policies, and maintains related certifications. Confer with potential study participants to explain the study and obtain the study specific, IRB approved informed consent, as well as appropriate HIPAA Authorization before performing any study related procedures. Review with the participant and family all study requirements including diagnostic procedures, questionnaires, and treatments. Conduct participant research visits and collect/record research related data. Submit data to study sponsors as required and documents in the patient's medical record as appropriate. Maintain the integrity and privacy of participant's research protocol chart with all required source data. Initiate/coordinate drug orders, laboratory/imaging procedures and treatments for participants based on protocol requirements. Maintain investigational device/product inventory or coordinate investigational device/product accountability with St. Elizabeth pharmacy or appropriate clinical department. Ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention. Monitor patient's progress and reports adverse events/protocol deviations as required. Participating in quality assurance activities of the sponsor, the FDA, IRB, other regulatory and accrediting agencies. Assist with documentation and submission for approvals, revisions, renewals, informed consents, unanticipated problems, and study closure as mandated by the study sponsors, St. Elizabeth Healthcare, the Institutional Review Board (IRB). Obtains, patient biologic specimens, or works with SEH laboratory/SEH clinical nursing staff to obtain laboratory specimens (blood, urine, saliva, etc.). Maintains IATA certification for the safe handling and shipping of biologic specimens. Works with clinical departments and finance departments to ensure appropriate billing/coding of study related activity. Assists with development of research billing grids, budgets, and monitoring of reimbursements. Performs other duties as assigned. Education, Credentials, Licenses: Bachelor's Degree in related area of study. Specialized Knowledge: Understanding of research processes Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines. Proficiency with Excel, Word, Outlook and PowerPoint is imperative. Ability to work effectively and in a professional manner with physicians, leadership, SEH/SEP associates, patients, external business partners, representatives of regulatory agencies and the general public. Kind and Length of Experience: 3 year's related experience in specialty area. FLSA Status: Exempt Right Career. Right Here. If you're looking for the right careers in healthcare, the right place to be is at St. Elizabeth. Join us, and you'll take pride in the level of care we offer our community.

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

Primary Responsibilities The primary responsibilities of the clinical coordinator for the Medical Imaging and Radiologic Sciences Sonography Program include working in partnership with the Radiologic Technology clinical coordinator(s) in the management and oversight of clinical education for medical imaging students. Responsibilities also include teaching and service related to a clinical faculty position. Teaching involves classroom, laboratory and clinical courses at the undergraduate level. Service includes administrative and committee responsibilities at the Program, School, and University levels as well as community and professional activities. Faculty are expected to pursue personal/professional development through continuing education, work toward advanced degrees and participate in professional activities that will support and promote the program. Specific sonography clinical coordinator responsibilities are assigned by the Director of Medical Imaging and Radiologic Sciences and may include but are not limited to the following: Correlates clinical education with didactic education Coordinates clinical education and evaluates its effectiveness Provides didactic and/or clinical instruction Evaluates students Supports the sonography program director to help assure effective program operation Participates in the assessment process Cooperates with the sonography program director in periodic review and revision of clinical course materials Maintains current knowledge of the discipline and educational methodologies through continuing professional development Maintains current knowledge of program policies, procedures, and student progress Assumes all duties and responsibilities of a Clinical Track Professor in Radiologic and Imaging Sciences IUSM is committed to being a welcoming campus community and we seek candidates whose research, teaching, and community engagement efforts contribute to robust learning and working environments for all students, staff, and faculty. We invite individuals who will join us in our mission to improve health equity and well-being for all throughout the state of Indiana. Ready to apply? Submit your letter of interest and current CV ( PDF ) via the IU application portal: