Clinical research associate jobs in Lexington, KY - 253 jobs

Join Cleveland Clinic's Heart, Vascular and Thoracic Institute to become a part of one of the most respected healthcare organizations in the world. This center cares for patients with a variety of heart, vascular and thoracic diseases, providing the most advanced treatments in a welcoming environment. Here, you can build a rewarding career, enhance your skills and develop life-long relationships with fellow caregivers. As a Research Coordinator in our Heart Vascular and Thoracic Institute, you will collaborate with Principal Investigators across multiple cardiology subspecialties and assist in coordinating the implementation and conduct of human research projects. You will utilize the nursing process to support study activities while ensuring strict adherence to research protocols, regulatory requirements, and institutional policies. This position offers a unique opportunity to leave a positive, lasting impression on patients - from the moment they enter the facility to the time they return home. A caregiver in this role works days from 7:00 a.m. - 3:30 p.m. After completing six months of orientation, there may be an opportunity to work remotely one day per week or flex schedule to be 4 10-hour shifts. A caregiver who excels in this role will: * Assist with coordinating the implementation and conduct of research projects ensuring adherence to research protocol requirements. * Complete and communicate regulatory documents, develop data, monitor plans, report Serious Adverse Events as the occur and complete FDA and sponsor forms. * Serve as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions. * Utilize the nursing process as a basis for patient care. * Assess research subjects, complete nursing assessments, document findings in research subject records and notify the physician of abnormal findings. * Establish a care plan in collaboration with the research subject, family and research team and coordinate ongoing care. * Identify discharge needs and facilitate discharge planning as appropriate. * Perform telephone triage, nursing procedures and treatments. * Evaluate, initiate and maintain standards of care consistent with CCHS policies & procedures. * Assist with specialized patient care equipment as required by the clinical research protocol. * Administer medications and treatments as ordered by a physician or LIP. * Direct, coordinate and participate in the evaluation & supervision of nursing care provided to research subjects, establishing patient care priorities and delegating nursing activities according to the patient needs and staff qualifications and capabilities. * Conduct and document the informed consent process. Minimum qualifications for the ideal future caregiver include: * Graduate from an accredited school of professional nursing * Current state licensure as a Registered Nurse (RN) * Basic Life Support (BLS) certification through the American Heart Association (AHA) * Two years of clinical experience * Within 90 days of hire, successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by Cleveland Clinic Preferred qualifications for the ideal future caregiver include: * Bachelor of Science in Nursing (BSN) * Cardiac background * EPIC experience * CCF experience & Research Our caregivers continue to create the best outcomes for our patients across each of our facilities. Click the link and see how we're dedicated to providing what matters most to you: ******************************************** Physical Requirements: * Requires full range of body motion, manual and finger dexterity, and eye-hand coordination. * Requires standing and walking for extended periods of time. * Requires corrected vision and hearing to normal range. * Requires working under stressful conditions and irregular hours. * Exposure to communicable diseases and/or body fluids. * Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. Physical Demand requirements are in excess of those for Light Work. Personal Protective Equipment: * Follows standard precautions using personal protective equipment as required. Pay Range Minimum Annual Salary: $57,510.00 Maximum Annual Salary: $87,697.50 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).

Highlights $40,000 - $45,000 salary + benefits! Unique opportunity to break into the Clinical Research space! Work with a company that truly cares about their employees and patients Consistent schedule, no overnights or weekends, Early Fridays, flex holidays, and more! **We can only consider local candidates at this time, no relocation candidates** About Our Client Our client is a long standing clinical research site in the Columbus, OH area that takes a truly unique patient-centric, service-oriented, approach to clinical research. Their reputation for excellence has been built across over 20 therapeutic areas, over 15 physicians, and hundreds completed trials! They are looking to expand their team with additional clinical research assistants; also providing the exciting opportunity to train and develop into CRCs over time! Job Description As a Clinical Research Assistant, you will play a crucial role in supporting clinical research activities. Your will work closely with study team members under the direct supervision of a research manager and support other study team members to achieve study objectives and company goals! Compassion, patient focused mindset, and collaboration are all important traits! Develop strong working relationships with team members and office staff to build a foundation of trust and respect Assist with the screening, recruiting and enrollment of research patients Perform patient scheduling Collect patient history Data entry and Management Coordinate follow-up care and laboratory procedures Adhere to an IRB approved protocol Assist in the informed consent process of research subjects Support the safety of research subjects Coordinate protocol related research procedures study visits, and follow-up care Schedule subject visits and procedures. Work with various clinical research software Qualifications Requirements: 1+ year experience in communication skills from a medical, patient facing setting Ability to work on site Monday - Friday in Columbus, OH Ability to or Willingness to learn blood draws, scans, EKG, vitals, etc Highly professional in demeanor and presentation

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, PTO 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.

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

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.

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)

Shriners Children's is an organization that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for our children and their families. All employees are eligible for medical, dental and vision coverage on their first day! In addition, upon hire all employees are eligible for a 403(b) and Roth 403 (b) Retirement Saving Plan with matching contributions of up to 6% after one year of service. Employees in a full-time or part-time status (40+ hours per pay period) will also be eligible for paid time off, life insurance, short term and long-term disability and the Flexible Spending Account (FSA) plans. Additional benefits available to full-time and part-time employees include tuition reimbursement, home & auto, hospitalization, critical illness, pet insurance and much more! Coverage is available to employees and their qualified dependents in accordance with the plans. Benefits may vary based on state law. Job Overview The Clinical Research Coordinator II is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SC (Shriners Children's) clinical research activities. Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and Research Programs Office at SC International Headquarters, the CRC II provides support in accordance with SC's policies and procedures, SC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SC's vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC II is the site's primary liaison among research participants, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards. Responsibilities Study Management and Operations (Good Clinical Practice) Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation. Supports the investigators' development of SC investigator-initiated research protocols. Performs critical analysis of proposed research projects in order to determine appropriateness and feasibility at the local site, including the evaluation of resources required, budgeting, and regulatory requirements. Supports the implementation of approved research protocols. Ensures studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, SC policies and standards. Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management. Actively collaborates with applicable headquarters departments, including Research Programs, Legal, and Compliance related to protocol reviews, IRB submissions, sponsored contracts, material transfers, data use agreements, and HIPAA compliance for projects conducted within SHC. Provides direction and education to clinical research staff on protocol-related activities. Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct and report the results of clinical research. Responsible for oversight and documentation of the delivery, storage, and disposition of investigational products at the site, in accordance with federal and state regulations and sponsor requirements. Effectively provides information about the use of investigational products to patients. Understands and adheres to safety monitoringand reporting requirements of regulatory agencies that oversee use of an investigational product in research. Data Management and Informatics Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study. Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting. Assists in the development of procedures to standardize data collection and management, including the safeguarding of data, for each protocol. Responsible for timely data collection. Ensures accurate entry of research and outcome data into secure research databases. Verifies data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents. Provides timely responses to data queries; reviews source documents and addresses data discrepancies. Participates in timely and thorough data cleaning and database lock procedures in preparation for data analysis. Contributes in compiling, critically analyzing and preparing study results to share with research team. Provides input into the dissemination of research results by verifying all regulatory and compliance criteria are met, confirming that the SC system is credited appropriately, and assisting with abstract and manuscript preparation and submission as applicable. Ethical and Participant Safety Considerations Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg Code and the International Conference of Harmonization GCP standards. Exhibits a commitment to human subjects' protection by providing the highest level of ethical and safety practices to protect all participants involved in research studies supported and approved by Shriners Children's. Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles when interacting with subjects. Possesses a thorough understanding of the ethical issues involved with vulnerable pediatric populations, and identifies and Implements additional safeguards that should be in place for SC's vulnerable populations. Reports any concerns or issues directly to the Department of Research Programs or other appropriate departments for follow-up. Safeguards all participants involved in a research study supported and approved by Shriners Children's. Maintains patient safety and privacy throughout the study. Collaborates with investigators and other research staff to mitigate risk. Protects the rights and well-being of human subjects. Confirms appropriate training and education are in place to safely perform study protocols. Adheres to and applies protocol eligibility criteria when recruiting patients. Demonstrates a clear understanding of an ethical and legally effective informed consent process. Effectively communicates with participants/families during the consent Communication, Teamwork, and Professionalism Facilitates the local site's research programs and projects through collaborative, timely communications and teamwork. Exhibits excellent communication and collaboration in all aspects of the research program within the site; between the site and the sponsor; and with appropriate outside entities. Establishes and maintains collaborative relationships with all involved in clinical research operations. Fosters teamwork by respecting and valuing the contributions of all involved in the clinical research process. Works effectively with SC leadership to ensure the research mission is upheld. Maintains scientific integrity, intellectual honesty, and excellence. Demonstrates interpersonal and professional skills, including but not limited to, professional appearance, tact, planning, punctuality, dependability and the ability to work effectively with a wide range of individuals in a diverse community. Provides expertise consultation and mentorship to site staff, residence, students, and volunteers with respect to research processes, Good Clinical Practices, and regulations governing clinical research. Interacts with other departments in a professional and timely manner to facilitate research coordination. This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned. Qualifications Required: 3 or more years Clinical Research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance Bachelor's Degree, or 5+ years of specific job-related experience in the administration of clinical research in lieu of degree Preferred: Bachelors degree in clinical research, science or other healthcare related field Master's degree in clinical research, science or other healthcare related field CCRP or CCRC certification

Our clinical operations activities are growing rapidly, and we are currently seeking full-time, office-based Regulatory Submissions Coordinators to join our Study Start-up team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. We are seeking entry level employees. If you want an exciting career where you can build a foundation in industry knowledge through our robust training program and develop and grow your career even further, then this is the opportunity for you. Responsibilities * Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial; * Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); * Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB); * Maintain timelines for study start-up through both internal and external collaboration; and * Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges. SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAMMedpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence- based learning & development models to advance professional learning and employee performance. In the program, you will…• Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;• Gain exposure to real-world tasks through a robust mentoring program; and• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials. Qualifications * A minimum of a PhD is required (preferably in a Life Sciences field); * 3.5 GPA and above preferred; * Some experience in an office setting is preferred; * Excellent organizational and prioritization skills; * Knowledge of Microsoft Office; and * Great attention to detail and excellent oral and written communication skills. Travel: None Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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.

Job Posting Title Clinical Coordinator Agency 131 DEPARTMENT OF CORRECTIONS Supervisory Organization DOC Ment Hlth/Admin Job Posting End Date Refer to the date listed at the top of this posting, if available. Continuous if date is blank. Note: Applications will be accepted until 11:59 PM on the day prior to the posting end date above. Estimated Appointment End Date (Continuous if Blank) Full/Part-Time Full time Job Type Regular Compensation $112,571.43 Basic Purpose: Under the general direction of the Chief Mental Health Officer (CMHO), responsible for the development, supervision, and management of a correctional mental health care system for a designated region or area and provide advanced level professional correctional mental health services in the diagnosis and/or treatment of inmates in state correctional facilities. Typical Functions: · Provides supervision, clinical services, and monitors the provision of mental health services to the assigned inmate population in an ethical manner while following agency policy and relevant professional community standards of practice and serves as the primary mental health consultant/liaison to administrative, medical, support and correctional staff. · Supervises clinical and support mental health services staff as designated by the chief mental health officer. This includes peer reviews of qualified mental health professionals and consultation with mental health, medical, and facility administrative staff on challenging cases. · Develops and implements quality assurance procedures as approved by the chief mental health officer. Evaluates mental health service delivery needs and makes recommendations for needed changes to include staffing, supplies, and programming. Assigns mental health caseloads to clinical staff, prioritizing based on the level of service needs in the inmate population. · Provides and supervises a wide range of correctional mental health services including evaluations, counseling, psychotherapy, and programs with special inmate populations, e.g., inmates with intellectual and/or developmental disabilities, those with a history of co-occurring substance abuse disorders, elderly inmates, and those with complex emotional, cognitive, and physical/medical disorders. Also provides and supervises crisis and suicide prevention and intervention. · Provides and supervises comprehensive discharge planning which may include applications for Social Security Administration benefits, Medicaid benefits, housing assistance, follow up mental health appointments in the community, coordination with programs developed by the Oklahoma Department of Mental Health and Substance Abuse Services and/or the Department of Human Services and its divisions, and transportation home. · With approval by the chief mental health officer, may prepare reports for use by departmental staff, the Pardon and Parole Board, and community agencies in compliance with all departmental, state, and federal laws and regulations concerning protected health information. · Develops, supervises, and assists in creating training programs for staff in the recognition and handling of problems involving behavior disorders or the psychological, social, or personality adjustments of inmates. Conducts, coordinates, or supervises in-service training programs for staff members and other professionals in those training programs; provides necessary training regarding department-wide policies. · With approval by the chief mental health officer, participates in and supervises psychological research projects to evaluate objectives, methods, and results of mental health interventions. · Supervise students who have been approved via agency processes to complete practicum and internship experiences in the fulfillment of advanced degrees related to mental health therapeutic services. Knowledge, Skills, Abilities, and Competencies: Knowledge of correctional mental health theory and evidenced-based practices for a diverse inmate population including inmates with mental illness, intellectual and/or developmental disabilities, inmates with a history of co-occurring substance abuse disorders, elderly inmates, and those with complex emotional, cognitive, and physical/medical disorders; of statistical methods and research design; of issues of discharging inmates and the problems of the continuity of mental health care of discharging inmates reentering the community; of correctional security and mental health practices. Within the correctional setting, have knowledge and experience in methods of crisis and suicide prevention and intervention; individual and group counseling and psychotherapy; diagnosis and treatment planning; behavior management techniques; and testing and assessment methods with interpretation of results. Ability to establish and maintain effective working relationships, to supervise and direct the work of others, to serve as a consultant and/or function in an administrative capacity, to work with community groups and agencies in developing correctional mental health programs and services, to exercise professional judgment in analyzing situations and making decisions. Possess advanced clinical skills with the ability to supervise and teach professional staff and students. Education and Experience: Licensed or licensed eligible in Oklahoma as mental health professional with a doctorate degree in psychology (Ph.D., Psy.D., or Ed.D.) with a specialty in clinical or counseling psychology or related field and five (5) years professional experience in a mental health setting, including two (2) years of correctional experience. Additional Job Description: Mental Health/Joseph Harp Correctional Center This is not a remote position. Equal Opportunity Employment The State of Oklahoma is an equal opportunity employer and does not discriminate on the basis of genetic information, race, religion, color, sex, age, national origin, or disability. Current active State of Oklahoma employees must apply for open positions internally through the Workday Jobs Hub. If you are needing any extra assistance or have any questions relating to a job you have applied for, please click the link below and find the agency for which you applied for additional information: Agency Contact

Scheduled Hours40Under the direction of a Research Coordinator or PI, participates in clinical research study activities including collecting and processing biological specimens, recruiting study participants, obtaining informed consent, and conducting chart reviews. The hours of this position are 10:00 am - 6:30 pm Monday-Friday, with occasional on-call shifts on the weekends (approximately 1 day/month).Job Description Primary Duties & Responsibilities: Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants. Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: Normal office environment. Physical Effort: Typically sitting at desk or table. Repetitive wrist, hand or finger movement. Equipment: Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications/Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This Job Required Qualifications: Basic Life Support certification must be obtained within one month of hire date. Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications: Clinical research or lab experience. Effective verbal, written and interpersonal communication skills. Effective organization skills. Preferred Qualifications Education: Associate degree Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Interpersonal Communication, Oral Communications, Organizing, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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.

Shriners Children's is an organization that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for our children and their families. All employees are eligible for medical, dental and vision coverage on their first day! In addition, upon hire all employees are eligible for a 403(b) and Roth 403 (b) Retirement Saving Plan with matching contributions of up to 6% after one year of service. Employees in a full-time or part-time status (40+ hours per pay period) will also be eligible for paid time off, life insurance, short term and long-term disability and the Flexible Spending Account (FSA) plans. Additional benefits available to full-time and part-time employees include tuition reimbursement, home & auto, hospitalization, critical illness, pet insurance and much more! Coverage is available to employees and their qualified dependents in accordance with the plans. Benefits may vary based on state law. Job Overview The Clinical Research Coordinator II is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SC (Shriners Children's) clinical research activities. Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and Research Programs Office at SC International Headquarters, the CRC II provides support in accordance with SC's policies and procedures, SC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SC's vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC II is the site's primary liaison among research participants, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards. Responsibilities Study Management and Operations (Good Clinical Practice) * Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation. * Supports the investigators' development of SC investigator-initiated research protocols. Performs critical analysis of proposed research projects in order to determine appropriateness and feasibility at the local site, including the evaluation of resources required, budgeting, and regulatory requirements. * Supports the implementation of approved research protocols. Ensures studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, SC policies and standards. * Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management. Actively collaborates with applicable headquarters departments, including Research Programs, Legal, and Compliance related to protocol reviews, IRB submissions, sponsored contracts, material transfers, data use agreements, and HIPAA compliance for projects conducted within SHC. Provides direction and education to clinical research staff on protocol-related activities. * Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct and report the results of clinical research. * Responsible for oversight and documentation of the delivery, storage, and disposition of investigational products at the site, in accordance with federal and state regulations and sponsor requirements. Effectively provides information about the use of investigational products to patients. * Understands and adheres to safety monitoringand reporting requirements of regulatory agencies that oversee use of an investigational product in research. Data Management and Informatics * Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study. * Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting. Assists in the development of procedures to standardize data collection and management, including the safeguarding of data, for each protocol. Responsible for timely data collection. Ensures accurate entry of research and outcome data into secure research databases. * Verifies data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents. Provides timely responses to data queries; reviews source documents and addresses data discrepancies. Participates in timely and thorough data cleaning and database lock procedures in preparation for data analysis. * Contributes in compiling, critically analyzing and preparing study results to share with research team. Provides input into the dissemination of research results by verifying all regulatory and compliance criteria are met, confirming that the SC system is credited appropriately, and assisting with abstract and manuscript preparation and submission as applicable. Ethical and Participant Safety Considerations * Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg Code and the International Conference of Harmonization GCP standards. Exhibits a commitment to human subjects' protection by providing the highest level of ethical and safety practices to protect all participants involved in research studies supported and approved by Shriners Children's. * Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles when interacting with subjects. Possesses a thorough understanding of the ethical issues involved with vulnerable pediatric populations, and identifies and * Implements additional safeguards that should be in place for SC's vulnerable populations. Reports any concerns or issues directly to the Department of Research Programs or other appropriate departments for follow-up. * Safeguards all participants involved in a research study supported and approved by Shriners Children's. Maintains patient safety and privacy throughout the study. Collaborates with investigators and other research staff to mitigate risk. Protects the rights and well-being of human subjects. Confirms appropriate training and education are in place to safely perform study protocols. * Adheres to and applies protocol eligibility criteria when recruiting patients. Demonstrates a clear understanding of an ethical and legally effective informed consent process. Effectively communicates with participants/families during the consent Communication, Teamwork, and Professionalism * Facilitates the local site's research programs and projects through collaborative, timely communications and teamwork. Exhibits excellent communication and collaboration in all aspects of the research program within the site; between the site and the sponsor; and with appropriate outside entities. Establishes and maintains collaborative relationships with all involved in clinical research operations. Fosters teamwork by respecting and valuing the contributions of all involved in the clinical research process. * Works effectively with SC leadership to ensure the research mission is upheld. Maintains scientific integrity, intellectual honesty, and excellence. * Demonstrates interpersonal and professional skills, including but not limited to, professional appearance, tact, planning, punctuality, dependability and the ability to work effectively with a wide range of individuals in a diverse community. * Provides expertise consultation and mentorship to site staff, residence, students, and volunteers with respect to research processes, Good Clinical Practices, and regulations governing clinical research. Interacts with other departments in a professional and timely manner to facilitate research coordination. This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned. Qualifications Required: * 3 or more years Clinical Research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance * Bachelor's Degree, or 5+ years of specific job-related experience in the administration of clinical research in lieu of degree Preferred: * Bachelors degree in clinical research, science or other healthcare related field * Master's degree in clinical research, science or other healthcare related field * CCRP or CCRC certification

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.

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.

will be a key member of the medical team. This position will be responsible for daily blood collections and lab processing which will require careful attention to detail to ensure a high standard of proper lab techniques and sample processing. This position will work closely with the team leader and other medical team members to provide service to clinic participants and other staff members. Dependability and maintaining high work standards ae critical. Because this is an Alzheimer's disease and aging clinic, the applicant should have good communication skills and a willingness to work with cognitively impaired individuals. An unrestricted driver's license is preferred but not required for participant transport. Phlebotomy skills are highly desired. Skills / Knowledge / Abilities Phlebotomy and valid drivers license preferred. Does this position have supervisory responsibilities? No Preferred Education/Experience phlebotomy training highly desired Deadline to Apply 01/22/2026 Our University Community We value the well-being of each of our employees and are dedicated to creating a healthy place for everyone to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors, the University of Kentucky is a Tobacco & Drug Free campus. The University follows both the federal and state Constitutions as well as all applicable federal and state laws on nondiscrimination. The University provides equal opportunities for qualified persons in all aspects of institutional operations and does not discriminate on the basis of race, color, national origin, ethnic origin, religion, creed, age, physical or mental disability, veteran status, uniformed service, political belief, sex, sexual orientation, gender identity, gender expression, pregnancy, marital status, genetic information or social or economic status. Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.

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.

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.