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  • School Clinical Coordinator: Bio Med

    Akron Children's Hospital 4.8company rating

    Clinical research coordinator job in Akron, OH

    Bio Med Monday-Friday While school is in session The School Clinical Coordinator is responsible for the provision of school health services to the student population served. This position assists the Manager in the daily operations of the school district assigned in collaboration with the interdisciplinary teams. This position is responsible for planning, implementing, and evaluating delivery of student care within the school building of the assigned district. The School Clinical Coordinator contributes to development and evaluation of the assigned nursing personnel. This position is also responsible for assisting and providing nursing care, utilizing specialized knowledge, judgement, and skill. Responsibilities: 1. Provides leadership and direction regarding departmental goals and as directed by contract. 2. Demonstrates personal and professional accountability for themselves and the staff. 3. Maintains school clinic safety for staff and students. 4. Participates in performance improvement. 5. Participates in and supports staff recruitment and retention efforts. 6. Supports and assists with Human Resource Management including but not limited to coaching, development, and evaluation of nursing personnel. 7. Promotes a positive work environment and staff engagement. 8. Serves as a clinical resource to the interdisciplinary team. 9. Maintains appropriate student health records and documents services rendered. 10. Communicates effectively with management, parents/guardians, school authorities, and allied personnel. 11. Demonstrates the knowledge and skills necessary to provide care for the physical psychological, social, educational, and safety needs of the students served. 12. Other duties as required. Other information: Technical Expertise 1. Experience in a school setting preferred. 2. Experience in pediatric nursing preferred. 3. Experience working within in multidisciplinary team is preferred. 4. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required. Education and Experience 1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position. 2. Certification: BLS is required. Registered Nurse Licensure required. 3. Years of experience: Minimum 1 year experience in healthcare required. Minimum 1 year in a similar role preferred. 4. Years of experience supervising: None Part Time FTE: 0.600000 Status: Onsite
    $42k-53k yearly est. 13d ago
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  • Clinical Research Coordinator

    Actalent

    Clinical research coordinator job in Lima, OH

    The Clinical Research Coordinator (CRC) is responsible for ensuring the successful execution of clinical trials by adhering to Good Clinical Practices (GCP), FDA regulations, and ICH guidelines. This role involves screening, enrolling, and monitoring study participants while maintaining strict protocol and regulatory compliance. Key ResponsibilitiesPatient Coordination + Prioritize activities to meet protocol timelines. + Maintain compliance with FDA regulations and ICH guidelines throughout trial conduct. + Build and maintain positive relationships with study participants, investigators, sponsors, and internal research teams. + Coordinate and attend pre-study site visits, site initiation visits, and monitoring visits. + Identify and report adverse events (AEs) and serious adverse events (SAEs) promptly. + Prescreen candidates and obtain informed consent per SOPs. + Perform and train others on basic clinical procedures (e.g., blood draws, vital signs, ECGs). + Review lab results and other test data for completeness and alert values, ensuring timely investigator review. + Communicate study medication details, required procedures, and eligibility criteria with investigators and staff. Documentation + Accurately record and enter data in real time on paper or electronic source documents. + Track study medication inventory, dispensation, and patient compliance. + Resolve data queries and correct source data within sponsor timelines. + Assist with regulatory documentation and source document creation/review. Patient Recruitment + Collaborate on recruitment strategies and materials. + Develop recruitment plans and engage with potential candidates from subject databases. + Actively participate in outreach and recruitment efforts. + Review protocol amendments for clarity and feasibility. + Ensure all training and study requirements are met prior to trial initiation. + Attend investigator meetings and ensure adequate site supplies for protocol initiation. Required Skills & Expertise + Strong knowledge of clinical research processes, GCP, and federal regulations. + Excellent organizational, prioritization, and leadership skills. + Proficiency with clinical trial databases, IVR systems, EDC platforms, and MS Office. + Ability to work independently in a fast-paced environment with minimal supervision. + Strong communication skills-both written and verbal. + Critical thinking and problem-solving abilities. + Friendly, professional demeanor with a positive attitude under pressure. Education & Experience + Bachelor's degree preferred or equivalent combination of education and experience. + Minimum 3 years of Clinical Research Coordinator experience required. + Prior experience with Care Access Research protocols preferred. + Recent phlebotomy experience required. Certifications/Licenses + Relevant clinical certifications as applicable. Job Type & Location This is a Permanent position based out of Lima, OH. Pay and Benefits The pay range for this position is $75000.00 - $80000.00/yr. Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Workplace Type This is a fully onsite position in Lima,OH. Application Deadline This position is anticipated to close on Jan 26, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $75k-80k yearly 8d ago
  • Director - Clinical Research Scientist - Global and US Medical Affairs

    Eli Lilly and Company 4.6company rating

    Clinical research coordinator job in Gas City, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. 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 Clinical Research Scientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans. Key Responsibilities 1. Business & Customer Support Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups. Lead data analyses and health outcomes research to address customer questions. Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners. Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements. Support training of sales, medical, and patient support teams. Lead definition of Patient Journey and contribute clinical perspective to patient programs. Participate in relevant professional and industry associations. 2. Scientific Exchange & Data Dissemination Ensure compliance with global and local regulations governing scientific communication. Address unsolicited scientific inquiries in alignment with medical governance standards. Support scientific meetings, advisory boards, symposia, and other expert engagements. Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts. Build and maintain relationships with key opinion leaders and scientific societies. Represent the company at medical congresses and support scientific booth activities. Contribute to data analyses, publication development, and Clinical Trial Registry reporting. 3. Clinical Planning Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams. Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements. Maintain up‑to‑date understanding of clinical and competitive data. Provide regional clinical insights to inform development plans and study protocols. 4. Clinical Research Execution Review and approve informed consent documents to ensure accurate risk communication. Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out. Support investigator/site training and address study‑related medical questions. Oversee local safety monitoring and adverse event follow‑up. Review investigator‑initiated trial (IIT) proposals as needed. Ensure global alignment of Phase 3b/4 and applicable early‑phase studies. 5. Regulatory Support Contribute to development and review of local labeling and labeling changes. Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities. Participate in risk management planning with global and local teams. 6. Scientific & Professional Development Stay informed on therapeutic area trends, market changes, and competitive landscape. Provide scientific training to clinical study teams and act as a protocol subject‑matter expert. Represent the organization at medical congresses and contribute to medical budget planning. Seek opportunities for external scientific engagement. 7. Leadership & Collaboration Set and pursue professional development goals and support growth of colleagues and direct reports. Contribute to recruitment, diversity, and retention efforts when applicable. Participate in committees, Six Sigma initiatives, and cross‑functional projects. Model leadership behaviors and serve as an ambassador for patients and the company. Basic Qualifications An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience Additional Preferences Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information) Ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $177k-308k yearly Auto-Apply 6d ago
  • Clinical Research Associate (CRA)

    Pharmavise Corporation

    Clinical research coordinator job in Indianapolis, IN

    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.
    $52k-83k yearly est. 5d ago
  • Clinical Scientist

    Eliassen Group 4.7company rating

    Clinical research coordinator job in Frankfort, KY

    **Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
    $130k-150k yearly 7d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research coordinator job in Indiana

    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
    $53k-84k yearly est. 60d+ ago
  • Clinical Trial Coordinator - Onsite Position - Columbus, Ohio

    Orsini Healthcare 4.4company rating

    Clinical research coordinator job in Columbus, OH

    Careers with real impact. Every role at Orsini moves a patient closer to life-changing therapy. We partner with biopharma innovators, healthcare providers, and payers to make access simple, compassionate, and reliable - so no patient is left behind. Make your next role matter. ABOUT ORSINI Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™ OUR MISSION Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™. CORE VALUES At the heart of our company culture, the Orsini LIVE IT Core Values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. COMPENSATION & LOCATION The salary range for this role is $80,000-$90,000. This on-site position based out of our Columbus, Ohio. Travel to other locations may occur, although minimal. POSITION SUMMARY The Clinical Trial Coordinator will oversee and manage the dispensing operations for clinical trials and Early Access Programs for Orsini. This role ensures compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards while coordinating with sponsors, CROs, investigators, and internal pharmacy teams. The position is critical for maintaining accuracy, integrity, and timely delivery of investigational products to trial participants. Essential Duties Serve as the primary liaison between the specialty pharmacy, clinical trial sponsors, CROs, and clinical sites. Provide timely updates on IP status, shipment schedules, and dispensing activities. Coordinate all pharmacy-related activities for assigned clinical trials, including investigational product (IP) receipt, storage, dispensing, and accountability. Ensure adherence to study protocols, sponsor requirements, confidentiality, and regulatory guidelines. Maintain accurate documentation for IP handling, including temperature logs, chain of custody, and dispensing records. Ensure compliance with state and federal pharmacy laws, clinical trial regulations, and specialty pharmacy accreditation standards. Prepare for and support audits and inspections by sponsors, CROs, and regulatory authorities. Manage investigational product inventory, including reconciliation and returns in conjunction with the inventory management team. Implement quality assurance processes to ensure accuracy and prevent protocol deviations. Train pharmacy staff on study-specific requirements and handling procedures. Maintain SOPs and ensure proper documentation for all trial-related activities Disclaimer: The information written in this indicates the general nature and level of work to be performed. This is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description. KNOWLEDGE, SKILLS, AND TRAINING Pharmacy Technician License. Bachelor's degree in Life Sciences, or related field. Minimum 2-3 years of experience in clinical trials or investigational drug services. Familiarity with GCP, FDA regulations, and clinical trial operations. Strong organizational and project management skills. Excellent communication and collaboration abilities. Proficiency in clinical trial management systems and pharmacy dispensing software. NICE TO HAVE'S Certified Clinical Research Coordinator (CCRC) or equivalent. Specialty Pharmacy experience. EMPLOYEE BENEFITS We offer a comprehensive benefits package designed to support your health, financial security, and overall well-being: Medical Coverage, Dental, and Vision Coverage 401(k) with employer match Accident and Critical Illness coverage Company-paid life insurance options Generous PTO, paid holidays, and floating holidays Tuition reimbursement program. Equal Employment Opportunity Orsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws. Americans with Disabilities Act Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law. Powered by JazzHR Tuke6w6iG6
    $80k-90k yearly 10d ago
  • Clinical Research Coordinator II

    Imperial Council A A O N M S 4.3company rating

    Clinical research coordinator job in Lexington, KY

    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
    $41k-55k yearly est. Auto-Apply 2d ago
  • Clinical Scribe (3886) KY ENT NICHOLASVILLE RD

    Lexington Clinic 4.4company rating

    Clinical research coordinator job in Lexington, KY

    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)
    $40k-53k yearly est. Auto-Apply 60d+ ago
  • Study Start-Up Coordinator- PharmD

    Medpace 4.5company rating

    Clinical research coordinator job in Cincinnati, OH

    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 PharmD 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.
    $45k-61k yearly est. Auto-Apply 10d ago
  • Clinical Research Coordinator I

    BHS 4.3company rating

    Clinical research coordinator job in Lexington, KY

    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.
    $42k-60k yearly est. Auto-Apply 11d ago
  • Clinical Research Coordinator I

    Mass General Brigham

    Clinical research coordinator job in Lexington, KY

    Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD) and other neurodevelopmental disorders. The Center is seeking a Research Coordinator I to implement a portfolio of clinical research trials and projects related to ASD. The Clinical Research Coordinator I will work under the supervision of the Senior Clinical Research Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinical research including the development, initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines. Job Summary Summary Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions -Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met. -Recruiting patients for clinical trials, conducts phone interviews. -Verifies the accuracy of study forms and updates them per protocol. -Prepares data for analysis and data entry. -Documents patient visits and procedures. -Assists with regulatory binders and QA/QC Procedures. -Assists with interviewing study subjects. -Assists with study regulator submissions. Qualifications Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities - Careful attention to detail and good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - Computer literacy. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Remote Type Onsite Work Location 1 Maguire Road Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly Auto-Apply 5d ago
  • Clinical Research Coordinator 1

    Alliance for Multispecialty Research

    Clinical research coordinator job in Lexington, KY

    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.
    $38k-56k yearly est. Auto-Apply 60d+ ago
  • Sr. Clinical Research Associate - FSP

    Parexel 4.5company rating

    Clinical research coordinator job in Frankfort, KY

    **CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $71k-96k yearly est. 44d ago
  • Study Coordinator II BioA

    Labcorp 4.5company rating

    Clinical research coordinator job in Greenfield, IN

    We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team in Greenfield, IN. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career. In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery. Essential Job Duties: Writes Study Protocols, Methods and Reports With minimal support and guidance, drafts protocols, methods, amendments, and reports; utilizing sources such as Documentum, Toxicology protocols and client supplied information Reviews study activities for compliance against protocol/SOW, Standard Operating Procedure (SOP), Policies, and regulatory agency guidelines. With support, assists Scientist with report preparation, including table and figure preparation; compiles analytical information from operations teams. Under direction of Scientist, supports with Quality Assurance Unit (QAU) audits of study documents, drafts responses as applicable, and follows up with appropriate personnel to ensure that all responses and/or necessary document/raw data clarifications are completed within specified timelines. Reviews client comments in protocol, method drafts and reports with Scientist, works with them to determine appropriate responses; addresses comments under guidance of Scientist to ensure all necessary document/data clarifications are completed in a timely manner. Supports report production processes through finalization Assists with archiving of study related materials Drives/Maintains Study and Client Communications Efficiently communicate and serve as a secondary to support the Scientist with client contact on assigned studies. Proactively communicates and interacts with study team, other departments, and clients as applicable. Attends and engages in pre-initiation and other internal study-related meetings, and attends conference calls; takes and distributes meeting minutes / action items, as appropriate. Support PM's and Scientists with preparing for and attends routine client visits. With support manages data transfer to clients as requested. Drives/Contributes to Process Improvement/Adherence Participates in the development and maintenance of standard report/table formats as needed. Participates in the development and maintenance of standard protocol, method and Sample Analysis Plan (SAP) formats as needed. Identifies opportunities to increase the efficiency of daily/routine procedures and reporting methods; provides input on and assists with implementation of new technologies, system changes, and enhancements. Study/Timeline Management With support plans, prioritizes, and manages own workload and multiple responsibilities. With support uses project tracking systems, as appropriate. Manages standard projects and study designs, and drives to increase study load over time. Maintains well-documented, organized, and up-to-date study files, including real-time study schedule updates, as applicable. Demonstrates active engagement with study progress/timelines. Actively promotes a team environment; identifies and escalates any activities that do not promote a team environment. Other related duties as assigned Minimum Required: Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education Ability to learn/utilize word processing software, database, spreadsheet, and specialized software Excellent communication and interpersonal skills Excellent attention to detail Ability to prioritize, organize, and manage time Application Window - 1/21 thru 1/31/2026 Pay Range: $24 - $25 per hour All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
    $24-25 hourly Auto-Apply 2d ago
  • Clinical Research Coordinator II

    Shriners Childrens Hospital 4.4company rating

    Clinical research coordinator job in Lexington, KY

    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
    $46k-61k yearly est. Auto-Apply 8d ago
  • Clinical Research Coordinator I

    University of Kentucky 4.2company rating

    Clinical research coordinator job in Lexington, KY

    The Markey Cancer Center is currently seeking to fill a Clinical Research Coordinator I position to work with one of our clinical trials team. The primary responsibilities for this position include: obtain, abstract and collate data, reports related to studies from patient medical records; maintain and submit all reports, forms and updated records to groups required by study; assist in designing a system for organizing, planning and controlling workflow related to the conduct of clinical studies and protocols; coordinate flow of patient through clinical study or protocol, monitoring all events related to patient and communicating any pertinent information to investigators and appropriate health professionals; learn basics of Good Clinical Practice (GCP) and standard operating procedures (SOP); monitor patient safety and general well-being; assist investigators with identification and recruitment of patients; ensure that pre-study and eligibility requirements of the protocol have been met for patients; maintain cooperative and professional relationships with all Clinical Research participants, other health professionals and study sponsors and/or monitors in planning care for study participation and to ensure protocol compliance; and other duties as assigned. This position has a fully onsite work arrangement. IMPORTANT: Resumes and CVs cannot be substituted for a completed application. Incomplete applications could disqualify you from being considered for this position. If the information on your resume is not entered on the application, this will prevent us from being able to assess your education and experience when trying to determine a salary offer. To be considered you must fully complete the online application being sure to only put one (1) job title for each entry (multiple job titles for one employer must have separate entries), the # of hours worked per week and your ending salary. You will also be required to upload a cover letter and resume. To view our exceptional benefits, please visit ******************************** Skills / Knowledge / Abilities Planning & organization, communication (written & verbal), time management, Microsoft Office Windows, Outlook, Excel & Word; BLS certification, phlebotomy training, ECG training, EPIC, OnCore. Does this position have supervisory responsibilities? No Preferred Education/Experience Bachelor's degree in a health related field and 1 year of experience with clinical trials; previous experience with data management, or in a health care facility preferred. Deadline to Apply 01/20/2026 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.
    $40k-52k yearly est. 8d ago
  • Clinical Research Coordinator

    Central Ohio Urology Group 3.8company rating

    Clinical research coordinator job in Columbus, OH

    About the Role The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. What You'll Be Doing Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results. Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract. Acts as a liaison between sponsor and the research department. In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria. Acts as a study resource for patients and family. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation. Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction. Dispenses study medications in accordance to protocol requirements within his/her scope of practice. Performs Investigational Product accountability for accurate compliance. Collects, processes and ships blood/urine specimens at scheduled times. Supervisors scheduling of research patient visits and procedures consistent with protocol requirements. Performs study specific procedures, including but not limited to ECG's, vital signs, height, weight, injections etc. within his/her scope of practice. Collect, compile and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups. Responsible for the reporting of and follow up on adverse events and serious adverse events per study protocol. Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance. Contacts outside health care providers and communicates with subjects to obtain follow up information. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Ensures filing and maintenance of all regulatory documents. Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. Maintains required continuing education hours required for certifications. Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). Maintains a high level of patient confidentiality. Performs all other duties as assigned. What We Expect from You Associates or Bachelor's Degree from an accredited college or university. Good Clinical Practice (GCP) Certificate International Air Transport Association (IATA) Certificate CCRC certification through an accredited organization (ACRP/SoCRA) is required 2-3 years related Research experience Preferred. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Travel Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected. What We are Offer You At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters” Compassion Make Someone's Day Collaboration Achieve Possibilities Together Respect Treat people with dignity Accountability Do the right thing Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more. About US Urology Partners U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy. U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.
    $43k-62k yearly est. Auto-Apply 12d ago
  • Clinical Coordinator

    Oklahoma State Government

    Clinical research coordinator job in Lexington, KY

    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
    $112.6k yearly Auto-Apply 26d ago
  • Clinical Coordinator

    Baptist Healthcare System 4.3company rating

    Clinical research coordinator job in Lexington, KY

    The clinical coordinator role assumes entry-level and clinical leadership and accountability for nursing care team operations while maintaining responsibility defined in the RN . As a coordinator, this role provides ongoing coordination of unit-level activities supporting excellence in professional nurse practice environment, evidence-based care delivery and related nursing, patient, and family-centered outcomes in collaboration with the multidisciplinary team as identified by the director. This position also serves as a clinical nurse as the individual spends majority of his/her time (>50%) coordinating, ensuring, and providing direct patient care activities on the unit/clinic through medication administration, provision of nursing rounds, assessments, and treatments; facilitating admission, transfer and discharge activities; provision of patient and family-centered communication and education; care coordination and individualized treatment planning as applicable, etc. Possesses authority and freedom to make nursing care decisions within the full scope of nursing practice. Other responsibilities may include supporting the Director as needed through coordination of the following priorities: nursing care team development, program planning, monitoring financial and human resources, process improvements, unit/clinic staffing plan and daily staffing activities. : Neuro ICU Clinical Coordinator Unit Description: 2B ICU is a 19-bed neuro ICU. Serving CVA, neurosurgical, carotid surgery and carotid stent patients. This unit supports our comprehensive stroke program if the patient needs critical care placement. In addition, the unit cares for surgical post-op, cardiac interventions, sepsis, general surgery and complex care ICU patients. Shift: Full-Time, Days : The clinical coordinator role assumes entry-level and clinical leadership and accountability for nursing care team operations while maintaining responsibility defined in the RN job description. As a coordinator, you will be responsible for: Provides ongoing coordination of unit-level activities supporting excellence in professional nurse practice environment, evidence-based care delivery and related nursing, patient, and family-centered outcomes in collaboration with the multidisciplinary team as identified by the director. This position also serves as a clinical nurse as the individual spends majority of his/her time (>50%) coordinating, ensuring, and providing direct patient care activities on the unit/clinic through medication administration, provision of nursing rounds, assessments, and treatments; facilitating admission, transfer and discharge activities; provision of patient and family-centered communication and education; care coordination and individualized treatment planning as applicable, etc. Possesses authority and freedom to make nursing care decisions within the full scope of nursing practice. Other responsibilities may include supporting the Director as needed through coordination of the following priorities: nursing care team development, program planning, monitoring financial and human resources, process improvements, unit/clinic staffing plan and daily staffing activities. Minimum Education, Experience, Training and Licensures Required: Bachelor's degree. Minimum of two years of management experience. Current RN license. ACLS certification. Basic Life Support (BLS) certification is required. If not already certified, must obtain BLS within 30 days of their hire date. Benefits: Health, Vision, Dental and Pet Insurance Life Insurance Short Term and Long-Term Disability and Life Insurance Identity Theft Protection Tuition Reimbursement up to $6,000 annually Company paid Maternity and Paternity Leave 5 days of Paid Time Off available upon hire Bereavement Leave (includes pets) PTO Sell Back Program Compassionate Leave Sharing Program (PTO Donation) Employee Support Fund, for employees in need of emergency financial support Retirement with Company Match 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.
    $51k-69k yearly est. Auto-Apply 7d ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in Lexington, KY?

The average clinical research coordinator in Lexington, KY earns between $32,000 and $67,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average clinical research coordinator salary in Lexington, KY

$46,000

What are the biggest employers of Clinical Research Coordinators in Lexington, KY?

The biggest employers of Clinical Research Coordinators in Lexington, KY are:
  1. BHS
  2. University of Kentucky
  3. Imperial Council A A O N M S
  4. Shriners Hospitals for Children
  5. Alliance for Multispecialty Research
  6. Mass General Brigham
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