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SUMMARYThe Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.<ul><li>Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.</li><li>Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).</li><li>Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.</li><li>Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.</li><li>Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.</li><li>Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.</li><li>Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.</li><li>Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.</li><li>Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.</li><li>Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.</li><li>Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.</li><li>Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.</li><li>Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.</li><li>Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.</li><li>Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.</li><li>Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.</li><li>Adheres to the USRC Research quality assurance program guidelines.</li><li>Travel to Investigator Meetings or similar research related meetings is required.</li><li>Travel may be required between dialysis facilities or nephrology practices within the community.</li><li>Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.</li><li>May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.</li><li>Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.</li><li> Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.</li><li> Participate in staff meetings as required.</li><li>Regular and reliable attendance is required for the job.</li><li>Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.</li><li>Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.</li><li>Regular and reliable attendance is required for the job.</li></ul>

U.S. Renal Care

Clinical Research Coordinator

Compensation Type: SalariedCompensation: $25.58Job SummaryThe Coordinator will be responsible for front-line management, planning, coordination and successful execution of all services provided by Testing Services: academic testing (in-person and virtual), accommodated testing, placement testing, and vendor specific testing. A Coordinator partners with department leadership to create an engaging environment designed to enhance the student experience. This role will lead staff training, address on-site issues, process academic exams, and communicate to a diverse audience in a variety of settings. The individual best suited for this role is one who is open and willing to working with diverse student populations while remaining consistent and unbiased in the delivery of services. The incumbent will be dedicated to creating a positive, equitable, and inclusive experience for students during their time at Columbus State.ESSENTIAL JOB FUNCTIONSCoordination of Testing Services<ul><li>Responsible for the coordination and administration of comprehensive test proctoring services, including instructional make-up exams, distance learning, special testing requests (proficiency exams, HESI, BOA, Virtual Testing with RM) as well as accommodated testing. Serves as a liaison between all testing locations to ensure consistent processes and practices.</li><li>Administers and monitors academic testing (in-person and virtual). Ensures test instrument security and standardized administration within the guidelines provided by instructors, established college procedures, external certification providers, and National College Testing Association (NCTA) standards. Processes completed tests in accordance with college procedures and maintains department documents. Ensures a safe and supportive learning environment with department procedures, Columbus State’s Academic and Student Code of Conduct policies, National College Testing Association standards, and the college’s security procedures.</li><li>Assists in the review and development of procedures for Testing Services and Instructional Services. Responsible for the front-line operations of testing services; working in conjunction with the DEIS, Assistant Directors, Supervisors, and Coordinators, in collaboration with faculty and campus student services. Provides input to policies for testing-related accommodations.</li><li>Functions as a working coordinator, providing direct service to customers, in-person and virtually. Provides support and functional supervision to assigned Instructional Services Specialists working in Columbus State Testing Centers. Assigns and delegates tasks, communicates job expectations, trains employees, participates in evaluations, employee selection, and other personnel actions. Provides direction and guidance regarding job methods, standards, and operations. Works with Virtual Proctors, Specialists, and other staff as needed with assigned projects. Presents technical concerns and works with appropriate personnel to achieve an appropriate resolution. Coordinates special testing projects. Works in conjunction with appropriate personnel to ensure maintenance and upgrades of testing systems.</li><li>Maintains integrity of testing materials and testing environment. Ensures front line staff enforce policies to maintain academic integrity. Ensures exams and spaces are monitored via video cameras and computer monitoring software. Performs walkthroughs and visual inspection of testing spaces during exams. Follows standard testing protocol by ensuring assessment integrity, distributing appropriate support materials, assisting students with accommodations, troubleshoots technology and Blackboard errors in accordance with college policies and procedures.</li></ul>Clerical<ul><li>Accurately records the receipt and distribution of tests. Completes and maintains required documentation including various spreadsheets, test administration logs, and virtual test proctoring forms. Gathers, maintains and presents statistical reports as needed. Responsible for reporting and tracking students served through Instructional Services – Testing Services. Maintains confidentiality of student files and other sensitive information.</li><li>Record any incidents of academic misconduct via an incident report. Report incidents of suspected academic misconduct to Student Conduct and the Instructional Services Assistant Director as needed. Report any issues with assistive technology software and hardware or general testing software programs to the department leadership team.</li><li>Answers telephones, schedules appointments, provides informational materials and answers questions, operates a variety of office and computer equipment. Uses computer software, assesses material needs, orders, receives, and maintains test instruments and supplies inventories.</li><li>Collaborates with IT and Accessibility Services to determine effective implementation of new testing and accessibility hardware and software. Works closely with the department’s leadership team when purchasing updated equipment and software which will streamline and enhance the services provided to students.</li></ul>​Customer Service<ul><li>Delivers excellent customer service and provides students, faculty, adjuncts, and staff with a secure, comfortable, and accessible environment. Keeps distractions to a minimum during testing appointments. Must be aware and able to conform to the proper etiquette for all individuals with a disability. Answers student, faculty, adjunct, and staff inquiries and makes referrals to other campus resources as appropriate.</li><li>Describes Instructional Services – Testing Services policies and procedures to students and instructors, providing relative training to campus stakeholders as appropriate. Collaborates internally and may facilitate appropriate training within the department as well as to business partners requiring Testing Services – Instructional Services training.</li></ul>Professional Development <ul><li>Attends Digital Education and Instructional Services staff meetings and scheduled training sessions. Stays current on National College Testing Association (NCTA) standards, vendor testing, virtual testing and accessibility related trends. Attends professional development trainings/workshops.</li><li>Maintains credentials &amp; any annual training/recertification necessary to administer any high-stakes certification examinations administered by Testing Services.</li></ul>​Culture of Respect <ul><li>Fosters and maintains a safe environment of respect and inclusion for faculty, staff, students, and members of the community.</li></ul>*Regular, predictable, and punctual attendance is required.Other duties as required MINIMUM EDUCATION AND EXPERIENCE REQUIRED<ul><li>Bachelor’s Degree in a closely related field.</li><li>Three (3) years’ experience in college testing, academic or student affairs, or related services.</li><li>State Motor Vehicle Operator's License or demonstrable ability to gain access to work site(s).</li><li>*An appropriate combination of education, training, coursework and experience may qualify a candidate.</li></ul>Compensation: $25.58CSCC has the right to revise this position description at any time. This position description does not represent in any way a contract of employment.Full Time/Part Time:Part timeUnion (If Applicable):Scheduled Hours:20Additional InformationIn order to ensure your application is complete, you must complete the following:<ul><li>Please ensure you have all the necessary documents available when starting the application process. For all faculty positions (Instructor, Annually Contracted Faculty, and Adjunct), you will need to upload an unofficial copy of your transcript when completing your aplication. </li><li>Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.</li></ul>If you are a current employee of Columbus State Community College, please log in to Workday to use the internal application process.Thank you for your interest in positions at Columbus State Community College. Once you have applied, the most updated information on the status of your application can be found by visiting your Candidate Home. Please view your submitted applications by logging in and reviewing your status.

COLUMBUS STATE COMMUNITY COLLEGE

Coordinator

<h4>Overview</h4>LMI is seeking a skilled Senior Operations Research Analyst&nbsp;supporting a DoD client. A successful LMI Senior Operations Research Analyst demonstrates competency in logistics operations reseach, and applies mathematical and statistical methods to the study and analysis of logistics problems leading to the development of new supply chain planning, inventory control, and forceasting models for weapon systems support. This role is expected to be hybrid, offering a combination of telework/client site work. Up to 3 days per week onsite will be expected. The client site location is at Wright-Patterson AFB.&nbsp;LMI is a consultancy dedicated to improving the business of government, drawing from deep expertise in advanced analytics, digital services, logistics, and management advisory services. Established in 1961, LMI is a trusted third party to federal civilian and defense agencies, free of commercial and political bias. We operate completely free of political and commercial bias, and we are entirely aligned with the goals of our clients. Our clients value our specialized services in logistics, intelligence, homeland security, health care, and energy and environment markets. We believe government can make a difference, and we seek talented, hardworking people who share that conviction. We offer a generous compensation package with excellent benefits that start the first day of employment. Business casual dress, flex time, and tuition reimbursement are a few of our many work-life benefits available to our employees.<h4>Responsibilities</h4><ul><li>Responsible for logistics, supply chain, and weapon systems analysis, including math modeling, logistics operations research, and systems analysis and programming.&nbsp; </li><li>Uses analytical models to assess operational capability, compute spare parts requirements, and compute stock leveling.</li><li>Provide sustainment requirements and cost estimates.&nbsp;</li><li>Support maintenance planning concepts and analyze and deliver recommendations for adjustment which include areas for improvement in optimizing maintenance intervention to meet supportability and affordability goals. </li><li>Support a Logistics IPTs in like and similar equipment analysis, maintenance task analysis, level of repair analysis, business case analysis for life cycle cost estimating, and implementation of a fleet management plan.</li><li>Deliver recommendations for adjustment of supply support concepts which include identification of areas for improvements in manufacturing processes which reduce customer wait times and pipeline spares.&nbsp;</li><li>Analyze and assess government agency logistics and supply chain policies and procedures against current performance metrics and make recommendations on policy and/or process improvements.</li><li>Support projects that re-design or enhance system support via supply chains.</li><li>Support fleet introduction and sustainment readiness reviews with an understanding of program documentation and planning.</li><li>Maintain interim operating procedures to support requirements in a client approved database developed for support of site activation.</li></ul><h4>Qualifications</h4><ul><li>BS degree in any Operations Research, Technical Management, Computer Science, Mathematics, Statistics, or Engineering related discipline is required.</li><li>MS degree may be substituted for two (2) years of experience and a PhD may be substituted for four (4) years of experience.</li><li>6+ plus years’ experience in DoD logistics and/or supply chain management.</li><li>Knowledge of commercially based advanced modeling, networking, scheduling and inventory optimization systems and techniques in order to support development of supply, inventory management, and distribution policy to improve materiel management of spare part inventories.</li><li>Good quantitative and analytical skills.&nbsp;</li><li>Demonstrated ability to use MS Office Suite to include Word, PowerPoint, and Excel.</li><li>Superior communication skills, both oral and written&nbsp;</li><li>High energy, enthusiasm, tact, ability to effectively interact with senior executives from Government and industry&nbsp;</li><li>Ability to create and foster a cooperative work environment.</li><li>Self-directed, detail oriented in completing assigned tasks, able to adapt to changing work efforts and manage impact of shifting priorities.</li><li>Availability for occasional travel.</li><li>This position requires an active security clearance.You must be a US citizen.</li><li>Availability to travel.</li></ul>Targeted Salary Range: $104,000-$150,000Disclaimer:The salary range displayed represents the typical salary range for this position and is not a guarantee of compensation. Individual salaries are determined by various factors including, but not limited to location, internal equity, business considerations, client contract requirements, and candidate qualifications, such as education, experience, skills, and security clearances.#LI-SH1<h4> LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a> Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Need help finding the right job? </h4>We can recommend jobs specifically for you!Click here to get started.

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