Clinical research coordinator jobs in Champaign, IL

Department: MED-Physical Med & Rehab Salary/Grade: RES/ Target hiring range for this position will be between $75,000-$100,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Job Summary: The Clinical Research Associate is responsible for coordinating clinical research-related activities as well as providing clinical research support to the research group. The PA/NP manages activities associated with highly complex clinical research studies including investigator-initiated trials single and multi-center trials and industry-initiated trials. Responsibilities include: performing patients assessments, conducting patient visits, collecting and documenting clinical research data, attending clinical trial conferences and meetings, acting as a liaison between patients and physicians, and acting as a resource to research study patients, physicians, and other/clinical personnel. This individual is the primary contact for all participants and coordinators to access at any time of day. This individual uses advanced communication skills to problem solve complex situations. This individual will provide clinical support and clinical research activities to the PI. This individual acts as a sub investigator on all clinical trials at any given time. The hours for this job are flexible and can be either part-time or full-time. Specific Responsibilities: Nurse Practitioner/Physician Assistant * Become familiar with all protocols conducted at the center. Participates in the initiation of study start-up activities. Contributes to the implementation of protocols and monitors study activities at all stages. * Evaluates volunteer subjects for potential study qualification in accordance with inclusion/exclusion criteria provided by study sponsor. Assists in patient recruitment as well as acting as a resource for the marketing personnel and * referring physicians. * For qualified participants, initiates medical and social histories, physical exam, and physiological measures as indicated in protocol. Records this data in detail. Schedules study visits as required by protocols. * Ensures appropriate laboratory, x-ray and other diagnostic examinations are * scheduled and completed per study protocol. Oversees any outside services as required. Conducts all necessary laboratory and imagining tests. * Performs complete medical histories and physical examinations for qualified participants with emphasis on patient's presenting complaints and findings pertinent to the study. Discriminates between normal and abnormal findings onhistory and physical in order to establish a differential diagnosis. Provides clinical support for divisional research activities within scope of license. * Review medical, laboratory, and other diagnosis data on study patients. Recognizes conditions beyond the scope of the Nurse Practitioner/Physician Assistant and confers with principal investigator. Makes principal investigator aware of any significant abnormalities. Notifies and follows up with patients as * appropriate. * Assists coordinators in assessment of adverse events. Ensures that serious adverse events are reported to the principal investigator and sponsor in a timely manner. Follows up with patients or patient family members in accordance with * procedures. Knowledge of community resources needed for patients. * Assists with collection of data requested by protocol. Ensures accuracy of data obtained. Collates and enters data into patient charts, sponsor case report forms, * and/or remote data entry equipment in a timely and precise manner. * Ensures that all study drug received in unit is accurately documented and sorted in locked location. Ensures that study drug is maintained in appropriate temperature controlled environment. Verifies that all study drugs is correctly labeled, and packaged. Ensures that appropriate study drug is dispensed to patient * along with detailed instructions on use. Maintains accurate documentation of each of these along with return study drug. * When studies require other supplies and/or equipment, will ensure their availability and ensure proper orientation has occurred prior to use. * Ensures patient compliance with study drug and study visits. Documents all efforts made to retrieve study medication. Notifies sponsor of any deviations from protocol. Whenever possible, obtains permission prior to deviation. * Schedules routine study reviews with sponsor monitors or appointed sponsor representative. Arranges access to all subject records for the indicated time period * of review. Allows time to respond to monitor questions and to make corrections to case report forms. Promptly respond to sponsor queries. * Prepares for and completes close out procedures for terminated studies. Ensures * all FDA, sponsor, and center regulations have been followed. * Assist with training of other center personnel who will be directly involved with the assigned study. * Works with other research coordinators and research assistants to provide back-up, replacement during absences, and follow-up as needed. * Provides health practices information and education to study patients regarding * medications, disease, diet, exercise, and any special procedures. Assists patients by providing appropriate referrals to physicians, clinics, or agencies. * Provides on-call services for study patients during evening and weekend on rotation basis with other coordinators/nurse practitioners/physician assistants. * Performs diagnostic procedures as required by study protocol. * Assists in training of center personnel, especially in the clinical assessment skills including blood draw and performing ECGs . Ensures gowns, gloves, goggles, masks and other personal protective equipment are used properly by all staff. * Participates in other division activity such as special projects, in-service, training, and any other duties assigned by supervisor * Must take the certification exam within 2 years, or with 1 year if has 1 year previous experience as a research coordinator. Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Graduate of an accredited Nurse Practitioner or Physician Assistant program; current Illinois licensure. * Must complete NU's IRB CITI training before interacting with any participants and must re-certify every 3 years. Minimum Competencies: (Skills, knowledge, and abilities) * Excellent clinical assessments skills * Detail-oriented and highly organized. * Ability to understand technical research protocols. * Excellent problem solving skills. * Able to make decisions independently and yet must be team oriented. * Must possess ability to articulate and clearly communicate study information to patients, and otherhealth care professionals. * Excellent written and oral communication skills. * Professional demeanor with ability to interact with pharmaceutical/sponsor representatives,regulatory agents, medical center administration, medical staff, peers, and patients. Preferred Qualifications: (Education and experience) * Previous research experience and 3+ years clinical experience as a Nurse Practitioner/PhysicianAssistant. * Graduate of an accredited master's program for Nurse Practitioner or Physician Assistant. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-GY2

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

Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Chicago, Illinois (IL). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Clinical Research Associate: * 2-4 years performing on-site monitoring and hands on experience with EDC Systems * Experience with Oncology is highly advantageous * Organization to perform monitoring duties across multiple sites is a must Compensation for the Clinical Research Associate: * Salary Range: $100,000-$120,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1

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

CRA II OR Senior CRA (home-based in the U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. Collaborating with investigators and site staff to facilitate smooth study conduct. Performing data review and resolution of queries to maintain high-quality clinical data. Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile Bachelor's degree in a scientific or healthcare-related field. Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills, with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license #LI-MM2 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Position Overview This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team. This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish. Essential Duties Include, but are not limited to, the following: Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies. Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships. Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates. Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams. Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements. Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies. Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team. Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate. Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management. Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members. Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study. Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members. Communicate project specific information to/from trial sites through teleconferences, newsletters, etc. Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis. Document monitoring activities in monitoring visit reports and follow-up letters. Communicate serious issues to appropriate parties, in a timely manner. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. Participate in Investigator Meetings, and other study trainings and meetings as required. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work designated schedule. Ability to work nights and/or weekends, as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 50% of working time away from work location may include overnight/weekend travel. Minimum Qualifications Bachelor's Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience. Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience. 4+ years clinical research monitoring experience or equivalent experience. No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability. Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems. Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively. Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices. Meticulousness with a focus on accuracy and precision in all tasks and activities. Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy. Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred Qualifications Experience or knowledge in In Vitro Diagnostics (IVD). Certifications related to clinical research. Working knowledge of the FDA submission process including IDE, PMA, and 510(k). Strong on-site monitoring experience in clinical trials, including: Site initiation. Routine monitoring visits. Site closeout. Knowledge of electronic trial master file (eTMF) systems and document management processes. This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish. #LI-JH1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Senior Clinical Research Coordinators at our Ravenswood, Chicago, IL location! The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8 AM - 5 PM Location: 1945 W Wilson Ave, Suite 6104, Chicago, IL 60640 Compensation: $35/hr with flexibility depending on experience Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Senior Clinical Research Coordinator (Sr CRC) will act as the lead CRC for a variety of assigned trials. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management. QUALIFICATIONS Bachelor's degree preferred but not required Phlebotomy experience is required; EKG or other patient labs/processes preferred 5+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

Min USD $24.04/Hr. Max USD $37.26/Hr. * Coordinates screening and enrollment of clinical trial patients. * Reviews physician patient schedules and assesses patients for possible clinical trial enrollment. * Educates patients and families during the informed consent process. * Registers patients and participants to protocols. * Ensures eligibility requirements are met and reviews with physician investigator. * Ensures protocol required patient testing is ordered and complete. * Maintains record of recruitment strategies. * Markets protocols as needed to meet recruitment goals. * Coordinates clinical trial activities research done at the clinic and hospital * Gathers and verifies source documents * Verifies the accuracy, completeness and timely submission of case report forms. * Collaborates with investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response. * Interviews patient to assess adverse events, medication compliance, and patient reported outcomes. * Obtains follow-up data required when patient is off active treatment. * Corrects and resubmits data or answers queries within one week of receipt or as requested by pharmaceutical company; reviews expectation reports; notifies research base of errors. * Maintains investigational drug (IND) inventory * Reviews protocols and assesses current inventory of IND. * Orders INDs from Pharmaceutical Management Branch at National Cancer Institute. * Maintains inventory on individual drug accountability records. * Ensures treatment order is correct by reviewing protocol guidelines and calculating dose prescribed. Qualifications Qualifications 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. * Must possess good communication and interpersonal relationship skills. Must be able to organize work with minimal supervision. Must be able to focus attention to minute details. Access, Work and Excel computer skills required. Education and/or Other Requirements A bachelors degree in nursing or other health-related field is preferred. Pertinent LPN or RN licensure/registration must be maintained. Previous research experience and/or recent nursing experience is preferred. Environmental Factors Direct patient care duties involve the potential for frequent exposure to blood and body fluids. Physical Demands The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. * Light physical exertion, including occasional standing, bending, reaching and occasional carrying of light loads. Mental Demands * While performing the duties of this job, the employee must be able to work under stress, adapt to changing conditions and meet strict time guidelines. * Ability to adhere to strict confidentiality requirements. Responsibilities General Skill Requirements In addition to the Essential Functions and Qualifications listed above, to perform the job successfully an individual must also possess the following General Skill Requirements. * Adaptability - Adapts to changes in the work environment; Manages competing demands; Accepts criticism and feedback; Changes approach or method to best fit the situation; ability to work with frustrating situations; work under pressure and on an irregular schedule such as unscheduled overtime, unanticipated changes in work pace; Works with numerous distractions. * Attendance and Punctuality - Schedules time off in advance; Begins working on time; Keeps absences within guidelines; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. * Communications - Expresses ideas and thoughts verbally; Expresses ideas and thoughts in written form; Exhibits good listening and comprehension; Keeps others adequately informed; Selects and uses appropriate communication methods. * Cooperation - Establishes and maintains effective relations; Exhibits tact and consideration; Displays positive outlook and pleasant manner; Offers assistance and support to co-workers; Works cooperatively in group situations; Works actively to resolve conflicts. * Job Knowledge - Competent in required job skills and knowledge; Exhibits ability to learn and apply new skills; Keeps abreast of current developments; Requires minimal supervision; Displays understanding of how job relates to others; Uses resources effectively. * Judgment - displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions; ability to work with and maintain confidential information. * Problem solving - Identifies problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Resolves problems in early stages; Works well in group problem solving situations. * Quality - Demonstrates accuracy and thoroughness; Displays commitment to excellence; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. * Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly; Achieves established goals. * Concentration - Maintains attention to detail over extended period of time; continually aware of variations in changing situations. * Supervision - ability to perform work independently or with minimal supervision; ability to assign and/or review work; train and/or evaluate other employees.

Job DescriptionAbout Hematogenix Want a job with greater meaning and higher purpose? Every day Hematogenix employees are warriors fighting a noble and global war on cancer. Helping patients every day, and helping partners every day - with our diagnostic and research services. Hematogenix is looking for talented and highly motivated individuals to join our team. We offer a competitive benefit package and career development opportunities to help you achieve your highest professional and personal goals. We are eager to show you all we have to offer and how you can grow with us. Hematogenix is a specialized contract research organization and clinical laboratory with a global presence. Our team of board-certified clinical, anatomic and research pathologists work in conjunction with top scientists from around the world to provide quality testing, consultation, and guidance for all aspects of the company's pharma and diagnostic services. Job Purpose: The Clinical Study Coordinator supports the successful delivery of clinical trial projects via operational/day-to-day management of workflows. Deliver excellent customer service to project stakeholders (e.g., clients, clinical sites). *Please note that this position requires you to be onsite at our Illinois, USA location. Accountabilities/Work Activities: Study Initiation Possess strong working knowledge of company capability's and how it typically aligns with clients' objectives and timelines. Comfortable developing and maintaining relationships with various project stakeholders where needed (external and internal) Planning & Design Contribute, when necessary, operational insights that will impact project scope. Assist the Project Managers with creation of study specific laboratory binders and regulatory documents. Executing Attend in-house initiation meetings with all project personnel in order to understand individual contributions of all, as well as overall study objectives and timelines. Provide guidance to Pharma Accessioning Team regarding query generation. Create and send clearly written data clarification messages to ensure outstanding queries are resolved in a timely fashion according to Communication and Escalation Plan established with each Sponsor. Maintain study tracking spreadsheets/documents in real time if applicable. Communicate effectively (verbal and written) when interacting with external stakeholders (e.g., CRAs, SCs, PIs, etc.) Interact effectively with all in-house project personnel and provide clear communication on status of cases (query resolution) or specific requests (e.g., expedited testing requests Perform data entry if needed and/or manage data entry needs of projects to ensure daily/weekly completion occurs. Process sample repatriations and maintain associated documentation. Monitoring & Controlling Participate in regular internal meetings with Project Manager to feed in views of project personnel, outline operational challenges, and learn of wider project progress. Participate in regular conference calls with clients. Provide support to Project Manager during client monitoring visits. Ensure project supplies and day-to-day resources are always appropriately used in an effort to reduce waste and increase efficiency. Study Closing Contribute to internal project closing meetings in order to share best practice. Provide QC support to Project Manager during close out visits. Experience and Education Bachelor of Science degree or similar degree related to the role 1-2 years' experience in Clinical Laboratory Science Skills and Qualifications Knowledge of GCP/CAP/CLIA and global clinical research industry Must be able to communicate effectively and persuasively, both verbally and in writing, with all levels of in-house Hematogenix personnel and other project stakeholders (e.g., CRAs, site officials) Working experience with laboratory information systems Personal computer skills (Microsoft Word, Excel, Power Point, etc.) Ability to ambulate throughout the office and laboratory. Benefits we Offer: Medical Dental Vison Life 401k PTO Competitive Salary Contact Information: ********************; ******************* Hematogenix provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Coordinates screening and enrollment of clinical trial patients. Reviews physician patient schedules and assesses patients for possible clinical trial enrollment. Educates patients and families during the informed consent process. Registers patients and participants to protocols. Ensures eligibility requirements are met and reviews with physician investigator. Ensures protocol required patient testing is ordered and complete. Maintains record of recruitment strategies. Markets protocols as needed to meet recruitment goals. Coordinates clinical trial activities research done at the clinic and hospital Gathers and verifies source documents Verifies the accuracy, completeness and timely submission of case report forms. Collaborates with investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response. Interviews patient to assess adverse events, medication compliance, and patient reported outcomes. Obtains follow-up data required when patient is off active treatment. Corrects and resubmits data or answers queries within one week of receipt or as requested by pharmaceutical company; reviews expectation reports; notifies research base of errors. Maintains investigational drug (IND) inventory Reviews protocols and assesses current inventory of IND. Orders INDs from Pharmaceutical Management Branch at National Cancer Institute. Maintains inventory on individual drug accountability records. Ensures treatment order is correct by reviewing protocol guidelines and calculating dose prescribed. Qualifications Qualifications 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. Must possess good communication and interpersonal relationship skills. Must be able to organize work with minimal supervision. Must be able to focus attention to minute details. Access, Work and Excel computer skills required. Education and/or Other Requirements A bachelors degree in nursing or other health-related field is preferred. Pertinent LPN or RN licensure/registration must be maintained. Previous research experience and/or recent nursing experience is preferred. Environmental Factors Direct patient care duties involve the potential for frequent exposure to blood and body fluids. Physical Demands The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Light physical exertion, including occasional standing, bending, reaching and occasional carrying of light loads. Mental Demands While performing the duties of this job, the employee must be able to work under stress, adapt to changing conditions and meet strict time guidelines. Ability to adhere to strict confidentiality requirements. Responsibilities General Skill Requirements In addition to the Essential Functions and Qualifications listed above, to perform the job successfully an individual must also possess the following General Skill Requirements. Adaptability - Adapts to changes in the work environment; Manages competing demands; Accepts criticism and feedback; Changes approach or method to best fit the situation; ability to work with frustrating situations; work under pressure and on an irregular schedule such as unscheduled overtime, unanticipated changes in work pace; Works with numerous distractions. Attendance and Punctuality - Schedules time off in advance; Begins working on time; Keeps absences within guidelines; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Communications - Expresses ideas and thoughts verbally; Expresses ideas and thoughts in written form; Exhibits good listening and comprehension; Keeps others adequately informed; Selects and uses appropriate communication methods. Cooperation - Establishes and maintains effective relations; Exhibits tact and consideration; Displays positive outlook and pleasant manner; Offers assistance and support to co-workers; Works cooperatively in group situations; Works actively to resolve conflicts. Job Knowledge - Competent in required job skills and knowledge; Exhibits ability to learn and apply new skills; Keeps abreast of current developments; Requires minimal supervision; Displays understanding of how job relates to others; Uses resources effectively. Judgment - displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions; ability to work with and maintain confidential information. Problem solving - Identifies problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Resolves problems in early stages; Works well in group problem solving situations. Quality - Demonstrates accuracy and thoroughness; Displays commitment to excellence; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly; Achieves established goals. Concentration - Maintains attention to detail over extended period of time; continually aware of variations in changing situations. Supervision - ability to perform work independently or with minimal supervision; ability to assign and/or review work; train and/or evaluate other employees. Not ready to apply? Connect with us for general consideration.

Under minimal to limited supervision, verifies budgetary information and coordinates pre-award planning and organization of proposals to one or more research agencies prior to submission to university grants and contracts office. Provides direction to investigators and administrative staff regarding personnel and other expenditures to ensure grants are in compliance with regulatory, funding agency, and policy requirements. Oversees, maintains, and reports finances of CALNS accounts for all components. Compiles and generates a range of comprehensive statistical for all academic and research components. Prepares and analyzes spending projections for grant funding. Duties and Responsibilities: * Provides the guidance and instruction to investigators in the interpretation of funding agency regulations and requirements. * Serves as a liaison between investigators, granting agencies (State of Alabama awards-AALGA, NSF, USDA, USDA-NIFA, USDoI), the AAMU OSP/Grants & Contracts personnel, and the AAMU Comptroller's office in the budgeting and preparation of grant proposals; research agency and AAMU requirements and prepares comprehensive budget justifications for investigators. * Develops and maintains specialized databases and systems for recording and tracking grant proposals, awards, and related statistical information; creates and distributes standard and special reports, studies, summaries, and analyses, as required. * Develops and maintains a library of reference documentation, including such information as funding agency requirements and forms, investigator profiles and curriculum vitae, and other pertinent material. * Provides advice and guidance to researchers on the application of grant funding policies, regulations, and procedures; facilitates and supports the research and identification of funding opportunities on behalf of investigators, as appropriate. * Monitors and coordinates the administration of post-award grants regarding compliance oversight to ensure that budgeting and administrative policies, procedures, and agency requirements are being followed; manages administrative problems and/or budget changes occurrences during the award granting period. * Maintains current knowledge of grant funding policies, regulations, and procedures; disseminates and/or presents changes to departments and advises on the implementation of changes and on the impact of changes on funded operations. Knowledge and ability to apply policies contained in the Super Circular. * Signs designated correspondence, requisitions, etc., in supervisor's absence, where permission to do so is granted. * Reviews departmental instructional and general budgets for new positions and approves payroll documents for availability of funding. * Monitors the supervision of institutional (bi-weekly) employees which include work allocation, training, and problem resolution; evaluate and report performance when needed. * Provides direction, consultation, assistance, and support to faculty and staff in developing, controlling budgets and costs, fulfilling budgetary requirements, and understanding financial reports/data and administrative policies and procedures. * Analyzes budget and financial data to identify and report on emerging trends. * Compiles and analyzes various CALNS statistical data to develop standard data for various CALNS and university presentations and publications. * Ensures accurate and timely response to requests for information. * Performs other duties that may be assigned by the immediate supervisor. Minimum Positions Requirements: (including certification, licenses, etc.): * Bachelor's degree in business, accounting, office administration, or other appropriate area. * Minimum of 3-5 years of experience with diverse clientele and directly related to the duties and responsibilities specified. * Certification in contracts and grants administration preferred. Knowledge, Skills and Abilities: Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community; Knowledge of finance, accounting, budgeting, revenue generating, and cost control procedures; Knowledge regarding NIFA financial reporting requirements, documentation, and procedures; Ability to foster a cooperative work environment; ability to analyze budgetary line items for compliance with budget guidelines; Database management skills; Ability to provide technical advice and information to faculty and staff in area of expertise; Proficient in the use of personal computers and related software applications; Ability to make administrative/procedural decisions and judgments; Knowledge of federal, state, or local funding sources. Skill in organizing resources and establishing priorities; Ability to learn, work and mentor others with BANNER, ez FedGrants, and REEport. Highly knowledgeable regarding OMB directives and policies.

The Clinical Research Coordinator serves as the principal study contact and implements clinical research study activities between the Clinical Research Department, SC Investigators, SC staff, and the pharmaceutical and medical device study sponsors. Job Relationships Reports to the Clinical Research Manager Principal Responsibilities Plan and coordinate the initiation of assigned IRB approved clinical trial protocols; following all federal/local requirements, ICH/GCP, OSHA, IATA requirements. Responsible for screening, consenting, and enrolling eligible patients, as well as following all enrolled study patients to study completion; conduct study visits per protocol, and collect, process, and ship all lab specimens as required and as per IATA training and certification. Responsible for providing SC Investigators with information about the protocol, protocol amendments, Investigator's Brochure, ICH/GCP guidelines, and other study-required training to ensure compliance with all applicable regulations and study-specific guidelines. Maintain adequate and accurate source documentation in each of the study patient's medical records regarding their participation in the clinical study; accurately enter data into the sponsor's case report forms per the sponsor's guidelines; maintain accurate investigational product accountability documentation regarding the receipt, disposition, dispensation, return and destruction. Monitor research patients for suspected adverse events and report serious adverse events (SAEs) and any protocol deviations to the study sponsor within the appropriate time frame; provide pertinent information for submission to the proper authorities. Schedule and meet with the study monitors/Clinical Research Associates (CRAs) to: Review data entry against source documentation and assist in resolving all discrepancies, including resolving data queries. Liaise between the study monitor, clinic staff, and the SC Investigators to ensure that quality research is being conducted according to the IRB approved protocol, amendments, procedures, laws, and regulations. Assist management team in the training and mentoring of new/ lesser experienced staff. As needed, obtain and maintain Allied Health Professional appointments at the local hospitals. Comply with the Springfield Clinic incident reporting policy and procedures. Provide excellent customer service and adhere to SC Code of Conduct and Ethics Standards. Perform other job duties as assigned. Education/Experience Minimum of a Bachelor's degree in a related field. Clinical Research experience strongly preferred. Licenses/Certificates CPR certification per American Heart Association guidelines required within 30 days of hire. It is strongly recommended that research certification (CCRP or CCRC) is obtained after two (2) years of employment and then subsequently maintained in good standing. Knowledge, Skills and Abilities A strong working knowledge of computer software including Microsoft Office, Electronic Medical Record(s), other SC platforms, and Sponsor required systems. Attention to detail and ability to follow and interpret approved clinical protocols is required. A strong working knowledge of GCP, ICH, CFR, and HIPAA laws and regulations will be required. Knowledge of Springfield Clinic policies and procedures. Ability to demonstrate good organizational skills, excellent oral & written communication skills, and excellent interpersonal skills in working effectively with Co-workers; Managers; Directors; Administration; Providers; Staff; Sponsors and Patients. Ability to recognize, evaluate and solve problems. Ability to manage projects in a team environment. Ability to function and perform daily work independently; perform duties and tasks assigned and follow through to completion. Must have the ability to control emotions and maintain composure under stress, using tact and good judgment. Must be able to stand and walk for long periods and capable of stooping, bending, and lifting. Working Environment Office based with travel to other Springfield Clinic locations (including satellite offices) and other business related travel, as required to conduct day to day business aspects of the department. PHI/Privacy Level HIPAA1

Posting Date 07/23/202526 E West Newell Rd., Danville, Illinois, 61832, United States of America DaVita is seeking a Clinical Coordinator who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way - the way you'd want your own care to be? If you haven't considered Nephrology before, read on as we think that you should. DaVita - which is Italian for "giving life" - is working to provide quality service to patients, partners, and teammates. Our mission is to be the Provider, Partner, and Employer of Choice. Some details about this position: At least 6 months dialysis experience is required. Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being. Training may take place in a facility or a training clinic other than your assigned home clinic Potential to float to various clinics during and after your training You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays What you can expect: Build meaningful and long term relationships with patients and their family in an intimate outpatient setting. Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians. Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge. Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up. You will work with your head, heart and hands each day in a fast paced environment. What we'll provide: DaVita Rewards package connects teammates to what matters most including: Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out Support for you and your family: family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave, pet insurance, and more Paid training Requirements: Current Registered Nurse (RN) license in the state of practice Current CPR certification required At least 18 months of registered nursing experience Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree Current CPR certification required Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system Supervisory experience preferred; willingness, desire, and ability to supervise required Basic computer skills and proficiency in MS Word and Outlook required DaVita is a clinical leader! We have the highest percentage of facilities meeting or exceeding CMS's standards in the government's two key performance programs. We expect our nurses to commit to improving patient health through clinical goal setting and quality improvement initiatives. Ready to make a difference in the lives of patients? Take the first step and apply now. #LI-ML3 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. Salary/ Wage Range $39.00 - $52.00 / hour For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

Department: MED-Physical Med & Rehab Salary/Grade: NEX/13 Target hiring range for this position will be between $50,000-$65,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Job Summary: Coordinates & completes the day to day administrative & technical activities involved in a single complex, large, nationwide or multiple moderately complex concurrent biomedical &/or social-behavioral research study(ies) involving multiple sites& /or longitudinal assessments/ interventions. Ensures that all activities are completed by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Specific Responsibilities: Technical * Participates in the planning & conduct of research studies. * Reviews project & protocol & recommends strategies to expedite study. * Recruits & retains participants. * Obtains informed consent. * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates &/or process responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. * Monitors & maintains systems for effective participant and data flow for studies. * Designs & constructs experimental stimuli. * Performs physical function assessment. Administration * Manages study databases which may include ensuring that data is collected & entered correctly. * Reviews & analyzes data. * Creates computer models, graphs, reports & summaries for use in publications, professional journals, & grant applications. * Writes portions of grant applications. * Co-authors scientific papers for presentation & publication. * Researches & obtains funding. * Creates & maintains study manuals regarding operating, safety, and etc. procedures. * Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner. Finance * May process payments for research participants per study protocol. * Creates lab financial plan & budget/audit expenses. * Obtains sales quotes for lab equipment & supplies. * Reviews & adjusts expenses to decrease costs. * Oversees repair & maintenance of all lab equipment & ensures that lab supplies are ready & available when necessary. * Administers budget including negotiating with grant sponsors. * Maintains & reconciles expenditures & balances in regard to research accounts & budgets. Supervision * Trains, directs, assigns duties to & may supervise research staff, students, residents &/or fellows. * Acts as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 4 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-GY2

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. Clinical Research Scientist - Medical Affairs Allergy, Immunology BU Purpose: The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly's R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly's medications. Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The application of scientific and clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral member of the medical affairs team. The Medical Affairs CRS supports the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s). The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local and global business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The global team CRS is responsible for collaborating with the global development teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Business/ customer support (pre and post launch support) Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers) Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts. Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan. Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, giving clinical input and insight to develop payer partnership programs and defend the product value. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for currently marketed brands. By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. Support training of sales representatives, and other medical representatives. Become familiar with market archetypes and potential influence on the medical interventions for the product. Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert supporting identification of Clinical Care Gaps (CCGs). Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service). Understand and apply knowledge of customer insights to all customer-related activities. Participate in local or national trade associations as appropriate. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff. Prepare or review scientific information in response to customer questions or media requests. Provide follow-up to information requested by health care professionals as per global SOPs. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Support the design of customer research as medical expert. Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Support efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams. Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes). Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design. Clinical Research/Trial Execution and Support Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects. Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel. Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Review lIT proposals and publications, as requested. Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. Regulatory Support Activities Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists. Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective. Participate in advisory committees. Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS). Scientific / Technical Expertise and continued development Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years). Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. Responsible for the scientific training of the clinical study team. Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Explore and take advantage of opportunities for extramural scientific experiences. Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget. Use knowledge of specific disease states and available treatments to provide scientific and medical input, contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality. Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable. Collaborate proactively and productively with all alliance, business, and vendor partners. Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness. Actively participate in recruitment, diversity, and retention and hiring efforts as applicable. Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management. Model the leadership behaviors. Be an ambassador of both patients and the Lilly Brand. Minimum Qualification Requirements: PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience Clinical trial experience in drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Other Information/Additional Preferences: Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills. Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills. Demonstrated 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 Disease advocates and lay organizations focused on relevant health issues Formulary representatives (private and government) Demonstrates the following competencies Making Business Decisions with data - Harnesses the power of data and analytics to solve problems, make good decisions and measure results. Job-Based Skills: Defines the problem or decision to be made within context of strategy or goals/objectives. Identifies relevant sources and validates accuracy of data. Analyzes and synthesizes data and identifies trends. Draws conclusions and makes timely, well-informed decisions. Engages data and analytics colleagues appropriately when needed. Scientific/Information Exchange - Maximizes engagement with key customers and colleagues through the integration of personal and/or non-personal channels when collaborating, discussing, and sharing science/information. Job-Based Skills: Identifies challenges, information gaps, education needs, and delivery preferences. Creates an engaging narrative. Generates content with the channel(s) and medium(s) in mind. Adjusts style and tone to meet the unique needs of each audience. Uses preferred channel(s) to deliver at the time of need. Measures knowledge gained. Technical/Functional Expertise - Leads with technical and functional expertise. Job-Based Skills: Establishes appropriate scientific and medical subject matter expertise (e.g., disease states, therapeutic landscapes, drug development processes, portfolio, etc.). Maintains relevant knowledge of the healthcare landscape (e.g., health, payer, and regulatory systems and processes) and environment (e.g., HCP experience models and patient flow maps, value/accountable care, and population health landscape, etc.). Understands the advancements in technology that are influencing area of expertise and function (i.e., real-world clinical practice, AI techniques, tools and platforms). Develops appropriate knowledge of activities that can be used to influence and deliver on organizational purpose (i.e., shape clinical practice, systems, tools and platforms). Masters individual workstream tools and processes. Strategic Agility - Defines and commits to an initial strategy or approach; monitors effectiveness; and adapts based on new information and/or insights. Job-Based Skills: Develops an actionable strategy or approach-involving colleagues and engaging stakeholders appropriately. Creates a clearly defined measurement plan with key metrics and triggers. Monitors progression and impact against key metrics. Identifies opportunities to improve. Reassesses strategy/approach and pivots when appropriate. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Department: MED-General Internal Salary/Grade: NEX/11 Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Specific Responsibilities: Technical * Participates in the planning & conduct of research study including participant recruitment and retention. * Obtains informed consent * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. Administration * Collects, records, reviews & summarizes research data. * Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. * Writes portions of grant applications & co-author scientific papers. * Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Finance * May process payments for research participants per study protocol. * Works with industry representatives to negotiate tentative grant funding. * Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget. Supervision * May provide work direction &/or train other research staff to interview/test participants. * May act as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Target hiring range for this position will be between $19.89 - 27.97 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-JP1

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

Department: MED-Infectious Disease Salary/Grade: NEX/11 Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Please note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters. Specific Responsibilities: Technical * Participates in the planning & conduct of research study including participant recruitment and retention. * Obtains informed consent * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. Administration * Collects, records, reviews & summarizes research data. * Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. * Writes portions of grant applications & co-author scientific papers. * Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Finance * May process payments for research participants per study protocol. * Works with industry representatives to negotiate tentative grant funding. * Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget. Supervision * May provide work direction &/or train other research staff to interview/test participants. * May act as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Target hiring range for this position will be between $19.89 - 27.97 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-JP1