Clinical research associate jobs in Evanston, IL

Salary Range: $160,000-$190,000 per year The University of Chicago's Department of Pediatrics, Section of Neonatology, is seeking full-time general pediatricians to join our multidisciplinary care team at the University of Chicago Comer Children's Hospital NICU as Clinical Associates with renewable terms of up to three years. Appointees will provide neonatal services at one or more level II nurseries in the University of Chicago Medicine system. These positions do not require teaching or scholarly activity. Compensation is dependent upon qualifications. These positions are benefits-eligible. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. Appointees will collaborate with a dynamic team of neonatologists, neonatal nurse practitioners, pediatric residents, nutritionists, and neonatal pharmacists, providing care under the supervision of the attending neonatologist. Responsibilities include daily patient care activities such as pre-rounding, presenting patients, order writing, addressing clinical problems, and communicating with parents and consultants. Following skills evaluation and, if necessary, additional training and support, appointees will perform standard neonatal procedures, attend high-risk deliveries, and perform neonatal resuscitations. At our level II nurseries, appointees will attend deliveries, perform neonatal resuscitations, stabilize infants for transport, and manage infants whose acuity allows them to remain at their birth hospital. Prior to the start of employment, qualified applicants must: 1) have a MD degree or equivalent, 2) have completed an ACGME-approved pediatric residency, 3) be board certified/eligible in general pediatrics, and 4) have or be eligible for permanent State of Illinois medical licensure. We especially welcome applicants with experience equivalent to one year of post-graduate work in a Level II NICU or one of higher acuity. To be considered, interested individuals must apply through The University of Chicago's Academic Recruitment job board, which uses Interfolio to accept applications: ************************************ Applicants must upload a CV and cover letter. Review of applications will continue until the positions are filled. For instructions on the Interfolio application process, please visit ****************************** Equal Employment Opportunity Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call ************ or emailequalopportunity@uchicago.eduwith their request.

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

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.***

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

CRA II or Senior CRA (Home-based in 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

The Sr CRA will be responsible for monitoring clinical studies at the site level ensuring adherence to protocols, timelines, ICH/GCP guidelines, and federal regulations. The Sr CRA will perform site qualification visits, study start-up activities, protocol implementation, on site monitoring, and close out activities as assigned and in accordance with Xeris SOPs and related study monitoring plans. **Responsibilities** - Serves as a CRA to conduct and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan. - Monitors data, on site and/or remotely (as needed), with a focus on participant safety, data integrity and regulatory compliance. Ensures the validity, correctness, and completeness of clinical data. - Ensures data accuracy, accountability and documentation through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF). - Conducts Investigational Product (IP) review and accountability on site. - Serves as point of escalation for clinical site management and investigator sites. Liaises with the in-house CRA interacting with investigator sites and responsible to support effective communications and resolution of issues. - Maintains routine contact with investigator sites between routine on site monitoring visits. - Identifies, assesses, and resolves issues related to site performance, program risks, data inconsistencies/deviations, quality and compliance. Re-educates investigator sites as required, escalates issues, and ensures implementation of corrective actions. - Ensures all essential documents are complete and in place, filed to the study electronic trial master file (eTMF) and inspection ready. Participates in eTMF QC activities and ensures consistency between ISF and eTMF. - Manages query resolution with investigator sites and data management operations. - Supports centralized risk-based monitoring oversight activities as assigned. - May support the Study Manager to formulate regional monitoring strategy, forecasting of site visits and/or overall clinical monitoring plans. - Provides oversight of CRO activities related to monitoring (when outsourced); may co-monitor with CRO or contracted CRAs. - Supports the maintenance of documentation to clinical systems (Clinical Trial Management Systems [CTMS], electronic data capture [EDC], Interactive Response Technology [IRT], etc.) and related supporting documents (manuals, completion guidelines, etc.) in collaboration with other study team members and/or external vendors as applicable. - May support development and revision of monitoring SOPs, processes, forms, templates, tools, etc. with aim of continual improvement and efficiency. - Supports audits/inspections/inspection readiness activities through collaboration with relevant clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA or external regulatory agencies as applicable. - Performs other tasks or responsibilities as assigned. **Qualifications** - Bachelor's degree (B.A./B.S.) or equivalent in life sciences or related discipline. - 6+ years' experience as a Clinical Research Associate. - Extensive knowledge of trial oversight activities, GCP/ICH and federal regulations, IRB/EC and Investigator responsibilities. - Familiarity with clinical trial systems (i.e. CTMS, EDC, eTMF, etc.). - Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.). - Ability to work independently and as part of a team. -Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications. - Working Conditions: If employee is Chicago based - this is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office as feasible when not traveling. On-site requirements may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 75%. _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-HYBRID _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $80,000 - $140,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US-IL-Chicago_ **Title** _Senior Clinical Research Associate (CRA)_ **ID** _2025-2205_ **Category** _Clinical Development_ **Type** _Full-Time_

**Title:** Clinical Research Associate (CRA) **Duration:** 12 Months **Remote Role (Occasional travel)** **Pay Range :** $25/hr to $29/hr (On W2) We are looking for a " **Clinical Research Associate (CRA)"** to join one of our Fortune 500 clients. **Job Summary:** + Conduct site qualification, initiation, monitoring, and close-out visits + Ensure compliance with protocols, GCP, and regulatory requirements + Perform source document verification and data query resolution + Support start-up tasks such as protocol development and site contracts + Maintain study documentation and monitor investigational product inventory + Prepare monitoring visit reports and follow-up letters **Qualifications:** + Bachelor's degree in Life Sciences or related field (Medical Technology preferred) + 2-4 years of clinical research experience, including site monitoring + Strong understanding of FDA regulations and GCP + Experience with medical devices or in vitro diagnostics (IVDs) preferred + Excellent communication, organizational, and time management skills + Proficient in Microsoft Office Suite **We are looking for the candidate who are eligible to work with any employers without sponsorship** . If you're interested, please click **"Apply"** button ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as pplicable Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to other project work and initiatives for process improvement, as required. Compensation and Benefits The salary range estimated for this position based in Illinois is $82,800.00-$135,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Responsibilities** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). + Support adoption of new technology or clinical applications through advocacy and evidence. + Participate in customer presentations regarding use of Interventional products for institution research purposes. + Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. + Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. + Grow technology leadership mindshare through joint scientific presentations and publications. + Install/upgrade research equipment and software & prototypes + Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures + Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. + Study new technology concepts and leverage expertise to move initiatives forward. Note: + No sponsorship available for this role now or in the future to work in the United States.. **Qualifications** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. + 3+ years of experience in Interventional healthcare industry or research. + Knowledge of Interventional procedures, anatomies, clinical practice. + Excellent written and verbal communication skills. + Excellent customer relationship management and collaboration skills. + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( + Quality, Compliance, and Continuous Improvement focus **Desired Characteristics** + 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. \#LI-BR3 \#LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. **Additional Information** GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** No

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Sr. Clinical Research Associate NY/NJ 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 (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. What You Will Be Doing: Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution. Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting. Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct. Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations. Your Profile: Advanced degree in a relevant field such as life sciences, nursing, or medicine. Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools. Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment. Must be located in the Midwest (areas like Chicago or Detroit/Ann Arbor, MI are ideal) Oncology monitoring experience required Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license 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

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Simpson Querrey Biomedical Research Center Job Description The Biorepository Research Coordinator is responsible for coordinating and supporting all operational activities within the biorepository. This includes the collection, processing, storage, and shipment of biological specimens in accordance with approved study protocols, institutional policies, and CAP-accreditation requirements. The Biorepository Research Coordinator ensures the integrity, traceability, and quality of all biospecimens and associated data while maintaining accurate documentation within the laboratory inventory database. This position serves as a key liaison between the biorepository, clinical teams, investigators, and research laboratories to facilitate efficient and compliant specimen workflows. The Biorepository Research Coordinator participates in reviewing and updating the biorepository inventory to ensure data accuracy, resolve discrepancies, and maintain compliance with documentation standards. Additional responsibilities include coordinating routine maintenance and repairs of laboratory equipment, ensuring the availability of required supplies and reagents, and supporting continuous process improvement initiatives. The Biorepository Research Coordinator is expected to communicate effectively, demonstrate strong organizational and technical skills, and foster collaborative working relationships across departments to advance the mission of the biorepository and research enterprise. Essential Job Functions: Coordinates biorepository workflows to ensure efficient and compliant specimen management across all stages of the biospecimen lifecycle. Collects, processes, stores, and ships biological specimens in accordance with approved study protocols, institutional policies, and CAP-accreditation requirements. Reviews and updates biorepository inventory records to ensure data accuracy, resolve discrepancies, and maintain compliance with documentation and audit standards. Maintains complete and accurate records of all specimen-related activities, including collection, processing, and storage details. Oversees the repair, calibration, and preventative maintenance of laboratory equipment to ensure operational readiness and compliance with quality standards. Monitors laboratory supply levels, initiates purchase requests, and ensures that required materials and reagents are available to support ongoing operations. Communicates effectively with clinical teams, investigators, and cross-functional collaborators to facilitate workflow coordination and problem resolution. Participates in process improvement initiatives, quality audits, and training activities to enhance operational efficiency and ensure adherence to best practices. Follows established safety protocols and maintains compliance with institutional and regulatory guidelines. Other job functions as assigned. Knowledge, Skills and Abilities: Required: Bachelor's degree in a scientific discipline (e.g., Biology, Molecular Biology, Biochemistry, or related field) Minimum of 2 years of relevant experience in a laboratory, biorepository, or research operations setting Demonstrated ability to handle and process biological specimens with precision and attention to detail. Excellent written and verbal communication skills Strong organizational and time management skills, with the ability to manage multiple tasks and priorities Proficiency in standard office and data management software, including Microsoft Excel and database entry Commitment to maintaining quality and regulatory compliance in all aspects of biorepository operations Preferred: Master's degree in a scientific or related discipline Experience working in a regulated or accredited laboratory environment Experience writing, revising, or implementing Standard Operating Procedures (SOPs) or other controlled documents Education Bachelor's Degree (Required) Pay Range $59,280.00-$96,928.00 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: Supplemental Life, AD&D and Disability Critical Illness, Accident and Hospital Indemnity coverage Tuition assistance Student loan servicing and support Adoption benefits Backup Childcare and Eldercare Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members Discount on services at Lurie Children's facilities Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

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.

Details Job Title CLINICAL RESEARCH COORDINATOR II Position Number 8150021 Job Category University Staff Job Type Full-Time FLSA Status Non-Exempt Campus Maywood-Health Sciences Campus Department Name HEMATOLOGY ONCOLOGY Location Code HEMATOLOGY - ONCOLOGY (06508A) Is this split and/or fully grant funded? Yes Duties and Responsibilities The Clinical Research Coordinator II is responsible for the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. These studies will be conducted at the Loyola University Medical Center and satellites. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research in coordination with Clinical Research Nurse. Responsibilities include assisting in the preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations; advise the IRB of amendment changes to the protocol and complete annual protocol renewals. Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines. Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations. He/she participates in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. The successful candidate will interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including collection of blood samples, processing and shipment. Maintain drug accountability, adequate study supplies and equipment. The coordinator will oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject's medical record. Report all serious adverse events promptly to investigators, sponsors and the IRB. Protect the rights, safety and well-being of human subjects involved in the clinical trials. Responsibilities of the CRC II include all the duties and responsibilities if CRC I, as well as the following: Coordination responsibilities * Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines. * Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. * In collaboration with the PI & RN, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria. * Coordinate collection of study specimens and processing. * Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. * Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. * Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. * Ensure adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. * Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. * Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. * Participate in monitor visits and regulatory audits. Regulatory responsibilities: * Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations. Minimum Education and/or Work Experience Bachelors Degree OR equivalent training acquired via work experience or education and 2-5 years of previous job-related experience Qualifications * Ability to follow oral and written instructions and established procedures * May require use of centrifuge, make slides for labs, ECG's to be performed and transmitted. * Medication administration Certificates/Credentials/Licenses SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire. Computer Skills Should have basic knowledge in Excel, WORD, EPIC (EMR for the hospital),and Internet based data submission. Supervisory Responsibilities No Required operation of university owned vehicles No Does this position require direct animal or patient contact? No Physical Demands Repetitive Motions Working Conditions None Open Date 05/07/2025 Close Date Position Maximum Salary or Hourly Rate 26.00/hour Position Minimum Salary or Hourly Rate 28.00/hour Special Instructions to Applicants As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago's mission, candidates should consult our website at ********************* For information about the university's focus on transformative education, they should consult our website at ***************************** About Loyola University Chicago Founded in 1870, Loyola University Chicago is one of the nation's largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With 15 schools, colleges, and institutes-including Business, Law, Medicine, Nursing, and Health Sciences-Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation's top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country's most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world. Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. To view our benefits in detail, click here. Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University's Nondiscrimination Policy.

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.

Business Unit: Rush Medical Center Hospital: Rush University Medical Center Department: Preventive Medicine-Res Adm Work Type: Full Time (Total FTE between 0.9 and 1.0) Shift: Shift 1 Work Schedule: 8 Hr (8:30:00 AM - 5:00:00 PM) Rush offers exceptional rewards and benefits learn more at our Rush benefits page (***************************************************** Pay Range: $21.61 - $30.53 per hour Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush's anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case. Temporary - This position may be limited to 1-2 years Summary: The EPI Research Coordinator 1 coordinates Epidemiological, Behavioral or Human Translational, or Population Health research studies and performs a variety of duties including the collection compilation and documentation of research data. The Coordinator 1 partners with other members of the research team to ensure the research is conducted in accordance with the study protocol, local, state, and federal guidelines related to epidemiologic/ behavioral/ translational research. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures. Required Job Qualifications: * Bachelor's Degree in related field. * Two years general research experience with two years working on Human Subjects research. * Demonstrate knowledge of Good Epidemiological Practice (GEP) and/or Good Clinical Practice (GCP). * Strong organizational skills. * Demonstrates basic computer skills. * Strong written and verbal communication skills. * Ability to collaborate within multi-disciplinary team settings. * May require personal transportation to field location depending on assignment. * Ability to work independently. * Ability to develop and maintain effective relationships with a variety of stakeholders. * Availability to work evenings, overnight and weekends if called for under the study protocols. Responsibilities: * Coordinates aspects of less complex research studies including, but not limited to, study start-up, initiation activities, participant recruitment, enrollment, completion of data collection, maintenance of data integrity, and study close-out. * Assists with the development of study related Standard Operating Procedures for new study protocols. * May assist in the collection of study data both through interviews and collecting samples or testing results as described by the study protocol. * May assist with preliminary data organization and/or guided analysis. * Primary participant contact for all study related questions and issues. * May help coordinate study team workload and training schedules to ensure optimal use of resources. * Follows Federal and Rush guidelines in the collection of study data and other study related activities. * Troubleshoots field issues when necessary. Uses discretion to resolve issues when unplanned events arise. * May assist with Institutional Review Board (IRB) assignments such as initial study approval, amendments, continuing reviews and updating study documents for IRB approval. * May assist PI with aspects of grant proposals. * May act as lead for less experienced Research Assistants, work-study students, interns and volunteers including orientation, training, and providing performance feedback. Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact * Study Preparation: * Ability to understand and follow institutional SOPs * Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. * Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct * Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff * Assist with planning and creation of appropriate recruitment and marketing materials * Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. * Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies * Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives * Assist in the creation or review of protocol specific source documents * Determine facility, equipment and outsource vendor requirements and availability * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance * Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks * Study Management: * Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. * Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies * Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records * Collect and evaluate concomitant medications * Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. * Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings * Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials * Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion * Maintain effective relationships with study participants and other Care Access Research personnel * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management * Strong and clear communication skills, both verbally and in writing * Accept accountability for actions and function independently * Patient Coordination: * Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment * Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial * Administer delegated study questionnaires, where appropriate. * Collect and evaluate medical records with the support of medically qualified members of the study team. * Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion * Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) * Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol * Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround * Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. * Monitor patient progress on study medication * Documentation: * Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP * Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. * Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart * Accurately transcribe data to CRF or EDC. * Resolve data management queries and correct source data as needed * Record protocol exemptions and deviations as appropriate with sponsor. * Complete Note(s)-to-File for patient chart and regulatory filing if necessary * Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing * Maintain copies of patient-specific correspondence in source charts * Assist regulatory personnel with completion of continuing/final review reports * Perform other duties as assigned. The Expertise Required * Excellent working knowledge of clinical trials, medicine and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ * Ability to communicate and work effectively with a diverse team of professionals * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel. * Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision Certifications/Licenses, Education, and Experience: * BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred * RN or LPN preferred * Research Professional Certification- CRCC or exam eligibility preferred * A minimum of 3 to 4 years Clinical Research experience * A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together * Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study. The expected salary range for this role is $70,000-$100,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Benefits & Perks (US Full Time Employees Only) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

The Clinical Research Coordinator I will perform multiple and varied tasks critical to the management of clinical research studies. The Clinical Research Coordinator I is expected to exhibit basic knowledge of clinical research activities and adhere to federal and other applicable regulations. The Clinical Research Coordinator I must ensure compliance with protocol guidelines, identify problems and/or inconsistencies and monitor subject process throughout the clinical research study. To consistently embody AMR's Core Values: Excellence and Consistency Collaborative Innovation Respect for our Subjects, Sponsors and Team Members Community Unimpeachable Ethics The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Coordinate clinical trials per FDA requirements and GCP guidelines per sponsor protocols. Basic understanding of SOPs and ensure they are adhered to in the conduct of the clinical research study. Basic understanding of medications per clinical trial. Acquire detailed knowledge of the protocol and procedures associated with each clinical research study. Effectively communicate with clinical research sponsors, CROs, monitors/CRAs, IRBS, laboratories and clinical personnel within the research industry. Advise Investigator, Sub-Investigator and staff on protocols, procedures required for the successful implementation and completion of each clinical research study. Notify Investigator, monitor/CRA of any adverse events or serious adverse events per the protocol. Maintain familiarity with each clinical research study's requirements and apply all applicable regulations accurately. Complete all required documentation in a legible and timely fashion. Ensure all necessary documents are appropriately signed and dated. Travel to Investigator Meeting as needed. Possess a willingness to assume responsibility for tasks outside of your current role and to work flexible hours as needed. Other duties as assigned Desired Skills and Qualifications: Successful completion of a formal medical/clinical educational program or in the alternative has a strong knowledge of medical terminology and the ability to learn quickly. Clinical experience involving patient care in a healthcare environment preferred but not required. Ability to interpret and perform clinical, laboratory and diagnostic tests (such as vital signs, height, weight, temperature, etc.) preferred. Ability to function independently with minimal supervision, and to exercise discretion and a high level of good clinical and other professional judgement. Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing conditions and deadlines). Exceptional written and verbal communication skills. Ability to work independently, lead clinical research studies and complete tasks. Calm, friendly, approachable, and presents a professional image. Excellent listening, written, and verbal communication skills. Committed, highly energetic, self- motivated and highly organized. Demonstrated proficiency in office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers. Proficient in Microsoft Office products including Outlook, Word, and Excel. Professional and highly motivated “self-starter” with the ability to exercise initiative. Excellent task management and prioritization skills. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.