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  • Senior Clinical Research Associate (FSP) - Central Region - Oncology

    Thermo Fisher Scientific 4.6company rating

    Clinical research associate job in Chicago, IL

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Essential Functions and Other Job Information: Essential Functions Monitors investigator sites with a risk-based monitoring approach: applies root Functions 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 applicable. 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. Qualifications: Education and Experience: Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as traveling clinical research associate). Valid driver's license where applicable. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Effective clinical monitoring skills Demonstrated understanding of medical/therapeutic area knowledge and medical terminology Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manages Risk Based Monitoring concepts and processes Effective oral and written communication skills, with the ability to communicate effectively with medical personnel Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues Effective interpersonal skills Strong attention to detail Effective organizational and time management skills Ability to remain flexible and adaptable in a wide range of scenarios Ability to work in a team or independently as required Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Good presentation skills Compensation and Benefits The salary range estimated for this position based in Illinois is $79,200.00-$136,000.00.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:
    $79.2k-136k yearly 1d ago
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  • Clinical Research Associate

    Northwestern University 4.6company rating

    Clinical research associate job in Chicago, IL

    Department: MED-Impact Institute Salary/Grade: RES/ Hiring: HIV Implementation Science Coordination Initiative Project Director (Clinical Research Associate), Institute for Sexual and Gender Minority Health and Wellbeing Program Description: Implementation science (IS) is a relatively new field with exciting opportunities for growth and innovation focused on methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine healthcare and public health settings. The HIV Implementation Science Coordination Initiative (ISCI) is the national coordinating and technical support center for Centers for AIDS Research/AIDS Research Centers research-practice partnerships funded as part of the Ending the HIV Epidemic plan. ISCI provides high-quality IS coordination, consultation and data management for NIH-funded Ending the HIV Epidemic (EHE) implementation research teams and creates opportunities to share generalizable knowledge to help end the HIV epidemic in the United States. ICI identifies and disseminates best practices in HIV implementation research, while providing training, and resources to support academic researchers and practice-based partners. Position Description: The Project Director will lead project and personnel management for ISCI, overseeing complex multi-investigator projects across multiple institutions and supervising several research staff. This role involves developing and managing project plans with defined timelines, deliverables, and resources, while identifying opportunities for growth, assessing potential impacts, and collaborating with cross-functional teams to implement innovative solutions. The ideal candidate is an experienced leader with expertise in project management of complex, multi-investigator projects across multiple institutions, experience supervising multiple staff, strong written and oral communication skills, effective time management capabilities, and ability to work independently. The average target hiring range for this position will be between $80,000 - $95,000 per year. Final 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. Duties and Responsibilities: Project and Personnel Management * Develops and implements comprehensive project plans, including timelines and deliverables. * Assists in the development and execution of new initiatives, leads strategic planning efforts to ensure alignment with project goals and objectives. * Identifies opportunities for project growth, assesses potential impacts, and collaborates with cross-functional teams to implement innovative solutions. * Leads and coordinates multiple teams, ensuring effective communication and collaboration across the project. * Trains, directs, assigns duties to, and supervises research staff and/or fellows. * Allocates and manages project resources, including personnel, budget, and materials, to ensure optimal project performance. * Acts as the primary contact for stakeholders (sponsoring agencies and collaborators), providing regular updates on project progress and addressing any issues or concerns. * Maintains project documentation, including project plans, progress reports, and final reports. * Ensures that all project activities adhere to quality standards and regulatory requirements. * Evaluates project outcomes and processes to identify areas for improvement and implement best practices. Administration * Analyzes, evaluates and interprets data to determine relevance to research. * Prepares results and may lead and co-author scientific papers for presentation and publication and disseminate information via seminars, lectures, etc. * Creates data for use in grant submission and develops new proposals for research including obtaining financial support. * Ensures that all study documents associated with current local, state, and federal regulatory guidelines, requirements, laws and research protocols are completed in a timely manner. Finance * May create and/or manage research study budget which may include deciding on and approving expenditures of funds based on budget. * Monitors accounts. * Ensures appropriate allocation and compliance. Miscellaneous * Performs other duties as assigned. Position Details: This is a full-time position based on the Chicago campus of Northwestern University. Minimum Qualifications (Education, experience, and any other certifications or clearances) * Master's or doctoral degree in social/behavioral science (e.g., psychology, sociology, anthropology), public health, humanities, or related field * At least 5 years of experience with managing complex projects that involve multiple principal investigators, sites, institutions, and/or public health practice settings. * Experience in project management and supervising multiple staff is required. * Experience using project management software. * Experience using Microsoft Office 365 and basic computer programs (e.g., Teams, Sharepoint, OneNote, Word, Excel, PowerPoint, Adobe, Google, etc.) * 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) * Strong project coordination skills and the ability to prioritize tasks. * Demonstrated attention to detail and ability to adhere to instructions/procedures. * Good communication skills; demonstrated effective spoken and written communication. * Good time management skills; efficient and resourceful in problem-solving. * Demonstrated ability to take ownership of the work, possessing initiative, good follow-through; ability to work without supervision. Preferred Competencies (Skills, knowledge, and abilities) * Familiarity with implementation science concepts (e.g., models and frameworks, determinants, outcomes, strategies, study designs). * Familiarity with HIV prevention and care research To apply: Applicants should email application materials to ********************* with the subject line "ISCI Project Director." Applications should include a CV and cover letter explaining fit with this position; relevant work or educational experiences, including experiences with research topic areas, and the names of two references who will be contacted only for finalists. Consideration of applications will begin immediately and continue until the position is filled. 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.
    $80k-95k yearly Easy Apply 60d+ ago
  • Clinical Research Associate

    ZP Group 4.0company rating

    Clinical research associate job in Chicago, IL

    Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Chicago, Illinois (IL). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Clinical Research Associate: * 2-4 years performing on-site monitoring and hands on experience with EDC Systems * Experience with Oncology is highly advantageous * Organization to perform monitoring duties across multiple sites is a must Compensation for the Clinical Research Associate: * Salary Range: $100,000-$120,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1
    $100k-120k yearly 41d ago
  • Clinical Research Associate

    Ire

    Clinical research associate job in Downers Grove, IL

    CRA II OR Senior CRA (home-based in the U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. Collaborating with investigators and site staff to facilitate smooth study conduct. Performing data review and resolution of queries to maintain high-quality clinical data. Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile Bachelor's degree in a scientific or healthcare-related field. Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills, with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license #LI-MM2 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
    $42k-68k yearly est. Auto-Apply 42d ago
  • Clinical Research Associate (Spanish Speaking)

    Propharmagroup

    Clinical research associate job in Chicago, IL

    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. 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. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
    $42k-68k yearly est. Auto-Apply 11d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research associate job in Chicago, IL

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K
    $42k-68k yearly est. 60d+ ago
  • Clinical Research Operations Manager

    Ann & Robert H. Lurie Children's Hospital of Chicago 4.3company rating

    Clinical research associate job in Chicago, IL

    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 Ann & Robert H. Lurie Children's Hospital of Chicago Job Description Summary Based on specific research program needs, patient facing vs. data administrative responsibilities will vary. Coordinates all clinical research activities with moderate supervision. Coordinates & completes activities associated with the creation and implementation of participant recruitment strategies designed to enhance enrollment in a single complex, large, nationwide or multiple moderately complex concurrent biomedical &/or social-behavioral research studies involving multiple sites &/or longitudinal assessments/ interventions. Job Duties: Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies. Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor. Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed. Identifies and recruits eligible study subjects; conducts informed consent/assent process. Arranges and conducts clinical research visits. Conducts site qualifications, study initiation, monitoring and/or close-out visits. Attends investigator meetings. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis. Creates and/or updates case report forms and/or source document templates and/or data dashboards. Coordinates reimbursement of subjects. Maintains inventory of supplies/equipment. Prepares lab kits and requisitions prior to visits. Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly. Records data on source documents and CRF's and/or electronic web based systems. Conducts literature searches and assists with QA/QC procedures. Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.). Maintains all study documents (regulatory binders, source documents, correspondence, etc.). Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning, presenting, etc.). Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients. QA/QC checks for database validity and data monitoring. Tracking deadlines for grants/deliverables. Recruitment Focused Tasks: Coordinates and guides the creation and implementation of a recruitment & retention plan associated with clinical research, Investigator Initiated, Sponsored, & Outcomes studies involving human subjects ensuring the protection of their safety, rights, and welfare. Determines, interprets and applies rules and regulations (LCH, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study recruitment and enrollment activities ensuring appropriate compliance. Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (LCH's IRB, sponsors (NIH, industry), government agencies (FDA), etc.), advertisers, etc. to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite study recruitment and enrollment while ensuring compliance. Creates research study recruitment materials and execute implementation of marketing materials across multiple platforms (e.g., print, digital, radio, television). Designs recruitment screening tools and best practices to support clinical and outcomes research in collaboration with CRP's, DAR, IM, and the IRB. Facilitate script development and feedback sessions with hospital Advisory Boards and community stakeholders. Develop and facilitate research protocols related to measuring the use and effectiveness of educational videos and other recruitment materials in the research community. Investigator initiated, sponsored, and externally sponsored both type and sponsor (Focus on diversity & minorities) - evaluate barriers to increase recruitment of children, teenagers, and young adults who are underrepresented in bio-medical research Assist teams in creation of recruitment plans and materials prior to IRB submissions until study is completed. Move regulatory functions to bottom (not enforcement role) Other job functions as assigned. K.S.A.'s: High School Diploma with three to five years of clinical research experience -or Associates /two years of College with two to four years research experience -or- Bachelors with one to three years research experience. Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred. Good clinical practices documentation required. Familiarity and experience with FDA and IRB regulatory requirements preferred. Clinical Research Experience preferred. Education High School Diploma/GED (Required) Pay Range $83,200.00-$137,280.00 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: ***********************************
    $83.2k-137.3k yearly Auto-Apply 15d ago
  • Senior Clinical Research Associate (Midwest - Illinois/Michigan)

    Icon Central Laboratories

    Clinical research associate job in Chicago, IL

    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
    $62k-100k yearly est. Auto-Apply 8d ago
  • Senior Clinical Research Associate

    Onpoint Clinical Staffing Services 4.2company rating

    Clinical research associate job in Chicago, IL

    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.
    $64k-101k yearly est. 4d ago
  • Study Coordinator

    Hematogenix Laboratory Sv

    Clinical research associate job in Tinley Park, IL

    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.
    $38k-54k yearly est. Easy Apply 19d ago
  • Clinical Research Coordinator II

    Loyola University of Chicago Inc. 4.2company rating

    Clinical research associate job in Chicago, IL

    Details Job Title CLINICAL RESEARCH COORDINATOR II Position Number 8150021 Work Modality 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.
    $51k-66k yearly est. 60d+ ago
  • Clinical Research Coordinator

    Revival Research Institute

    Clinical research associate job in Elgin, IL

    Unique opportunity to make an Impact in the healthcare industry Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking a full-time Clinical Research Coordinator with a minimum of 1 year of clinical experience, for our Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Phlebotomy skills preferred. Psychology experienced with knowledge regarding the psychiatric rating scale is preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
    $45k-66k yearly est. 60d+ ago
  • Clinical Research Coordinator III - Neurology

    Rush University Medical Center

    Clinical research associate job in Chicago, IL

    Business Unit: Rush Medical Center Hospital: Rush University Medical Center Department: Neurological Sciences-Res Adm **Work Type:** Full Time (Total FTE between 0.9 and 1.0) **Shift:** Shift 1 **Work Schedule:** 8 Hr (8:00:00 AM - 4:00:00 PM) Rush offers exceptional rewards and benefits learn more at our Rush benefits page (***************************************************** **Pay Range:** $29.36 - $42.61 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. This role is for Neurology clinical research **Job Summary:** The Clinical Research Coordinator III (CRC III) independently manages the full scope of clinical research study execution for complex, multi-site, or longitudinal protocols. This role is responsible for ensuring compliance with regulatory and institutional requirements, coordinating communication with investigators and sponsors, and resolving operational challenges. The CRC III is distinguished by their ability to work with limited oversight, provide peer mentorship, and serve as a departmental resource. The CRC III guides others in best practices, supports quality improvement efforts, and contributes to a culture of research excellence. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures. **Required Job Qualifications:** **Education:** - Bachelor's degree **Experience:** - 3+ years of experience in coordinating clinical trials - Independent site management experience OR Experience (in lieu of a degree) - 4 years total experience in coordinating clinical trials with increasing complexity Knowledge, Skills, & Abilities: - Regulatory Knowledge - Understands and applies GCP and research documentation rules; able to guide others on best practices for complex or multi-site studies. - Regulatory Compliance - Knows and applies NIH, FDA, and IRB rules for high-complexity studies; helps interpret policies when needed. - Project & Time Management - Manages multiple studies with little oversight; sets priorities and keeps study tasks on track. - Problem-Solving & Critical Thinking - Solves complex problems using good judgment and a deep understanding of study protocols and regulations. - Detail & Organization - Keeps regulatory documents, source notes, and data well-organized and accurate; helps prepare for audits. - Participant & Vendor Interaction - Communicates effectively and respectfully with participants, sponsors, and vendors; protects privacy and follows study rules. - Communication Skills - Shares study information clearly with sponsors, team members, and junior staff in both writing and speech. - Teamwork & Leadership - Works independently but also supports CRC I and II staff by offering guidance and collaboration. - Flexibility - Willing to adjust schedule when needed for study visits, deadlines, or sponsor meetings. - Travel Readiness - Can travel nearby for site support, meetings, or training if the study requires it. - Other duties as assigned. **Preferred Job Qualifications:** **Experience:** - 3-5 years' experience in clinical research conduct and regulatory management, or hold a valid research administration certification - Managing NIH, pharmaceutical or device clinical trials - Relevant certification strongly preferred: Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) **Job Responsibilities:** 1. Coordinates all aspects of the study including recruitment, consent, screening, scheduling, and tracking, and ensures study updates are provided throughout the conduct of the study. 2. Ensures data is entered into the study's electronic data capture system and that queries are responded to and resolved in a timely manner. 3. Manages the preparation and submission of study-related documents, protocols, and amendments to the IRB per policy and procedure. 4. Maintains accurate and complete procedural documentation in compliance with institutional, local, state, and federal guidelines and regulations related to clinical research. 5. Oversees and audits source documentation and data entries across studies to ensure full alignment with protocol and 100% source documentation verification; provides coaching and correction to staff as needed to maintain audit readiness. 6. Oversee the collection, processing, and shipment of potentially biohazardous specimens, if applicable. 7. Oversee administration of structured tests and questionnaires according to research study protocols, including utilizing study-related technology and equipment as part of assessment procedures, if applicable. 8. Reviews and finalizes summary report(s) for distribution to PI, Administrator, department stakeholders, Sponsor, and Compliance, and ensures accurate study updates throughout the conduct of the study. 9. Prepares for internal and external audits or monitoring visits and responds to monitoring queries to ensure compliance with applicable guidelines. 10. Ensures unanticipated problems (e.g., protocol deviations, adverse events, and serious adverse events) are documented and reported in a timely manner. 11. Provides recommendations to proactively address complex issues and/or protocol variances related to study activities. 12. Delivers peer training, mentorship, and coaching to less experienced staff and supports onboarding of CRC I and II staff; models regulatory and procedural best practices in daily study operations. 13. May summarize and share relevant research updates during internal or external presentations; maintains current knowledge of clinical research trends, policies, and best practices. 14. Other duties as assigned. 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. **Position** Clinical Research Coordinator III - Neurology **Location** US:IL:Chicago **Req ID** 23807
    $29.4-42.6 hourly 17d ago
  • Clinical Research Coordinator

    Alliance for Multispecialty Research

    Clinical research associate job in Oak Brook, IL

    The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
    $45k-66k yearly est. Auto-Apply 42d ago
  • Clinical Research Assistant Part-time

    Ortho Molecular Products 4.0company rating

    Clinical research associate job in Barrington, IL

    Shape the Future of Functional Medicine with AI Join our team at Ortho Molecular Products in advancing clinical accuracy and innovation! In this role you'll support the review and fact-checking of clinical content for HANS HQ and other Ortho Molecular physician resources. HANS HQ is a purpose-built AI agent designed exclusively for functional medicine-trained on clinically vetted research to serve as a clinical thinking partner and workflow command center. Unlike general AI tools, HANS HQ understands root cause analysis, systems biology, and functional medicine frameworks, generating patient education, clinical protocols, lab interpretation, and personalized communications while preserving full clinical autonomy. This position is part-time (20 hours per week) hybrid work model based in Barrington, IL What to Expect: Conduct systematic literature reviews and evidence synthesis on assigned functional medicine topics (e.g., gastrointestinal health, microbiome science, metabolic dysfunction, detoxification pathways, hormonal health, etc.) to support Director of Clinical Intelligence clinical content development Research and compile peer-reviewed scientific evidence, clinical guidelines, and practice parameters relevant to functional and integrative medicine as requested Assist in organizing and summarizing research findings, clinical outcomes, and case evidence to support clinical content accuracy and credibility Support the review and fact-checking of clinical content for HANS HQ and other Ortho Molecular physician resources, ensuring medical accuracy and appropriate evidence hierarchy Assist Director of Clinical Intelligence with the evaluation of clinical literature and research data, providing summaries and insights for clinical content creation Collaborate with Director of Clinical Intelligence and clinical team members to identify knowledge gaps, track emerging research, and organize resources for content development Support the research organization, database management, citation management, and documentation of sources and evidence trails for clinical projects Assist with preparation and organization of research findings in formats suitable for clinical presentations and physician training resources What You Will Contribute: Must be at least 18 years old The ideal candidate is a 3rd or 4th year medical student Strong interest in pursuing a career in the functional medicine industry Proficient in using and working with AI tools and technologies Excellent writing and communication skills Experience reviewing and analyzing clinical reviews and research What You Will Receive: $25.00/Hourly On-Site Wellness Meals: Company-paid meals to support your health. Gym Membership Reimbursement: Encouraging your fitness and well-being. Employee Assistance Program (EAP): Access to confidential support services. Voluntary Benefits: Options including short-term disability, life insurance (whole/term), hospital indemnity, critical illness, and accident expense coverage. Growth and Development Opportunities: Access to company university and tuition reimbursement programs. On-Staff Health Coach: Personalized coaching available one-on-one or in groups. Health and Wellness Initiatives: Participate in walking challenges, weight loss programs, health risk assessments, and more! Why Work at Ortho Molecular Products: Our healthcare system faces significant challenges, with issues like complexity and inefficiency. At Ortho Molecular Products, our vision is to help transform the practice of medicine. We work tirelessly to assist healthcare providers in adopting improved solutions for health issues, integrating lifestyle medicine and evidence-based nutritional therapies that enhance patient outcomes. Our commitment involves crafting scientifically grounded products and pioneering innovative clinical initiatives tailored to support doctors in supporting their patients' recovery and well-being. We are looking for people who align with our mission and want to invest their lifework and passion into transforming the practice of medicine. Our team is purpose-driven, values-based, and service-focused. We are looking for likeminded people who want to join the movement that is changing the way healthcare is being delivered. Ortho Molecular Products is an Equal Opportunity Employer. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. We invite you to explore the Ortho website to learn about our career opportunities and apply (******************************** Join us in our mission to revolutionize healthcare and empower clinicians to make a difference!
    $25 hourly Auto-Apply 21d ago
  • Clinical Research Assistant Part-time

    Job Listingsortho Molecular Products, Inc.

    Clinical research associate job in Barrington, IL

    Shape the Future of Functional Medicine with AI Join our team at Ortho Molecular Products in advancing clinical accuracy and innovation! In this role you'll support the review and fact-checking of clinical content for HANS HQ and other Ortho Molecular physician resources. HANS HQ is a purpose-built AI agent designed exclusively for functional medicine-trained on clinically vetted research to serve as a clinical thinking partner and workflow command center. Unlike general AI tools, HANS HQ understands root cause analysis, systems biology, and functional medicine frameworks, generating patient education, clinical protocols, lab interpretation, and personalized communications while preserving full clinical autonomy. This position is part-time (20 hours per week) hybrid work model based in Barrington, IL What to Expect: Conduct systematic literature reviews and evidence synthesis on assigned functional medicine topics (e.g., gastrointestinal health, microbiome science, metabolic dysfunction, detoxification pathways, hormonal health, etc.) to support Director of Clinical Intelligence clinical content development Research and compile peer-reviewed scientific evidence, clinical guidelines, and practice parameters relevant to functional and integrative medicine as requested Assist in organizing and summarizing research findings, clinical outcomes, and case evidence to support clinical content accuracy and credibility Support the review and fact-checking of clinical content for HANS HQ and other Ortho Molecular physician resources, ensuring medical accuracy and appropriate evidence hierarchy Assist Director of Clinical Intelligence with the evaluation of clinical literature and research data, providing summaries and insights for clinical content creation Collaborate with Director of Clinical Intelligence and clinical team members to identify knowledge gaps, track emerging research, and organize resources for content development Support the research organization, database management, citation management, and documentation of sources and evidence trails for clinical projects Assist with preparation and organization of research findings in formats suitable for clinical presentations and physician training resources What You Will Contribute: Must be at least 18 years old The ideal candidate is a 3rd or 4th year medical student Strong interest in pursuing a career in the functional medicine industry Proficient in using and working with AI tools and technologies Excellent writing and communication skills Experience reviewing and analyzing clinical reviews and research What You Will Receive: $25.00/Hourly On-Site Wellness Meals: Company-paid meals to support your health. Gym Membership Reimbursement: Encouraging your fitness and well-being. Employee Assistance Program (EAP): Access to confidential support services. Voluntary Benefits: Options including short-term disability, life insurance (whole/term), hospital indemnity, critical illness, and accident expense coverage. Growth and Development Opportunities: Access to company university and tuition reimbursement programs. On-Staff Health Coach: Personalized coaching available one-on-one or in groups. Health and Wellness Initiatives: Participate in walking challenges, weight loss programs, health risk assessments, and more! Why Work at Ortho Molecular Products: Our healthcare system faces significant challenges, with issues like complexity and inefficiency. At Ortho Molecular Products, our vision is to help transform the practice of medicine. We work tirelessly to assist healthcare providers in adopting improved solutions for health issues, integrating lifestyle medicine and evidence-based nutritional therapies that enhance patient outcomes. Our commitment involves crafting scientifically grounded products and pioneering innovative clinical initiatives tailored to support doctors in supporting their patients' recovery and well-being. We are looking for people who align with our mission and want to invest their lifework and passion into transforming the practice of medicine. Our team is purpose-driven, values-based, and service-focused. We are looking for likeminded people who want to join the movement that is changing the way healthcare is being delivered. Ortho Molecular Products is an Equal Opportunity Employer. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. We invite you to explore the Ortho website to learn about our career opportunities and apply (******************************** Join us in our mission to revolutionize healthcare and empower clinicians to make a difference! We can recommend jobs specifically for you! Click here to get started.
    $25 hourly Auto-Apply 18d ago
  • Clinical Research Coordinator

    Insight Hospital & Medical Center

    Clinical research associate job in Chicago, IL

    WE ARE INSIGHT: Envisioning and implementing a holistic approach to neurological treatment is our goal, and our unique research and powerful solutions illuminate the path toward greater innovations for the future of healthcare. Patients and families seeking effective surgical procedures, rehabilitation, and neurological treatment can trust in our highly skilled and renowned surgical team. As we provide comprehensive services at our state-of-the-art inpatient and outpatient facilities, we remain driven by our basic oath to help patients heal while providing a genuine, human touch. The Clinical Research Coordinator (CRC) will work collaboratively with a multi-institutional team. The CRC will support principal investigators, work as a link between sponsor and institute, oversee details of clinical studies and ensure compliance with study review board and clinical research regulations. The CRC can be part of multiple research projects and should have the ability to multi-tasks. Duties * Provide technical support and assist Principal Investigators in study design and operations. * Direct, and coordinate clinical trials projects. * Solicits industry trials for potential participation. * Act as a main point of contact for study protocols and coordinate between clinical study team and CRO/Sponsor. * Evaluate protocols and assist in study selection. * Implement and ensure clinical trials operations and regulatory compliance. * Review GCP guidelines, maintain GCP/CITI certification and obtain study-specific required certification for participating study staff. * Manage all clinical trial patients enrolled in studies, discuss protocols and informed consents, and ensure eligibility criteria and recruitment. * Coordinate all study visits including site initiation, study closeout, external audits, and monitoring visits. * Create study-specific source document binders for each study and subject. * Maintain regulatory documents required for study site, sponsor, and IRB for initiation, interim reports, and close-out documentation. * Assign tasks to other members of the research team, ensure they comply with the protocols, and ensure performing all protocol visits, assessments, and procedures. * Maintain databases for all clinical trials. * Report adverse events to the Data Safety and Monitoring Board, sponsor, IRB, FDA and all governing bodies. * Submit protocols and amendments to the IRB. * Complete study source documentation, complete study report forms via proposed procedure, maintain proper study close-out and ensure meeting sponsor deadlines. Requirements Education: * Bachelor's degree in health-related field with minimum one year experience as a CRC is required * - Two years healthcare related field experience or experience in human research. * - Clinical research certification * GCP and IATA certification are required (or willing to obtain them within the first month of assignment). * SOCRA or ACRP certification are preferred. * Basic Skills: * Medical terminology and knowledge of disease processes * Working knowledge of clinical research design and regulatory requirements * Analytical skills to gather and interpret research data. * Excellent interpersonal, verbal, and written communication skills. * Organized and detail-oriented individual. * Comfortable working in a team environment * Capability to work under minimal supervision * Proficient in spreadsheets and clinical research software. * Understand clinical procedures, regulations and be an excellent team player working with physicians, nurses, non-clinical, laboratory and ancillary staff * Capability to meet data deadlines and maintain confidentiality * Ability to travel to INSIGHT local offices when needed * Behavioral Competencies: * Ability to relate and work effectively with others. * Demonstrated skills in verbal and written English communications for safe and effective patient care and to meet documentation standards. * Proven excellence in patient safety and care. * Friendly, empathetic & respectful. * Reliable in work results, timeliness & attendance. * Ability to relate to and work effectively with a wonderfully diverse populace. * Able to work in a fast-paced, and stressful environment while maintaining positive energy. * Able to work under pressure and in situations that benefit from patience, tact, stamina and endurance. * Detailed oriented, conscientious and committed to precision in work results. * Committed to contributing to a positive environment, even in rapidly changing circumstances. * Is aware of standards and performs in accordance with them. * Able to provide eligibility for employment for any U.S. employer. Benefits: * Paid Sick Time - effective 90 days after employment * Paid Vacation Time - effective 90 days after employment * Health, vision & dental benefits - eligible at 30 days, following the 1st of the following month * Short and long-term disability and basic life insurance - after 30 days of employment Insight Employees are required to be vaccinated for COVID-19 as a condition of employment, subject to accommodation for medical or sincerely held religious beliefs. Insight is an Equal Opportunity Employer & Values Workplace Diversity!
    $45k-66k yearly est. 60d+ ago
  • Unblinded Clinical Research Coordinator

    DM Clinical Research

    Clinical research associate job in Chicago, IL

    Unblinded Clinical Research Coordinator DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP. Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans. Provide consultative support regarding the preparation and dosing of drugs. Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. Understand and apply all applicable site procedures. Ensure receipt and proper storage of IP and bioretention samples. Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. Review protocols and provide input on clinical and pharmacy supply needs. Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. Temperature reporting. Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. Knowledge & Experience: Education: High School Diploma or equivalent required Foreign Medical Graduate is a plus Pharmacy Technician Certification a plus Experience: Clinical Experience Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Docs. Excellent communication and customer service skills. Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred but not required
    $45k-66k yearly est. 60d+ ago
  • Unblinded Clinical Research Coordinator I (2607)

    Dm Clinical Research Group

    Clinical research associate job in Melrose Park, IL

    DM Clinical Research is looking to hire an Unblinded Clinical Research Coordinator I to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP. Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans. Provide consultative support regarding the preparation and dosing of drugs. Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. Understand and apply all applicable site procedures. Ensure receipt and proper storage of IP and bioretention samples. Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. Review protocols and provide input on clinical and pharmacy supply needs. Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. Temperature reporting. Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. Knowledge & Experience: Education: High School Diploma or equivalent required Foreign Medical Graduate is a plus Pharmacy Technician Certification a plus Experience: Clinical Experience Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Docs. Excellent communication and customer service skills. Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred but not required
    $45k-66k yearly est. 12d ago
  • Clinical Research Assistant

    Eyesouth Partners

    Clinical research associate job in Oak Forest, IL

    University Retina is a full-service practice that specializes in helping patients heal eyesight-robbing diseases of the retina, vitreous, and macula. Led by a team of board-certified ophthalmologists and retina specialists, the practice has locations in Oak Forest, Bedford Park, Lemont, Lombard, and Lincolnwood,Illinois. With a dedication to education, technology, charity, and compassionate care, the University Retina team strives to provide patients with the highest level of retinal care in the world. The physicians diagnose and treat retinal-related conditions, including macular degeneration, diabetic retinopathy, retinal detachment repair, and other disorders of the retina, vitreous, and macula. All University Retina offices are equipped with state-of-the-art technology, and each patient's treatment plan includes the most current and effective therapies or services available. Position Summary We are now hiring for a Clinical Research Assistant that will support a high-volume Resarch Department within an ophthalmic practice that focuses on providing quality and compassionate care to each patient needed complete eye care services. Pay Range - $21.00-$23.50/hr. Commensurate with experience Responsibilities A CRA is responsible for performing procedures and coordinating the execution of clinical trials in accordance with research protocols. • Recruit and screen subjects to participate in trials • Coordinate patient visits and perform procedures related to research • Collect accurate data obtained from research visits • Monitor research participants to ensure adherence to study protocol • Adhere to Good Clinical Practice (GCP) guidelines including regulatory and ethical standards • Maintain relationships with site staff, study subjects, and sponsor delegates • Perform other related duties as assigned by the Clinical Research Coordinator • Maintain compliance with all research Standard Operating Procedures (SOPs) Qualifications Education and/or Work Experience Requirements: • 2+ years in healthcare, preferably ophthalmology, but not necessarily in clinical research • Analytical mindset • Attention to detail • Exceptional interpersonal skills • Superior verbal and written communication skills • Understanding of laboratory procedures and equipment • Proficiency in MS Office - Word, Excel and Outlook • High school diploma or equivalent GED Company Benefits We offer a competitive benefits package to our employees: Medical Dental Vision 401k w/ Match HSA/FSA Telemedicine Generous PTO Package We also offer the following benefits for FREE: Employee Discounts and Perks Employee Assistance Program Group Life/AD&D Short Term Disability Insurance Long Term Disability Insurance For more information related to our benefits offered, please follow the link to our benefits page: *********************************************************** (If the link does not work for you, please copy and paste it into your browser). EyeSouth Partners is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
    $21-23.5 hourly Auto-Apply 44d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Hoffman Estates, IL?

The average clinical research associate in Hoffman Estates, IL earns between $34,000 and $84,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Hoffman Estates, IL

$54,000
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