Title: Clinical Research Associate Type: Remote - Field - Chicago/Wisconsin The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager. Accountabilities - Contributes to the selection of potential investigators. - In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. - Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. - Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. - Actively participates in Local Study Team (LST) meetings. - Contributes to National Investigators meetings, as applicable. - Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. - Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. - Updates CTMS and other systems with data from study sites as per required timelines. - Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. - Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits. - Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. - Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. - Ensures data query resolution in a timely manner. - Works with data management to ensure robust quality of the collected study data. - Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. - Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP. - Follows up on outstanding actions with study sites to ensure resolution in a timely manner. - Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required. - Assists site in maintaining inspection ready ISF. - Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM. - Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate. - Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF. - Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. - Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). - Ensures compliance with local, national and regional legislation, as applicable. - Collaborates with local MSLs as directed by LSM or line manager. Requirements: - Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*). - Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. - Good medical knowledge and ability to learn relevant AZ Therapeutic Areas. - Basic understanding of the drug development process. - Good understanding of Clinical Study Management including monitoring, study drug handling and data management. - Excellent attention to details. - Good written and verbal communication skills. - Good collaboration and interpersonal skills. - Good negotiation skills. - Ability to travel nationally/internationally as required. - Valid driving license The annual base pay for this position ranges from $112,154.40 - $168,231.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 16-Mar-2026 Closing Date 03-Apr-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

We are seeking a compassionate registered nurse (RN) to join our growing team! In this role, you will provide critical after-hours support, triaging hospice patients and family needs over the phone wit professionalism and empathy. You will help ensure timely interventions and coordination of care for patients receiving hospice services. Built around a mission to improve the lives of nurses and patients, IntellaTriage has been providing after-hours nurse triage for hospice and home health providers since 2008. Utilizing best-in-class technology, IntellaTriage provides round-the-clock direct access to licensed, registered nurses using client-customized protocols for patient-centered, compassionate care. We are growing rapidly and excited to support our clients’ nursing staff in the field by leveraging our remote team of nurses to manage after-hours care delivery. Our triage nurses become an extension of our clients’ care team, and they trust us to support them and their patients during their non-core hours. Learn more at www.intellatriage.com. Why Join Us - Base pay at $25 an hour with multiple opportunities to increase the hourly rate with a potential to earn up to $28 an hour within your first 6 months of hire - 3 weeks of paid remote training - Supportive clinical team - Work from home allows you to create a comfortable and personalized workspace - Shorter shifts that provide a better work-life balance and reduce potential for burnout - Working remotely gives you more time to spend with those you love! What do our nurses say? When asked what inspires her, 2024 IntellaTriage Nurse of the Year shared: “Helping people. That’s it. And knowing this team has your back—that makes all the difference. People say it takes a special kind of person to do hospice, and I think that’s true. You’re walking with people and their families through one of the most sacred times in life. It’s an honor to support them and guide them through that journey. I’m so grateful to have been chosen for this award.”    At IntellaTriage we recognize nurses who go above and beyond to make a meaningful impact on patients’ lives. This years' honoree exemplifies what it means to lead with compassion, skill, and dedication. Read more about being a nurse at IntellaTriage, and the reward:  https://intellatriage.com/telehealth-solutions-media/2024-nurse-of-the-year/

**We need a CRA in the Southeast, USA. i.e. GA, FL, NC, SC, etc. Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management. To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology or Cardiology. Position Summary: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. Essential functions of the job include but are not limited to: - Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Updates, tracks and maintains study specific trial management tools/systems, and status reports. - If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. - If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. - Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. - Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. - Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. - Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Travels as necessary according to project needs. - Performs other duties as assigned by management. Qualifications: Minimum Required: - 4-year college degree or equivalent experience in a scientific or healthcare discipline. - Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research Other Required: - Excellent communication and organizational skills are essential. A team player. - Evidence of a client focused approach - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail. - Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed. - Fluency in English and for non-English speaking countries the local language of country where position based Preferred: - Graduate or postgraduate degree - Lupus monitoring experience - Experience monitoring in rare and complex therapeutic areas - Experience monitoring EDC trials and EHR records - Experience in biopharma or relevant therapeutic area - Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country - Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines. - Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management. Competencies: - Exhibits self-motivation and is able to work and plan independently as well as in a team environment - Understands clinical trials methodology, including a working knowledge of protocols and indications being studied - Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills - Collects data of consistently high standard - Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency - Fluency in English and for non-English speaking countries the local language of country where position based About Precision for Medicine Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offerings enable the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for complex disease states. Precision medicine is revolutionizing the attack on cancer. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. We invite you to learn more about our growing organization serving clients that are researching groundbreaking therapies. We strive to ensure employees feel appreciated through a multitude of benefits including paid time off, volunteer time off, robust medical offerings, non-vested 401k plus company match, paid parental leave and more. At Precision, your ideas and contributions are valued and nurtured, impacting positive change for the company. Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $91,500—$137,300 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

**We need a CRA in the Southeast, USA. i.e. GA, FL, NC, SC, etc. Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management. To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology or Cardiology. Position Summary: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. Essential functions of the job include but are not limited to: - Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Updates, tracks and maintains study specific trial management tools/systems, and status reports. - If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. - If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. - Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. - Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. - Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. - Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Travels as necessary according to project needs. - Performs other duties as assigned by management. Qualifications: Minimum Required: - 4-year college degree or equivalent experience in a scientific or healthcare discipline. - Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research Other Required: - Excellent communication and organizational skills are essential. A team player. - Evidence of a client focused approach - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail. - Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed. - Fluency in English and for non-English speaking countries the local language of country where position based Preferred: - Graduate or postgraduate degree - Lupus monitoring experience - Experience monitoring in rare and complex therapeutic areas - Experience monitoring EDC trials and EHR records - Experience in biopharma or relevant therapeutic area - Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country - Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines. - Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management. Competencies: - Exhibits self-motivation and is able to work and plan independently as well as in a team environment - Understands clinical trials methodology, including a working knowledge of protocols and indications being studied - Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills - Collects data of consistently high standard - Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency - Fluency in English and for non-English speaking countries the local language of country where position based About Precision for Medicine Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offerings enable the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for complex disease states. Precision medicine is revolutionizing the attack on cancer. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. We invite you to learn more about our growing organization serving clients that are researching groundbreaking therapies. We strive to ensure employees feel appreciated through a multitude of benefits including paid time off, volunteer time off, robust medical offerings, non-vested 401k plus company match, paid parental leave and more. At Precision, your ideas and contributions are valued and nurtured, impacting positive change for the company. Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $91,500—$137,300 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.