Clinical research associate jobs in Longmont, CO

University of Colorado Anschutz Medical Campus Department\: Orthopedics Job Title\: Clinical Sciences Entry Professional #\: 00796643- Requisition #\:38350 Job Summary: This Entry Clinical Science Professional (ie\: research assistant) will serve as a Research Coordinator for CU Sports Medicine. CU Sports Medicine is one of the premier sports medicine groups in the Rocky Mountain region with regional, national and international recognition and influence. The clinical group headed by Dr. Eric McCarty are orthopedic sports medicine surgeons as well as non-operative fellowship trained sports medicine physicians from the Family Medicine and PM&R Departments of University of Colorado School of Medicine. The group serves as the team physicians for the Denver Broncos, Denver Nuggets, Colorado Rockies, Colorado Avalanche, Colorado Mammoth, Colorado Rapids as well as the University of Colorado and multiple high schools throughout the front range of Colorado. Their research efforts include mainly the investigation of clinical outcomes on their patients which range from the elite world class athlete to the recreational weekend warrior. Interaction is wide and varied with unique athletes and patients from around the Front Range. Additionally, there is interaction with other sports medicine facilities and researchers across campus as well as across the country which CU Sports Medicine collaborates with on multicenter research efforts. Primary research responsibilities for this position arc focused on orthopedic surgery investigation of the knee and shoulder. The position reports directly to Dr. Jonathan Bravman, though has heavy involvement from several other motivated researchers, including Dr. Rachel Frank, Dr. Adam Seidl and Dr. Michelle Wolcott. Key Responsibilities: Assist with and oversee the day to day operations of clinical trials and studies Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews Travel to various clinics and hospital operating rooms to support performance of clinical trials occasionally required Interface with Industry Representatives to ensure surgical equipment is available/present at surgery for clinical trial execution Collection of surgical tissue samples with preparation and transport to lab for processing Work Location: Onsite - this role is expected to work onsite and is located in Aurora, CO. Why Join Us: The University of Colorado Orthopedic Department is one of the nation's top orthopedic programs, and the University of Colorado Hospital has been ranked the #1 hospital in Colorado 7 years running. The department has a robust research infrastructure and offers extensive opportunities to be a part of high-quality clinical research and participate in cutting-edge projects. Our research continues to advance the field of orthopedics with technological advances and discoveries in orthopedic care. Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: Medical\: Multiple plan options Dental\: Multiple plan options Additional Insurance\: Disability, Life, Vision Retirement 401(a) Plan\: Employer contributes 10% of your gross pay Paid Time Off\: Accruals over the year Vacation Days\: 22/year (maximum accrual 352 hours) Sick Days\: 15/year (unlimited maximum accrual) Holiday Days\: 10/year Tuition Benefit\: Employees have access to this benefit on all CU campuses ECO Pass\: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage. Qualifications: Minimum Qualifications Bachelor's degree in any field from an accredited institution A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis. Preferred Qualifications Bachelor's degree in science or health related field from an accredited institution Clinical research or related experience Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) Competencies, Knowledge, Skills, and Abilities Knowledge and understanding of federal regulations and Good Clinical Practice (GCP) Ability to communicate effectively, both in writing and orally Ability to establish and maintain effective working relationships with employees at all levels throughout the institution Applicants must meet minimum qualifications at the time of hire. How to Apply: For full consideration, please submit the following document(s): Curriculum vitae / Resume Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to\: Thomas Roller, ****************************. Screening of Applications Begins: Screening begins immediately and continues until December 19, 2025. Anticipated Pay Range: The starting salary range ( or hiring range ) for this position has been established as HIRING RANGE $48,446 - $61,623 The above salary range ( or hiring range ) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator Equal Employment Opportunity Statement: CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities. ADA Statement: The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ******************************** . Background Check Statement: The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. Vaccination Statement: CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.

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. **What You Will Be Doing:** + Serve as the primary point of contact between investigational sites and the sponsor + Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH-GCP, SOPs, and regulations + Maintain up-to-date documentation in CTMS and eTMF systems + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting + Support subject recruitment and retention efforts at the site level + Oversee drug accountability and ensure proper storage, return, or destruction + Resolve data queries and drive timely, high-quality data entry + Document site progress and escalate risks or issues to the clinical team + Assist in tracking site budgets and ensuring timely site payments (as applicable) + Collaborate with cross-functional partners including CTAs, LTMs, and CTMs **You are:** + A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN + Eligible to work in United States without visa sponsorship + A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry + Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology + Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF + A clear communicator, problem-solver, and collaborative team player + Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in the West region (AZ, CO, CA, UT) near major HUB airports to support efficient regional travel **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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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

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

Posting Detail Information Working TitleClinical Sciences Research Associates I, II, III - Open Pool FY26 Research Professional PositionYes Posting Number202500839AP TypeAdmin Professional/ Research Professional Classification Title Number of Vacancies Work Hours/Week Proposed Annual Salary RangeNon-Exempt (NEX) (eligible for compensatory/over time) Position Range: NEX RAI $47,000 - $65,000 & NEX RAII $50,000- $73,200 or Exempt (EX) (not eligible to earn compensatory/over time) Position Range: EX RAII $52,000- $75,000 EX RAIII $62,000 - $92,000. Employee Benefits Colorado State University is not just a workplace; it's a thriving community that's transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact. + Review our detailed benefits information here. (*************************************************************************************** + Explore the additional perks of working at CSU here. + For the total value of CSU benefits in addition to wages, use our compensation calculator (******************************************************** . + Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in (************************************************************** ! Desired Start Date Position End Date (if temporary) To ensure full consideration, applications must be received by 11:59pm (MT) on12/31/2025 Description of Work Unit Founded in 1870, Colorado State University is among the nation's leading research universities and enrolls approximately 32,000 undergraduate, graduate, and professional students. Located an hour north of the Denver metro area, Fort Collins is a vibrant community of approximately 157,000 residents that offers the convenience of a small town with all the amenities of a large city. Fort Collins is situated on the Front Range of the Rocky Mountains with views of 14,000 foot peaks, and offers access to numerous cultural, recreational, and outdoor opportunities. The Department of Clinical Sciences mission is to assure the health and productivity of animals to meet societal needs through high quality educational programs for professional veterinary medical students, graduate veterinarians, and the public through a faculty and veterinary medical center of excellence, and to advance and disseminate comparative biomedical knowledge in an environment of interdisciplinary collaboration. Our areas of expertise include animal health, imaging and diagnostics, infectious disease, cancer, and orthopaedics. The department is highly interactive and offers research associates a friendly but rigorous learning environment. There is ample opportunity for informal interactions between RA's and faculty, thus encouraging the kind of discussions and collaborations that are critical to success in the cutting-edge atmosphere of modern clinical research. Program faculty members are housed on South Campus, CSU . Most of the laboratory space is relatively close in proximity to the faculty. University facilities that support research efforts include immunotherapy and stem cell therapy, cancer, diagnostics and treatment, fundamental causes of heart disease and developing novel new treatments, reproductive biology of domestic animals, improved quality of life for animals and indirectly improve human health, orthopaedic health in horses and humans and in-vivo orthopaedic and soft tissue preclinical research. Position Summary Research Associate I, II or III positions are available in the Department of Clinical Sciences, in the area(s) of animal health, infectious disease, cancer, orthopedics, and reproduction. These positions include interaction with the Principal Investigator as well as other research assistants. The individual will be part of a team of researchers completing a federally funded research project and will have a broad range of responsibilities. Specific positions available may be NEX (Non-Exempt/Eligible for compensatory/over time) or EX (Exempt from earning compensatory/over time). When matched with a position, you will be notified of NEX /EX status at time of interview. Non-Exempt ( NEX )(eligible for compensatory/over time) Position Range: NEX RAI $47,000 - $65,000 & NEX RAII $50,000- $73,200 or Exempt (EX)(not eligible to earn compensatory/over time) Position Range: EX RAII $52,000- $75,000 EX RAIII $62,000 - $92,000. Salary is commensurate with experience and qualifications. The successful candidate must be legally eligible to work in the U.S. by date of hire; the Clinical Sciences department will not provide visa sponsorship for these positions. Required Job Qualifications Candidates with a bachelor's degree, or an associate degree with 2 years of related professional experience, or a High School Diploma (or GED ) and 4 years of related professional experience will be considered for employment at the Research Assistant Ilevel.Research Associate II and III candidates must have a bachelor's degree or higher in the specified or related field and years of experience generally would not substitute for the degree. Research Associate I ( NEX ) Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level: + B.A./B.S. in a related field OR + Associate degree in a related discipline plus 2 years of relevant, specialized training/experience OR + High School Diploma (or GED ) plus 4 years of relevant, specialized training/experience AND + 1- 3 years of relevant professional experience + Excellent communication, interpersonal skills, and customer service + Exemplary organizational and time management skills + Successful candidate must be legally authorized to work in the United States by time of application; the Clinical Sciences department will not provide visa sponsorship for these positions Research Associate II ( NEX or EX) Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level: + B.A./B.S. in a related field + 3 or more years of relevant professional experience or a master's degree with no experience + Excellent communication, interpersonal skills, and customer service + Exemplary organizational and time management skills + Successful candidate must be legally authorized to work in the United States by time of application; the Clinical Sciences department will not provide visa sponsorship for these positions Research Associate III (EX) Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level: + B.A./B.S. in a related field + 5 or more years of experience or a master's degree with 2 years of experience. Individuals with a PhD who have no experience may also be appointed to this position if appropriate + Excellent communication, interpersonal skills, and customer service + Exemplary organizational and time management skills + The successful candidate must be legally eligible to work in the U.S. by date of hire; the Clinical Sciences department will not provide visa sponsorship for these positions. Preferred Job Qualifications Essential Duties Application Details Special Instructions to Applicants Please submit a letter of intent outlining your specific area(s) of expertise, curriculum vitae, and the names and contact information of three references. References will not be contacted without prior notification of candidates. Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution. The department accepts applications on an ongoing basis from individuals who are interested in obtaining research positions within the department in laboratories in the areas of animal health, infectious disease, cancer, orthopedics, and reproduction. The open positions may be temporary or special assignment and may be for limited time periods. This pool is valid through 12/31/25. Individuals wishing to be considered beyond this date must reapply. CSU is committed to full inclusion of qualified individuals. If you are needing assistance or accommodations with the search process, please reach out to the listed search contact. Conditions of EmploymentPre-employment Criminal Background Check (required for new hires) Search ContactClinical Sciences HR, cvmbs-clinsci_********************* EEO Colorado State University ( CSU ) provides equal employment opportunities to all 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. Background Check Policy Statement Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so. References Requested References Requested Minimum Requested3 Maximum Requested3 Supplemental Questions Required fields are indicated with an asterisk (*). Applicant Documents Required Documents + Cover Letter + Resume or CV Optional Documents

Senior Clinical Research Associate - Cardiovascular At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders. We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients! About the Position: Edgewise is headquartered in Boulder, Colorado; this is a position for a growing Colorado-based Clinical Development team. The assigned clinical trials will be highly complex and high risk, e.g. multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidates may be asked to provide support to the Edgewise clinical study lead for more than one study or across programs. Key Responsibilities: Lead site start-up activities (e.g. oversight of CRO start-up activities, accountable for essential document package review, site initiation slide deck, vendor training, participate in remote/or on-site initiation visits) and contribute to feasibility, as required. Collaborate with contracts team to lead review and negotiation of site and vendor budgets/contracts. Contribute to the development and review of study, patient and site facing documents (e.g. protocols, ICFs and study plans). Oversee Edgewise contract CRA and/or CRO monitoring activities (e.g. visit schedules, monitoring visit reviews, monitoring plan review). May include on-site co-monitoring with CRO CRA, ensuring compliance with protocol and regulatory requirements. Provide additional clinical monitoring training support to CRO personnel, as needed. Attend CRO monitoring meetings. May include assigned monitoring responsibilities for sites. Review and oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits. Support the Edgewise clinical study lead in managing progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment and other tasks as assigned. Proactively review electronic data capture (EDC) for completion and to identify issues and generate queries. Identify and monitor risks and decisions at the study level and implementation of mitigation strategies. Identify potential operational challenges, and in collaboration with senior team members, provide guidance and solutions to ensure study execution remains on track. Contribute to drafting Standard Operating Procedures (SOPs) and adhere to Clinical Operations processes and SOPs to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections. Responsible for the oversight of assigned vendors. Collaborate with internal teams (e.g. Clinical Operations, Regulatory Affairs, Data Management, Medical Monitoring, CMC, etc) to ensure seamless trial execution and provide regular study updates to the appropriate internal stakeholders. May be accountable for reviewing site or vendor invoicing and financial management in accordance with the clinical trial agreement / scope of work. Support TMF activities as required (e.g. review of TMF index, document provision, etc.). Support onboarding and mentoring of new department members. Required Education, Experience, Skills: At least 4+ years of relevant clinical operations experience and a BS or BA (Life Sciences) Minimum 4 years of independent on-site monitoring experience (across all visit types and inclusive of remote monitoring), with at least 3 years cardiac study experience in a pharmaceutical sponsor environment preferred (global pharma or biotech preferred). Excellent attention to detail, verbal, written, interpersonal and presentation skills are required Must be familiar with routine medical/scientific terminology; Proficiency with MS Office required (inclusive of PPT); Smart Sheet proficiency desirable Knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials is required Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision Highly productive, engaged and accountable Team-player desiring to work in a fast-moving, dynamic start-up environment This is a full-time position (40 hours/week), hybrid, Colorado based preferred. 20-50% travel. Salary range: $100,000 - $140,000, title and salary commensurate with experience Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan. There is no deadline because the employer accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities Leads a team of clinicians and technicians in carrying out complex study protocols: o Management may include multiple concurrent studies o Studies may require multiple visits by participants o Studies may require travel to other states Responsible for understanding protocol requirements and utilizing critical thinking skills Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals Creates case report forms, based on written protocol Develops, completes, and maintains source documents Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols Assures clinical supply accountability for assigned trials Responsible for securing all sponsor-supplied devices and equipment Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish. Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Skills / Qualifications Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training Must not have any disciplinary action on license history Clinical Research Experience preferred Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management; prior management experience preferred Strong organizational and critical thinking skills, including attention to detail Travel is required up to 25% Must be capable of performing all clinical tasks relevant to licensure and/or training Must possess excellent written and verbal communication skills Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc. Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook) Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company Technical background is a plus #LI-TK1 Company Overview Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today'. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world's most trusted testing partner”. All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) “If you need an accommodation filling out an application, or applying to a job, please email ***********************”

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA 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 SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs 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 training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client 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 (Investigator Site File (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 LSAD 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 finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client 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, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (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 LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD 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. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + 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 Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities * Leads a team of clinicians and technicians in carrying out complex study protocols:o Management may include multiple concurrent studieso Studies may require multiple visits by participantso Studies may require travel to other states * Responsible for understanding protocol requirements and utilizing critical thinking skills * Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals * Creates case report forms, based on written protocol * Develops, completes, and maintains source documents * Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File * Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols * Assures clinical supply accountability for assigned trials * Responsible for securing all sponsor-supplied devices and equipment * Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish. * Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. * Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Skills / Qualifications * Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred * Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training * Must not have any disciplinary action on license history * Clinical Research Experience preferred * Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management; prior management experience preferred * Strong organizational and critical thinking skills, including attention to detail * Travel is required up to 25% * Must be capable of performing all clinical tasks relevant to licensure and/or training * Must possess excellent written and verbal communication skills * Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc. * Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook) * Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company * Technical background is a plus #LI-TK1 Company Overview Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner". All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) "If you need an accommodation filling out an application, or applying to a job, please email ***********************"

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.

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities Leads a team of clinicians and technicians in carrying out complex study protocols: o Management may include multiple concurrent studies o Studies may require multiple visits by participants o Studies may require travel to other states Responsible for understanding protocol requirements and utilizing critical thinking skills Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals Creates case report forms, based on written protocol Develops, completes, and maintains source documents Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols Assures clinical supply accountability for assigned trials Responsible for securing all sponsor-supplied devices and equipment Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish. Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Skills / Qualifications Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training Must not have any disciplinary action on license history Clinical Research Experience preferred Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management; prior management experience preferred Strong organizational and critical thinking skills, including attention to detail Travel is required up to 25% Must be capable of performing all clinical tasks relevant to licensure and/or training Must possess excellent written and verbal communication skills Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc. Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook) Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company Technical background is a plus #LI-TK1 Company Overview Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today'. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world's most trusted testing partner”. All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) “If you need an accommodation filling out an application, or applying to a job, please email ***********************”

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Department: MCR MCR Research (Trauma/Critical Care/Multidisciplinary) FTE: Full Time, 1.0, 80.00 hours per pay period (2 weeks) Shift: Days Pay: $24.11 - $36.17 / hour. Pay is dependent on applicant's relevant experience Summary: Coordinates the administrative and clinical aspects of research projects. Responsibilities: * Collaborates with principal investigator, sponsor and research staff to plan, conduct and evaluate project protocols. Monitors and reports on progress of projects as necessary. * Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Performs specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms. * Coordinates with investigator to manage adverse events, compliance and other participant-related issues. Facilitates the education of necessary parties such as participants, sponsors and clinicians involved in service delivery. * Implements and oversees the study's compliance with applicable regulations and standards. Assists with responding to and preparing for audits. * Within scope of job, requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a fast-paced environment and take appropriate action. Requirements: * Bachelor's degree. * 2 years of experience coordinating clinical research studies and clinical trials, or 2 years of experience in data management and knowledge of IRB clinical research application procedures. * BLS through the American Heart Association or the American Red Cross CPR for the Professional Rescuer with card in-hand before start date. BLS or CPR card must be good through sixty days of hire. Preferred: * Comfortable in the ER, Inpatient settings and with seeing full traumas * Experience with data studies We improve lives. In big ways through learning, healing, and discovery. In small, personal ways through human connection. But in all ways, we improve lives. UCHealth invests in its Workforce. UCHealth offers a Three Year Incentive Bonus to recognize employee's contributions to our success in quality, patient experience, organizational growth, financial goals, and tenure with UCHealth. The bonus accumulates annually each October and is paid out in October following completion of three years' employment. UCHealth offers their employees a competitive and comprehensive total rewards package (benefit eligibility is based off of FTE status): * Medical, dental and vision coverage including coverage for eligible dependents * 403(b) with employer matching contributions * Time away from work: paid time off (PTO), paid family and medical leave (inclusive of Colorado FAMLI), leaves of absence; start your employment at UCHealth with PTO in your bank * Employer-paid basic life and accidental death and dismemberment coverage with buy-up coverage options * Employer paid short term disability and long-term disability with buy-up coverage options * Wellness benefits * Full suite of voluntary benefits such as flexible spending accounts for health care and dependent care, health savings accounts (available with HD/HSA medical plan only), identity theft protection, pet insurance, and employee discount programs * Education benefits for employees, including the opportunity to be eligible for 100% of tuition, books and fees paid for by UCHealth for specific educational degrees. Other programs may qualify for up to $5,250 pre-paid by UCHealth or in the form of tuition reimbursement each calendar year Loan Repayment: * UCHealth is a qualifying employer for the federal Public Service Loan Forgiveness (PSLF) program! UCHealth provides employees with free assistance navigating the PSLF program to submit their federal student loans for forgiveness through Savi. UCHealth always welcomes talent. This position will be open for a minimum of three days and until a top applicant is identified. UCHealth recognizes and appreciates the rich array of talents and perspectives that equal employment and diversity can offer our institution. As an equal opportunity employer, UCHealth is committed to making all employment decisions based on valid requirements. No applicant shall be discriminated against in any terms, conditions or privileges of employment or otherwise be discriminated against because of the individual's race, color, national origin, language, culture, ethnicity, age, religion, sex, disability, sexual orientation, gender, veteran status, socioeconomic status, or any other characteristic prohibited by federal, state, or local law. UCHealth does not discriminate against any qualified applicant with a disability as defined under the Americans with Disabilities Act and will make reasonable accommodations, when they do not impose an undue hardship on the organization. Who We Are (uchealth.org)

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will reports patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor Degree is preferred At least one year of experience in healthcare, research or other science related field At least one year of experience planning and managing clinical trial process Pay range $29.33/hr - $35.00/hr About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

LEW I S & ASSOCIATES is a leader in providing Legal and Administrative staffing services. We are a sole source staffing firm giving you convenient ways of working with us. We make every effort to ensure the highest degree of professionalism and integrity in the staffing process. We understand the demanding role of recruiting to source the highest level of legal professionals while incorporating proven, innovative, and successful recruiting techniques. Job Description Our client is seeking a litigation associate with two to four years of experience to join the Trial Department in its Denver office. This associate will work in all phases of commercial litigation, with an emphasis on intellectual property litigation, from pleading through trial and appeal. This associate will have the opportunity to take depositions, appear in court, and work closely with partners. Strong academic performance, excellent writing skills, and two to four years of litigation experience are required. Specifically, we are seeking someone who has experience beyond document review and has handled significant parts of active cases. Admission to the Colorado bar is a plus. Additional Information Only candidates that meet the requirements will be contacted.

Posting TitleSenior Electric Grid Cybersecurity Researcher . . TypeRegular . Hours Per Week40 . Working at NLRNLR is located at the foothills of the Rocky Mountains in Golden, Colorado is the nation's primary laboratory for energy systems research and development. Join the National Laboratory of the Rockies (NLR), where world-class scientists, engineers, and experts are accelerating energy innovation through breakthrough research and systems integration. From our mission to our collaborative culture, NLR stands out in the research community for its commitment to an affordable and secure energy future. Spanning foundational science to applied systems engineering and analysis, we focus on solving complex challenges to deliver advanced, secure, reliable, and cost-effective energy solutions. Our work helps strengthen U.S. industries, support job creation, and promote national economic growth. At NLR, you'll find a mission-driven environment supported by state-of-the-art facilities, multidisciplinary research teams, and strong collaborations with industry, academia, and other national laboratories. We offer robust professional development opportunities, and a competitive benefits package designed to support your career and well-being. Job Description The Cybersecurity Threat Analysis Group (CTAG) within the National Laboratory of the Rockies (NLR) Cybersecurity Research Center performs research to make cybersecurity an enabling part of the nation's energy ecosystem. This is primarily accomplished through engaging with energy sector partners, government program offices, and national security organizations. Research areas within CTAG includes energy system modeling and simulation, threat to consequence risk analysis, and hardware & software supply chain security. CTAG is seeking an experienced senior electric grid cybersecurity research professional to lead our Energy Threat Analysis Center (ETAC) portfolio of work. The ETAC is an operational collaborative that convenes experts from the U.S. Department of Energy and the U.S. energy sector to collectively identify, analyze, and mitigate cyber threats to America's critical energy infrastructure. The successful candidate will bring a combination of strong technical security background and power systems engineering. This role also requires proficiency in developing and executing cybersecurity research within a laboratory environment, knowledge of cutting-edge adversarial Tactics, Techniques, and Procedures, experience leading complex cybersecurity programs across a matrixed organization, a passion for leading and driving new research, and the ability to collaborate with partners from across the national laboratory complex, the Department of Energy, industry, and national security partners. Responsibilities include: Provide technical leadership supporting multi-partner programs, coordinating with program office leadership, tasking and mentoring staff in support of program objectives Lead adversarial research initiatives targeting energy sector systems, including threat emulation, cyber range experimentation, and model-based simulation, defining experimental objectives and strategies Independently design, execute, and evaluate complex adversary-defender studies, including multi-stage attack-chain modeling, vulnerability exploration, and defense validation, ensuring reproducible and rigorous research outcomes Proven leadership in offensive cybersecurity research and program management, including planning and executing complex experiments with strategic impact Advanced proficiency in Python, PowerShell, C/C++, or other languages, enabling automation, data-driven analysis, and modeling integration across projects Expert-level knowledge of ICS, OT, and energy sector systems, including protocols, architectures, and security considerations Writing high-quality intelligence assessments and briefings for both senior-level and technical audiences Contribute specialized knowledge to collaborative response efforts based on cyber incidents Provide technical thought-leadership by proposing and leading new areas of work Support quick reaction tasking requiring research into areas of government concern Serve as a Subject Matter Expert (SME) in adversarial TTPs, cybersecurity mitigations, best practices, and reverse engineering Serve as a SME within our growing supply chain security portfolio of work Collaborate with fellow researchers, Department of Energy staff as well as industrial partners to ensure research relevance and impact . Basic QualificationsRelevant PhD and 9 or more years of experience . Or, relevant Master's Degree and 12 or more years of experience . Or, relevant Bachelor's Degree and 14 or more years of experience . Applies advanced scientific technical principles, theories and concepts. Contributes to the development of new principles and concepts. Considered a national subject matter expert. Demonstrates leadership in a number of areas, including all team, task and/or project lead responsibilities. Demonstrated management of complex and/or impactful projects. Excellent technical writing, interpersonal and communication skills. * Must meet educational requirements prior to employment start date. Additional Required Qualifications Must be able to obtain and maintain a DOE security clearance at the Q/TS/SCI level. Eligibility requirements: To obtain a clearance, an individual must be at least 18 years of age; U.S. citizenship is required except in very limited circumstances. See DOE O 472.2A for additional information. Polygraph may be required. Knowledge of and demonstrated experience in power systems engineering principles and practices Demonstrated experience leading cybersecurity programs for national security partners Demonstrated experience in adversarial cybersecurity practices (e.g., red teaming, reverse engineering, threat hunting) Demonstrated experience with threat hunting or detection engineering Experience deploying and configuring operational technology system components (e.g., SCADA RTUs, PLCs, and HMI) Familiarity with applicable security frameworks, best practices and guidance as provided by IEC62443, NERC CIP, NIST and IEEE Understanding of MITRE ATT&CK for ICS to develop real-world security test strategies Excellent leadership, communication, problem solving and project management skills Strong writing and public speaking skills demonstrated through proposals, presentations, business development and/or customer engagement Preferred Qualifications . Job Application Submission Window The anticipated closing window for application submission is up to 30 days and may be extended as needed. Annual Salary Range (based on full-time 40 hours per week) Job Profile: Researcher V / Annual Salary Range: $140,900 - $253,600 NLR takes into consideration a candidate's education, training, and experience, expected quality and quantity of work, required travel (if any), external market and internal value, including seniority and merit systems, and internal pay alignment when determining the salary level for potential new employees. In compliance with the Colorado Equal Pay for Equal Work Act, a potential new employee's salary history will not be used in compensation decisions. Benefits SummaryBenefits include medical, dental, and vision insurance; short*- and long-term disability insurance; pension benefits*; 403(b) Employee Savings Plan with employer match*; life and accidental death and dismemberment (AD&D) insurance; personal time off (PTO) and sick leave; paid holidays; and tuition reimbursement*. NLR employees may be eligible for, but are not guaranteed, performance-, merit-, and achievement- based awards that include a monetary component. Some positions may be eligible for relocation expense reimbursement. Limited-term positions are not eligible for long-term disability or tuition reimbursement. * Based on eligibility rules Badging RequirementNLR is subject to Department of Energy (DOE) access restrictions. All employees must also be able to obtain and maintain a federal Personal Identity Verification (PIV) card as required by Homeland Security Presidential Directive 12 (HSPD-12), which includes a favorable background investigation.Drug Free Workplace NLR is committed to maintaining a drug-free workplace in accordance with the federal Drug-Free Workplace Act and complies with federal laws prohibiting the possession and use of illegal drugs. Under federal law, marijuana remains an illegal drug. If you are offered employment at NLR, you must pass a pre-employment drug test prior to commencing employment. Unless prohibited by state or local law, the pre-employment drug test will include marijuana. If you test positive on the pre-employment drug test, your offer of employment may be withdrawn. Submission Guidelines Please note that in order to be considered an applicant for any position at NLR you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application. . Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard basis of age (40 and over), color, disability, gender identity, genetic information, marital status, domestic partner status, military or veteran status, national origin/ancestry, race, religion, creed, sex (including pregnancy, childbirth, breastfeeding), sexual orientation, and any other applicable status protected by federal, state, or local laws. Reasonable Accommodations E-Verify ******************** For information about right to work, click here for English or here for Spanish. E-Verify is a registered trademark of the U.S. Department of Homeland Security. This business uses E-Verify in its hiring practices to achieve a lawful workforce.

As the region's leading and most comprehensive provider of cancer care, we are excited to offer an outstanding opportunity for an experienced Pharmacy Coordinator - Clinical Research to join our dedicated research team at our Midtown Denver location. We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It's much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment. No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient's hand, or a scheduler on the phone finding an appointment that fits into a patient's schedule, we are deeply connected to our patients and do what we can to help. If this sounds like you, we'd love to have you join our team. Salary Range: $25.00-$34.00 Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance. Responsibilities Essential Duties and Responsibilities: * Maintain accurate patient records, including demographics, current medication list, disease states list, allergy list, insurance information, and prescription information. Utilize pharmacy management system to screen for drug interactions. * Process prescriptions and bill insurance for payment. * Troubleshoot Medicare Part B verification requirements. * Submit prior authorizations. * Assist with applying for patient financial assistance through manufacturer or foundation programs for high-cost oral drugs. Act as a subject matter expert and resource for other staff on financial assistance and billing for oral medications. * Act as a resource for other staff on dispensing oral drugs and financial assistance. * Ensure that the most cost-effective drugs are ordered from vendors. * Receive, verify, and process drug orders. * Assist with drug recalls and expired or non-utilized drug returns. * Prepare and label prescriptions and ensure they are checked for accuracy by a physician or pharmacist. * Ensure prescriptions and paperwork are signed off by a physician or pharmacist. * Obtain patient or patient representative signatures on all medications being dispensed. * File and store prescription hardcopies. * Maintain and file daily reports. * Document all patient interactions and outcomes in the EHR. * Track and report monthly inventory in the pharmacy management system. * Assist with patient monitoring activities, including prescription refills, prescription adherence, and prescription persistence. * Interact with patients regarding prescription dispensing, financial assistance, and patient follow-up. * Maintain the safety of the MID by adhering to infection-control procedures, policies, and regulations. * Prepares and maintains all central drug accountability records in compliance with applicable regulations. To include blinded studies and any associated documentation. * Responsible for receiving, accountability, distribution, and destruction of any IP(investigational product) maintained on site at the midtown location. * Assists with the process of label generation for all oral medications. * Assists with the input and management of any sponsor IVRS IP management portals. * Responsible for scheduling and managing all monitor and audit visits related to drug accountability. * Responsible for uploading and reviewing all electronic documents associated with drug accountability for accuracy. * Collaboration with on-site pharmacy teams to ensure understanding and accurate collection of IP related information. * Training and education of site pharmacy staff as needed to support collection of appropriate pharmacy related information. * Act as resource and support for all aspects of temperature monitoring systems used in all offices. * Provides timely escalation to management on issues associated with IP or temperature monitoring. Qualifications Education/Training: High School Diploma required. Associate's degree in a clinical or scientific related discipline preferred. Minimum 3 years of experience in clinical research, regulatory affairs and/or an oncology related field preferred. Pharmacy Tech experience preferred. Business Experience: Experience in Microsoft Office Experience working with Sponsor Monitor representatives. Specialized Knowledge/Skills - Experience working in clinical research is preferred Must have excellent communication skills Strong ability to multi-task Excellent time management skills Must have strong interpersonal skills to be able to interact with multiple people on many different levels. Must have a high level of attention to detail Must be able to work in a fast paced environment Working Conditions: Traditional outpatient clinic/office environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements: Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire. Candidates will be required to show proof of being vaccinated against influenza upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law. This job posting will remain open until we have identified an adequate applicant pool. Applicants are strongly encouraged to apply early.

Posting Date 12/03/2025 1453 Denver Ave, Loveland, Colorado, 80538, United States of America DaVita is hiring a Clinical Coordinator to lead outpatient dialysis care for patients with end-stage renal disease. In this role, you'll oversee treatment, guide clinical staff, and ensure the highest standards of care and safety. Key Responsibilities: * Coordinate patient care plans and monitor outcomes * Supervise clinical staff, including PCTs * Ensure safe, compassionate dialysis delivery * Build long-term relationships with patients and families * Work in a fast-paced, team-oriented environment Requirements: * Current RN license and CPR certification * 18+ months RN experience, including 6+ months dialysis * Charge RN readiness approval required * ADN required; BSN preferred * ICU, ER, or Med/Surg experience preferred * CNN/CDN certification a plus * Basic computer skills (MS Word, Outlook) * Flexible schedule, including weekends and holidays What We Offer: * Medical, dental, vision, 401(k) match * PTO and PTO cash-out * Paid training and development * Family and mental health support (Headspace, EAP, child/elder care) Ready to lead and make a difference? Apply now. #LI-CC3 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. The Wage Range for the role is $43.00 - $57.00 per hour. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

**Primary City/State:** Fort Collins, Colorado **Department Name:** Research **Work Shift:** Day **Job Category:** Research **Estimated Pay Range:** $27.16 - $40.22 / hour, based on location, education, & experience. In accordance with State Pay Transparency Rules. A rewarding career that fits your life. Those who have joined the Banner mission come from all walks of life, united by the common goal: Make health care easier, so life can be better. If changing health care for the better sounds like something you want to be part of, apply today. Located just 45 minutes north of Denver, Northern Colorado offers trendy restaurants, a thriving retail sector, and endless cultural amenities. Between wildflower-filled meadows and spectacular views of the Rocky Mountains, you will find adventures by horse, mountain bike and boat plus, endless hiking trails and world class skiing. We currently have a full-time opening, as a **Clinical Research Coordinator** supporting two of our Orthopedics locations. This is an on-site role, where you will be responsible for enrolling patients in our current Orthopedic studies, having consenting conversations with eligible patients, along with collecting and organizing the data of the study. This position will work closely with the physicians overseeing the study. **The preferred candidate will have prior experience in research.** **Location:** Will float between the following clinics throughout the week: -Banner Health Clinic--Orthopedics 5890 W 13th St, Ste 101 Greeley, CO 80634 -Joint Replacement Center 702A W Drake Rd Fort Collins, CO 80526 **Shift:** Monday - Friday, 8am - 5pm See the **Benefits Guide under the Total Rewards** section of this posting **,** to learn more about our great benefit package! If interested, apply today! Banner Fort Collins Medical Center is built on a 28-acre campus, is a 29-bed facility and a level IV trauma center. The state-of-the-art, two-story facility features a 24-bed inpatient unit, emergency department, lab services, labor and delivery rooms, medical imaging, surgical services and women's services. The campus also includes an outpatient clinic. Banner Health was recognized by Becker's as a Top 150 Places to Work in Healthcare in 2023. POSITION SUMMARY This position is responsible for coordinating and/or implementing assigned protocols. This position includes collecting and recording medical data and history, assisting in patient assessments, and maintaining study files. CORE FUNCTIONS 1. Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: assisting in the recruitment and screening of volunteers; registering patients; providing information on clinical trials and protocols to interested participants in a timely and helpful manner; obtaining relevant medical history on candidates by phone and in person; collecting previous relevant medical records data on patient; explaining procedures and consent forms; compiling all information prior to the initial visit; responding to inquiries from study participants or collateral informants in a timely and helpful manner; updating databases with patient information; and/or, performing other related activities. 2. Performs tasks required by protocol, which may include obtaining patient medical history, systems review, phlebotomy, EKG, and cognitive assessment on patients. Collects vital signs. Maintains quality assurance on designated protocols. Collects data as required and assists in interpreting and evaluating results as required. 3. Triages adverse events and communicates with the research physician regarding the occurrence of adverse events. Collects information regarding indicated medical follow-up with the subject and collateral informants as needed. 4. Provides educational information to patients and their families. Serves as a resource and support person for patients and families by being a consistent person they can contact within the clinical research program. Provides information to the patient and family related to the healthcare of the patient such as health maintenance, prevention, and anticipatory guidance relevant to study-related diseases. 5. Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate IRB (Institutional Review Board) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process. 6. Serves as a liaison to other departments and programmatic areas, as well as community agencies. 7. Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment. 8. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. 9. Department level responsibility. Some positions may have frequent interaction with patients, families, visitors, physicians, and related clinical departments. MINIMUM QUALIFICATIONS Must possess knowledge of clinical research methodologies as normally obtained by the completion of a bachelors' degree in a healthcare field. Experience typically gained through two to four years clinical research experience. Familiarity with medical and clinical terminology. Must have excellent organizational and task management skills. Ability to maintain confidentiality of patient and study information. Ability to maintain knowledge of Federal and State regulations governing practice as well as Institute policies and procedures related to medical and nursing practice. Excellent human relations, organizational and communication skills are required. PREFERRED QUALIFICATIONS Possession of Clinical Research Coordinator Certification (CRCC). Additional related education and/or experience preferred. **Anticipated Closing Window (actual close date may be sooner):** 2026-03-25 **EEO Statement:** EEO/Disabled/Veterans (***************************************** Our organization supports a drug-free work environment. **Privacy Policy:** Privacy Policy (********************************************************* EOE/Female/Minority/Disability/Veterans Banner Health supports a drug-free work environment. Banner Health complies with applicable federal and state laws and does not discriminate based on race, color, national origin, religion, sex, sexual orientation, gender identity or expression, age, or disability

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Research Treatment Nurse for the Drug Development Unit your primary responsibility is to treat and manage patients enrolled on clinical trial. You will closely follow study patient(s) throughout treatment course ensuring protocol compliance You will administer chemotherapy as ordered by physicians You will read and interpret EKGs Must communicate all protocol related issues/problems to the investigator You will assess patient for side effects of treatment and symptoms related to disease or disease progression You will assess lab data and communicates abnormal findings to the investigator and oncologist You will assess and document patient compliance with medications and return visits You will communicate with the pharmacy staff to provide timely and accurate study drug distribution You will maintain a current medication list and records in protocol specific requirements You will provide data team with completed follow-up forms, medical records, lab data and other source documents in a timely manner You will educate and orient ancillary staff in study specific procedures You will document and report adverse events You will perform telephone triage Assesses the patients EMR to ensure that all required data has been entered prior to patients scheduled appointment You will perform patient counseling and referral to appropriate support services You will monitor schedules daily for appropriate treatment distribution and additional patient visits You should have for this position: An Associate Degree; preferably a Bachelor's Degree Current licensure in the state of Colorado as a Registered Nurse Knowledge of medical and research terminology Knowledge of FDA Code of Federal Regulations and GCP Knowledge of the clinical research processes Knowledge of Phase I protocol One year of acute care nursing experience required At least on year of oncology experience preferred At least one year of experience in a research setting preferred Current BLS certification Current ACLS certification (can complete within nine months of start date) ONS Chemotherapy Provider card (can complete within nine months of start date) Research Certification (ACRP or CCRP) Preferred The salary range for this position is: $83,000 - $100,000 annually About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.