Clinical research coordinator jobs in Colorado

We anticipate the application window for this opening will close on - 28 Nov 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** In this exciting role as a Clinical research Specialist, you will have primary responsibility to manage day-to-day study operations within the Medtronic Clinical Physiology Lab. This is a Research Specialist role reporting to the Clinical Lab Manager. The Clinical Research Specialist will independently develop and maintain clinical study documentation including developing clinical investigation plans, case report forms, IRB submissions, trail master files, SOPs and additional plans and documents as needed. The Clinical research Specialist will facilitate and maintain clinical study databases and assist with the drafting, distribution and tracking of study paperwork, and informed consents. Additionally, the CRS role is expected to assist in the laboratory and clinical study operations through study execution, recruitment and scheduling, and maintenance of procedures in one or more of the following areas: production, research and development, quality control/assurance, and/or compliance/environmental safety. **Location:** Denver, CO **Travel** up to 15% (primarily domestic and occasionally international). **Operating Unit** The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM. ACM is a $2B global business focused on airway management and patient monitoring technologies. We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it's like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space. + Develop, draft and maintain clinical study documentation + Execute study protocols in the lab + Develop, draft and maintain accessory plans for clinical studies + Establish and maintain regular communication with research management and product managers + Enter data and maintain database of subject demographic information. + Conduct laboratory support functions such as ordering, stocking, and distributing supplies and equipment, and collecting, washing, and storing equipment. + Maintain organizational standards: GCP, GLP, CITI training. + Prepare and maintain general laboratory quality controls and appropriate auditable documentation + Collaborate in study conduct and study subject communication, interactions, and ensure confidentiality. + Data coordination- actively participate in the development and testing of case report forms, study reports, and study databases based on protocol requirements. + Ensure timely and quality completion of data forms, verify study data, and generate, manage and resolve data discrepancies. + May process compensation & identify and resolve compensation discrepancies. + Document coordination - create and manage clinical study files and oversee the organization and distribution of clinical study documents. + Assist with periodic audits of clinical study files for completeness and accuracy. + Additional tasks as assigned **Qualifications - External** **Must Have:** **Minimum** **Requirements** Requires a Baccalaureate degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. **Nice to Have** + Experience in pre-market/ investigational and post market studies + Experience with database management, subject recruitment and consenting, data collection, and clinical reporting. + Knowledge and familiarity with the operations of a medical research laboratory + Ability to follow established guidelines/procedures for the preparation of various administrative forms, as well as learn new tasks independently. + Able to read and interpret technical procedures and regulatory requirements. + Experience in medical device clinical product trials and governing regulations. + Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial. + Leadership skills include strong communication, sense of urgency, high accountability, problem solving, quality focus, business integration acumen, and change management. + Demonstrated ability to work effectively on cross-functional teams. + Experience in a high-demand and fast-paced environment. + Strong problem-solving skills. + Community outreach capabilities **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$83,200.00 - $124,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans (************************************************************************************************************** **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (************************* . It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will... + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email ******************* To request removal of your personal information from our systems please email *****************************

Posting Detail Information Working Title Clinical Sciences Research Associates I, II, III - Open Pool FY26 Position Location Fort Collins, CO Work Location Position is fully in-office/in-person Research Professional Position Yes Posting Number 202500839AP Position Type Admin Professional/ Research Professional Classification Title Number of Vacancies Work Hours/Week Proposed Annual Salary Range 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. 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) on 12/31/2025 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 I level. 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

National Jewish Health is seeking a skilled and visionary Director of Clinical Research Services to oversee the Clinical Research Services Office and drive institutional success in advancing clinical research. This leadership role is instrumental in fostering collaboration, ensuring regulatory compliance, and developing innovative approaches to enhance research operations. Why National Jewish Health? Top Respiratory Hospital: Recognized as a leader in respiratory care and research, National Jewish Health is home to passionate physicians and staff dedicated to finding effective treatments for chronic and life-threatening diseases. Collaborative Environment: The centrally located clinical research unit promotes strong interdepartmental relationships and direct engagement between physicians and research participants. Opportunity for Impact: This role offers the chance to shape the future of clinical research at a globally recognized institution. The successful candidate will bring expertise in clinical research operations, a strategic mindset, and a proven ability to lead within complex regulatory environments. A commitment to advancing innovation in a collaborative, mission-driven environment is essential. With a 125-year history of groundbreaking care and discovery, National Jewish Health offers the opportunity to lead transformative clinical research that impacts lives worldwide. Position Summary Manages the Clinical Research Services Office and staff and provides leadership in support of institutional, department and faculty goals related to the conduct of clinical research. Essential Duties Manages and develops an effective staff: providing effective communication, leadership, guidance and resources. Determines staff qualifications and competency: recruits, interviews, selects, hires, trains, orients, mentors, evaluates, coaches, counsels, disciplines, and rewards. Establishes and monitors staff safety and regulatory compliance. Serves as liaison between Principal Investigators and clinical research resources. Builds relationships with faculty and staff to enhance and grow the clinical research enterprise at National Jewish Health. Assures the allocation, sharing and efficient utilization of clinical research resources while ensuring quality and consistency. Assures compliance with all applicable regulatory requirements for FDA regulated clinical research. Oversees uniform application of clinical research systems, policies and procedures across all clinical research areas. Acts as a liaison among research managers, both clinical and administrative, to assure optimization of clinical research for the institution. Establishes new business partnerships and maintains existing ones. Works with investigators, sponsors, community members, and internal team members to optimize study processes and enrollment. Initiates and maintains contact with pharmaceutical companies regarding ongoing and future studies. Conducts prequalification visits with sponsor representatives ensuring that studies are conducted and coordinated well and in accordance with sponsor Standard Operating Procedures, FDA regulations and ICH/GCP Guidelines. Directly oversees projects assigned to the research unit including start-up, implementation and close-out. Ensures prompt start-up, efficient and compliant implementation and orderly close-out. Works with the Manager of Clinical Research Finance & Systems in developing budgets that are fiscally sound and inclusive of all potential expenses. Interfaces with internal and external clinical resources to determine pricing. Ensures financial viability of Clinical Research Services program Works with Research Regulatory Affairs to ensure timely IRB submission and regulatory compliance. Develops programs to maximize subject recruitment at both the institutional and project level. Creates, updates, and manages research unit policies and procedures demonstrating an in-depth understanding of FDA and IRB Regulations and ICH/GCP Guidelines. Institutes policies that are compliant with ICH/GCP regulations and guidelines, as well as institutional policies and procedures. Assures adequate functioning of research unit equipment necessary for clinical research. Serves as the unit representative to the FDA and assists FDA and Investigators during FDA audits. Manages the institutional FDA competency program. Competencies Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health. Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures. Building Strategic Relationships: Identifying opportunities and taking action to build strategic relationships between one's area and other areas, teams, departments, units, or organizations to help achieve business goals. Business Acumen: Using economic, financial, market, and industry data to understand and improve business results; using one's understanding of major business functions, industry trends, and own organization's position to contribute to effective business strategies and tactics. Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences. Impact and Influence: Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one's own behavior to accommodate tasks, situations, and individuals involved. Taking advantage of opportunities to make a difference and have an impact. When used well, the intended outcome of this competency is the creation of goodwill, trust, and respect while motivating people to want to follow you even when they don't have to. Informing and Communicating: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message. Managing Conflict: Dealing effectively with others in an antagonistic situation; using appropriate interpersonal styles and methods to reduce tension or conflict between two or more people. Addresses conflicts by focusing on the issues at hand to develop effective solutions when disputes or disagreements occur; helps others resolve conflicts by providing impartial mediation when needed. Talent Management for Leaders: Clearly establishes and communicates expectations and accountabilities; monitors and evaluates performance; provides effective feedback and coaching; identifies development needs and helps employees address them to achieve optimal performance. Supervisory or Managerial Responsibility Manages 10-20 employees. Travel None Core Values Be available to work as scheduled and report to work on time. Be willing to accept supervision and work well with others. Be well groomed, appropriately for your role and wear ID Badge visibly. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures. Wears appropriate PPE as outlined by the infection control policies and procedures. Demonstrates compliance with all state, federal and all other regulatory agency requirements. Minimum Qualifications Education: Bachelor's Degree in Biology, Chemistry, Behavioral Science, Science, Health, or Nursing required. Work Experience: A minimum of seven (7) years of recent and related clinical research experience with at least two (2) years' experience in FDA-regulated research and 2 years' experience at the management level. Special Training, Certification or Licensure: Current Clinical Research Coordinator or Clinical Research Associate Certification preferred. Salary Range: $135,674.89 - $179,430.05 Benefits At National Jewish Health, we recognize that our outstanding faculty and staff are the essence of our organization. For every aspect of health care, our employees are our greatest asset. With that in mind, we have designed a valuable, comprehensive benefits package to meet the needs of our employees and their families. Comprehensive Medical Coverage: Multiple Cigna health plans for Colorado, regional office and remote employees. Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) available to pair with some plans. Paid Time Off: Generous PTO accruals to use for vacation and sick days, and six paid holidays, all compliant with Colorado state sick leave regulations. Dental & Vision Plans: Coverage effective the first of the month after hire. Retirement Savings: 403(b) plan with employer contributions after two years. Wellness Incentives: Earn up to $200 annually for preventive health activities. Tuition Reimbursement: Up to $5,250 annually for full-time and part-time employees. Child Care Assistance: Childcare Flex Spending Account (FSA) with annual employer contribution. Loan Forgiveness: Public Service Loan Forgiveness (PSLF) eligible employer. Disability & Life Insurance: Employer-paid plans and optional buy-up choices. Voluntary Benefits: Full suite of coverage options such as Accident, Hospital Indemnity and Legal Plan Exclusive Discounts: Savings on local services, insurance, and RTD bus passes. Visa sponsorship is not available for this position. Applicants must be legally authorized to work in the United States without the need for employer sponsorship, now or in the future. Anticipated Application Deadline: 2025-10-10

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.

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 ***********************"

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 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 ***********************”

Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Clinical Research Manager (RN) at our Midtown location. Bring your established Oncology and or Research experience and join a team dedicated to providing an excellent experience to patients. 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: $110,000-$145,000.00 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; potential for research bonus depending on financials of department after one year of employment; 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. A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis. Responsibilities * Manages clinical research program and operations in accordance with USOR SOP and ICH GCP guidelines. * Responsible for ensuring at the administrative level that all research activities are coordinated with affected departments within the practice. * Coaches and develops staff. Responsible for recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, and progressive discipline. * Enforces adherence to company policies. * Develops research accountability standards, metrics, and reports and identifies areas for improvement. Implement action plans designed to improve practice research operations and quality assurance functions. * Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. * Develops accountability standard to ensure that targets and budgets are achieved. * Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program. * Responsible to promote or market research program to the practice, community and referring physicians. * Responsible for coordinating research activities with other (non-USOR) bases or sponsors. Qualifications Bachelors degree in a clinical or scientific related discipline desired, Bachelors degree in nursing preferred. Business Experience: * Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology * Minimum of 2 years of supervisory experience preferred, experience in clinical research preferred If required for state of practice, current licensure as a registered nurse (RN) SoCRA or ARCP certification preferred Specialized Knowledge/Skills * Excellent communication skills, strong ability to multitask Strong interpersonal skills Must be able to work in a fast paced constantly changing environment Knowledge and proficiency in all basic computer programs, windows, excel etc. * Special knowledge of GCP and ICH guidelines Specific knowledge of all aspects of clinical research * Ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions * Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails * Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle Working Conditions: 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 full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. 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. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.) 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.

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 ***********************”

University of Colorado Anschutz Medical Campus Department\: Department of Ophthalmology Job Title\: Senior Clinical Research Coordinator #00841904 - Requisition #38236 Job Summary: The Department of Ophthalmology participates in multiple sponsored and investigator-initiated clinical trials for diseases and disorders of the eye. Our involvement in a wide variety of studies including surveys, observational, interventional, device and drug trials contribute valuable knowledge for the ophthalmic community at large. Key Responsibilities: Grade retinal images for image biomarkers Mark retinal images to develop artificial intelligence (AI) algorithms for image biomarkers Confirm and adjust AI-detection of image biomarkers Review patient charts and images for progression of age-related macular degeneration Perform baseline and longitudinal retinal imaging grades for qualitative and quantitative image biomarkers Adjudicate phenotyping of age-related macular degeneration stage Assist in analysis and writing of research manuscripts related to age-related macular degeneration Assist with and oversee the day-to-day operations of studies Collect, code, and analyze data obtained from research in an accurate and timely manner Adhere to research regulatory standards Assist and train junior team members Assist with developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies Assist with identifying issues related to operational efficiency and share results with leadership Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention Serve as a resource and participate in study initiation and close out duties Work Location: Onsite - this role is expected to work onsite and is located in Aurora, CO. Why Join Us: The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world. The technological innovations conceived and developed by departmental faculty have changed the practice of eye care throughout the world. Our educational programs train the next generation of leaders in ophthalmology. Our specialists have developed national and international reputations for excellence in routine and complex ophthalmic care. We have invested heavily in tracking our clinical outcomes and we are proud that our clinicians perform at the highest levels in their respective fields. The mission of the Department of Ophthalmology is to be a nationally recognized department of ophthalmology by providing exemplary patient care founded on educational leadership, innovative research, and high ethical standards. 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 Substitution A: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis. Two (2) years clinical research or related experience Preferred Qualifications Bachelor's degree in science or health related field Three (3) years of clinical research or related experience Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) Background understanding of age-related macular degeneration including prior research in this area and/or grading retinal images 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 Outstanding customer service skills Knowledge of basic human anatomy, physiology, medical terminology Ability to interpret and master complex research protocol information How to Apply: For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to\: Ashley Woodhouse, ******************************* Screening of Applications Begins: Applications will be accepted until finalists are identified, but preference will be given to complete applications received by December 1, 2025. Those who do not apply by this date may or may not be considered. Anticipated Pay Range: The starting salary range for this position has been established as: $56,995 - $72,498 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.

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

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#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.

Internal Job Description Job Title: Clinical Research Coordinator Work Set-Up: Working On-site Schedule: 40 hours per week. Responsibilities: Phlebotomy is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role. Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including spirometry, and vital signs. Coordinate clinical research studies conducted by a supervising principal investigator. Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research. Safeguard the well-being of the subjects and ensure and maintain high standards: Maintain a safe environment in accordance with Health and Safety policies. Act as a volunteer advocate. Address volunteer and visitor concerns proactively and take remedial action as required. Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer. Report any deviation from normal practice to senior staff. Support Study Conduct By: Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems. Participating in project meetings with the project team as needed. Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents. Planning logistical activity for procedures as per protocol. Generating volunteer instructions. Identifying and obtaining required supplies and equipment. Preparing and delivering study-specific training materials, documents, and records. Troubleshooting study issues. Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards. Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness. Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria. Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits. Responsible for the correct administration and custody of study drug according to site standard operating procedures. Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol. Cooperating with the study monitor and reserving sufficient time for questions during monitoring. Following ICH GCP guidelines with regards to all study and patient activities. Qualifications: Equivalent education and experience - High School Diploma and 1 years' relevant work experience in clinical research At least 1 year experience working in a clinical research setting preferred. Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies. Working knowledge of clinical trials. Working knowledge of the principles of Good Clinical Practices (GCP). In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules. Skill in carrying out required clinical procedures. Working knowledge of medical terminology. Ability to pay close attention to detail. Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients. Please note, this position is not eligible for sponsorship. #LI-CES and #LI-DNP #LI-HCP #ONSITE IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

+ Department: SYS NoCo Oncology Research + FTE: Full Time, 0.8, 64.00 hours per pay period (2 weeks) + Shift: Days + Pay: $24.11 - $36.17 / hour. Pay is dependent on applicant's relevant experience 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. 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. 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)

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.

**Become a part of our caring community and help us put health first** The Senior Clinical Operations Training Professional provides training support (both virtual and onsite) and implements organizational processes and programs to ensure new hires to the organization, along with, the staff and facilities in emerging markets are fully prepared for successful operations. This role includes an opportunity to travel to new and existing clinics across the US and participate in go-live support. The Senior Clinical Operations Training Professional collaborates with training colleagues, market leadership, clinical and non-clinical associates throughout the organization. Secures needed resources and establishes/verifies key performance indicators to ensure readiness. Leads the transition to ongoing operational processes. Understands department, segment, and organizational strategy and operating objectives, including their linkages to related areas to connect the dots within the market. Follows established guidelines/procedures. Makes decisions on moderately complex to complex issues regarding technical approach for project components and work is performed with minimal direction. Has advanced level knowledge and a deep understanding of clinical workflows. Will conduct in-person, classroom, one on one and virtual learning sessions for care team members. **Use your skills to make an impact** **Required Qualifications** + Clinical and operational experience in a healthcare facility. + Five or more years training experience in a clinical setting to include electronic medical record implementation + Experience providing training and support virtually + Strong written and verbal communication skills + Strong customer service skills + Prior experience with delivering presentations to all levels of leadership. + Demonstrated ability to translate analytics into action and use the data to impact and influence business outcomes. + Microsoft Office proficiency - able to write queries, create forms, reports, presentations, and documents in Word, Power Point, Access and Excel **Preferred Qualifications** + Bachelor's Degree + eCW and/or Athena EMR experience + Understanding of Value Based Care model **Additional Information** + Travel required up to 75% of the time. Work from home when not traveling. + Strong preference incumbent live near a PCO market in the following states: GA, TX, NC, SC, IN, KY, FL, AZ, MS, LA, TN, KS, VA, MO Travel: While this is a remote position, occasional travel to Humana's offices for training or meetings may be required. **Scheduled Weekly Hours** 40 **Pay Range** The compensation range below reflects a good faith estimate of starting base pay for full time (40 hours per week) employment at the time of posting. The pay range may be higher or lower based on geographic location and individual pay will vary based on demonstrated job related skills, knowledge, experience, education, certifications, etc. $78,400 - $107,800 per year This job is eligible for a bonus incentive plan. This incentive opportunity is based upon company and/or individual performance. **Description of Benefits** Humana, Inc. and its affiliated subsidiaries (collectively, "Humana") offers competitive benefits that support whole-person well-being. Associate benefits are designed to encourage personal wellness and smart healthcare decisions for you and your family while also knowing your life extends outside of work. Among our benefits, Humana provides medical, dental and vision benefits, 401(k) retirement savings plan, time off (including paid time off, company and personal holidays, volunteer time off, paid parental and caregiver leave), short-term and long-term disability, life insurance and many other opportunities. Application Deadline: 11-29-2025 **About us** About CenterWell Senior Primary Care: CenterWell Senior Primary Care provides proactive, preventive care to seniors, including wellness visits, physical exams, chronic condition management, screenings, minor injury treatment and more. Our unique care model focuses on personalized experiences, taking time to listen, learn and address the factors that impact patient well-being. Our integrated care teams, which include physicians, nurses, behavioral health specialists and more, spend up to 50 percent more time with patients, providing compassionate, personalized care that brings better health outcomes. We go beyond physical health by also addressing other factors that can impact a patient's well-being. About CenterWell, a Humana company: CenterWell creates experiences that put patients at the center. As the nation's largest provider of senior-focused primary care, one of the largest providers of home health services, and fourth largest pharmacy benefit manager, CenterWell is focused on whole-person health by addressing the physical, emotional and social wellness of our patients. As part of Humana Inc. (NYSE: HUM), CenterWell offers stability, industry-leading benefits, and opportunities to grow yourself and your career. We proudly employ more than 30,000 clinicians who are committed to putting health first - for our teammates, patients, communities and company. By providing flexible scheduling options, clinical certifications, leadership development programs and career coaching, we allow employees to invest in their personal and professional well-being, all from day one. **Equal Opportunity Employer** It is the policy of Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status. It is also the policy of Humana to take affirmative action, in compliance with Section 503 of the Rehabilitation Act and VEVRAA, to employ and to advance in employment individuals with disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment. Centerwell, a wholly owned subsidiary of Humana, complies with all applicable federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, sex, sexual orientation, gender identity or religion. We also provide free language interpreter services. See our full accessibility rights information and language options *************************************************************

) Contract Duration: Open-ended contract (average duration between 3-6 months) Job Type: Full-time (40 hours/week, Monday-Friday during standard business hours) We are seeking a proactive and experienced Clinical Research Coordinator (CRC) to join our team in support of an ongoing oncology clinical trial. This onsite, full-time contract role offers an opportunity to contribute meaningfully to research. The ideal candidate will be comfortable working independently and serving as a primary CRC for the study. Key Responsibilities + Data Management: Collect study data and enter it into electronic data capture (EDC) systems. + Query Resolution: Address and resolve data queries promptly. Qualifications & Skills + Minimum of 2 years of experience as a clinical research coordinator. + Minimum of 1 year of Oncology clinical trial experience required + Proficiency with Electronic Data Capture (EDC) systems and clinical trial management tools. + Strong attention to detail and problem-solving skills. Work Environment + This role operates during standard business hours in a dynamic, fast-paced research setting. Pay and Benefits The pay range for this position is $25.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Englewood,CO. Application Deadline This position is anticipated to close on Nov 13, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full-time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Compensation: $28.00 - 31.00/hr (Depending on education, experience, and skillset) Shift: Monday-Friday 08:00 am - 4:30 pm Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the Clinical Research field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

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. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. 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_

**All the benefits and perks you need for you and your family:** + Benefits from Day One + Paid Days Off from Day One + Student Loan Repayment Program + Career Development + Whole Person Wellbeing Resources **Our promise to you:** Joining AdventHealth is about being part of something bigger. Its about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **Schedule:** Full-time **Shift** : Days **Location:** 2525 S DOWNING ST, Denver, 80210 **The role you'll contribute:** The Clinical Research Coordinator II RN (CRC-II RN) serves the AdventHealth Research Institute (AHRI) at the Rocky Mountain Region (RMR). Under limited supervision the CRC II RN is responsible for the planning, coordination, evaluation, and performance of nursing care for research participants and collecting data for assigned research projects across multiple locations. The CRC-II RN follows study-specific protocol guidelines, communicates with AHRI Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead and clinical research support staff. The CRC-II RN works to advocate for the patient, while adhering to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines. Works closely with AHRI Core managers to schedule clinical operations to facilitate the initiation and completion of clinical research studies. Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Lead and Director of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects; abides by hospital and departmental policies and SOPs, as well as all applicable local, state, and federal regulations Serves as liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP). Prepares all documentation for clinical research purposes as may be required by Principal Investigators to track all submissions to IRB and OSP and will meet all reasonable deadlines for submission. Tracks all submissions to IRB and OSP and maintains timely turnaround of all documents to avoid delays in study initiation and/or progress. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all. **The value you'll bring to the team:** + Delivers safe care and demonstrates regard for the dignity and respect of all participants. Maintains adequate skills in clinical competencies including but not limited to physical assessment, phlebotomy and IV insertion. Practices the principles of Universal Precautions. Understands and abides by HIPAA regulations. + Maintains a clean, prepared clinical space. May perform set-up and turnover procedures in all clinical areas, per SOPs, in a timely manner. + Participates in internal and/or external training programs to maintain licensure. + Utilizes positive interpersonal communication skills; communicates effectively with members of the healthcare team, patients, investigators, sponsors of research and administration. **The expertise and experiences you'll need to succeed:** **Required qualifications:** + Associate in Nursing + 2 years of Clinical Research experience + RN - Registered Nurse - State Licensure and/or Compact State Licensure active State of Colorado license This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location. **Category:** Research **Organization:** AdventHealth Rocky Mountain **Schedule:** Full-time **Shift:** 1 - Day **Req ID:** 25040513 We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.