Clinical research associate jobs in Fort Collins, CO

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

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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What You Will Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN Eligible to work in United States without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in the West region (AZ, CO, CA, UT) near major HUB airports to support efficient regional travel What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What You Will Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN Eligible to work in United States without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in the West region (AZ, CO, CA, UT) near major HUB airports to support efficient regional travel What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What You Will Be Doing:** + Serve as the primary point of contact between investigational sites and the sponsor + Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH-GCP, SOPs, and regulations + Maintain up-to-date documentation in CTMS and eTMF systems + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting + Support subject recruitment and retention efforts at the site level + Oversee drug accountability and ensure proper storage, return, or destruction + Resolve data queries and drive timely, high-quality data entry + Document site progress and escalate risks or issues to the clinical team + Assist in tracking site budgets and ensuring timely site payments (as applicable) + Collaborate with cross-functional partners including CTAs, LTMs, and CTMs **You are:** + A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN + Eligible to work in United States without visa sponsorship + A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry + Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology + Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF + A clear communicator, problem-solver, and collaborative team player + Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in the West region (AZ, CO, CA, UT) near major HUB airports to support efficient regional travel **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

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

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

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities Leads a team of clinicians and technicians in carrying out complex study protocols: o Management may include multiple concurrent 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 ***********************”

Posting Details Information California Baptist University, an evangelical Christian university affiliated with the California Southern Baptist Convention, invites applications for the open rank faculty position of Clinical Coordinator for the Communication Sciences and Disorders program. Candidates must embrace the mission of California Baptist University and demonstrate a clear understanding of, and commitment to, excellence in teaching through the integration of the Christian faith. This is a 12-month faculty position with administrative responsibilities and a starting date of July 1, 2026. The Clinical Coordinator for Communication Sciences and Disorders is an experienced, ASHA certified and state licensed speech language pathologist. The successful candidate will join an established program and faculty within the CBU College of Health Science. For more information about this position, please contact Dr. Bryan Ness, Chair of the Department of Communication Sciences and Disorders , at ******************** Pay Range The compensation for this appointment will range from $90,000 - $105,000 annually and reflects what California Baptist University reasonably expects to pay for this faculty appointment. Actual compensation may vary based on the qualifications and experience of the applicant, as well as market conditions. In addition to wages, CBU offers a robust suite of employee benefits. Qualifications Qualified applicants will hold a master's degree, clinical doctorate, and/or research doctoral degree in speech-language pathology, a current Certificate of Clinical Competence in speech-language pathology from the American Speech-Language-Hearing Association, and be eligible for licensure in California. The successful candidate will join a collegial and supportive faculty and will be expected to uphold the mission of California Baptist University. The successful candidate will possess a minimum of three years clinical experience and have supervised student interns. The candidate will also demonstrate a strong commitment to clinical and teaching excellence. Teaching Responsibilities The Clinical Coordinator teaching responsibilities include classroom instruction, clinical supervision, and supporting clinical education experiences for students placed in externships. The Clinical Coordinator's administrative responsibilities include overseeing the externship clinical placement process for both undergraduates (SLPa practicum) and graduate students, communicating with and supporting clinical supervisors, providing clinical advising, contributing to clinical education development, supporting departmental program assessment, and participating in department and university service. The successful candidate will demonstrate a strong commitment to excellent clinical supervision and teaching and will be expected to maintain an active program of community engagement and service. The successful candidate will be willing and able to integrate Christian faith in the classroom. Nondiscrimination Statement State and Federal law permit California Baptist University to discriminate on the basis of religion in order to fulfill its purpose. The University does not discriminate contrary to either State or Federal law. Quick Link to Posting ***************************************** Supplemental Questions Required fields are indicated with an asterisk (*). * * Are you a Christian? * Yes * No * * Do you attend church regularly? * Yes * No * If no, please explain (required): (Open Ended Question) * * Are you both familiar with and not in conflict with the fundamental doctrines and practices of the California Southern Baptist Convention as stated in the Baptist Faith and Message dated June 14, 2000? (Please see above link for more information) * Yes (I am familiar and not in conflict) * No (I am in conflict or not familiar) Applicant Documents Required Documents * Christian Experience Essay Optional Documents * Cover Letter * Curriculum Vitae * Letter of Reference 1 * Other Document

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

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_

GENERAL DESCRIPTION The Clinical Research Coordinator will be responsible for the oversite of research projects. In addition, the Clinical Research Coordinator must be able to provide efficient services to our physicians as well as provide quality, courteous and compassionate services to our patients in adherence to the guidelines, policies and procedures set forth by Urology Associates. ESSENTIAL JOB FUNCTIONS Develop the research department in scope, size, reputation and professionalism. Assist with the recruitment of studies, budget evaluation and negotiation, protocol evaluation and communication with study sponsors. Maintain certifications in, and continually update knowledge of FDA, GCP, ICH, federal and state regulations, etc. Obtain and maintain patient consent with the highest ethical standards. Work with staff including management in a leadership role in areas such as training, delegating responsibilities, etc. Work directly with patients for screening, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc. Communicate with and support patients and their families as necessary. Work with the EMR and data management systems to complete EDC, eCRFs, locate patients and maintain records. Must have the ability to gain knowledge of relevant software and programs. Have a basic and working knowledge of trial design, statistical methods, etc. Triage, record and report adverse events. Record and report any protocol deviations. Work closely with IRB and study sponsors, PIs and Sub-Is. Attend meetings and calls. Create and maintain department SOPs, NDAs, CVs, certifications, etc. Evaluate, purchase and maintain necessary equipment. Maintain study budgets and monitor invoicing, billing, and payments. Participate in site visits, SIVs, monitoring, etc. Complete necessary study close-out steps and documentation. Communicate regularly with supervisor, keeping him/her apprised of all pertinent information and providing feedback. Ensure compliance for all regulatory requirements including OSHA, CLIA and HIPAA; immediately and accurately document and report occurrences to supervisor; and ensure compliance with all legal and regulatory requirements as outlined in the corporate compliance plan. Support and adhere to all company policies, procedures and management decisions; maintain confidentiality of patients' medical information; and all confidential administrative related issues. Demonstrate dependability in attendance, punctuality in reporting for work and initiative in completing a full work schedule; meeting or exceeding all established deadlines and utilizing all resources and supplies efficiently and appropriately. Demonstrate the ability to concentrate during the course of the day. Display a positive outlook with a helpful, constructive manner when working with other employees. Demonstrate superior patient relations and interpersonal skills; demonstrate an appropriate level of mental and emotional tolerance and even temperament when dealing with staff, patients and general public using tact, sensitivity and sound judgment; promote a positive work environment and contribute to the overall efforts of the department and the company. OTHER DUTIES Assist in performing special projects and other related duties as assigned or directed by CPC physicians and Administrative staff. Complete other tasks as assigned. POSITION REQUIREMENTS Must have knowledge of and experience with relevant federal and state regulatory guidelines. Must have a minimum of two (2) years of experience with conducting clinical trials. Urology based clinical experience is preferred. Experience with evaluating and implementing study protocols and budgets. Certification by ACRP or an equivalent is preferred. Proficiency in computer software to include Microsoft Office, EMR and Practice Management systems. Ability to plan, schedule, prioritize and complete multiple tasks and demands is required Excellent oral and written communication, interpersonal, problem-solving and organizational skills are required. Occasional overtime, evening and weekend work is required. A valid driver's license, dependable automobile and current auto insurance are required for occasional travel for business purposes and to work at satellite locations. ESSENTIAL PHYSICAL REQUIREMENTS Requires prolonged sitting and standing, some bending, stooping and stretching, or performing other work requiring moderate physical exertion. Capacity to maintain physical activity over prolonged periods of time (stamina). Able to see for the purpose of reading information received in different formats including but not limited to paper, computer, reports, bulletins and manuals. Able to hear for work-related purposes. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Able to lift up to a minimum of 25 pounds. ESSENTIAL ENVIRONMENTAL CONDITIONS Work is generally performed under normal office working conditions. Normal level of visual strain. Ability to cope with stress caused by public in

Department: PVH Pharmacy FTE: Full Time, 1.0, 80.00 hours per pay period (2 weeks) Shift: Days Pay: $64.68 - $90.55 / hour. Pay is dependent on applicant's relevant experience The Pharmacy Clinical Coordinator is responsible for developing, implementing, and overseeing clinical pharmacy services to ensure safe, effective, and cost-efficient medication use. This role involves coordinating clinical programs and initiatives, participating in interdisciplinary teams and system efforts, and identifying and leading quality improvement projects related to medication therapy. Where applicable, the Clinical Coordinator will collaborate on these efforts with the Clinical Pharmacy Manager. Key responsibilities will include formulary management, optimization of drug utilization, and clinical quality improvement initiatives. Minimum Requirements: * Bachelor's Degree of Pharmacy from an accredited school of pharmacy. * State licensure as a Pharmacist. * 2 years post graduate experience. Preferred: * Completion of a PGY1 residency and 4 years of clinical work experience in a hospital setting. * Board certification At UCHealth, We Improve Lives Picture yourself on a dynamic team improving lives in the following way(s): * Providing top of scope practice * Values a multidisciplinary team approach to achieve exceptional outcomes * Prioritizes wellness, a patient perspective and evidence-based practice * Models proficiency through precepting those new to healthcare and/or UCHealth * Welcomes new knowledge in a fast paced, innovative environment * Contributes to secure safety and quality practices 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. AF123 Who We Are (uchealth.org)

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. Hourly Range: $19.00 - $21.00/hr (depending on education, experience, and skillset) Monday - Friday - Morning Office Hours Job Summary: With moderate oversight, the Research Assistant I provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. Communicating with study participants, caregivers, third party vendors and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. 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. Office/administrative tasks assigned ie: resupplying exam rooms, ordering office supplies, answering phone calls, etc. Education/Experience/Skills: High school graduate or equivalent. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds and/or pushing carts up to 50 pounds Reporting to work, as scheduled, is essential. On site work arrangement. 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.

Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol. Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research. May collaborate with Research Site Leader in the study selection process. Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors. Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians. May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting. Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Qualifications Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred. Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology. SoCRA or ACRP certification preferred. OR Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.

**U** **niversity of Colorado Anschutz Medical Campus** **Department: Orthopedics** **Job Title:** #:** **- Requisition #:38350** Entry Clinical Science Professional Key Responsibilities: + Assist with and oversee the day to day operations of clinical trials and studies + Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial + Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required + Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews + Travel to various clinics and hospital operating rooms to support performance of clinical trials occasionally required + Interface with Industry Representatives to ensure surgical equipment is available/present at surgery for clinical trial execution + Collection of surgical tissue samples with preparation and transport to lab for processing **Work Location:** Onsite **Why Join Us:** **Why work for the University?** + 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 **Qualifications:** **Minimum Qualifications** + Bachelor's degree in any field from an accredited institution + A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis. **Preferred Qualifications** + Bachelor's degree in science or health related field from an accredited institution + Clinical research or related experience + Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) **Competencies, Knowledge, Skills, and Abilities** + Knowledge and understanding of federal regulations and Good Clinical Practice (GCP) + Ability to communicate effectively, both in writing and orally + Ability to establish and maintain effective working relationships with employees at all levels throughout the institution **How to Apply:** 1. Curriculum vitae / Resume 2. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address **Screening of Applications Begins:** **Anticipated Pay Range:** **HIRING RANGE** **$48,446 -** **$61,623** **Equal Employment Opportunity Statement:** **ADA Statement:** **Background Check Statement:** **Vaccination Statement:** **Job Category** **Primary Location** **Schedule** **Posting Date** **Unposting Date** **To apply, visit ******************************************************************** (****************************** Copyright 2025 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency (***************************** Clinical Sciences Entry Professional - 38350 University Staff This (ie: research assistant) will serve as a Research Coordinator for CU Sports Medicine. CU Sports Medicine is one of the premier sports medicine groups in the Rocky Mountain region with regional, national and international recognition and influence. The clinical group headed by Dr. Eric McCarty are orthopedic sports medicine surgeons as well as non-operative fellowship trained sports medicine physicians from the Family Medicine and PM&R Departments of University of Colorado School of Medicine. The group serves as the team physicians for the Denver Broncos, Denver Nuggets, Colorado Rockies, Colorado Avalanche, Colorado Mammoth, Colorado Rapids as well as the University of Colorado and multiple high schools throughout the front range of Colorado. Their research efforts include mainly the investigation of clinical outcomes on their patients which range from the elite world class athlete to the recreational weekend warrior. Interaction is wide and varied with unique athletes and patients from around the Front Range. Additionally, there is interaction with other sports medicine facilities and researchers across campus as well as across the country which CU Sports Medicine collaborates with on multicenter research efforts. Primary research responsibilities for this position arc focused on orthopedic surgery investigation of the knee and shoulder. The position reports directly to Dr. Jonathan Bravman, though has heavy involvement from several other motivated researchers, including Dr. Rachel Frank, Dr. Adam Seidl and Dr. Michelle Wolcott. - this role is expected to work onsite and is located in Aurora, CO. The University of Colorado Orthopedic Department is one of the nation's top orthopedic programs, and the University of Colorado Hospital has been ranked the #1 hospital in Colorado 7 years running. The department has a robust research infrastructure and offers extensive opportunities to be a part of high-quality clinical research and participate in cutting-edge projects. Our research continues to advance the field of orthopedics with technological advances and discoveries in orthopedic care. We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: There are many additional perks & programs with the CU Advantage (******************************************************* URL=************************** . Applicants must meet minimum qualifications at the time of hire. For full consideration, please submit the following document(s):Questions should be directed to: Thomas Roller, **************************** (******************************************************* URL=****************************) . Screening begins immediately and continues until December 19, 2025. The starting salary range (or hiring range) for this position has been established as 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 (******************************************************* URL=****************************** 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. 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 ******************************** (******************************************************* URL=********************************) . 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. CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (******************************************************* URL=*********************************************************************************** . 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 (******************************************************* URL=************************************************************************************* . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20259 - SOM-ORTHO GENERAL OPERATIONS : Full-time : Nov 21, 2025 : Ongoing Posting Contact Name: Thomas Roller Posting Contact Email: **************************** (******************************************************* URL=****************************) . Position Number: 00796643jeid-adf976958b823f4aa28b80325f606e6f The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.

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 ***********************”