Clinical research associate jobs in Fort Collins, CO - 25 jobs

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

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. 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. This pool will close at 12:00 AM (MT) on 7/1/26. Individuals wishing to be considered beyond this date must reapply. **Conditions of Employment:** Pre-employment criminal background check (required for new hires) **Essential Job Duties:** Essential job duties vary depending on the hiring laboratory and research program, but may include: + Conducting laboratory, field, or computational research activities. + Collecting, managing, and analyzing research data. + Assisting with experimental design and protocol implementation. + Maintaining laboratory equipment, materials, and documentation. + Contributing to manuscripts, reports, and presentations. + Collaborating with faculty, staff, graduate students, and other research personnel. Specific duties will be defined at the time of hire by the supervising faculty member. **Supervision:** This position reports to a faculty member within the Department of Clinical Sciences. Day-to-day supervision and expectations are defined by the hiring laboratory. **Minimum Education:** Candidates with a bachelor's degree, or an associate degree with 2 years of related professional experience, or a High School Diploma (or GED) and 4 years of related professional experience will be considered for employment at the Research Assistant I level. Research Associate II and III candidates must have a bachelor's degree or higher in the specified or related field and years of experience generally would not substitute for the degree. Research Associate I (NEX): Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level: + B.A./B.S. in a related field. OR + Associate degree in a related discipline plus 2 years of relevant, specialized training/experience. OR + High School Diploma (or GED) plus 4 years of relevant, specialized training/experience. AND + 1- 3 years of relevant professional experience. + Excellent communication, interpersonal skills, and customer service. + Exemplary organizational and time management skills. + Successful candidate must be legally authorized to work in the United States by time of application; the Clinical Sciences department will not provide visa sponsorship for these positions. Research Associate II (NEX or EX) Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level: + B.A./B.S. in a related field. + 3 or more years of relevant professional experience or a master's degree with no experience. + Excellent communication, interpersonal skills, and customer service. + Exemplary organizational and time management skills. + Successful candidate must be legally authorized to work in the United States by time of application; the Clinical Sciences department will not provide visa sponsorship for these positions. Research Associate III (EX) Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level: + B.A./B.S. in a related field. + 5 or more years of experience or a master's degree with 2 years of experience. Individuals with a PhD who have no experience may also be appointed to this position if appropriate. + Excellent communication, interpersonal skills, and customer service. + Exemplary organizational and time management skills. + The successful candidate must be legally eligible to work in the U.S. by date of hire; the Clinical Sciences department will not provide visa sponsorship for these positions. **Preferred Qualifications:** Preferred qualifications vary by laboratory and may include: + Ability to work independently and collaboratively in a research environment. + Experience with data analysis, scientific writing, or specialized research techniques relevant to the hiring lab. **Application Instructions:** This is an **open pool** posting. Applications will be reviewed as hiring needs arise, and qualified applicants may be contacted by individual faculty members if a suitable opportunity becomes available. This pool will expire on **July 1, 2026** . Applicants wishing to be considered beyond this date must reapply. **Salary Range** Non-Exempt (NEX) (eligible for compensatory/over time) Position Range: NEX RAI $47,000 - $65,000 & NEX RAII $50,000- $73,200 or Exempt (EX) (not eligible to earn compensatory/over time) Position Range: EX RAII $52,000- $75,000 EX RAIII $62,000 - $92,000. **Required Application Documents** To apply, please upload the following applicant documents. Ensure your materials fully address the required and preferred job qualifications of the position. 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. Cover Letter, Resume/CV **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! **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 for the finalist before a final offer. 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. **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. Inspired by its land-grant heritage, Colorado State University is committed to excellence and engagement, setting the standard for public research universities in teaching, research, service and extension for the benefit of the citizens of Colorado, the United States, and the world. Prospective Employees, click here to learn more about CSU's perks and purpose. (************************************************ Current employees will need to apply for jobs in Workday.

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.

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

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

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities Leads a team of clinicians and technicians in carrying out complex study protocols: o Management may include multiple concurrent studies o Studies may require multiple visits by participants o Studies may require travel to other states Responsible for understanding protocol requirements and utilizing critical thinking skills Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals Creates case report forms, based on written protocol Develops, completes, and maintains source documents Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols Assures clinical supply accountability for assigned trials Responsible for securing all sponsor-supplied devices and equipment Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish. Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Skills / Qualifications Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training Must not have any disciplinary action on license history Clinical Research Experience preferred Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management; prior management experience preferred Strong organizational and critical thinking skills, including attention to detail Travel is required up to 25% Must be capable of performing all clinical tasks relevant to licensure and/or training Must possess excellent written and verbal communication skills Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc. Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook) Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company Technical background is a plus #LI-TK1 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 ***********************”

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#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 Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world's most trusted testing partner”. All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) “If you need an accommodation filling out an application, or applying to a job, please email ***********************”

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **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_

Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Clinical Research Coordinator/RN at our Skyridge location in Boulder. Bring your established Oncology and or Research experience and join a team dedicated to providing an excellent experience to patients. We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It's much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment. No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient's hand, or a scheduler on the phone finding an appointment that fits into a patient's schedule, we are deeply connected to our patients and do what we can to help. If this sounds like you, we'd love to have you join our team. Salary Range: $60,000-$75,000 for non-nurses and $80,000-$97,000 for nurses Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; potential for research bonus depending on financials of department after one year of employment; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance. A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis. Responsibilities * 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. * Knowledge of medical terminology, nursing assessment, anatomy and physiology, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology, clinical trials and GCPconcepts. -Experience with computer data entry and database management. -Excellent written and oral communication skills. * Excellent organizational skills-Attention to details and accuracy-Ability to read, analyze, and interpret technical procedures such as protocols, informed consent documents, and regulatory documents. -Ability to work independently, organize, prioritize, and follow through with results.-Ability to solve practical problems and implement solutions. Working Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.) All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire. Candidates will be required to show proof of being vaccinated against influenza upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law. This job posting will remain open until we have identified an adequate applicant pool. Applicants are strongly encouraged to apply early. To apply for this position, start the process by clicking the blue "apply" button.

Full-time Description Who We Are At Panorama Eyecare, we are not just a team; we are a community of dedicated professionals united in our quest to provide the best eyecare anywhere. Our unflinching commitment to excellence and our core values are what make us an Employer of Choice. Join us in shaping the future of eyecare as we thrive together! The Position: As a Clinical Research Coordinator at Panorama Eyecare, you will play a pivotal role in our mission to deliver the best eyecare. You'll be part of a collaborative team that values Partnership, Engagement, Excellence, and Stewardship. Together, we create an environment where mutual respect is at the forefront, equipping you with the tools, training, and empowerment necessary to excel in your role. The Role Our Clinical Research Coordinators are medical professionals that are responsible for the management and well-being of ophthalmic patients enrolled in clinical trials. They will work with the entire health care team to provide exceptional care to study patients and ensure that studies are conducted in an accurate and ethical manner. Responsible for all study patient care including but not limited to: performing study related testing, educating and consenting participants, dispensing study product, scheduling visits, completing source documentation, distributing stipends, and communicating with participants Promotes and enrolls clinical research patients into research program Attends study surgeries and provides guidance for ASC staff Identifies potential Adverse Events/Serious Adverse Events and follows reporting requirements Receives, manages, and dispenses investigational product Conducts calibration checks on all study equipment Tracks study supply inventory and re-orders as necessary Attends periodic investigator meetings Facilitates communication between ECNC and all Sponsors, IRBs, and labs Captures accurate and detailed source information Completes data entry for all studies Assists study monitors with data review and query resolution Ensures study logs are completed in an appropriate and timely manner Trains study and clinic staff on protocol requirements and changes Ensures highest level of protocol compliance at all times Self-study is required to obtain/maintain Certified Clinical Research Coordinator Certification within 30 months of employment Maintains Good Clinical Practice Certification Coordinates scheduling needs with other departments High attention to detail and accuracy Ability to acquire additional skills as necessary to perform the study being conducted Performs additional duties when necessary Requirements Who You Are High school diploma or equivalent required Experience utilizing Microsoft Office Applications (Outlook, Word, etc.) COA/COT and/or CCRC preferred. Certifications must be maintained. GCP certification maintenance required Prior experience with human subjects. Prior research related experience preferred Phlebotomy certification preferred Additional Job Details Works at our clinic location, Eye Center of Northern Colorado - Precision (3151 Precision Dr, Fort Collins, CO). This is a Full-Time Position. Compensation for this role will be $27 - $33 an hour based on experience/certification. Our Growth Opportunities At Panorama Eyecare, we care about our employee's ability to grow within the company. Therefore, we have created career growth plans that allow employees the ability to work toward their professional growth. We encourage all employees to apply for internal openings they may be qualified for, and we welcome the opportunity to interview and coach employees on how to grow. Our Employee Perks PTO Accruals Start at 3 Weeks Comprehensive Medical and Dental Insurance Company Paid Optical Allowance Company Paid Routine Eye Care Short Term and Long-Term Disability Insurances Educational Allowance Generous Paid Holiday Program 401K With Company Match Join Our Team! Embark on a rewarding journey with Panorama Eyecare and become part of a team that embodies the values of Partnership, Engagement, Excellence, and Stewardship. As an Eyecare Professional, you will not only provide exceptional patient care, but also shape the future of our practices. Together, we are transforming the eyecare landscape. Apply now and let your passion for excellence and patient well-being shine! EEOC Panorama Eyecare is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any characteristic protected by law. Salary Description $27-$33 / hour

Work Study - Bodhi Bodega Coordinator # of Positions to Fill: 1 Department/Program: Student Affairs 51000 Reports to: Director of Residential and Campus Life / Dean of Students FLSA Classification: Non-Exempt/Hourly FTE: 25% (10 hrs/week) Compensation: $18.00 per hour Application Deadline: 1/21/26 or until filled Job Summary The Bodhi Bodega Coordinator oversees all aspects of the University's Community Supported Agriculture program and campus-based food pantry, along with appropriate faculty, staff, and student groups. This role is responsible for member relations, weekly share coordination, produce distribution, and communication. The BBC manages both the operational and administrative sides of the program to ensure a smooth, community-centered experience for members. Job Duties & Responsibilities • Manage CSA membership enrollment, records, and communications. • Coordinate weekly harvest lists with the farm team and pack CSA shares. • Organize and oversee member pickup or delivery logistics. • Maintain accurate inventory and track produce allocation. • Communicate regularly with members through newsletters, emails, or social media updates. • Handle payments, renewals, and customer service inquiries. • Support event days or farm tours related to the CSA program. What Naropa Requires… Student must be awarded federal work study hours by the Financial Aid office in order to fill this position. • High degree of emotional intelligence, critical thinking, and assertive communication skills. • Ability to create and maintain a positive team environment and behave professionally with everyone encountered in the course and scope of the job duties. • Ability to do some light to heavy lifting. • Willingness to help with housekeeping duties as required. • Self-motivated, reliable, energetic and detail oriented. • Punctuality, dependability, ingenuity, teamwork, and honesty. • Ability to work as scheduled; must be available evenings and weekends. • Ability to receive and respond to emails in a timely manner. • A good attitude and a sense of humor. • Must be willing and able to wear appropriate clothing. • All job candidates must demonstrate an appropriate level of understanding of and appreciation for the values of Naropa University and the capacity to demonstrate an integration and embodiment of these values as evidenced in work, communication, collaboration styles, and other general workplace behaviors. Physical Requirements & Environmental Conditions Maximum amount of weight employee must be able to lift/carry with or without reasonable accommodation(s): • 25 pounds (occasionally 50 to 70 pounds with assistance). During regular daily activities, employee must be able to do the following with or without reasonable accommodation (check all that apply): Stand, walk, sit, handle/finger, bend at the waist, reach above shoulder level, kneel, crouch and crawl. During regular daily activities, employee may be exposed to the following: Interruptions/distractions, heat/cold, dust, dampness, heights, moving machinery. Naropa recognizes the following holidays throughout the year: Martin Luther King, Jr. Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Fall Break, 4th Thursday and Friday in November, and Winter Break, the last two weeks in December encompassing the Christmas holiday as well as New Year's. Naropa's health and welfare benefits include the following: medical, dental, vision, FSA, HSA, employer-paid short-term and long-term disability, employer-paid life insurance and accidental death and dismemberment, an employer-sponsored pre-tax retirement savings plan, which includes up to 2.5% employer matching, and a variety of voluntary, employee-paid supplemental insurance plans. A comprehensive benefits package is available to full-time employees who work a minimum of 30 hours each week. Employees who work 20 - 29 hours each week are eligible for only the employer-paid short-term & long-term disability, employer-paid life insurance & accidental death and dismemberment, and the retirement plan, which includes up to 2.5% employer matching. Employees who work fewer than 20 hours per week are eligible to participate in Naropa's retirement plan only, which includes up to 2.5% employer matching. All regular full-time and part-time faculty and staff, including student workers, accrue sick leave benefits. Full-time and part-time staff positions accrue vacation and personal time. All leave accrual rates vary based on the position, hours worked, and years of service. The University recognizes the importance of including its employees in its organizational mission and values and welcomes employees into the classroom to “touch the magic.” Specifically, regular employees are provided generous tuition remission opportunities for themselves and their family members. Naropa University participates in the Council of Independent Colleges Tuition Exchange Program (CIC-TEP). CIC-TEP is a network of CIC colleges and universities willing to accept, tuition-free, students from families of full-time employees of other CIC participating institutions (full-time as designated by the employer/institution). Additional information can be found here: ************************************************************* Naropa University is an equal opportunity, non-discriminatory employer and Title IX is a federal civil rights law that prohibits gender discrimination, sexual harassment, sexual and relationship violence. This law applies to all students, faculty, and staff. JOB CODE: AY2526 0081

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. 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 Employees are our number one asset. UCHealth promotes a culture that invests in professional success and personal well-being through a comprehensive total rewards program. * Recognition + Performance bonus: UCHealth offers a 3-Year Incentive Bonus to recognize employee contributions to our success in quality, patient experience, organizational growth, financial goals and tenure. The bonus accumulates annually each October and is paid out in October during the third year of employment. + Performance-based pay increase: The Annual Merit Pay Increase recognizes work performance that meets or consistently exceeds performance standards documented through UCHealth's established evaluation process and accounts for increased experience, skills and cost of living. + Market reviews: All UCHealth positions are reviewed annually to ensure UCHealth base pay aligns with market standards. Base pay rates are adjusted as needed to stay market competitive. Health and well-being + Medical, dental and vision coverage. + Access to 24/7 mental health and well-being support for employees and dependents. + Discounted gym memberships and fitness resources. + Free Care.com membership. + Voluntary benefits such as accident insurance, critical illness insurance, group legal plan, identity theft protection, pet insurance, auto and home insurance, and employee discount programs. + Time away from work: Paid time off (PTO), paid family and medical leave (inclusive of Colorado FAMLI), leaves of absence. + New employees receive an initial PTO load with first paycheck. + Employer-provided basic life and accidental death and dismemberment coverage with buy-up coverage options. + Employer-provided short-term disability and long-term disability with a buy-up coverage option. Retirement and savings + 403(b) plan with employer matching contribution. + Additional 457(b) plan may be available. + Flexible spending accounts for health care and dependent day care; health savings account available when enrolled in high-deductible (HD) medical plan. Education and career growth + UCHealth provides access to academic degrees and certificate programs to promote professional and personal growth. + Up to 100% of tuition, books and fees paid for by UCHealth for specific educational degrees. + Other programs may qualify for up to $10,000/year pre-paid by UCHealth or up to $5,250/year in the form of tuition reimbursement. + Access to LinkedIn Learning, which offers thousands of virtual courses and seminars, and internal professional development opportunities. + Employees have access to free assistance navigating the Public Service Loan Forgiveness program and submitting their federal student loans for forgiveness. *Eligibility for some programs is based on an employee's scheduled work hours. 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 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 ay 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 the do not impose an undue hardship on the organization. Who We Are (uchealth.org) AF123

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. 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 Employees are our number one asset. UCHealth promotes a culture that invests in professional success and personal well-being through a comprehensive total rewards program. * Recognition * Performance bonus: UCHealth offers a 3-Year Incentive Bonus to recognize employee contributions to our success in quality, patient experience, organizational growth, financial goals and tenure. The bonus accumulates annually each October and is paid out in October during the third year of employment. * Performance-based pay increase: The Annual Merit Pay Increase recognizes work performance that meets or consistently exceeds performance standards documented through UCHealth's established evaluation process and accounts for increased experience, skills and cost of living. * Market reviews: All UCHealth positions are reviewed annually to ensure UCHealth base pay aligns with market standards. Base pay rates are adjusted as needed to stay market competitive. Health and well-being * Medical, dental and vision coverage. * Access to 24/7 mental health and well-being support for employees and dependents. * Discounted gym memberships and fitness resources. * Free Care.com membership. * Voluntary benefits such as accident insurance, critical illness insurance, group legal plan, identity theft protection, pet insurance, auto and home insurance, and employee discount programs. * Time away from work: Paid time off (PTO), paid family and medical leave (inclusive of Colorado FAMLI), leaves of absence. * New employees receive an initial PTO load with first paycheck. * Employer-provided basic life and accidental death and dismemberment coverage with buy-up coverage options. * Employer-provided short-term disability and long-term disability with a buy-up coverage option. Retirement and savings * 403(b) plan with employer matching contribution. * Additional 457(b) plan may be available. * Flexible spending accounts for health care and dependent day care; health savings account available when enrolled in high-deductible (HD) medical plan. Education and career growth * UCHealth provides access to academic degrees and certificate programs to promote professional and personal growth. * Up to 100% of tuition, books and fees paid for by UCHealth for specific educational degrees. * Other programs may qualify for up to $10,000/year pre-paid by UCHealth or up to $5,250/year in the form of tuition reimbursement. * Access to LinkedIn Learning, which offers thousands of virtual courses and seminars, and internal professional development opportunities. * Employees have access to free assistance navigating the Public Service Loan Forgiveness program and submitting their federal student loans for forgiveness. * Eligibility for some programs is based on an employee's scheduled work hours. 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 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 ay 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 the do not impose an undue hardship on the organization. Who We Are (uchealth.org) AF123

Since 1970, Salud has been committed to providing a Medical Home to patients, where medical, dental, behavioral health services, and clinical pharmacists work together and coordinate efforts in a team-based system of care. We strive to improve the quality of our patient's lives who would otherwise have limited access to health care. We serve all individuals regardless of their insurance status or ability to pay. Job Description We are looking for a Full-Time, caring Dental Clinic Coordinator . You will perform duties that assist the Dental Director, Dentists, and Dental Hygienists in the care and treatment of patients. As a Dental Clinic Coordinator, you will perform duties in the areas of reception, inventory, and records management. We offer: $21.50 to $26 per hour Monday to Friday - 8 am to 5 pm Comprehensive Benefits Package includes: Medical PPO Plan (Similar to ACA Exchange Platinum Benefit Coverage Levels) Low employee premiums, especially given rich benefits $25 Primary Care Physician and Specialist Co-pays (in-network) Low deductibles and co-insurance Free provider visits and services at all Salud facilities Preferred prescription pricing at Salud pharmacies Dental PPO plan Includes Employee Discounts at All Salud Dental Facilities Vision Generous vacation accrual 10 Paid Holidays per year (includes 2 Floating Holidays and paid Birthday) Up to 8 Paid accrued Sick Days per year Defined Contribution Pension Plan. Salud contributes 5% of your compensation each month (no matching employee contribution is required…you receive the contribution no matter what). Employees who have worked at least 1,000 hours within 12 months are eligible 403b Retirement savings plan. You can contribute pre-tax or after-tax (Roth) towards your retirement savings Flexible Spending Accounts Basic Life and AD&D Supplemental Life and AD&D Short-Term & Long-Term Disability Accident & Critical Illness Insurance Employee Assistance Program Our Mission is to provide a quality, integrated healthcare home to the communities we serve About our Clinic: Our medical practice is quite lively. We treat our patients with the utmost respect and concern for their well-being while instilling a fun and vibrant atmosphere bringing smiles to all who enter our doors. A positive attitude toward modern dental medicine brings joy to the healing journey. Qualifications Education: Graduation from high school or equivalent is required Experience: Bi-lingual English and Spanish preferred Knowledge of front and back Dental Office procedures is preferred Previous dental assistant experience strongly desired The application window is anticipated to close by 1/31/26 Additional Information Salud Family Health is an Equal Opportunity Employer. We prohibit unlawful discrimination against applicants or employees on the basis of age 40 and over, race, color, religion, national origin, sex, disability, sexual orientation, gender identity, or any other applicable status protected by federal, state, or local laws. All your information will be kept confidential according to EEO guidelines.

Why Choose the Clinic Admissions Associate role at ABC: Pay: $19-$22 with bonus potential of up to $6,000 Structured career and compensation growth: Clear pathways to move up within the company from CAA to Operations and beyond. Generous Paid Time Off: 22 paid days off in year 1: 10 holidays, 10 paid days, PLUS 2 flex days Industry-leading benefits: Student Loan Repayment, Maternity/Paternity Award of up to $3,000, HSA for child care, Short Term Disability options, Calm App and DoorDash subscriptions Mission and Values based team culture Additional Rewards: Team outings and events to bond and celebrate our wins both big and small! Professional development: we want to pour into you as you pour into ABC Leadership opportunities: To be the best, we have to continually keep learning and you get to push yourself here to learn more and take on more responsibilities and show what you can do! 401K Retirement Plans with company matching Health Benefits covered up to 90%! Free Lunch Fridays! ABC Story Our story began in 2017 in Austin. TX. We started with humble roots but big aspirations. From 1 center in North Austin, our movement has grown to help numerous families in the autism community. Today, the ABC community is 3000+ strong serving thousands of children with ASD. Growth with intentionality: We have a maniac focus on our core values. Each center is purpose-built, each community of teammates is nurtured. What you will be doing at ABC: Responsible for the day-to-day administrative functions for our busy clinics such as document management, keeping track of people + things, and internal + external communication with referral sources Give great support to inbound calls from both prospective + current clients/families You will become a subject matter expert on autism in order to help others understand how we help our children + how we can help them Handle various marketing + admissions tasks to support the work of our operations manager and clinical leadership Embody our core values (Learning, Team, Excellence, Caring, + Fun!) and be a cultural role model for your teammates What you will bring to ABC: A positive and contagious attitude that shows your readiness to engage with our families! Experience in administrative work, customer service, client relations, or related areas. Maybe you are looking to break into healthcare! A passion for work that benefits children with Autism Spectrum Disorder and their families! An eagerness to be a part of a caring and team-oriented company culture A deep commitment to show up everyday and be a leader at your center High School Diploma or GED Required. Bachelor's Degree preferred. How you can grow at ABC: As a CAA, you will always continue learning and growing! Here at ABC, we have both a direct path for growth, as well as creative job opportunities! Other CAA Growth Opportunities: Sr. CAA / Assistant Operations Manager / Clinic Operations Manager Various Additional Corporate Openings See what others have said when they made the decision to grow with us! Glassdoor LinkedIn © Copyright 2025

Since 1970, Salud has been committed to providing a Medical Home to patients, where medical, dental, behavioral health services, and clinical pharmacists work together and coordinate efforts in a team-based system of care. We strive to improve the quality of our patient's lives who would otherwise have limited access to health care. We serve all individuals regardless of their insurance status or ability to pay. Job Description We are looking for a Full-Time, caring Dental Clinic Coordinator. You will perform duties that assist the Dental Director, Dentists, and Dental Hygienists in the care and treatment of patients. As a Dental Clinic Coordinator, you will perform duties in the areas of reception, inventory, and records management. We offer: $21.50 to $26 per hour Monday to Friday - 8 am to 5 pm Comprehensive Benefits Package includes: Medical PPO Plan (Similar to ACA Exchange Platinum Benefit Coverage Levels) Low employee premiums, especially given rich benefits $25 Primary Care Physician and Specialist Co-pays (in-network) Low deductibles and co-insurance Free provider visits and services at all Salud facilities Preferred prescription pricing at Salud pharmacies Dental PPO plan Includes Employee Discounts at All Salud Dental Facilities Vision Generous vacation accrual 10 Paid Holidays per year (includes 2 Floating Holidays and paid Birthday) Up to 8 Paid accrued Sick Days per year Defined Contribution Pension Plan. Salud contributes 5% of your compensation each month (no matching employee contribution is required…you receive the contribution no matter what). Employees who have worked at least 1,000 hours within 12 months are eligible 403b Retirement savings plan. You can contribute pre-tax or after-tax (Roth) towards your retirement savings Flexible Spending Accounts Basic Life and AD&D Supplemental Life and AD&D Short-Term & Long-Term Disability Accident & Critical Illness Insurance Employee Assistance Program Our Mission is to provide a quality, integrated healthcare home to the communities we serve About our Clinic: Our medical practice is quite lively. We treat our patients with the utmost respect and concern for their well-being while instilling a fun and vibrant atmosphere bringing smiles to all who enter our doors. A positive attitude toward modern dental medicine brings joy to the healing journey. Qualifications Education: Graduation from high school or equivalent is required Experience: Bi-lingual English and Spanish preferred Knowledge of front and back Dental Office procedures is preferred Previous dental assistant experience strongly desired The application window is anticipated to close by 1/31/26 Additional Information Salud Family Health is an Equal Opportunity Employer. We prohibit unlawful discrimination against applicants or employees on the basis of age 40 and over, race, color, religion, national origin, sex, disability, sexual orientation, gender identity, or any other applicable status protected by federal, state, or local laws. All your information will be kept confidential according to EEO guidelines.

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Why Choose the Clinic Admissions Associate role at ABC: Pay: $19-$22 with bonus potential of up to $6,000 Structured career and compensation growth: Clear pathways to move up within the company from CAA to Operations and beyond. Generous Paid Time Off: 22 paid days off in year 1: 10 holidays, 10 paid days, PLUS 2 flex days Industry-leading benefits: Student Loan Repayment, Maternity/Paternity Award of up to $3,000, HSA for child care, Short Term Disability options, Calm App and DoorDash subscriptions Mission and Values based team culture Additional Rewards: Team outings and events to bond and celebrate our wins both big and small! Professional development: we want to pour into you as you pour into ABC Leadership opportunities: To be the best, we have to continually keep learning and you get to push yourself here to learn more and take on more responsibilities and show what you can do! 401K Retirement Plans with company matching Health Benefits covered up to 90%! Free Lunch Fridays! ABC Story Our story began in 2017 in Austin. TX. We started with humble roots but big aspirations. From 1 center in North Austin, our movement has grown to help numerous families in the autism community. Today, the ABC community is 3000+ strong serving thousands of children with ASD. Growth with intentionality: We have a maniac focus on our core values. Each center is purpose-built, each community of teammates is nurtured. What you will be doing at ABC: Responsible for the day-to-day administrative functions for our busy clinics such as document management, keeping track of people + things, and internal + external communication with referral sources Give great support to inbound calls from both prospective + current clients/families You will become a subject matter expert on autism in order to help others understand how we help our children + how we can help them Handle various marketing + admissions tasks to support the work of our operations manager and clinical leadership Embody our core values (Learning, Team, Excellence, Caring, + Fun!) and be a cultural role model for your teammates What you will bring to ABC: A positive and contagious attitude that shows your readiness to engage with our families! Experience in administrative work, customer service, client relations, or related areas. Maybe you are looking to break into healthcare! A passion for work that benefits children with Autism Spectrum Disorder and their families! An eagerness to be a part of a caring and team-oriented company culture A deep commitment to show up everyday and be a leader at your center High School Diploma or GED Required. Bachelor's Degree preferred. How you can grow at ABC: As a CAA, you will always continue learning and growing! Here at ABC, we have both a direct path for growth, as well as creative job opportunities! Other CAA Growth Opportunities: Sr. CAA / Assistant Operations Manager / Clinic Operations Manager Various Additional Corporate Openings See what others have said when they made the decision to grow with us! Glassdoor LinkedIn © Copyright 2025