Clinical research associate jobs in Arvada, CO - 132 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.

, you must reside in the same country where the job is located. Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Collaborate and liaise with study team members for project execution support as appropriate. - If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications - Bachelor's Degree Degree in scientific discipline or health care preferred. - Requires at least 2 years of year of on-site monitoring experience. - Equivalent combination of education, training and experience may be accepted in lieu of degree. - Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. - i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Good therapeutic and protocol knowledge as provided in company training. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). - Written and verbal communication skills including good command of English language. - Organizational and problem-solving skills. - Effective time and financial management skills. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

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

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

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

Clinical Research Associate I DEPARTMENT: Monitoring Preferred Locations: CA,CO, UT, NV, NE, KS, MO, IL, IN, KY, TN, OH Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America. The Role: Ora's Clinical Research Associate I (CRA I) develop strong clinical site relationships and are accountable for performance and compliance for assigned protocols at our sites. Our CRA I's will work with the oversight of the Lead CRA's and Line Manager. As a CRA I, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross functionally within Ora. What You'll Do: Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gain in-depth understanding of the study protocol and related procedures. Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. Participate & provide input on site selection and validation activities. Perform remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased Subjects' right, safety and well-being are protected Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Collect, review, and monitor regulatory documentation for study start-up, study maintenance and study close-out. Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Supports audit/inspection activities as needed. Travel Requirements up to 75%. Adhere to all aspects of Ora's quality system. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business. What We Look For: Experience Needed for the Role: Bachelor's degree with 1 years' experience in the clinical research field or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education. Additional Skills and Attributes: Ophthalmic experience strongly preferred. Capacity to routinely assess protocol and GCP compliance. Demonstrated ability to verify source data to reported data. Strong attention to detail in order to review completeness of the investigator site file. Knowledge to reconcile and return/destroy test article while conducting initiation, interim, and close-out visits. Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs). Ability to read and demonstrate a comprehension of a clinical research protocol as well as understand the importance of following the protocol. Proficiency with Excel, CTMS and EDC. Multilingual communication is a plus. Competencies and Personal Traits: What We Do: Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. How We Do It: IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth. Why We Do It: Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see. What We Offer: Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. Financial: Competitive salaries along with a 401K plan through Fidelity with company match. Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. Career Development Opportunities: Continued opportunities to grow and develop your career journey. Global Team: Opportunities to work with colleagues across the globe. Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Our Privacy Policy | Ora (oraclinical.com)

As an important member of the Philips North America MRI Clinical Science team, the MRI Clinical Scientist will primarily collaborate with medical doctors and physicists at Children's Hospital in Denver Colorado and provide additional support for hospitals in Arizona (Phoenix Children's/ Barrow Neurological Institute) and California (UCSF & CHLA), with a focus on research, development, and evaluation of new medical applications for Magnetic Resonance Imaging to include co-creation and collaboration opportunities in the areas of pediatric, cardiac, fetal, and neuro imaging. Your role: * The MRI Clinical Scientist will guide, conduct, and support research and advanced clinical applications for the Magnetic Resonance Imaging (MRI) product line at luminary sites in North America. * Will be the expert MRI specialist on an assigned technical or clinical application area, build a network in the scientific community, report and advise about new insights and technologies within the MRI Business Unit. * Drive clinical co-creation projects at designated sites to generate transfers of ideas, research prototypes, solutions, and IP for product development and generate evidence to support claims through scientific publications. * Be hands-on, be able to independently run the Philips MR scanners and perform volunteer and patient scanning and guide the users on Philips scanner capabilities and development tools. * Increase visibility of Philips MR program through lectures and presentation at scientific or professional international conferences as well as involvement in professional organizations. * Assist the larger organization in clinical evaluation reports, white papers and materials to support new product introductions. * Support dedicated training courses on research tools and clinical capabilities. * Provide guidance in the sales process to luminary customers through broad MR and clinical expertise. You're the right fit if: * You have a minimum of a Ph.D. in physics (preferred), biomedical engineering, or comparable disciplines. * You've acquired a minimum of 2+ years' professional experience beyond a PhD program/academic setting, in MRI/clinical imaging, development on/advanced application of MR systems in a clinical setting, with the proven ability to conduct research and set up research studies. * You have a strong working knowledge of MRI Physics (Required), MR Pulse Programming, reconstruction, and AI development experience is strongly desired. * You have excellent communication, teaching, and presentation skills. You're an independent problem solver, with strong analytical and experimental skills. * You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This role will be based at Children's Hospital Colorado, in Denver, CO and must be on-site 3X per week. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. * Learn more about our culture. Philips Transparency Details: * The pay range for this position in Denver, CO is $101,625 to $162,600. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information: * US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. * For this position, you must reside within the Denver, CO area or be willing to relocate to Denver, CO. * May require travel up to 25%. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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 ***********************”

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

PXL is hiring a Clinical Scientist! **Job Purpose:** The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management). **Key Accountabilities** May include but not limited to the following: Clinical Trial Operational Delivery - May support a single study or multiple studies - May lead a study with limited scope (e.g., Survival Follow-up) - Liaises with cross-functional lines as appropriate - May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives Compliance with Parexel Standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - Demonstrated oral and written communication skills - MS Office Suite Experience Required- including Word, Excel, and Power Point - Proficient in written and spoken English - Proficient in local language (as applicable) - Willingness to travel as required for key company meetings Knowledge and Experience: - Pharmaceutical experience beneficial but not required - Therapeutic Area (TA) specific experience beneficial - 2 years medical monitoring experience preferred Education: - Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience - If no degree in Life Sciences, must have significant experience in clinical development (>5 years) \#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.

**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!_

Job TitleMRI Clinical ScientistJob Description As an important member of the Philips North America MRI Clinical Science team, the MRI Clinical Scientist will primarily collaborate with medical doctors and physicists at Children's Hospital in Denver Colorado and provide additional support for hospitals in Arizona (Phoenix Children's/ Barrow Neurological Institute) and California (UCSF & CHLA), with a focus on research, development, and evaluation of new medical applications for Magnetic Resonance Imaging to include co-creation and collaboration opportunities in the areas of pediatric, cardiac, fetal, and neuro imaging. Your role: The MRI Clinical Scientist will guide, conduct, and support research and advanced clinical applications for the Magnetic Resonance Imaging (MRI) product line at luminary sites in North America. Will be the expert MRI specialist on an assigned technical or clinical application area, build a network in the scientific community, report and advise about new insights and technologies within the MRI Business Unit. Drive clinical co-creation projects at designated sites to generate transfers of ideas, research prototypes, solutions, and IP for product development and generate evidence to support claims through scientific publications. Be hands-on, be able to independently run the Philips MR scanners and perform volunteer and patient scanning and guide the users on Philips scanner capabilities and development tools. Increase visibility of Philips MR program through lectures and presentation at scientific or professional international conferences as well as involvement in professional organizations. Assist the larger organization in clinical evaluation reports, white papers and materials to support new product introductions. Support dedicated training courses on research tools and clinical capabilities. Provide guidance in the sales process to luminary customers through broad MR and clinical expertise. You're the right fit if: You have a minimum of a Ph.D. in physics (preferred), biomedical engineering, or comparable disciplines. You've acquired a minimum of 2+ years' professional experience beyond a PhD program/academic setting, in MRI/clinical imaging, development on/advanced application of MR systems in a clinical setting, with the proven ability to conduct research and set up research studies. You have a strong working knowledge of MRI Physics (Required), MR Pulse Programming, reconstruction, and AI development experience is strongly desired. You have excellent communication, teaching, and presentation skills. You're an independent problem solver, with strong analytical and experimental skills. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This role will be based at Children's Hospital Colorado, in Denver, CO and must be on-site 3X per week. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in Denver, CO is $101,625 to $162,600. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. For this position, you must reside within the Denver, CO area or be willing to relocate to Denver, CO. May require travel up to 25%. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Our clinical operations activities are growing rapidly, and we are currently seeking an experienced Study Start-Up Coordinator to join our Regulatory Submissions team in Denver, CO. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. If you want an exciting career where you build upon the foundation of your previous expertise and can develop and grow your career even further, then this is the opportunity for you. *This position is office-based in Denver, CO. Responsibilities * Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial; * Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); * Collect, review, organize, and assemble regulatory start-up submissions (includes submissions to Institutional Review Boards); * Maintain timelines for study start-up through both internal and external collaboration; * Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements; and * Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges. SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAM Medpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence based learning & development models to advance professional learning and employee performance. In the program, you will… * Complete independent learning modules, interactive exercises, and team workshops through the core curriculum; * Gain exposure to real-world tasks through a robust mentoring program; and * Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials. Qualifications * A minimum of a Bachelor's degree is required (preferably in a Life Sciences field); * Experience as a Clinical Research Coordinator or industry equivalent (minimum 3 years); * Excellent organizational and prioritization skills; * Experience with Institutional Review Board (IRB) submissions and Informed Consent Form development is required; * Knowledge of Microsoft Office; and * Great attention to detail and excellent oral and written communication skills. Compensation A target salary range of $40,000 - $100,000 with potential for bonus awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). Applications will be accepted on an ongoing basis. For more details, please discuss with your recruiter. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Denver Perks * Denver Office Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Structured career paths with opportunities for professional growth * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * RTD Eco Pass * Secure bike storage room Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Clinical Research Coordinator (Open Rank, Intermediate or Senior) - 38698 University Staff Description University of Colorado Anschutz Medical CampusDepartment: RheumatologyJob Title: Clinical Research Coordinator (Open Rank, Intermediate or Senior) Position #:00843757 - Requisition #:38698 Job Summary:As a Clinical Research Coordinator in the Yomogida Lab at the University of Colorado Anschutz Medical Campus, you will play a key role in advancing groundbreaking research in immunology and pediatric autoimmune diseases. This position provides a unique opportunity to contribute directly to impactful biomedical research while developing strong hands-on laboratory and clinical research skills. In this role, you will communicate with patients and families to obtain informed consent for research participation and will be responsible for processing and storing clinical specimens according to established protocols. The position combines patient interaction with laboratory-based responsibilities, offering an ideal training environment for individuals interested in translational science, immunology, or future careers in medicine, graduate school, or industry research. Key Responsibilities:Identify eligible research participants and clearly explain study procedures to patients and families. Obtain informed consent/assent in accordance with IRB-approved protocols and institutional policies. Coordinate and assist with specimen collection during clinic visits and procedures. Process, label, and aliquot clinical biospecimens (blood, synovial fluid, and tissue) following established SOPs. Ensure proper storage and tracking of samples in liquid nitrogen, −80°C freezers, or other designated storage systems. Maintain accurate documentation in electronic lab notebooks, REDCap, and other data management systems. Perform basic wet-laboratory tasks, including pipetting, centrifugation, sterile technique, and preparation of reagents. Monitor and organize laboratory inventory, including ordering supplies and maintaining stock levels. Support lab operations by helping schedule meetings, maintain shared workspaces, and ensure regulatory compliance. Communicate effectively with clinical teams, study personnel, and other collaborators to ensure smooth workflow. Work Location:Onsite - this role is expected to work onsite and is located at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. Why Join Us:Join the Yomogida Lab at the University of Colorado Anschutz Medical Campus, a leading center for research in immunology and pediatric autoimmune diseases. Our team fosters a collaborative, supportive environment where you will gain hands-on experience working with human samples and observe how laboratory discoveries translate directly into clinical impact. We are deeply committed to training and career development. This position serves as an excellent launchpad for individuals pursuing advanced degrees such as a PhD, MD, or MD-PhD. Team members receive personalized mentorship, exposure to translational research, and opportunities to develop competitive research skills. As part of the vibrant CU Anschutz community, you will work alongside world-class researchers, clinicians, and trainees dedicated to improving child health. Why work for the University?We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including: Medical: Multiple plan options Dental: Multiple plan options Additional Insurance: Disability, Life, VisionRetirement 401(a) Plan: Employer contributes 10% of your gross pay Paid Time Off: Accruals over the year Vacation Days: 22/year (maximum accrual 352 hours) Sick Days: 15/year (unlimited maximum accrual) Holiday Days: 10/year Tuition Benefit: Employees have access to this benefit on all CU campuses ECO Pass: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage. Qualifications:Minimum Qualifications:Intermediate Level:Bachelor's degree in any field. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. One (1) year clinical research or related experience. An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment. Senior Level:Bachelor's degree in any field. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Two (2) years clinical research or related experience. An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment. Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications:Master's degree in biology, public health, molecular biology, clinical research, chemistry, biomedical sciences, genetics, or related field Experience in clinical research, participant recruitment, informed consent, or clinical trial coordination. Experience communicating with patients and families in a healthcare or research setting. Hands-on experience with wet laboratory procedures such as sample processing, tissue handling, or basic molecular techniques. Two (2) years or more years of experience in an experimental or wet laboratory. Familiarity with REDCap, EPIC, or other clinical data management systems. Knowledge, Skills, and Abilities:Knowledge and understanding of federal regulations and Good Clinical Practice (GCP). Ability to communicate effectively, both in writing and orally. Ability to establish and maintain effective working relationships with employees at all levels throughout the institution. Outstanding customer service skills. Knowledge of basic human anatomy, physiology, and medical terminology. Ability to interpret and master complex research protocol information. Ability to interact professionally with patients, families, and clinical staff. Competence in reviewing and abstracting patient information from electronic medical records (EPIC). Ability to perform basic wet laboratory techniques, including pipetting, centrifugation, biospecimen handling, sterile technique, and sample processing. Strong organizational and time-management skills, with the ability to prioritize tasks and in a fast-paced clinical research environment. Ability to follow detailed standard operating procedures (SOPs) and maintain accurate documentation. Demonstrated reliability and professionalism. Attention to detail and commitment to accurate documentation and adherence to standard operating procedures (SOPs). Ability to maintain confidentiality and comply with HIPAA, biosafety, and institutional research regulations. Conditions of Employment:Work onsite at Children's Hospital Colorado and the Barbara Davis Center. Ability to work in clinical environments, including outpatient clinics and procedure areas. Handling of human biospecimens (blood, synovial fluid, and tissue) in accordance with biosafety and HIPAA guidelines. Adherence to all institutional training requirements, including HIPAA, CITI, Biosafety, Bloodborne Pathogens, and COI disclosures. Use of personal protective equipment (PPE) such as gloves, lab coats, and eye protection when required. Ability to stand, walk, or transport samples between locations for extended periods. Occasional flexible scheduling, depending on patient availability or procedure. How to Apply:For full consideration, please submit the following document(s): A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position. Curriculum vitae / ResumeThree to five professional references, including name, address, phone number (mobile number if appropriate), and email address. Questions should be directed to: Kentaro Yomogida, kentaro. yomogida@cuanschutz. edu Screening of Applications Begins:Applications will be accepted until finalists are identified, but preference will be given to complete applications received by January 31st, 2026. Those who do not apply by this date may or may not be considered. Anticipated Pay Range: The starting salary range (or hiring range) for this position has been established as:Intermediate Level: $52,721 - $67,061Senior Level: $56,995 - $72,498 The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator Equal Employment Opportunity Statement: CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities. ADA Statement:The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr. adacoordinator@cuanschutz. edu . Background Check Statement:The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. Vaccination Statement:CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program. Application Materials Required: Cover Letter, Resume/CV, List of References Job Category: Research Services Primary Location: Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20229 - SOM-MED-RHEUM GENRL OPERATIONS Schedule: Full-time Posting Date: Jan 15, 2026 Unposting Date: Ongoing Posting Contact Name: Kentaro Yomogida Posting Contact Email: kentaro. yomogida@cuanschutz. edu Position Number: 00843757

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives. The Associate Clinical Project Manager will be involved and assist with the management and execution of clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. Additionally they will assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts. General Responsibilities Coordinate project deliverables such as team meetings, project budgets and timelines, and systems to track study metrics. Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools. Oversee and provide clinical input for the design of the Case Report Forms and electronic databases. Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products. Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation. Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required. Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports. Assure clinical studies are adequately managed to meet the protocol objectives and schedules. If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies. Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified. Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds. Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable. Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines. Effectively communicate with LivaNova study management, participating sites, and any vendors on issues, questions and/or study updates. Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times. Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC). For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability plan and report. Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries. Coordinates closeout of sites/study, archive study documents. Skills and Experience Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO. Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation. Working knowledge of medical terminology. Capability and willingness to learn device function. Ability to interface effectively with medical professionals. Strong analytical and organization skills, with excellent attention to detail and accuracy. Project oversight and tracking capability. Good oral and written communication skills. Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously. Experience with electronic data capture (EDC) and clinical trial management systems (CTMS). Demonstrated ability to perform in a team environment. Ability to travel as necessary to clinical centers to establish and manage clinical studies. Experience as a Project Coordinator/Manager is a plus. Education Minimum Bachelor's Degree in Nursing (a Master's Degree in Nursing is also accepted for candidates who did not complete an undergraduate nursing program). Travel Requirements This position requires regular business travel of 25% or more of the time. Pay Transparency A reasonable estimate of the annual base salary for this position is $95,000 - $105,000 + discretionary annual bonus. Pay ranges may vary by location. Employee benefits include: Health benefits - Medical, Dental, Vision Personal and Vacation Time Retirement & Savings Plan (401K) Employee Stock Purchase Plan Training & Education Assistance Bonus Referral Program Service Awards Employee Recognition Program Flexible Work Schedules Welcome to impact. Welcome to innovation. Welcome to your new life.

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives. The Associate Clinical Project Manager will be involved and assist with the management and execution of clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. Additionally they will assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts. General Responsibilities * Coordinate project deliverables such as team meetings, project budgets and timelines, and systems to track study metrics. * Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools. * Oversee and provide clinical input for the design of the Case Report Forms and electronic databases. * Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products. * Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation. * Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required. * Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports. * Assure clinical studies are adequately managed to meet the protocol objectives and schedules. * If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies. * Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified. * Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds. * Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable. * Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines. * Effectively communicate with LivaNova study management, participating sites, and any vendors on issues, questions and/or study updates. * Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times. * Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC). * For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability plan and report. * Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries. * Coordinates closeout of sites/study, archive study documents. Skills and Experience * Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO. * Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation. * Working knowledge of medical terminology. * Capability and willingness to learn device function. * Ability to interface effectively with medical professionals. * Strong analytical and organization skills, with excellent attention to detail and accuracy. * Project oversight and tracking capability. * Good oral and written communication skills. * Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously. * Experience with electronic data capture (EDC) and clinical trial management systems (CTMS). * Demonstrated ability to perform in a team environment. * Ability to travel as necessary to clinical centers to establish and manage clinical studies. * Experience as a Project Coordinator/Manager is a plus. Education * Minimum Bachelor's Degree in Nursing (a Master's Degree in Nursing is also accepted for candidates who did not complete an undergraduate nursing program). Travel Requirements * This position requires regular business travel of 25% or more of the time. Pay Transparency * A reasonable estimate of the annual base salary for this position is $95,000 - $105,000 + discretionary annual bonus. Pay ranges may vary by location. Employee benefits include: * Health benefits - Medical, Dental, Vision * Personal and Vacation Time * Retirement & Savings Plan (401K) * Employee Stock Purchase Plan * Training & Education Assistance * Bonus Referral Program * Service Awards * Employee Recognition Program * Flexible Work Schedules Welcome to impact. Welcome to innovation. Welcome to your new life.

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

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