Clinical research associate jobs in Loveland, CO - 41 jobs
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Senior Clinical Research Coordinator
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Senior Research Coordinator
Unblinded Clinical Research Coordinator - 244137
Medix™ 4.5
Clinical research associate job in Denver, CO
Job Title: Unblinded ClinicalResearch Coordinator
Pay Range: Up to $27 per hour
Schedule: Monday - Friday, 8:00 AM - 5:00 PM
Duration: 90-day contract with potential for extension or conversion to a permanent position based on performance and trial needs.
Position Summary:
This full-time role supports the day-to-day operations of clinical trials, with a strong focus on Investigational Product (IP) management while maintaining study integrity between blinded and unblinded staff. The Unblinded CRC serves as the subject-matter expert for IP handling and works closely with the Site Manager, study team, sponsors, and participants to ensure compliance with protocols and SOPs.
Key Responsibilities:
Managing all aspects of Investigational Product (receipt, storage, dispensing, administration, accountability, and return/destruction)
Maintaining the study blind and communicating appropriately with blinded and unblinded team members
Conducting patient-facing visits, including vitals, ECGs, lab collection, and protocol-required procedures
Completing accurate source documentation and EDC entry within required timelines
Monitoring study activities for regulatory and protocol compliance
Recording and reporting adverse events and resolving sponsor queries
Participating in site audits, monitor visits, investigator meetings, and site initiation visits
Maintaining temperature logs, pharmacy binders, and master study logs
This position reports directly to the Site Manager/Director and plays a critical role in ensuring studies run smoothly and compliantly.
Required Qualifications:
Recent, heavy hands-on injection or vaccine administration experience, including independent injection administration in accordance with medication protocols
Patient-facing clinical experience (Medical Assistant, ClinicalResearch Assistant, Research Assistant, LPN, etc.)
Ability to work directly with study participants in a clinical setting
Strong attention to detail and accurate documentation skills
Ability to complete source documentation during patient visits and enter data into EDC within required timelines
Ability to follow study protocols, SOPs, and regulatory requirements
Basic understanding of GCP and FDA regulations (training acceptable)
Strong communication and organizational skills
Ability to work Monday-Friday, 8:00 AM-5:00 PM
Ability to start ASAP
Preferred Qualifications:
Previous experience as a ClinicalResearch Coordinator (CRC)
Unblinded CRC or Investigational Product (IP) management experience
Experience with drug accountability, temperature logs, and pharmacy binders
Experience with Investigational Product preparation and administration
Experience participating in monitor visits, audits, SIVs, and investigator meetings
Experience using EDC systems and resolving sponsor queries
Work Environment:
On-site clinicalresearch site supporting active clinical trials and patient-facing activities.
$27 hourly 4d ago
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Clinical Research Associate, Sponsor Dedicated
Iqvia 4.7
Clinical research associate job in Denver, CO
, 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 clinicalresearch 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 clinicalresearch 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 clinicalresearch 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
$58k-78k yearly est. 4d ago
Clinical Sciences Research Associates I, II, III - Open Pool FY 26
Colorado State University 4.0
Clinical research associate job in Fort Collins, CO
The Department of Clinical Sciences mission is to assure the health and productivity of animals to meet societal needs through high quality educational programs for professional veterinary medical students, graduate veterinarians, and the public through a faculty and veterinary medical center of excellence, and to advance and disseminate comparative biomedical knowledge in an environment of interdisciplinary collaboration.
ResearchAssociate I, II or III positions are available in the Department of Clinical Sciences, in the area(s) of animal health, infectious disease, cancer, orthopedics, and reproduction. These positions include interaction with the Principal Investigator as well as other research assistants. The individual will be part of a team of researchers completing a federally funded research project and will have a broad range of responsibilities. Specific positions available may be NEX (Non-Exempt/Eligible for compensatory/over time) or EX (Exempt from earning compensatory/over time). When matched with a position, you will be notified of NEX/EX status at time of interview.
This pool will close at 12:00 AM (MT) on 7/1/26. Individuals wishing to be considered beyond this date must reapply.
**Conditions of Employment:**
Pre-employment criminal background check (required for new hires)
**Essential Job Duties:**
Essential job duties vary depending on the hiring laboratory and research program, but may include:
+ Conducting laboratory, field, or computational research activities.
+ Collecting, managing, and analyzing research data.
+ Assisting with experimental design and protocol implementation.
+ Maintaining laboratory equipment, materials, and documentation.
+ Contributing to manuscripts, reports, and presentations.
+ Collaborating with faculty, staff, graduate students, and other research personnel.
Specific duties will be defined at the time of hire by the supervising faculty member.
**Supervision:**
This position reports to a faculty member within the Department of Clinical Sciences. Day-to-day supervision and expectations are defined by the hiring laboratory.
**Minimum Education:**
Candidates with a bachelor's degree, or an associate degree with 2 years of related professional experience, or a High School Diploma (or GED) and 4 years of related professional experience will be considered for employment at the Research Assistant I level.
ResearchAssociate II and III candidates must have a bachelor's degree or higher in the specified or related field and years of experience generally would not substitute for the degree.
ResearchAssociate I (NEX): Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level:
+ B.A./B.S. in a related field.
OR
+ Associate degree in a related discipline plus 2 years of relevant, specialized training/experience.
OR
+ High School Diploma (or GED) plus 4 years of relevant, specialized training/experience.
AND
+ 1- 3 years of relevant professional experience.
+ Excellent communication, interpersonal skills, and customer service.
+ Exemplary organizational and time management skills.
+ Successful candidate must be legally authorized to work in the United States by time of application; the Clinical Sciences department will not provide visa sponsorship for these positions.
ResearchAssociate II (NEX or EX)
Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level:
+ B.A./B.S. in a related field.
+ 3 or more years of relevant professional experience or a master's degree with no experience.
+ Excellent communication, interpersonal skills, and customer service.
+ Exemplary organizational and time management skills.
+ Successful candidate must be legally authorized to work in the United States by time of application; the Clinical Sciences department will not provide visa sponsorship for these positions.
ResearchAssociate III (EX)
Applicants must have at least one of the following post-baccalaureates (or equivalent) experience level:
+ B.A./B.S. in a related field.
+ 5 or more years of experience or a master's degree with 2 years of experience. Individuals with a PhD who have no experience may also be appointed to this position if appropriate.
+ Excellent communication, interpersonal skills, and customer service.
+ Exemplary organizational and time management skills.
+ The successful candidate must be legally eligible to work in the U.S. by date of hire; the Clinical Sciences department will not provide visa sponsorship for these positions.
**Preferred Qualifications:**
Preferred qualifications vary by laboratory and may include:
+ Ability to work independently and collaboratively in a research environment.
+ Experience with data analysis, scientific writing, or specialized research techniques relevant to the hiring lab.
**Application Instructions:**
This is an **open pool** posting. Applications will be reviewed as hiring needs arise, and qualified applicants may be contacted by individual faculty members if a suitable opportunity becomes available. This pool will expire on **July 1, 2026** . Applicants wishing to be considered beyond this date must reapply.
**Salary Range**
Non-Exempt (NEX) (eligible for compensatory/over time) Position Range: NEX RAI $47,000 - $65,000 & NEX RAII $50,000- $73,200 or Exempt (EX) (not eligible to earn compensatory/over time) Position Range: EX RAII $52,000- $75,000 EX RAIII $62,000 - $92,000.
**Required Application Documents**
To apply, please upload the following applicant documents. Ensure your materials fully address the required and preferred job qualifications of the position. Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution.
Cover Letter, Resume/CV
**Employee Benefits**
Colorado State University is not just a workplace; it's a thriving community that's transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact.
+ Review our detailed benefits information here. (**************************************************************************************
+ Explore the additional perks of working at CSU here.
+ For the total value of CSU benefits in addition to wages, use our compensation calculator. (*******************************************************
+ Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in!
**Background Check Policy Statement**
Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks for the finalist before a final offer. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.
**EEO**
Colorado State University (CSU) provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Inspired by its land-grant heritage, Colorado State University is committed to excellence and engagement, setting the standard for public research universities in teaching, research, service and extension for the benefit of the citizens of Colorado, the United States, and the world.
Prospective Employees, click here to learn more about CSU's perks and purpose. (************************************************
Current employees will need to apply for jobs in Workday.
$62k-92k yearly 3d ago
Clinical Research Associate - Oncology - West Region (Denver, PHX, LA or San Fran)
Icon Clinical Research
Clinical research associate job in Denver, CO
ClinicalResearchAssociate - Oncology - West Region (AZ, CO, CA) ICON plc is a world-leading healthcare intelligence and clinicalresearch 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 clinicalresearch 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
$38k-61k yearly est. 47d ago
Clinical Research Associate 1
Allen Spolden
Clinical research associate job in Denver, CO
Responsible for providing ClinicalResearch 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 clinicalresearch 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 clinicalresearch 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
$38k-61k yearly est. 60d+ ago
Senior Clinical Research Associate - Cardiovascular (EDG-2025017)
Edgewise Therapeutics 4.0
Clinical research associate job in Boulder, CO
Senior ClinicalResearchAssociate - 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.
$100k-140k yearly 60d+ ago
Clinical Research Manager
Element 4.5
Clinical research associate job in Boulder, CO
Element has a current opening for a ClinicalResearch Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the ClinicalResearch 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
* ClinicalResearch 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 ***********************"
$100k-145k yearly Auto-Apply 16d ago
Clinical Research Manager
Job Listingselement Materials Technology
Clinical research associate job in Boulder, CO
Element has a current opening for a ClinicalResearch Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the ClinicalResearch 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
ClinicalResearch 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 ***********************”
$100k-145k yearly Auto-Apply 60d+ ago
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Parexel 4.5
Clinical research associate job in Denver, CO
**Job Purpose:** The Senior ClinicalResearchAssociate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Key Accountabilities:**
**Oversight of Monitoring Responsibilities and Study Conduct**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and
+ recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Collaboration**
+ Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
+ Partners with SCP and Country Study Operations Manager (SOM)
+ When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
+ May act as a Mentor for ClinicalResearchAssociates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience in clinicalresearch site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
+ Preferred therapeutic experience in Oncology
+ Global clinical trial experience preferred
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Travel (60-80%) within area is required
+ Valid driver's license and passport required
**Knowledge and Experience:**
+ Demonstrated knowledge of clinicalresearch and development processes and ability to gain command of process details
+ Demonstrated knowledge of global and local regulatory requirements
+ Demonstrated understanding of key operational elements of clinicalresearch (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
+ Demonstrated ability to support sponsor regulatory interactions/inspections
+ Demonstrated knowledge of the processes around protocol design and feasibility assessment
+ Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
+ Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
+ Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$76k-104k yearly est. 42d ago
Senior Clinical Research Associate
Onpoint Clinical Staffing Services 4.2
Clinical research associate job in Denver, CO
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 clinicalresearch 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.
$61k-94k yearly est. 14h ago
Experienced Study Start-Up Research Coordinator - Denver
Medpace 4.5
Clinical research associate job in Denver, CO
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 ClinicalResearch 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.
$40k-100k yearly Auto-Apply 5d ago
Trial Associate
Lewis & Associates 3.8
Clinical research associate job in Denver, CO
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.
$52k-97k yearly est. 60d+ ago
Senior Electric Grid Cybersecurity Researcher
Nrel
Clinical research associate job in Golden, CO
Posting Title Senior Electric Grid Cybersecurity Researcher . . Type Regular . Hours Per Week 40 . Working at NLR NLR 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
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Basic Qualifications
Relevant 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 Summary
Benefits 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 Requirement
NLR 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.
$44k-70k yearly est. Auto-Apply 44d ago
Clinical Research Coordinator - Environmental and Occupational Health Sciences
National Jewish Health 4.7
Clinical research associate job in Denver, CO
National Jewish Health is seeking a ClinicalResearch Coordinator (CRC) to join our team of lung disease researchers within the Division of Environmental and Occupational Health Sciences (DEOHS). The candidate selected for this role will be detail-oriented, coachable, and highly motivated. We are particularly eager to find someone who has experience interacting directly with patients.
The role of a CRC on our team varies some from day to day and all team members are cross trained to contribute to all of our clinical programs. This coordinator will primarily work with our Sarcoidosis and Interstitial Lung Disease research programs. Major job duties include recruiting participants in our clinics for research, conducting interviews, reviewing medical records, entering study data, and helping meet study regulatory and funding requirements.
Our team invests in training our CRCs so that they become highly skilled at multiple tasks. The ideal candidate will have the ability to work both independently and as an integral member of a team. Phlebotomy experience along with analytical skills and familiarity with database and statistical software are a plus.
As the leading respiratory hospital in the nation, National Jewish Health is pioneering a new era of preventive and personalized medicine. By combining our efforts in comprehensive care, academic education and ground-breaking research, we're able to develop approaches to care and treatment that help our patients live more productive lives.
Position Summary
The ClinicalResearch Coordinator position is a study coordinator with proven ability to work independently. Acts as a preceptor for Assistant ClinicalResearch Coordinator and ClinicalResearch Coordinator.
Essential Duties
Consistently applies ClinicalResearch Guidelines including Good Clinical Practice, HIPAA regulations, CRS Standard Operating Procedures, applicable NJH Policies and Procedures, and FDA, NIH, OHRP, ICH guidelines as applicable.
Independently masters study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
Independently performs study-related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies and NJH competency requirements.
Complies with regulatory bodies to create and maintain study records, and if applicable, dispensation and accountability of investigational product.
Efficiently implements and successfully executes complex research studies with high quality and appropriate enrollment.
Provides general guidance to new staff and study coordinators.
Competencies
Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health.
Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
Attention to Detail: Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
Champion of Change: Facilitating the implementation and acceptance of change within the workplace. Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
Patient Relations: Meeting patient and patient family needs; taking responsibility for a patient's safety, satisfaction, and clinical outcomes; using appropriate interpersonal techniques to resolve difficult patient situations and regain patient confidence.
Drive for Results: Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
Professional Development or Continuous Learning and Development: Actively identifying new areas for learning; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skill to enhance their contribution to the organization.
Initiative: Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
Supervisory or Managerial Responsibility
None
Travel
Less than 10%
Core Values
Be available to work as scheduled and report to work on time.
Be willing to accept supervision and work well with others.
Be well groomed, appropriately for your role and wear ID Badge visibly.
Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
Promotes a workplace culture based on mutual respect and merit, where all individuals are treated fairly and provided with equal opportunity to contribute to the mission and goals of the institution.
Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
Wears appropriate PPE as outlined by the infection control policies and procedures.
Demonstrates compliance with all state, federal and all other regulatory agency requirements.
Minimum Qualifications
Education: Bachelor's degree required.
Work Experience: A minimum of 1 year clinicalresearch experience required.
Special Training, Certification or Licensure: BLS required within one month of hire. CITI training required within one month of hire.
Salary Range: $25.04 - $33.11
Benefits
At National Jewish Health, we recognize that our outstanding faculty and staff are the essence of our organization. For every aspect of health care, our employees are our greatest asset. With that in mind, we have designed a valuable, comprehensive benefits package to meet the needs of our employees and their families.
Comprehensive Medical Coverage: Multiple Cigna health plans for Colorado, regional office and remote employees. Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) available to pair with some plans.
Paid Time Off: Generous PTO accruals to use for vacation and sick days, and six paid holidays, all compliant with Colorado state sick leave regulations.
Dental & Vision Plans: Coverage effective the first of the month after hire.
Retirement Savings: 403(b) plan with employer contributions after two years.
Wellness Incentives: Earn up to $200 annually for preventive health activities.
Tuition Reimbursement: Up to $5,250 annually for full-time and part-time employees.
Child Care Assistance: Childcare Flex Spending Account (FSA) with annual employer contribution.
Loan Forgiveness: Public Service Loan Forgiveness (PSLF) eligible employer.
Disability & Life Insurance: Employer-paid plans and optional buy-up choices.
Voluntary Benefits: Full suite of coverage options such as Accident, Hospital Indemnity and Legal Plan
Exclusive Discounts: Savings on local services, insurance, and RTD bus passes.
Anticipated Application Deadline: 2026-01-16
$25-33.1 hourly 60d+ ago
Research Coordinator
ADVU Advanced Urology C
Clinical research associate job in Lakewood, CO
Why Join Us?
At United Urology Group, our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care.
We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff! We deliver a cohesive approach to urologic care that provides patients with access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies. We offer competitive salaries and a great work/life balance: enjoy your weekends! UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more!
:
The Research Coordinator will screen, enroll, and follow study subjects for Phase I, II, III, and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are on study.
Primary Duties & Responsibilities:
Conducting Clinical Trials
Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol and ensure logistics for site implementation.
Review the protocol and the informed consent form for accuracy and clarity.
Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff.
Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO. Complete and submit CDA to Sponsor/CRO in accordance with site Standard Operating Procedures (SOP).
Schedule site Sponsor visits in accordance with internal SOP.
Prepare study charts, binders, and supplies for offsite storage in conjunction with the Regulatory Specialist, when applicable.
Ensure maintenance and calibration of site study required equipment.
Enrollment of Study Subjects
Review the study design and inclusion/exclusion criteria with the PI/SI, and if needed the Sponsor to ensure understanding.
Review, verify, and record/collect all relevant documentation in the subject's medical record needed to confirm study eligibility.
Review the protocol, informed consent form, and follow-up procedures with the potential study subjects.
Ensure the current approved informed consent is signed before subjects are screened and enrolled.
Inform and document notification of the subject's Primary Care Physician of trial participation if approved by the subject.
Perform delegated Protocol specific tasks as assigned by Principal Investigator.
Ensure that the randomization procedures are followed and documented per protocol guidelines.
Document protocol exemptions and deviations, as appropriate. Ensure duplication of each for filing in the subject source and with the regulatory specialist.
Ensure all procedures and documentation of subject participation are kept in accordance with FDA regulations, ICH guidance, and internal SOP.
Follow-Up Procedures
Schedule subjects for follow-up visits, collect subjects' responses to therapy, and interview subjects for adverse events and changes to concomitant medications. Ensuring that a review of EMR is made during the subject visit for any notable medical/medication changes from the last research visit.
Review laboratory data and communicate abnormal values to the PI/SI and as needed, primary care provider or specialist if additional medical attention is needed.
Assess and document subject compliance and accountability with Investigational Product (IP). Document re-education when appropriate.
Communicate with research staff to ensure timely and accurate study drug distribution when applicable.
Administer study drug therapy as needed and maintain the study drug dispensing log if a pharmacist is not involved.
Record all Adverse Events outlined in protocol and review them with the PI/SI.
Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be, contact the subject's primary care physician or specialist.
Administrative/Clerical
Reporting all Deviations/Adverse/SAE within Sponsor/IRB's timeframe and in accordance with site SOP.
Follow SOPs/GCPs/HIPPA according to the site, sponsor, ICH, and FDA.
Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications.
Follow up and document outstanding action items on Monitoring reports, ensure PI/SI oversight, and that the site Regulatory Specialist receives reviewed/corrected/signed copy of the report.
File appropriate regulatory or Sponsor communications with the site Regulatory Specialist.
Create and maintain Master Subject Log and Visit Log.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.
Qualifications:
Minimum High School Diploma or GED required.
Minimum of two (2) years of clinicalresearch experience.
Maintained certification of accreditation (CCRC/IATA/CPR/NIH/CITI) required and will be verified prior to employment.
Knowledge, Competencies & Skills:
Exceptional customer service skills.
Strong attention to detail, a willingness to learn & the ability to stay organized.
Ability to perform clinical assessments.
Strong understanding of FDA clinical trial phases I-IV.
Strong understanding of GCP set forth by the ICH.
Proficient knowledge of medical terminology.
Proficient knowledge of Research-related Terminology.
Strong communication skills, both verbal & written.
Proficient computer software and database skills.
Comfortable working in a fast-paced environment.
Very comfortable asking probing questions to patients, if applicable.
Must demonstrate a caring, compassionate, and patient attitude.
Maintain HIPAA compliance.
Multitasking and proactive problem-solving.
Ability to type a minimum of 40 words per minute.
Job Type: Full-Time
Pay Range: $30.00 - $31.50 per hour
Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws.
This position has no close date. Applications will be accepted until an offer has been extended and accepted.
Equal Opportunity Employer: Our Practice is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability, veteran status, or sexual orientation.
The successful candidate(s) for any UUG position will be subject to a pre-employment background check.
Since 1970, Salud has been committed to providing a Medical Home to patients, where medical, dental, behavioral health services, and clinical pharmacists work together and coordinate efforts in a team-based system of care. We strive to improve the quality of our patient's lives who would otherwise have limited access to health care. We serve all individuals regardless of their insurance status or ability to pay.
Job Description
We are looking for a Full-Time, caring
Dental Clinic Coordinator
. You will perform duties that assist the Dental Director, Dentists, and Dental Hygienists in the care and treatment of patients. As a Dental Clinic Coordinator, you will perform duties in the areas of reception, inventory, and records management.
We offer:
$21.50 to $26 per hour
Monday to Friday - 8 am to 5 pm
Comprehensive Benefits Package includes:
Medical PPO Plan (Similar to ACA Exchange Platinum Benefit Coverage Levels)
Low employee premiums, especially given rich benefits
$25 Primary Care Physician and Specialist Co-pays (in-network)
Low deductibles and co-insurance
Free provider visits and services at all Salud facilities
Preferred prescription pricing at Salud pharmacies
Dental PPO plan
Includes Employee Discounts at All Salud Dental Facilities
Vision
Generous vacation accrual
10 Paid Holidays per year (includes 2 Floating Holidays and paid Birthday)
Up to 8 Paid accrued Sick Days per year
Defined Contribution Pension Plan. Salud contributes 5% of your compensation each month (no matching employee contribution is required…you receive the contribution no matter what). Employees who have worked at least 1,000 hours within 12 months are eligible
403b Retirement savings plan. You can contribute pre-tax or after-tax (Roth) towards your retirement savings
Flexible Spending Accounts
Basic Life and AD&D
Supplemental Life and AD&D
Short-Term & Long-Term Disability
Accident & Critical Illness Insurance
Employee Assistance Program
Our Mission is to provide a quality, integrated healthcare home to the communities we serve
About our Clinic:
Our medical practice is quite lively. We treat our patients with the utmost respect and concern for their well-being while instilling a fun and vibrant atmosphere bringing smiles to all who enter our doors. A positive attitude toward modern dental medicine brings joy to the healing journey.
Qualifications
Education:
Graduation from high school or equivalent is required
Experience:
Bi-lingual English and Spanish preferred
Knowledge of front and back Dental Office procedures
is preferred
Previous dental assistant experience strongly desired
The application window is anticipated to close by 1/31/26
Additional Information
Salud Family Health
is an Equal Opportunity Employer. We prohibit unlawful discrimination against applicants or employees on the basis of age 40 and over, race, color, religion, national origin, sex, disability, sexual orientation, gender identity, or any other applicable status protected by federal, state, or local laws. All your information will be kept confidential according to EEO guidelines.
$21.5-26 hourly 14h ago
Senior Clinical Research Associate
Onpoint Clinical Staffing Services 4.2
Clinical research associate job in Denver, CO
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 clinicalresearch 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.
$61k-94k yearly est. 60d+ ago
Senior Clinical Research Project Coordinator - Denver
Medpace 4.5
Clinical research associate job in Denver, CO
Medpace is a leading CRO for Biotech companies and we are currently seeking a full-time, office-based Project Coordinator to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular/Metabolic/Renal, Infectious Disease/CNS/Ophthalmology and more. If you are looking for a fast paced, collaborative work environment in clinicalresearch and want to develop your career even further, then this is the opportunity for you. Medpace provides Project Coordinators a 4-6 week training program that incorporates a virtual and hands on learning experience, especially for those without previous clinicalresearch experience.
Responsibilities
* Engage in clinical trial management on a day to day level;
* Work closely with the project CTM for timely delivery of tasks consistently with a high degree of accuracy;
* Compile and maintain project-specific status reports;
* Interact with the Sponsor, study sites, and internal associates;
* Provide oversight and quality control of our internal regulatory filing system;
* Manage study supplies;
* Create and maintain project timelines; and
* Coordinate project meetings and produce quality meeting minutes.
Qualifications
* Bachelor's degree in a health/life sciences field;
* Prior experience as a Study Coordinator or within the pharmaceutical industry; and
* Excellent computer (word-processing, databases, Excel, Windows), organizational, and communication skills.
Compensation
A target salary range of $40,000 - $85,000 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.
$40k-85k yearly Auto-Apply 4d ago
Trial Associate
Lewis & Associates 3.8
Clinical research associate job in Denver, CO
LEW I S & ASSOCIATES is a leader in providing Legal and Administrative staffing services. We are a sole source staffing firm giving you convenient ways of working with us. We make every effort to ensure the highest degree of professionalism and integrity in the staffing process. We understand the demanding role of recruiting to source the highest level of legal professionals while incorporating proven, innovative, and successful recruiting techniques.
Job Description
Our client is seeking a litigation associate with two to four years of experience to join the Trial Department in its Denver office. This associate will work in all phases of commercial litigation, with an emphasis on intellectual property litigation, from pleading through trial and appeal. This associate will have the opportunity to take depositions, appear in court, and work closely with partners.
Strong academic performance, excellent writing skills, and two to four years of litigation experience are required. Specifically, we are seeking someone who has experience beyond document review and has handled significant parts of active cases. Admission to the Colorado bar is a plus.
Additional Information
Only candidates that meet the requirements will be contacted.
How much does a clinical research associate earn in Loveland, CO?
The average clinical research associate in Loveland, CO earns between $31,000 and $75,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Loveland, CO