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Experienced Study Start-Up Research Coordinator - Denver
Medpace 4.5
Clinical research coordinator 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 ClinicalResearchCoordinator 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 10d ago
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Clinical Research Manager
Job Listingselement Materials Technology
Clinical research coordinator 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
Clinical Research Coordinator (Open Rank, Intermediate or Senior)
University of Colorado 4.2
Clinical research coordinator job in Aurora, CO
ClinicalResearchCoordinator (Open Rank, Intermediate or Senior) - 38698 University Staff Description University of Colorado Anschutz Medical CampusDepartment: RheumatologyJob Title: ClinicalResearchCoordinator (Open Rank, Intermediate or Senior) Position #:00843757 - Requisition #:38698 Job Summary:As a ClinicalResearchCoordinator in the Yomogida Lab at the University of Colorado Anschutz Medical Campus, you will play a key role in advancing groundbreaking research in immunology and pediatric autoimmune diseases.
This position provides a unique opportunity to contribute directly to impactful biomedical research while developing strong hands-on laboratory and clinicalresearch skills.
In this role, you will communicate with patients and families to obtain informed consent for research participation and will be responsible for processing and storing clinical specimens according to established protocols.
The position combines patient interaction with laboratory-based responsibilities, offering an ideal training environment for individuals interested in translational science, immunology, or future careers in medicine, graduate school, or industry research.
Key Responsibilities:Identify eligible research participants and clearly explain study procedures to patients and families.
Obtain informed consent/assent in accordance with IRB-approved protocols and institutional policies.
Coordinate and assist with specimen collection during clinic visits and procedures.
Process, label, and aliquot clinical biospecimens (blood, synovial fluid, and tissue) following established SOPs.
Ensure proper storage and tracking of samples in liquid nitrogen, −80°C freezers, or other designated storage systems.
Maintain accurate documentation in electronic lab notebooks, REDCap, and other data management systems.
Perform basic wet-laboratory tasks, including pipetting, centrifugation, sterile technique, and preparation of reagents.
Monitor and organize laboratory inventory, including ordering supplies and maintaining stock levels.
Support lab operations by helping schedule meetings, maintain shared workspaces, and ensure regulatory compliance.
Communicate effectively with clinical teams, study personnel, and other collaborators to ensure smooth workflow.
Work Location:Onsite - this role is expected to work onsite and is located at the University of Colorado Anschutz Medical Campus in Aurora, Colorado.
Why Join Us:Join the Yomogida Lab at the University of Colorado Anschutz Medical Campus, a leading center for research in immunology and pediatric autoimmune diseases.
Our team fosters a collaborative, supportive environment where you will gain hands-on experience working with human samples and observe how laboratory discoveries translate directly into clinical impact.
We are deeply committed to training and career development.
This position serves as an excellent launchpad for individuals pursuing advanced degrees such as a PhD, MD, or MD-PhD.
Team members receive personalized mentorship, exposure to translational research, and opportunities to develop competitive research skills.
As part of the vibrant CU Anschutz community, you will work alongside world-class researchers, clinicians, and trainees dedicated to improving child health.
Why work for the University?We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including: Medical: Multiple plan options Dental: Multiple plan options Additional Insurance: Disability, Life, VisionRetirement 401(a) Plan: Employer contributes 10% of your gross pay Paid Time Off: Accruals over the year Vacation Days: 22/year (maximum accrual 352 hours) Sick Days: 15/year (unlimited maximum accrual) Holiday Days: 10/year Tuition Benefit: Employees have access to this benefit on all CU campuses ECO Pass: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage.
Qualifications:Minimum Qualifications:Intermediate Level:Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
One (1) year clinicalresearch or related experience.
An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
Senior Level:Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Two (2) years clinicalresearch or related experience.
An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:Master's degree in biology, public health, molecular biology, clinicalresearch, chemistry, biomedical sciences, genetics, or related field Experience in clinicalresearch, participant recruitment, informed consent, or clinical trial coordination.
Experience communicating with patients and families in a healthcare or research setting.
Hands-on experience with wet laboratory procedures such as sample processing, tissue handling, or basic molecular techniques.
Two (2) years or more years of experience in an experimental or wet laboratory.
Familiarity with REDCap, EPIC, or other clinical data management systems.
Knowledge, Skills, and Abilities:Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Ability to interact professionally with patients, families, and clinical staff.
Competence in reviewing and abstracting patient information from electronic medical records (EPIC).
Ability to perform basic wet laboratory techniques, including pipetting, centrifugation, biospecimen handling, sterile technique, and sample processing.
Strong organizational and time-management skills, with the ability to prioritize tasks and in a fast-paced clinicalresearch environment.
Ability to follow detailed standard operating procedures (SOPs) and maintain accurate documentation.
Demonstrated reliability and professionalism.
Attention to detail and commitment to accurate documentation and adherence to standard operating procedures (SOPs).
Ability to maintain confidentiality and comply with HIPAA, biosafety, and institutional research regulations.
Conditions of Employment:Work onsite at Children's Hospital Colorado and the Barbara Davis Center.
Ability to work in clinical environments, including outpatient clinics and procedure areas.
Handling of human biospecimens (blood, synovial fluid, and tissue) in accordance with biosafety and HIPAA guidelines.
Adherence to all institutional training requirements, including HIPAA, CITI, Biosafety, Bloodborne Pathogens, and COI disclosures.
Use of personal protective equipment (PPE) such as gloves, lab coats, and eye protection when required.
Ability to stand, walk, or transport samples between locations for extended periods.
Occasional flexible scheduling, depending on patient availability or procedure.
How to Apply:For full consideration, please submit the following document(s): A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.
Curriculum vitae / ResumeThree to five professional references, including name, address, phone number (mobile number if appropriate), and email address.
Questions should be directed to: Kentaro Yomogida, kentaro.
yomogida@cuanschutz.
edu Screening of Applications Begins:Applications will be accepted until finalists are identified, but preference will be given to complete applications received by January 31st, 2026.
Those who do not apply by this date may or may not be considered.
Anticipated Pay Range: The starting salary range (or hiring range) for this position has been established as:Intermediate Level: $52,721 - $67,061Senior Level: $56,995 - $72,498 The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
This position may be eligible for overtime compensation, depending on the level.
Your total compensation goes beyond the number on your paycheck.
The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator Equal Employment Opportunity Statement: CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment.
We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
ADA Statement:The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process.
To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.
adacoordinator@cuanschutz.
edu .
Background Check Statement:The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors.
To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases.
If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively.
In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
Application Materials Required: Cover Letter, Resume/CV, List of References Job Category: Research Services Primary Location: Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20229 - SOM-MED-RHEUM GENRL OPERATIONS Schedule: Full-time Posting Date: Jan 15, 2026 Unposting Date: Ongoing Posting Contact Name: Kentaro Yomogida Posting Contact Email: kentaro.
yomogida@cuanschutz.
edu Position Number: 00843757
$57k-72.5k yearly Auto-Apply 8d ago
Clinical Research Manager
Element 4.5
Clinical research coordinator 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 21d ago
Clinical Scientist
Eliassen Group 4.7
Clinical research coordinator job in Denver, CO
**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs
**Description:**
_Remote_
Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation.
_This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._
Salary: $130,000 - $150,000/ yr. w2
**Responsibilities:**
**Responsibilities**
+ Lead development of clinical study protocols, case report forms, and associated study documents.
+ Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee.
+ Contribute scientific input into study design, endpoints, and overall clinical strategy.
+ Review and interpret clinical data to support study reports, publications, and regulatory submissions.
+ Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams.
+ Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews.
+ Ensure scientific consistency across programs and alignment with regulatory and clinical goals.
+ Support the development of data collection tools and ensure clarity, accuracy, and completeness.
+ Assist with medical writing elements related to clinical reports and study documentation.
**Experience Requirements:**
**Experience Requirements**
+ Electrophysiology and Pulse Field Ablation experience required.
+ Background supporting clinical studies in industry or academia.
+ Strong understanding of clinicalresearch methods and safety reporting.
+ Ability to evaluate and interpret clinical data.
+ Strong scientific writing skills and attention to detail.
+ Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions.
+ Excellent communication and analytical capabilities.
+ Prior experience as a Clinical Scientist in medical devices preferred.
+ Experience with Class III devices or IDE studies preferred.
+ Experience contributing to regulatory submissions or interacting with health authorities preferred.
+ Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred.
**Education Requirements:**
**Education Requirements**
+ MS, PhD, or MD.
**_Recruitment Transparency Notice_**
**_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._**
_Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._
_W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._
_Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._
_About Eliassen Group:_
_Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._
_Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._
_Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
$130k-150k yearly 7d ago
Senior Clinical Research Associate - Cardiovascular (EDG-2025017)
Edgewise Therapeutics 4.0
Clinical research coordinator job in Boulder, CO
Senior ClinicalResearch Associate - Cardiovascular At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:
Edgewise is headquartered in Boulder, Colorado; this is a position for a growing Colorado-based Clinical Development team. The assigned clinical trials will be highly complex and high risk, e.g. multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidates may be asked to provide support to the Edgewise clinical study lead for more than one study or across programs.
Key Responsibilities:
Lead site start-up activities (e.g. oversight of CRO start-up activities, accountable for essential document package review, site initiation slide deck, vendor training, participate in remote/or on-site initiation visits) and contribute to feasibility, as required.
Collaborate with contracts team to lead review and negotiation of site and vendor budgets/contracts.
Contribute to the development and review of study, patient and site facing documents (e.g. protocols, ICFs and study plans).
Oversee Edgewise contract CRA and/or CRO monitoring activities (e.g. visit schedules, monitoring visit reviews, monitoring plan review). May include on-site co-monitoring with CRO CRA, ensuring compliance with protocol and regulatory requirements. Provide additional clinical monitoring training support to CRO personnel, as needed. Attend CRO monitoring meetings. May include assigned monitoring responsibilities for sites.
Review and oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits.
Support the Edgewise clinical study lead in managing progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment and other tasks as assigned.
Proactively review electronic data capture (EDC) for completion and to identify issues and generate queries. Identify and monitor risks and decisions at the study level and implementation of mitigation strategies. Identify potential operational challenges, and in collaboration with senior team members, provide guidance and solutions to ensure study execution remains on track.
Contribute to drafting Standard Operating Procedures (SOPs) and adhere to Clinical Operations processes and SOPs to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
Responsible for the oversight of assigned vendors.
Collaborate with internal teams (e.g. Clinical Operations, Regulatory Affairs, Data Management, Medical Monitoring, CMC, etc) to ensure seamless trial execution and provide regular study updates to the appropriate internal stakeholders.
May be accountable for reviewing site or vendor invoicing and financial management in accordance with the clinical trial agreement / scope of work.
Support TMF activities as required (e.g. review of TMF index, document provision, etc.).
Support onboarding and mentoring of new department members.
Required Education, Experience, Skills:
At least 4+ years of relevant clinical operations experience and a BS or BA (Life Sciences)
Minimum 4 years of independent on-site monitoring experience (across all visit types and inclusive of remote monitoring), with at least 3 years cardiac study experience in a pharmaceutical sponsor environment preferred (global pharma or biotech preferred).
Excellent attention to detail, verbal, written, interpersonal and presentation skills are required
Must be familiar with routine medical/scientific terminology;
Proficiency with MS Office required (inclusive of PPT); Smart Sheet proficiency desirable
Knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
Highly productive, engaged and accountable
Team-player desiring to work in a fast-moving, dynamic start-up environment
This is a full-time position (40 hours/week), hybrid, Colorado based preferred. 20-50% travel.
Salary range: $100,000 - $140,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
$100k-140k yearly 60d+ ago
Clinical Research Associate, Sponsor Dedicated
Iqvia 4.7
Clinical research coordinator 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. 9d ago
Clinical Research Manager
Element Materials Technology 4.4
Clinical research coordinator 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
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
Clinical Research Associate I
Ora 4.3
Clinical research coordinator job in Denver, CO
Job Description
ClinicalResearch Associate I
DEPARTMENT: Monitoring
Preferred Locations: CA,CO, UT, NV, NE, KS, MO, IL, IN, KY, TN, OH
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
At Ora, we are building the future of ophthalmic clinicalresearch. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinicalresearch to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
The Role:
Ora's ClinicalResearch Associate I (CRA I) develop strong clinical site relationships and are accountable for performance and compliance for assigned protocols at our sites. Our CRA I's will work with the oversight of the Lead CRA's and Line Manager. As a CRA I, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross functionally within Ora.
What You'll Do:
Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gain in-depth understanding of the study protocol and related procedures.
Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
Participate & provide input on site selection and validation activities.
Perform remote and on-site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased
Subjects' right, safety and well-being are protected
Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with ClinicalResearch Lead and CRA line manager.
Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Supports audit/inspection activities as needed.
Travel Requirements up to 75%.
Adhere to all aspects of Ora's quality system.
Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
Responsibilities may differ from the above based on the specific needs of the business.
What We Look For:
Experience Needed for the Role:
Bachelor's degree with 1 years' experience in the clinicalresearch field or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education.
Additional Skills and Attributes:
Ophthalmic experience strongly preferred.
Capacity to routinely assess protocol and GCP compliance.
Demonstrated ability to verify source data to reported data.
Strong attention to detail in order to review completeness of the investigator site file. Knowledge to reconcile and return/destroy test article while conducting initiation, interim, and close-out visits.
Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
Ability to read and demonstrate a comprehension of a clinicalresearch protocol as well as understand the importance of following the protocol.
Proficiency with Excel, CTMS and EDC.
Multilingual communication is a plus.
Competencies and Personal Traits:
What We Do:
Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
How We Do It:
IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
Why We Do It:
Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.
What We Offer:
Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
Career Development Opportunities: Continued opportunities to grow and develop your career journey.
Global Team: Opportunities to work with colleagues across the globe.
Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.
Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Our Privacy Policy | Ora (oraclinical.com)
$42k-67k yearly est. 9d ago
Clinical Research Associate - Oncology - West Region (Denver, PHX, LA or San Fran)
Icon Clinical Research
Clinical research coordinator job in Denver, CO
ClinicalResearch Associate - 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. 52d ago
Clinical Research Associate 1
Allen Spolden
Clinical research coordinator 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
Clinical Research Coordinator/RN
Us Oncology, Inc. 4.3
Clinical research coordinator job in Lone Tree, CO
Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced ClinicalResearchCoordinator/RN at our Skyridge location in Lone Tree. Bring your established Oncology and or Research experience and join a team dedicated to providing an excellent experience to patients.
We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It's much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.
No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient's hand, or a scheduler on the phone finding an appointment that fits into a patient's schedule, we are deeply connected to our patients and do what we can to help.
If this sounds like you, we'd love to have you join our team.
Salary Range: $60,000-$75,000 for non-nurses and $80,000-$97,000 for nurses
Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; potential for research bonus depending on financials of department after one year of employment; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance.
A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis.
Responsibilities
* Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
* Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
* Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
* Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
* Participates in required training and education programs. Responsible for education of clinic staff regarding clinicalresearch.
* May collaborate with Research Site Leader in the study selection process.
* Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors.
* Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
* May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
* May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.
* Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Qualifications
* Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.
* SoCRA or ACRP certification preferred.
or
* Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience, preferably in oncology. Experience in clinicalresearch preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred.
* Knowledge of medical terminology, nursing assessment, anatomy and physiology, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology, clinical trials and GCPconcepts. -Experience with computer data entry and database management. -Excellent written and oral communication skills.
* Excellent organizational skills-Attention to details and accuracy-Ability to read, analyze, and interpret technical procedures such as protocols, informed consent documents, and regulatory documents. -Ability to work independently, organize, prioritize, and follow through with results.-Ability to solve practical problems and implement solutions.
Working Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)
All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.
Candidates will be required to show proof of being vaccinated against influenza upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.
This job posting will remain open until we have identified an adequate applicant pool. Applicants are strongly encouraged to apply early. To apply for this position, start the process by clicking the blue "apply" button.
$80k-97k yearly 60d+ ago
Clinical Research Coordinator - Environmental and Occupational Health Sciences
National Jewish Health 4.7
Clinical research coordinator job in Denver, CO
National Jewish Health is seeking a ClinicalResearchCoordinator (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 ClinicalResearchCoordinator position is a study coordinator with proven ability to work independently. Acts as a preceptor for Assistant ClinicalResearchCoordinator and ClinicalResearchCoordinator.
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: 2026-01-23
$25-33.1 hourly 60d+ ago
Research Coordinator
ADVU Advanced Urology C
Clinical research coordinator 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 ResearchCoordinator 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.
$30-31.5 hourly Auto-Apply 60d+ ago
Sr. Clinical Research Associate - FSP
Parexel 4.5
Clinical research coordinator job in Denver, CO
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The ClinicalResearch Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
LI-LG4
\#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. 44d ago
Senior Clinical Research Associate
Onpoint Clinical Staffing Services 4.2
Clinical research coordinator 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. 3d ago
Clinical Research Coordinator
Nexus HR Services
Clinical research coordinator job in Centennial, CO
ClinicalResearchCoordinator - Centennial, CO
Compensation: $50,000 - $70,000 Annually
Overview: Nexus HR is seeking a ClinicalResearchCoordinator to join our team. In this pivotal role, you will maintain a neat and professional appearance, demonstrate commitment to serve at all times, uphold guidelines as set forth in the employee handbook, and maintain patient confidentiality at all times.
About the Job
The ClinicalResearchCoordinator is involved in all aspects of clinical trials research from pre-study planning to study completion, and includes direct involvement in case management of study participants. Works under the supervision of the Principal Investigator and Site Manager.
Duties and Responsibilities:
Own end-to-end management and execution of all clinicalresearch activities
Independently conduct and complete study visits, including protocol review with the Principal Investigator
Lead patient recruitment and retention initiatives and support internal study marketing efforts
Ensure compliant informed consent before any study procedures
Review medical records and eligibility criteria with investigators or site leadership
Perform safety assessments (e.g., vitals, venipuncture, ECGs)
Create, maintain, and complete source documentation and regulatory binders
Schedule subjects, manage follow-up, and coordinate with physicians and sponsors
Collaborate with clinical teams to ensure protocol adherence and documentation accuracy
Complete CRFs and manage queries in a timely, compliant manner.
Coordinateresearch operations across multiple studies, phases, and therapeutic areas
Complete and maintain training in ICH/GCP, HIPAA, SOPs, IATA, and other required technical skills
Understand Investigator and Site responsibilities under FDA, DHHS, and OHRP regulations
Knowledgeable of the drug development process (IND to NDA, IDE to PMA, Phases I-IV)
Comprehend and communicate informed consent elements per the Declaration of Helsinki
Understand IRB regulations and their role in clinical trials
Identify and report adverse and serious adverse events promptly
Participate in site initiation, monitoring, and closeout visits, as well as sponsor meetings
Engage in peer review of data quality
Adhere to company policies and procedures
Maintain regular attendance as an essential job function
Qualifications:
Bachelor's degree in biology, chemistry, human sciences, or a related scientific field; relevant clinical experience may substitute
2-5 years of healthcare and/or clinicalresearch experience.
Certification in the field (CCRC, CCRA, or CCRP) preferred
Strong attention to detail and organizational skills
Excellent written and verbal communication
Ability to manage multiple studies concurrently
Proficient in basic computer applications
Demonstrates honesty, integrity, and professionalism
Effective team player in a high-performance environment
Benefits:
401(k) and 401(k) matching
Health, dental, and vision insurance
Life and disability insurance (short-term and long-term)
Flexible spending accounts (FSA)
Health Savings Accounts (HSA)
Employee Assistance Program (EAP)
Paid time off (PTO) and holiday pay
Wellness programs
$50k-70k yearly 36d ago
Sr Coordinator - Loyalty
Frontier Careers
Clinical research coordinator job in Denver, CO
Why Work for Frontier Airlines?
At Frontier, we believe the skies should be for everyone. We deliver on this promise through our commitment to Low Fares Done Right. This is more than our tagline - it's our driving philosophy. Every member of Team Frontier has an important role to play in bringing this vision to life. Our successful business model allows travelers to take advantage of our fast-growing route network while our bundled and unbundled pricing options allow our customers to personalize their travel experience and only pay for the services they need - saving them money along the way.
What We Stand For
Low Fares Done Right is our mission and we strive to bring it to life every day. Our ‘Done Right' promise means delivering not only affordable prices, but making travel friendly and easy for our customers. To do this, we put a great deal of care into every decision and action we take. We must be efficient with the use of our resources and make smart decisions about how we run our business. We must also innovate and be pioneers - we're not afraid to try new things. While our business requires us to fly high in the air, we also consider ourselves down-to-earth in our approach, creating a warm and friendly experience that truly demonstrates Rocky Mountain Hospitality.
Work Perks
At Frontier, we like to think we're creating something very special for our team members. Work is why we're here, but the perks are nice too:
Flight benefits for you and your family to fly on Frontier Airlines.
Buddy passes for your friends so they can experience what makes us so great.
Discounts throughout the travel industry on hotels, car rentals, cruises and vacation packages.
Discounts on cell phone plans, movie tickets, restaurants, luggage and over 2,000 other vendors.
Enjoy a ‘Dress for your Day' business casual environment.
Flexible work schedules that support work/life balance.
Total Rewards program including a competitive base salary, short term incentives, long-term incentives, paid holidays, 401(k) plan, vacation/sick time and medical/dental/vision insurance that begins the 1
st
of the month following your hire date.
We play our part to make a difference. The HOPE League, Frontier Airlines' non-profit organization, is dedicated to providing employees financial assistance during catastrophic hardship.
Who We Are
Frontier Airlines is a leading ultra-low cost carrier headquartered in Denver, Colorado. With a mission to deliver Low Fares Done Right, the company provides affordable, convenient and accessible air travel throughout the U.S., Caribbean, Mexico and Latin America. Frontier's highly fuel-efficient, all-Airbus fleet is among the youngest and most modern of any carrier within the U.S. That, combined with the airline's many weight-saving initiatives and focus on operational efficiencies, makes Frontier America's Greenest Airline.* Each Frontier Airlines plane tail features a special animal with a unique name and backstory. Many of the featured species are endangered or threatened, part of the airline's commitment to underscore and raise awareness for their plight. Frontier serves approximately 100 destinations throughout North America and operates 500-plus daily flights, on average. The airline employs more than 7,000 team members and has crew bases in more than a dozen U.S. cities. Frontier Airlines., Inc., is a subsidiary of Frontier Group Holdings, Inc. (NASDAQ: ULCC).
* Frontier is the most fuel-efficient of all major U.S. carriers when measured by ASMs per fuel gallon consumed.
What Will You Be Doing?
The Senior Coordinator, Loyalty is responsible for leading select communications, marketing and reports across all channels to support the Frontier Airlines Discount Den and GoWild! programs, as well as occasional support for the Co-Brand Credit Card or Frontier Miles programs. This position will be responsible for the execution of strategic marketing plans, per the direction of the Manager, Loyalty Products and Director of Loyalty Growth & Strategy.
Essential Functions
With the Manager, Loyalty Products, identify opportunities and lead Frontier's tactical marketing strategy to support the various loyalty partners in the development, testing and execution of marketing campaigns including: direct mail, email, insert production, statement messaging, airport signage, internet, social media and the in-flight channel
Leads facilitating discussions between the Frontier team and the partner for all strategy and tactical components of the program
Identify, recommend and support new marketing channels and opportunities for Discount Den, GoWild! and the credit card program and other partners
Oversee production and printing of physical marketing and support materials while ensuring on-time distribution of these materials via comat or other shipping methods
Support other Loyalty Marketing initiatives as needed
Qualifications
Bachelor's degree with emphasis in marketing or equivalent area of study
2-5 years in sales, marketing and/or communications or related field
Knowledge of airline and credit card marketing, as well as frequent flyer program rules and procedures
Advanced Excel and PowerPoint for analytics and presentations
Familiarity with HTML, SQL or JSON coding preferred
Ability to manage multiple priorities and manage marketing projects, production schedules, and promotional events, while consistently meeting deadlines
Must have good attention to detail for copy proofing/editing
Exceptional presentation and oral communication skills
Exceptional writing and copy editing skills
Ability to work collaboratively with other departments, partners and staff
Ability to manage multiple contractors/trainers
Strong corporate vendor development and relationship building skills
Ability to travel 50% of time
Knowledge, Skills and Abilities
Comfortable receiving feedback and quickly change course based on business needs
Team player who can work collaboratively with other departments, partners and marketers
Must have excellent communication and interpersonal skills
Must be self-motivated, self-starter, have a sense of urgency and extremely well-organized
Ability to work with minimum supervision in a collaborative team environment
Microsoft office product skills including Excel and PowerPoint
Ability to meet deadlines while working in a fast-paced, changing environment
Must exercise sound business judgment and handle confidential information with sensitivity
Must be a team player with ability to work on several projects at a time
Must be comfortable working around the airports both above and under wing when needed
Equipment Operated
Standard office equipment, including PC, copier, fax machine, printer
Work Environment
Typical office environment, adequately heated and cooled
Physical Effort
Generally, not required.
Supervision Received
Considerable Latitude: The incumbent establishes methods and procedures for attaining specific goals and objectives, and receives guidance in terms of broad goals. Only the final results of work are typically reviewed.
Positions Supervised
None
Salary Range: $58,394 - $77,508. Please note: this posting has a closing date of on or before midnight 6.30.25 MT.
Workplace Policies
Disclaimer: The above statements are intended only to describe the general nature and level of work required of the referenced position; they are not intended to be an exhaustive list of all responsibilities, duties, and skills required of individuals in this position. Please be advised that duties and expectations of this position may be subject to change.
Frontier Airlines, Inc. is an equal opportunity employer and, as such, is committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, national origin, age, marital status, veteran status, sexual orientation, gender identity or expression, disability status, pregnancy, genetic information, citizenship status or any other basis protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Frontier Airlines is a Zero Tolerance Drug-Free Workplace. All prospective DOT safety-sensitive employees are subject to pre-employment testing for the following drugs and their metabolites: Marijuana, Cocaine, Amphetamines, Opioids and Phencyclidine (PCP). Further, any DOT safety-sensitive job applicant who is found to have tested positive on any required drug or alcohol test at a former employer will be considered ineligible for employment with Frontier.
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
$58.4k-77.5k yearly 60d+ ago
Clinical Research Coord II
Uc Health 4.6
Clinical research coordinator job in Loveland, CO
Department: MCR MCR Research (Trauma/Critical Care/Multidisciplinary) FTE: Full Time, 1.0, 80.00 hours per pay period (2 weeks) Shift: Days Pay: $24.11 - $36.17 / hour. Pay is dependent on applicant's relevant experience
Summary:
Coordinates the administrative and clinical aspects of research projects.
Responsibilities:
* Collaborates with principal investigator, sponsor and research staff to plan, conduct and evaluate project protocols. Monitors and reports on progress of projects as necessary.
* Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Performs specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
* Coordinates with investigator to manage adverse events, compliance and other participant-related issues. Facilitates the education of necessary parties such as participants, sponsors and clinicians involved in service delivery.
* Implements and oversees the study's compliance with applicable regulations and standards. Assists with responding to and preparing for audits.
* Within scope of job, requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a fast-paced environment and take appropriate action.
Requirements:
* Bachelor's degree.
* 2 years of experience coordinatingclinicalresearch studies and clinical trials, or 2 years of experience in data management and knowledge of IRB clinicalresearch application procedures.
* BLS through the American Heart Association or the American Red Cross CPR for the Professional Rescuer with card in-hand before start date. BLS or CPR card must be good through sixty days of hire.
Preferred:
* Comfortable in the ER, Inpatient settings and with seeing full traumas
* Experience with data studies
We improve lives. In big ways through learning, healing, and discovery. In small, personal ways through human connection. But in all ways, we improve lives.
UCHealth invests in its Workforce.
UCHealth offers a Three Year Incentive Bonus to recognize employee's contributions to our success in quality, patient experience, organizational growth, financial goals, and tenure with UCHealth. The bonus accumulates annually each October and is paid out in October following completion of three years' employment.
UCHealth offers their employees a competitive and comprehensive total rewards package (benefit eligibility is based off of FTE status):
* Medical, dental and vision coverage including coverage for eligible dependents
* 403(b) with employer matching contributions
* Time away from work: paid time off (PTO), paid family and medical leave (inclusive of Colorado FAMLI), leaves of absence; start your employment at UCHealth with PTO in your bank
* Employer-paid basic life and accidental death and dismemberment coverage with buy-up coverage options
* Employer paid short term disability and long-term disability with buy-up coverage options
* Wellness benefits
* Full suite of voluntary benefits such as flexible spending accounts for health care and dependent care, health savings accounts (available with HD/HSA medical plan only), identity theft protection, pet insurance, and employee discount programs
* Education benefits for employees, including the opportunity to be eligible for 100% of tuition, books and fees paid for by UCHealth for specific educational degrees. Other programs may qualify for up to $5,250 pre-paid by UCHealth or in the form of tuition reimbursement each calendar year
Loan Repayment:
* UCHealth is a qualifying employer for the federal Public Service Loan Forgiveness (PSLF) program! UCHealth provides employees with free assistance navigating the PSLF program to submit their federal student loans for forgiveness through Savi.
UCHealth always welcomes talent. This position will be open for a minimum of three days and until a top applicant is identified.
UCHealth recognizes and appreciates the rich array of talents and perspectives that equal employment and diversity can offer our institution. As an equal opportunity employer, UCHealth is committed to making all employment decisions based on valid requirements. No applicant shall be discriminated against in any terms, conditions or privileges of employment or otherwise be discriminated against because of the individual's race, color, national origin, language, culture, ethnicity, age, religion, sex, disability, sexual orientation, gender, veteran status, socioeconomic status, or any other characteristic prohibited by federal, state, or local law. UCHealth does not discriminate against any qualified applicant with a disability as defined under the Americans with Disabilities Act and will make reasonable accommodations, when they do not impose an undue hardship on the organization.
Who We Are (uchealth.org)
$24.1-36.2 hourly 50d ago
Clinical Research Coordinator
Denver 4.0
Clinical research coordinator job in Littleton, CO
GENERAL DESCRIPTION The ClinicalResearchCoordinator will be responsible for the oversite of research projects. In addition, the ClinicalResearchCoordinator must be able to provide efficient services to our physicians as well as provide quality, courteous and compassionate services to our patients in adherence to the guidelines, policies and procedures set forth by Urology Associates.
ESSENTIAL JOB FUNCTIONS
Develop the research department in scope, size, reputation and professionalism.
Assist with the recruitment of studies, budget evaluation and negotiation, protocol evaluation and communication with study sponsors.
Maintain certifications in, and continually update knowledge of FDA, GCP, ICH, federal and state regulations, etc.
Obtain and maintain patient consent with the highest ethical standards.
Work with staff including management in a leadership role in areas such as training, delegating responsibilities, etc.
Work directly with patients for screening, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc.
Communicate with and support patients and their families as necessary.
Work with the EMR and data management systems to complete EDC, eCRFs, locate patients and maintain records.
Must have the ability to gain knowledge of relevant software and programs.
Have a basic and working knowledge of trial design, statistical methods, etc.
Triage, record and report adverse events.
Record and report any protocol deviations.
Work closely with IRB and study sponsors, PIs and Sub-Is.
Attend meetings and calls.
Create and maintain department SOPs, NDAs, CVs, certifications, etc.
Evaluate, purchase and maintain necessary equipment.
Maintain study budgets and monitor invoicing, billing, and payments.
Participate in site visits, SIVs, monitoring, etc.
Complete necessary study close-out steps and documentation.
Communicate regularly with supervisor, keeping him/her apprised of all pertinent information and providing feedback.
Ensure compliance for all regulatory requirements including OSHA, CLIA and HIPAA; immediately and accurately document and report occurrences to supervisor; and ensure compliance with all legal and regulatory requirements as outlined in the corporate compliance plan.
Support and adhere to all company policies, procedures and management decisions; maintain confidentiality of patients' medical information; and all confidential administrative related issues.
Demonstrate dependability in attendance, punctuality in reporting for work and initiative in completing a full work schedule; meeting or exceeding all established deadlines and utilizing all resources and supplies efficiently and appropriately.
Demonstrate the ability to concentrate during the course of the day.
Display a positive outlook with a helpful, constructive manner when working with other employees.
Demonstrate superior patient relations and interpersonal skills; demonstrate an appropriate level of mental and emotional tolerance and even temperament when dealing with staff, patients and general public using tact, sensitivity and sound judgment; promote a positive work environment and contribute to the overall efforts of the department and the company.
OTHER DUTIES
Assist in performing special projects and other related duties as assigned or directed by CPC physicians and Administrative staff.
Complete other tasks as assigned.
POSITION REQUIREMENTS
Must have knowledge of and experience with relevant federal and state regulatory guidelines.
Must have a minimum of two (2) years of experience with conducting clinical trials.
Urology based clinical experience is preferred.
Experience with evaluating and implementing study protocols and budgets.
Certification by ACRP or an equivalent is preferred.
Proficiency in computer software to include Microsoft Office, EMR and Practice Management systems.
Ability to plan, schedule, prioritize and complete multiple tasks and demands is required
Excellent oral and written communication, interpersonal, problem-solving and organizational skills are required.
Occasional overtime, evening and weekend work is required.
A valid driver's license, dependable automobile and current auto insurance are required for occasional travel for business purposes and to work at satellite locations.
ESSENTIAL PHYSICAL REQUIREMENTS
Requires prolonged sitting and standing, some bending, stooping and stretching, or performing other work requiring moderate physical exertion.
Capacity to maintain physical activity over prolonged periods of time (stamina).
Able to see for the purpose of reading information received in different formats including but not limited to paper, computer, reports, bulletins and manuals.
Able to hear for work-related purposes.
Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment.
Able to lift up to a minimum of 25 pounds.
ESSENTIAL ENVIRONMENTAL CONDITIONS
Work is generally performed under normal office working conditions.
Normal level of visual strain.
Ability to cope with stress caused by public in
$44k-55k yearly est. Auto-Apply 60d+ ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Westminster, CO?
The average clinical research coordinator in Westminster, CO earns between $32,000 and $66,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Westminster, CO