Clinical research assistant work from home jobs - 132 jobs
Emergency Radiologists - Clinical Associates
AMN Healthcare 4.5
Remote job
Job Description & Requirements Emergency Radiologists - Clinical Associates
Emergency Radiologists - Clinical Associates
Salary Range: $430,000 - $480,000 per year as well as an anticipated annual incentive payment between $30,000 to $75,000 based on work schedule
The University of Chicago s Department of Radiology seeks Clinical Associates at 100% effort for renewable terms of up to three years. Appointees will have responsibilities that include interpretation of all aspects of emergency radiology diagnostic examinations and will be joining our team of six emergency radiologists, extending an existing evening shift. Work shifts will be primarily nights and weekends; arrangements are flexible and may be fully remote. The anticipated clinical schedule is 7 days on clinical service and 14 days off clinical service. These positions do not require teaching or scholarly activity. Compensation (including a generous package of fringe benefits) depends on qualifications. For information on benefits, please consult the University of Chicago Benefits Guide: .
Prior to the start of employment, qualified applicants must: 1) have a medical doctorate or equivalent, 2) hold or be eligible for medical licensure in the State of Illinois and the State of Indiana, and 3) be American Board of Radiology certified or eligible.
We especially welcome applicants with emergency radiology fellowship training or equivalent experience. Basic pediatric ER radiology skills are also sought.
The University of Chicago has retained AMN Healthcare to support this recruitment. CJ Stanford, Senior Search Consultant and Nicole Sturznickel, Senior Search Consultant with AMN Healthcare is leading the search. Inquiries, applications, and nominations must be sent by email to CJ Stanford and Nicole Sturznickel at and . Please note all job seekers wishing to be considered for the position must also submit their materials through The University of Chicago s Academic Recruitment job board, which uses Interfolio to accept applications: . Applicants must upload a CV including bibliography and cover letter. Review of applications ends when the positions are filled.
For instructions on the Interfolio application process, please visit .
Equal Employment Opportunity Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination .
Job seekers in need of a reasonable accommodation to complete the application process should call or email with their request.
Facility Location
Situated on the banks of Lake Michigan, this Midwestern metropolis combines global high-style with a friendly, down-home soul. Along with its superb medical facilities, visitors to Chicago relish the city s 29-mile long lakefront park, fabulous shopping districts, multicultural neighborhoods and world-class arts and entertainment.
Job Benefits
About the Company
At AMN Healthcare, we strive to be recognized as the most trusted, innovative, and influential force in helping healthcare organizations provide quality patient care that continually evolves to make healthcare more human, more effective, and more achievable.
Radiology Physician, Radiologist, Radiology Doctor, Radiology Specialist, Imaging Radiologist, Diagnostic Radiologist, radiology radiology, radiologist
AMN Healthcare is a digitally enabled workforce solutions partner focused on solving the biggest challenges affecting healthcare organizations today. We offer a single-partner approach to optimize labor sources, increase operating margins, and provide technologies to expand the reach of care.
$36k-44k yearly est. 4d ago
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Clinical Research Associate
Praxis Precision Medicines
Remote job
At Praxis, we turn neuroscience discoveries into treatments that improve patients' lives. The ClinicalResearch Associate (CRA) plays a key role in monitoring clinical trials and ensuring they are conducted to the highest quality and compliance standards. This position involves direct site management, monitoring visits, and close collaboration with site staff and cross-functional teams to support the successful execution of studies.
Key Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, ICH-GCP, and regulatory requirements.
Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases.
Review monitoring reports and follow-up letters to ensure timely resolution of issues.
Assist CTMs in site activation activities and provide ongoing site management support.
Collaborate with cross-functional teams (Data Management, Medical, Regulatory, Quality) to maintain high-quality trial conduct.
Identify and escalate protocol deviations, data integrity issues, and safety concerns.
Maintain study files and documentation, ensuring compliance with SOPs and trial master file (TMF) requirements.
Support investigators and site staff with training and guidance on study procedures.
Qualifications
Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus).
3+ years of clinicalresearch experience, including site monitoring responsibilities.
Strong knowledge of ICH-GCP, FDA regulations, and international trial standards.
Excellent organizational, communication, and problem-solving skills.
Ability to manage multiple priorities and work independently as well as in a team.
Willingness to travel as needed for monitoring visits (up to 50-75%).
Preferred Experience
Previous experience in CNS or rare disease clinical trials.
Strong understanding of GCP, FDA, and global trial regulations.
Familiarity with registrational trial requirements.
Praxis Values
Patients First
Scientific Rigor
Integrity
Collaboration
Urgency with Purpose
Accountability
The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Compensation & Benefits
At Praxis, we believe that taking care of our people (and
their
people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together!
To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
Annualized Base Salary$103,000-$122,000 USD
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************.
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
$103k-122k yearly Auto-Apply 3d ago
Clinical Research Associate - Oncology
ZP Group 4.0
Remote job
Piper Companies is seeking a well-rounded ClinicalResearch Associate with direct oncology monitoring experience to work with a Global CRO. The ClinicalResearch Associate will be working remote with some travel included. Requirements for the ClinicalResearch Associate include:
* Conducting site monitoring visits in line with GCP and ICH guidelines
* Ensure project needs are met by collaborating with local sites
* Oversee regulatory submissions, CRF completion, and data query resolutions
* Ensure documentation is properly formatted and filed; TMF and ISF
* Mentor clinical staff during visits
Qualifications for the ClinicalResearch Associate include:
* 2+ years of Oncology monitoring experience
* 2+ years of onsite monitoring experience
* Able to travel locally for work
* Proficient in GCP and ICH guidelines
* Understand Microsoft Office and mobiles devices
* Strong understanding of Phase 1 oncology trials (phase 2 and 3 are welcomed)
* Bachelor's degree in a related field
Compensation for the ClinicalResearch Associate includes:
* Salary range: $90,000 - $120,000
* Comprehensive benefit package: Medical, Dental, Vision, 401k match plus PTO, Sick leave as required by law, and Paid Holidays
Keywords: Clinicalresearch associate, CRA, hospital, travel, oncology, documentation, trials, trial sites, cancer, cancer research, GCP, ICH, recruitment plans, projects, project, protocol adherence, regulatory submissions, enrollment, CRF completion, data, data query, start-up phase, phase 1, trial master file, TMF, Investigators site file, ISF, mentorship, Microsoft office, mobile devices
#LI-BH1 #LI-REMOTE
This job opens for applications on 1/9/2025. Applications for this job will be accepted for at least 30 days from the posting date.
$90k-120k yearly 1d ago
Clinical Research Associate (West Coast)
Atrium Staffing
Remote job
Our client is a respected global clinicalresearch partner, known for delivering high-quality trial support and regulatory compliance across a variety of therapeutic areas. This organization partners with major biopharmaceutical sponsors to ensure efficient and ethical clinicalresearch execution across the U.S. They are currently looking to add a ClinicalResearch Associate (West Coast) to their team.
Salary/Hourly Rate:
$100k - $120k, Based on experience, with travel reimbursement and potential performance incentives.
Position Overview:
An exciting opportunity has opened for a ClinicalResearch Associate (West Coast) with extensive site monitoring experience to join a growing team focused on West Coast clinical trials. The ClinicalResearch Associate (West Coast) will be the key contact for assigned investigative sites, ensuring protocol adherence, subject safety, and quality data collection throughout the trial lifecycle. This remote-based position is ideal for a motivated and experienced ClinicalResearch Associate (West Coast) who is comfortable traveling to various regional sites while managing multiple aspects of site performance.
Responsibilities of the ClinicalResearch Associate (West Coast):
* Perform all required monitoring visits (SQV, SIV, IMV, COV) in alignment with protocol and regulatory standards.
* Serve as the primary liaison between the sponsor and site staff, providing timely updates and training as needed.
* Conduct source data verification (SDV) and ensure data accuracy in all systems.
* Support safety reporting by tracking and managing adverse events (AEs) and serious adverse events (SAEs).
* Document visit findings through clear and timely reports and follow-up correspondence.
* Maintain oversight of site documentation, including regulatory binders and monitoring files.
* Contribute to subject recruitment planning and site engagement strategies.
* Attend internal project meetings, highlighting site progress and raising any concerns.
* Support audit readiness and facilitate the resolution of site-level issues.
Required Experience/Skills for the ClinicalResearch Associate (West Coast):
* Minimum of 5 years of experience as a ClinicalResearch Associate, with demonstrated success in site monitoring.
* Strong knowledge of ICH-GCP and regulatory requirements.
* Ability to manage multiple sites and travel up to 80%.
* Experience with clinical trial management systems (CTMS), EDC platforms, and Microsoft Office.
* Excellent organizational, analytical, and communication skills.
Education Requirements:
* Bachelor's degree in a scientific discipline, Nursing, or an equivalent field is required.
Benefits:
* Competitive compensation package.
* Health, dental, and vision insurance.
* 401(K) with company matching.
* Paid time off and holidays.
* Full travel reimbursement and per diem.
* Career development and training opportunities.
$100k-120k yearly 21d ago
Clinical Research, Clinical Research Associate (Remote)
Castle Biosciences 3.7
Remote job
Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood! Learn more at ************************* Castle Biosciences Inc. is growing, and we are seeking to hire a full-time ClinicalResearch Associate to work remotely from a home-based office in the USA, preferably located in the greater Chicago area, St. Louis, Missouri, Ohio, Virginia, Pennsylvania, Nashville, Indianapolis, or Atlanta within close proximity to a major airport.
Why Castle Biosciences?
* Exceptional Benefits Package:
* Excellent Annual Salary + 20% Bonus Potential
* 20 Accrued PTO Days Annually
* 10 Paid Holidays
* 401K with 100% Company Match up to 6%
* 3 Health Care Plan Options + Company HSA Contribution
* Company Stock Grant Upon Hire
Salary Range: $90,000 - $95,000. Salary Range is based on Experience and Education levels.
A DAY IN THE LIFE OF A ClinicalResearch Associate
The ClinicalResearch Associate (CRA) is responsible for managing sites participating in Castle's clinical studies. Daily tasks vary based on study and site needs and may include attending team meetings, training site staff, sending emails, and traveling to U.S. sites to monitor data. The CRA performs all aspects of clinical monitoring and site management in compliance with ICH GCP, FDA guidelines, local regulations, protocols, and Castle's SOPs. This role ensures protocol and regulatory compliance, manages study documentation, and fosters strong relationships with sites. CRAs also play a key role in protecting participant safety, ensuring data quality, and representing Castle in the broader research community.
REQUIREMENTS
* Bachelor's degree in a science or healthcare-related field or a registered nursing certification, or equivalent certification/licensure from an appropriately accredited institution.
* 3 years of CRC experience or previous 1 year experience as a CRA.
* Direct patient care or clinicalresearch experience required.
* Familiarity with clinicalresearch and study development processes.
* Valid Driver's License where applicable.
* In some cases, a combination of education, professional training, and demonstrated experience that provides the required knowledge, skills and abilities may be considered.
TRAVEL/WORK ENVIRONMENT
* Regular overnight travel by car and air, typically 50-60% of the time, with potential peaks up to 80%
* Flexibility to accommodate an often changing and unpredictable timeline
* Frequent laptop use
* When in the office, there is a standard office environment with the use of a desk/phone/computer
* Generally, proof of COVID-19 vaccination will be required to access study sites, in accordance with site-specific guidelines and subject to any applicable exceptions as required by Federal, State, and Local laws.
SCHEDULE
* M-F travel-based position; working remotely from your home based in the USA near a major airport.
* Preferred locations include greater Chicago area, St. Louis MO, Ohio, Virginia, Pennsylvania, Nashville or Atlanta within close proximity to a major airport.
READY TO JOIN OUR BIOTECH TEAM?
We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon!
Castle Biosciences Awards and Research Developments!
WORK AUTHORIZATION
All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.
ABOUT CASTLE BIOSCIENCES INC.
At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.
Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.
Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com.
This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
No third-party recruiters, please
$90k-95k yearly 1d ago
Clinical Research Associate / Clinical Monitor / Site Manager - Home-Based (Eastern U.S.)
Alcedis
Remote job
As an innovative research institute, Alcedis provides clinicalresearch services supported by a modern information technology infrastructure. Our flat hierarchies and collaborative culture foster a flexible, dynamic, and team-oriented working environment.
We are seeking a ClinicalResearch Associate / Clinical Monitor / Site Manager (home-based) to join our Clinical Operations team. In this role, you will play a key part in site monitoring activities and in ensuring protocol compliance and overall study quality at investigational sites. You will independently monitor U.S. study sites and may also support Canadian sites as needed, working in close and regular contact with the responsible Project Manager or Lead ClinicalResearch Associate at Alcedis in Germany or the United States.
We are looking for candidates based in the Eastern United States, ideally in or near major metropolitan areas such as Boston, New York City, Philadelphia, Pittsburgh, Columbus, Detroit, Atlanta, or Raleigh-Durham. Candidates located in other parts of the Eastern U.S. will also be considered.
Provide on-site and remote support in the organization and conduct of the study and supervision of the investigators
Prepare, conduct and follow-up of site initiation, monitoring and close-out visits (remote or on-site)
Assess study progress at assigned sites according to predefined guidelines and ensure complete, accurate documentation
Validate study data collected by investigators (source data verification)
Prepare monitoring visit reports and related documentation
Evaluate study sites for compliance with applicable regulations, guidelines, and study protocols
Collaborate closely with data manager and project manager
Generate, track, and resolve queries
Train investigators and study coordinators in the use of EDC systems
Conduct feasibility assessments for new study sites and upcoming projects
Support and coordinate study sites, including assistance with documentation and escalation of site-level issues
Prepare documents for submission to regulatory authorities and ethics committees
From day one, we expect you to bring:
Bachelor's degree in natural or life sciences or a comparable qualification (e.g., Study Nurse certification)
At least 3 years of hands-on monitoring experience in GCP-regulated interventional clinical trials
Working knowledge of data privacy and protection regulations relevant to clinical trials, including HIPAA (U.S.) and FDA 21 CFR Part 11, familiarity with GDPR (EU) is a plus
Ability to work independently, plan proactively, and execute tasks with foresight and attention to detail
Strong communication and organizational skills
Collaborative, team-oriented mindset
Excellent written and spoken English
Willingness to travel and flexibility to support study needs
Annual salary: $75,000 - $95,000 DOE
15 days of paid vacation per year
6 paid sick days per year
Health, dental and vision insurance for you and your dependents
Employee life insurance
Health Savings Account (HSA)
401(K)
You'll work in a future-oriented and secure working environment
A forward-looking, growth-oriented work environment
Exciting and challenging projects that make an impact
Flat organizational structure with an open and collaborative culture
A dedicated, successful, and supportive team environment
Varied work with the autonomy to take ownership of your projects
Flexible working hours to support work-life balance
We welcome applicants of all backgrounds and do not discriminate based on race, ethnicity, gender, sexual orientation, disability, age, religion, or any other protected characteristic.
Come join us! Take the next step and apply today - we can't wait to meet you!
To apply, submit your resume, a short cover letter, and a Clinical Trial Experience Table detailing your study experience (type, phase, sites, role) directly through the link or alternatively via our careers page: Career | Alcedis
For more information about our company, please visit our website at Alcedis | Digital Clinical Trials
$75k-95k yearly 3d ago
Remote Women's Fertility Clinical Research Associate III
Global Channel Management
Remote job
Remote ClinicalResearch Associate III needs 2 years of site management and field monitoring experience
Remote ClinicalResearch Associate III requires:
Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm
EST
Qualifications:
BS/BA
Minimum of 2 years of site management and field monitoring experience
Knowledge of applicable standards and regulations for clinical trials
Proven oral and written communication skills
Proven planning skills; ability to create and track detailed project plans
Proven interpersonal, leadership, organizational and effective time management skills
Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion
Preferred:
Experience in womens fertility
VD Study Experience
Medidata RAVE system
Remote ClinicalResearch Associate III duties:
Performs Site initiation, interim & close out monitoring visits
Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete
Manages site communication and escalates to leadership in a timely fashion when needed
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports
Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings
$50k-80k yearly est. 60d+ ago
Clinical Research Associate
Histosonics 3.6
Remote job
HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.
Location: Remote position, ideally candidates will live in a major metro area with an international airport in the Northeast, Southeast or West Coast.
Travel Expectation: Travel (by automobile or air, day trips and overnight stays) up to 30% of the time.
Position Summary:
The ClinicalResearch Associate will play a key role in proactively helping the conduct of pre-market and post-market global clinical studies to ensure compliance with all the regulatory requirements and company strategic initiatives. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies. This role will be responsible for study site management, including site qualification, training, activation, and monitoring.
Key Responsibilities:
* Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations
* Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits
* Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed
* Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans
* Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns
* Ensures quality and completeness of central and site master files
* Oversees site investigational product requirements and device accountability
* Supports the planning and coordination of Investigator Meetings
* Other duties as assigned
Qualifications and Skills:
* 2+ years clinicalresearch study monitoring for medical device or related experience
* BS degree in relevant area of study
* Knowledge of federal and local regulations and policies pertinent to research involving human subjects
* Knowledge of ICH, GCP and Declaration of Helsinki
* Excellent communication, interpersonal and organizational skills
* Ability to collaborate in a team environment and work independently
* Self-starter with the ability to manage projects and effectively prioritize tasks in a dynamic, start-up environment
* Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time
HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
#LI-Remote
$55k-90k yearly est. 52d ago
Clinical Research Associate II
Glaukos Corporation 4.9
Remote job
How will you make an impact?
Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinicalresearch studies sponsored by Glaukos. The ClinicalResearch Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.
What will you do?
CLINICAL SITE MONITORING
Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
Assist with selection of potential investigators
Conduct initial and ongoing site training throughout the course of the study
Verify informed consent process is properly followed
Evaluate investigator compliance with the study protocol and applicable regulations
Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
Verify and reconcile site's essential documents against the trial master file as required
Oversee and conduct monitoring activities, including remote monitoring when applicable
Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study
CLINICAL SITE MANAGEMENT
Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.
Create and maintain appropriate documentation (e.g., visit reports/letters)
regarding site management, monitoring visit findings, and action plans
Ensure audit and inspection readiness of assigned sites
Advise on pre-audit activities for GCP requirements
Be familiar with assigned study timelines and communicate potential issues to study management
How will you get here?
Works independently with minimal supervision
Conducts all types of site visits
Build strong productive relationships with study investigators, site staff, and study management personnel
Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinicalresearch experience
Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA
Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinicalresearch studies
Must have proficient computer skills and experience with Microsoft Office
Must be willing and able to travel approximately 75-80%, including overnight, domestic and international
Must have Self-directed behavior
#GKOSUS
$53k-81k yearly est. Auto-Apply 4d ago
Clinical Research Associate II
Global 4.1
Remote job
How will you make an impact?
Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinicalresearch studies sponsored by Glaukos. The ClinicalResearch Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.
What will you do?
CLINICAL SITE MONITORING
Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
Assist with selection of potential investigators
Conduct initial and ongoing site training throughout the course of the study
Verify informed consent process is properly followed
Evaluate investigator compliance with the study protocol and applicable regulations
Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
Verify and reconcile site's essential documents against the trial master file as required
Oversee and conduct monitoring activities, including remote monitoring when applicable
Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study
CLINICAL SITE MANAGEMENT
Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.
Create and maintain appropriate documentation (e.g., visit reports/letters)
regarding site management, monitoring visit findings, and action plans
Ensure audit and inspection readiness of assigned sites
Advise on pre-audit activities for GCP requirements
Be familiar with assigned study timelines and communicate potential issues to study management
How will you get here?
Works independently with minimal supervision
Conducts all types of site visits
Build strong productive relationships with study investigators, site staff, and study management personnel
Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinicalresearch experience
Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA
Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinicalresearch studies
Must have proficient computer skills and experience with Microsoft Office
Must be willing and able to travel approximately 75-80%, including overnight, domestic and international
Must have Self-directed behavior
#GKOSUS
$50k-79k yearly est. Auto-Apply 4d ago
Clinical Research Scientist Interventional Solutions
Gehc
Remote job
SummaryAre you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities
Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities.
Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions).
Support adoption of new technology or clinical applications through advocacy and evidence.
Participate in customer presentations regarding use of Interventional products for institution research purposes.
Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs.
Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations
Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns.
Grow technology leadership mindshare through joint scientific presentations and publications.
Install/upgrade research equipment and software & prototypes
Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures
Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products.
Study new technology concepts and leverage expertise to move initiatives forward.
Note:
No sponsorship available for this role now or in the future to work in the United States..
Qualifications
PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field.
3+ years of experience in Interventional healthcare industry or research.
Knowledge of Interventional procedures, anatomies, clinical practice.
Excellent written and verbal communication skills.
Excellent customer relationship management and collaboration skills.
Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas.
Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task.
Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams.
Able to individually lead complex projects with autonomy, rigor, drive & competence
Ability to travel (
Quality, Compliance, and Continuous Improvement focus
Desired Characteristics
5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics.
Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department)
Demonstrated record of innovation and development.
History of publications, clinical/non-clinical experiments, knowledge in statistics
Programming / Image processing experience
Experience with academic and/or clinicalresearch collaborations
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
#LI-BR3
#LI-Remote
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
$97.6k-146.4k yearly Auto-Apply 52d ago
Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate) (LA)
Medpace 4.5
Remote job
ClinicalResearch Coordinators wanted at Medpace! Become a CRA and join our growing team! This is an exciting opportunity for clinicalresearch professionals with at least one year of ClinicalResearch Coordinator experience to fill ClinicalResearch Associate (CRA) openings with Medpace. Through our PACE Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
WE OFFER THE FOLLOWING
* Competitive travel bonus;
* Equity/Stock Option program;
* Training completion and retention bonus
* Annual merit increases;
* 401K matching;
* The opportunity to work from home;
* Flexible work hours across days within a week;
* Retain airline reward miles and hotel reward points;
* Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
* In-house travel agents, reimbursement for airline club, and TSA pre-check;
* Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
* CRA training program (PACE);
* Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
* In-house administrative support for all levels of CRAs; and
* Opportunities to work with international team of CRAs.
Responsibilities
* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinicalresearch physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Medical device and/or investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinicalresearch site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
* Must have a minimum of a Bachelor's degree in a health or science related field;
* Experience as a ClinicalResearch Coordinator (minimum 1 year);
* Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely;
* Must maintain a valid driver's license and the ability to drive to monitoring sites;
* Proficient knowledge of Microsoft Office;
* Strong communication and presentation skills; and
* Must be detail-oriented and efficient in time management.
Compensation
A target salary range of $60,000 - $140,000 with potential for bonus and equity 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). For more details, please discuss with your recruiter.
#LI-Remote
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.
Medpace Perks
* Flexible work environment
* Competitive PTO packages - starting at 20+ days
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Competitive compensation and benefits package
* Structured career paths with opportunities for professional growth
* Discounts for local businesses
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.
Department: MED-Impact Institute Salary/Grade: NEX/11 Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
Job Activities: Primary activities involve the scheduling and retention of research participants in the RADAR study with young people ages 16-29. Specific activities include: following established protocols for contacting and scheduling participants; tracking participants for retention purposes; conducting study assessments; maintaining accurate, timely and detailed records of participant contact; maintaining and updating databases; and other project-related responsibilities.
The Research Study Coordinator is expected to work in-person at study sites without a regular work from home schedule. The position will also require some evening hours (e.g., 11 AM - 7 PM) and weekend shifts to maximize retention efforts for study participants who are unavailable during the regular workday.
We are seeking a diverse pool of candidates. Candidates from backgrounds traditionally underrepresented in research are encouraged to apply.
Please note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters.
Work Location Requirement
As this role supports an in-person research study, full-time on-site presence is required. Direct coordination with participants, staff, and study resources must occur on campus to ensure the integrity of study operations and participant engagement. Remote, hybrid, or work-from-home arrangements are not possible for this position.
Driver's License Requirement
Because this position involves the use of a mobile unit to conduct research study visits, applicants must hold a valid driver's license and meet the eligibility criteria of the University's Safe Driver Program. This includes following all program guidelines regarding responsibilities, safe driving practices, and authorization for vehicle use on University business.
Specific Responsibilities:
Technical
* Participates in the planning & conduct of research study including participant recruitment and retention.
* Obtains informed consent
* Administers tests &/or questionnaires following protocols.
* Collects, compiles, tabulates & processes responses.
* Gathers information.
* Extracts & analyzes data from medical charts.
* Completes basic clinical procedures such as drawing blood & obtaining blood pressure.
Administration
* Collects, records, reviews & summarizes research data.
* Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests.
* Prepares reports for investigators and sponsors on recruitment status and other pertinent study data.
* Writes portions of grant applications & co-author scientific papers.
* Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols.
Finance
* May process payments for research participants per study protocol.
* Works with industry representatives to negotiate tentative grant funding.
* Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget.
Supervision
* May provide work direction &/or train other research staff to interview/test participants.
* May act as a mentor in regard to education of junior coordinators.
Miscellaneous
Performs other duties as assigned.
Minimum Qualifications:
* Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
* Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience.
* Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
* Strong project coordination skills and the ability to prioritize tasks.
* Supervisory experience.
* Effective time management skills.
* Efficient and resourceful in problem-solving.
* Demonstrated attention to detail and ability to adhere to instructions/procedures.
* Good communication skills; demonstrated effective spoken and written communication.
* Demonstrated ability to take ownership of the work, possessing initiative, and good follow-through.
* Knowledge of basic computer skills, familiarity with Windows environment.
Preferred Qualifications:
* Experience working with LGBT youth.
* Experience working in public health, psychology, and/or medical research.
* Experience working in non-profit, community-based settings.
* Experience recruiting and tracking study participants or experience with youth development and community outreach.
* Phlebotomy certification and experience
Preferred Competencies: (Skills, knowledge, and abilities)
* Knowledge of HIV and HIV risk among YMSM.
* Ability to work in a team environment.
* Ability to work with minimum supervision and guidance.
* Ability to receive and benefit from feedback; willingness to expand skill set and improve.
* Flexibility in adapting to new procedures and environments.
Target hiring range for this position will be between $19.89 -$24.04 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.
Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more.
Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more.
Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more.
Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.
$19.9-24 hourly 18d ago
Respiratory Care Research Coordinator (Intermittent)
University of Washington 4.4
Remote job
School of Nursing has an outstanding opportunity for a Respiratory Care Research Coordinator (Intermittent) (Respiratory Care Lead (NE H NI CNU)
The Spirometry 360 research team provides methodological spirometry expertise to clinical and study teams, including virtual spirometry coaching, overreading and grading, and training to facilitate optimal spirometry implementation. The Spirometry 360 Respiratory Care Research Coordinator will assist with the development and implementation of research protocols while ensuring research projects are conducted in compliance with federal regulations, institutional/departmental guidelines, and other regulatory standards. The research team primarily supports studies on pediatric and adult asthma and other respiratory conditions. An ideal candidate is an independent worker who is comfortable working in a team setting.
This position is fully remote and requires the ability to manage multiple, and often changing, priorities and timelines, and frequent communication with the project team regarding the status of assigned tasks and any issues that may arise.
Key Responsibilities:
Regulatory and research protocol adherence.
Development of process and workflows.
General research support.
Regulatory and Research Protocol Adherence (45%):
Conduct research activities in accordance with applicable institutional/departmental guidelines, federal regulations, and principles.
Overread spirometry tests and record grades into research data portals in accordance with national standards (e.g., American Thoracic Society) and study protocols.
Provide virtual spirometry coaching to study participants as outlined in study protocol.
Report any protocol deviations or concerns to program director to ensure research quality.
Development of Processes and Workflows (40%):
Contribute to the development of workflows and protocols for data collection, including synchronous spirometry coaching, overreading, logistics, and data reporting.
Assist with creating and performing quality assessment and improvement methods.
Ensure consistent updates are communicated between team and research partners.
General research support (15%):
Provide instructions on home spirometry maneuvers to practitioners, coordinators, participants and caregivers.
Attend Spirometry 360 team meetings, meetings with research collaborators and external vendors, as appropriate.
Other duties as assigned.
Minimum Requirements:
Completion of a respiratory care program approved by the State of Washington Department of Health AND eighteen months of experience as a Respiratory Care Practitioner.
Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
Legal Requirement
Licensed as a Respiratory Care Practitioner (Registered Respiratory Therapist - RRT) by the State of Washington.
Additional Requirements:
Two years of experience coaching and reading spirometry maneuvers.
Human Subjects Protection training (e.g., CITI) and Good Clinical Practice (ICH-GCP) certification, current at time of hire or completed prior to start. Training must be maintained per sponsor/IRB requirements.
Desired Qualifications:
NBRC Registered Respiratory Therapist (RRT) credential or active state Respiratory Care Practitioner (RCP) license.
Experience working within clinical setting.
Pediatric spirometry experience.
Research experience.
Strong organizational skills and attention to detail.
Strong verbal and written communication skills with the ability to manage relationships and interact with a wide range of researchers, clinicians, and research participants.
Proficiency in Microsoft Office software.
Proficiency with audio/visual conference software, e.g. Zoom.
Conditions of Employment
Typical hours occur between 9am and 6pm
The schedule may require occasional prearranged hours outside of business hours due to the nature of global spirometry testing.
Local travel, within Western Washington State, may be required 1-2 times annually.
This is a permanent position, albeit on an intermittent basis, as work becomes available.
Compensation, Benefits and Position Details
Pay Range Minimum:
$40.98 hourly
Pay Range Maximum:
$58.60 hourly
Other Compensation:
-
Benefits:
For information about benefits for this position, visit ****************************************************************************************
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a temporary position
FTE (Full-Time Equivalent):
0.00%
Union/Bargaining Unit:
Not Applicable
About the UW
Working at the University of Washington provides a unique opportunity to change lives - on our campuses, in our state and around the world.
UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.
Our Commitment
The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81.
To request disability accommodation in the application process, contact the Disability Services Office at ************ or **********.
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.
$40k-55k yearly est. 3d ago
Director - Clinical Research Scientist - Immunology/Gastroenterology Development
Eli Lilly and Company 4.6
Remote job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinicalresearch scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement.
Key Objectives/Deliverables
The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule
Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications.
Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy.
Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
Minimum Requirements
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD
3+ years of clinical development experience, including mid-to-late-stage development
Additional Skills/Preferences
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
Previous GI drug development experience
Pediatric drug development experience
Oral/written communication/listening skills are essential
Strong relationship-building and interaction skills with peers and management
Preferred location is Indianapolis, though remote arrangements may be considered
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $338,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$93k-127k yearly est. Auto-Apply 2d ago
Regulatory Assistant - Clinical Research
Cenexel 4.3
Remote job
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinicalresearch managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel ClinicalResearch also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Hourly Rate: $20.00 - $22.00/hr (depending on education, experience, and skillset)
Schedule: Monday - Friday 08:00 AM - 04:30 PM
Job Summary:
Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to site SOPs, ICH, GCP, and FDA guidelines.
SOPs (Standard Operating Procedures)
ICH (International Council for Harmonization)
GCP (Good Clinical Practices)
FDA (Food and Drug Administration)
Essential Responsibilities and Duties:
Complies with current protocols, site SOPs, GCPs, IRB (Institutional Review Board) and FDA guidelines.
Uploads regulatory documents with RealTime eDOCs System and files is paper binders, as necessary.
Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums.
Tracks submissions and ensure timely filing of documents.
Obtains CVs (Curriculum Vitae) of external Investigators and other contract personnel and their signatures for appropriate regulatory documents.
Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff.
Assists in obtaining necessary signatures from investigators.
Works closely with study sponsor/CRO and key clinical trial personnel on relevant regulatory document issues.
Ensures Clinical Conductor regulatory information is current.
Participates in team meetings and complies with training requirements.
Assists sponsors/CRO's as needed.
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:
Must be able to effectively communicate verbally and in writing.
Minimum: High School graduate or equivalent.
Minimum of 1 year of related experience in clinicalresearch
Must be self-directed and able to work with minimal supervision.
Able to take a flexible approach to shifting priorities.
Motivated to work consistently in a fast-paced and rapidly changing environment.
Working Conditions
Indoor, Office environment.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
Ability to work overtime, weekends, and/or holidays as needed.
Ability to travel as needed.
Remote work arrangement depending on location.
CenExel ClinicalResearch is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
$20-22 hourly 33d ago
Clinical Research Coordinator (Onsite Dallas, TX)
Syneos Health Clinical Lab
Remote job
Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinicalresearch services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas.
Illingworth Research Group is a global organization operating in over 45 countries, bringing clinicalresearch directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives.
Job Responsibilities
ClinicalResearch Project Planning and Preparation
Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility,
timing, and resources.
Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study.
Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV,
Sponsor discussions, or other related meetings).
Take the lead and/or overall coordination of all required start-up activities including, but not
limited, to the following:
o Clinic logistics planning, schedule of clinic activities, and team training.
o Preparation, review, and/or finalization of clinic source documents, time and events
tables, and other required study materials; review of Case Report Forms (CRFs),
laboratory workbooks, staff requirements, and schedules.
o In collaboration with the responsible teams, establishes and/or maintains safety
assessment requirements, Quality Control (QC) and monitoring plans,
pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other
elements as applicable to the study.
o Confirms all required regulatory and contractual documentation is present prior to study
start.
Support the Principal Investigator as needed with study related tasks such as, but not limited to:
o Delegation of Authority Log.
o Management of daily tasks.
o Visit calendar development and maintenance.
o Scheduling and attending monitor visits.
Advertise, recruit, and screen potential participants for the study.
Clinical Conduct
Perform all study activities following Good Clinical Practices (GCP).
Manage multiple clinical trials simultaneously.
Protect the safety of human subjects.
Monitor appropriate sources for specific clinical study or federal regulation updates.
Collect and enter study data into the appropriate system.
Coordinate and monitor screening activities; provides support as required.
Assist with informed consent of study subjects.
Submit data in required timeframe.
Monitor appropriate sources for specific clinical study or federal regulation updates.
Complete Case Report Forms.
Facilitate audits of study data.
Develop patient rapport to explain research protocols and minimize protocol violations.
Develop rapport with study team to educate team on study procedures and minimize protocol
violations.
Respond to inquiries by auditors for data clarification or additional data in required timeframe.
Take the lead and/or overall coordination of clinic activities including, but not limited to:
o Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up)
as required and provides on-call support when applicable.
o Screens eligibility prior to randomization; oversees, coordinates and/ or performs study
drug administration, and other activities as delegated and required.
o In collaboration with the responsible teams, monitors that all study-related activities are
conducted according to protocol, SOP, and applicable regulations.
Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs)
reporting, study logs and tracker, quality control, and Monitor findings.
Post-Clinic/Close-Out Activities
Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings.
Review and/or oversee close-out of study documentation, deviation reporting, CRF completion
and sign-off, and other study-related reports/documentation.
Review and update TMF documentation.
Finalize study and/or volunteer logs.
Ensure completion of other close-out activities as required (return of study supplies, IRB reports,
archiving, etc.).
Responsible for monitoring subjects' compliance throughout the trial and address day-to-day.
subject or study issues and escalate as appropriate.
Prepare for and participates in sponsor/monitor/QA audits.
Provide accurate and timely project status updates to Project Managers and sponsor.
Collaborate within and between teams during process improvement exercises, SOP creation.
and/or revision, internal and external meetings, and other company-related initiatives and goals.
Accommodate flexible schedule (available days, afternoons, nights, and weekends).
Perform other work-related duties as assigned.
Coordinate and Perform Regulatory Activities
Maintain proper protocol, consent, amendment, and yearly renewal submission if requested.
Report adverse events relating to the trial.
Maintain study files.
Travel up to 100%
QUALIFICATION REQUIREMENTS
Registered Nurse and/ or University Degree such as Bachelor of Science Degree required.
ClinicalResearch certification preferred.
A minimum of 1 year experience in clinicalresearch required, preferably in coordination of clinicalresearch projects. 2+ years preferred.
Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines.
Required skills: problem solving, planning, and evaluation.
Possess good time management, detail-oriented, and able to multi-task.
Good interpersonal and communication skills with a team focus.
Knowledge of SOP writing.
Ability to anticipate problems and provide solutions in a timely manner.
Ability to coordinate multiple clinicalresearch projects with competing deadlines.
Proficiency in computer software programs (e.g. Word, Excel, Power Point).
Proficiency in use of various clinical trial EDC software preferred.
Disclaimer:
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its
sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents
may differ from those listed in the . The Company, at its sole discretion, will determine
what constitutes as equivalent to the qualifications described above. Further, nothing contained herein
should be construed to create an employment contract. Occasionally, required skills/experiences for jobs
are expressed in brief terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates, including the implementation
of the EU Equality Directive, in relation to the recruitment and employment of its employees. The
Company is committed to compliance with the Americans with Disabilities Act, including the provision of
reasonable accommodations, when appropriate, to assist employees or applicants to perform the
essential functions of the job.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Additional Information:
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
$44k-62k yearly est. Auto-Apply 48d ago
Clinical Research Coordinator III - RN
Invitrogen Holdings
Remote job
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinicalresearch through our PPD clinicalresearch portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Discover Impactful Work:
We are seeking a ClinicalResearch Coordinator III (Registered Nurse) to support our government customer on-site in
Silver Spring, Maryland
. This is a per diem, non benefited position. Availability needed (6:00 am - 10: 00 am).
Relocation assistance is NOT provided for this role.
Must be a U.S. citizen.
Must be able to pass a comprehensive background check, which includes a drug screening and a physical.
Required to be a Registered Nurse licensed to practice in the state of Maryland.
A day in the Life:
Organizes and prioritizes all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting.
Reviews and understands research protocols, ensuring applicable regulations and guidelines are followed.
Organizes research information for clinical projects
Selects and observes subjects and assists with data analysis and reporting.
Oversees experiment scheduling and collection of data.
Participates in source document and study document design, writing SSP, materials planning, visit schedule creation, etc.
Enters required data routinely on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary.
Maintains study/test article or investigational product accountability and administration.
Monitors study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance.
Relies on experience and judgment to plan and accomplish goals. Works under general supervision and performs a variety of tasks.
Keys to Success:
Required Education
Required to be a Registered Nurse licensed to practice in the state of Maryland, who is skilled and qualified in nursing procedures to include, but not limited to the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314.
Basic Life Support (BLS -CPR/AED) certification.
Required Experience and Skills:
Five (5) years of experience in clinicalresearch coordination, with expertise in FDA-regulated trials.
Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform).
Must be able to work both independently and in a team setting following a brief period of specific technical training.
Must have excellent communication, organization, and prioritization skills.
Ability to establish and maintain effective working relationships with coworkers, managers and customers.
Maintenance of Certification in ClinicalResearch Coordination by Association of ClinicalResearch Professionals (ACRP) or Society of ClinicalResearch Associates (SoCRA).
Desired Experience and Skills
Advanced Cardiac Life Support (ACLS) certification encouraged.
Certification in clinicalresearch (e.g., CCRP or CCRA) is preferred.
Commission for Case Manager Certification (CCMC) certification preferred.
Compensation and Benefits
The salary pay range estimated for this position CRA (Level II) based in Maryland is $38.46-$44.23.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
$44k-62k yearly est. Auto-Apply 60d+ ago
Study participant - NL
Prolifics 4.2
Remote job
Study Participants
About Prolific
Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world.
Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills.
The role
We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects.
Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter.
What you'll bring
A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable)
A willingness to take our screening to assess your suitability for our participant pool
Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time
A reliable and fast internet connection and access to a computer
A willingness to self-declare your earnings, as our participants are self-employed
A Paypal account to receive payment from our clients
What you'll be doing in the role
Completing paid research studies such as answering surveys, participating in experiments, and providing written responses
Providing feedback, judgements, and opinions in structured research tasks
Contributing to high-quality research outcomes by responding thoughtfully and accurately
Key study types
Surveys and Questionnaires
Behavioural Experiments
User Research and Product Feedback
Educational and Academic Studies
Interviews and Open-Ended Responses
Quality Checks and Attention Tasks
Why Prolific is a great platform to join as a Participant
Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home.
We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines.
We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity.
Links to more information on Prolific
Website
Youtube
Privacy Statement
By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.