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  • Research Nurse (Per Diem, Boston MA)

    Syneos Health Clinical Lab

    Remote research nurse 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 clinical research 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 clinical research 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 Fully conversant with the trial protocol, Case Report Forms (CRFs/eCRF), off-site manual (if applicable), supporting documents, procedures, and timelines to enable day to day running of the trial including all relevant SOPs. Communicate effectively with the Illingworth research nurse project manager (RNPM), Research nurse manager, site staff and the Principal Investigator, to ensure a smooth and efficient flow of information. Maintain accurate documentation including electronic transfer of data as per Illingworth SOPs throughout the trial, ensuring subject confidentiality, adhering to GCP and data protection requirements. Attend Site Initiation Visits (SIV) as required and any other necessary meetings, including multi- disciplinary, project management and client-facing meetings. Coordinate (working with the RN team) and complete subject trial visits on- and off-site. Ensure all trial related procedures and assessments are completed according to the protocol and relevant SOPs and that data is collected accurately. Administer trial medication as per the protocol, and facilitate the safe storage, transfer, and accountability of trial medication in accordance with Illingworth SOPs. Process and safely package and dispatch samples, liaising with courier companies and organizations in line with project requirements and supporting documents. Assist in identifying potentially eligible patients for research projects and assist with patient recruitment into clinical trials providing information and support for those patients for on- and off-site care. Ensure the accurate reporting of adverse events (AEs) and serious adverse events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) to the site team and relevant RNPM, providing support for any additional follow-up that may be required. Report any suspected misconduct or fraud to Illingworth and associated companies. Qualifications: Registered nurse with a minimum of 2 years' post qualification experience. Research and clinical trials experience with GCP certification. Knowledge of research design and methodology desirable. Experience and knowledge of clinical nursing skills such as Venepuncture and ECG preferable. Ability to work autonomously with initiative in a team within a multidisciplinary environment. Excellent verbal and written communication skills. Ability to prioritize and manage multiple tasks. Good working knowledge of computer software including Outlook, Word, Excel, and PowerPoint as a minimum. Hourly rate: 48-58/hr 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-63k yearly est. Auto-Apply 60d+ ago
  • Research Study Coordinator (Data Editor, Health Disparities & Public Policy))

    Northwestern University 4.6company rating

    Remote research nurse job

    Department: MED-Psych & Behavioral Science Salary/Grade: NEX/11 . The Health Disparities & Public Policy program investigates health disparities in traditionally underserved populations. For the past 30 years, we have been conducting the Northwestern Juvenile Project, a longitudinal study of the health needs and outcomes of 1,829 youth involved with the justice system (now median age 44). The Research Study Coordinator will: review and process incoming structured interview data for coherence, missing information, coding errors, and logical inconsistencies; code open-ended questions; work collaboratively with other staff members to request clarifications and provide feedback; and maintain codebooks and manuals that document the status of edits and revisions. This position will work standard business hours Monday through Friday, with 3 days in-office on our Streeterville (Chicago) campus office required, and the option to work remotely 2 days per week. The Research Study Coordinator will complete all activities by strictly following all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), and Code of Federal Regulations (CFR). Specific Responsibilities: Technical * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. Administration * Collects, records, reviews & summarizes research data. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * 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.) * Keen attention to detail * Excellent organizational skills and habits * Strong troubleshooting and problem-solving skills * Intermediate proficiency with Microsoft Word and Excel * Strong interpersonal skills (listening, asking questions, providing feedback) * Ability to work independently and efficiently Preferred Qualifications: (Education and experience) * Experience working with empirical research studies * Experience with research involving structured interview data and data processes * Experience with human subjects research Preferred Competencies: (Skills, knowledge, and abilities) * Experience with REDCap or other survey software * Sound decision making based on available documentation Target hiring range for this position will be between $19.89 - 27.97 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. #LI-JP1
    $19.9-28 hourly 10d ago
  • Clinical Research Coordinator, Sr - Floater

    U.S. Renal Care, Inc. 4.7company rating

    Remote research nurse job

    The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.
    $47k-76k yearly est. 8h ago
  • Clinical Research Associate - Oncology

    ZP Group 4.0company rating

    Remote research nurse job

    Piper Companies is seeking a well-rounded Clinical Research Associate with direct oncology monitoring experience to work with a Global CRO. The Clinical Research Associate will be working remote with some travel included. Requirements for the Clinical Research 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 Clinical Research 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 Clinical Research 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: Clinical research 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 12/8/2025. Applications for this job will be accepted for at least 30 days from the posting date.
    $90k-120k yearly 3d ago
  • Clinical Research Associate- Remote

    Icon Clinical Research

    Remote research nurse job

    Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field. + Minimum of 2 years of experience as a Clinical Research Associate. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply
    $56k-88k yearly est. 31d ago
  • Clinical Research Associate

    Histosonics 3.6company rating

    Remote research nurse 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 Clinical Research 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 clinical research 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. 23d ago
  • Clinical Research Associate

    Actalent

    Remote research nurse job

    We are seeking a dedicated Clinical Research Associate (CRA) responsible for managing and monitoring clinical trial activities at assigned study sites, ensuring compliance with protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. This role involves building collaborative relationships with investigative sites to ensure subject safety, protocol compliance, and the validity of study data. Responsibilities * Serve as the primary point of contact for investigators and site staff. * Collaborate closely with sites to complete required site visits and perform site management activities to meet project timelines and deliverables. * Ensure all site management and monitoring activities comply with ICH-GCP, SOPs, Clinical Monitoring Plan, Protocol, study plans, local laws, and regulations. * Verify the accuracy and completeness of study data through source data review and verification. * Conduct site staff training and retraining on study protocol requirements and procedures. * Manage site-level queries, protocol deviations, and issues, escalating as necessary. * Ensure timely and accurate updating of data systems by sites. * Ensure timely and accurate reporting of adverse events, serious adverse events, and data safety. * Prepare and submit visit reports, follow-up letters, and other documentation promptly. * Maintain accurate and up-to-date study files, including regulatory documents and monitoring records. * Support site audits and inspections. * Support site feasibility assessments and patient recruitment strategies. * Act as a liaison between sites and sponsors, ensuring effective communication and issue resolution. * Work with sites to adapt, drive, and track the subject recruitment plan to enhance predictability. * Attend project meetings and provide updates on site status and progress. * Identify risks and recommend mitigation strategies. * Ensure events are properly followed to completion. * Lead and conduct presentations. * Coordinate, organize, and manage clinical study coordinator teleconferences as needed. Essential Skills * Bachelor's Degree in a scientific discipline or healthcare preferred. * Minimum 5 years of onsite monitoring experience. * In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, such as ICH-GCP guidelines. * Ability to travel up to 80%, including overnight stays. * Experience managing serious adverse events in collaboration with safety surveillance. * Effective organizational, communication, and interpersonal skills. * Ability to lead and conduct presentations. * Experience in clinical trial management systems (CTMS), EDC platforms, and Microsoft Office suite. * Strong analytical and problem-solving abilities. * Experience working in a fast-paced, collaborative environment. * Effective time and financial management skills. Additional Skills & Qualifications * Experience managing aspects of CRO functions is a plus. * Prior experience in patient recruitment & retention strategies and site relationship management. Work Environment Join a goals-driven, passionate group where employees strive to meet objectives in a dynamic environment. As a smaller company, there is high visibility and a performance-driven culture. We offer a rewards program with compensation, cellphone reimbursement, tuition reimbursement, a 5% matching 401K, and great benefits, backed by the financial stability of the parent company. Job Type & Location This is a Permanent position based out of Houston, TX. Pay and Benefits The pay range for this position is $140000.00 - $160000.00/yr. Other benefits are: Tuition reimbursement: 8K per year Holiday Pay 12 per year Vacation: at least 10 days annually Sick days 5 Annual performance bonus 10 - 15% Cell phone reimbursement $125 per month Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Dec 19, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $50k-80k yearly est. 1d ago
  • Clinical Research Associate; Oncology Monitoring Experience Required

    Alira Health 4.4company rating

    Remote research nurse job

    🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Job Description 2+ years oncology monitoring is a requirement for this position.KEY RESPONSABILITIES Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in set up/collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Performs quality control and verification of documents collected at sites for eTMF/TMF. Conducts investigational product accountability. Reviews site regulatory binder for required documents. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. Participates in internal, client/sponsor, scientific, and other meetings as required. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Participates in internal, client/sponsor, scientific, and other meetings as required. Assists in CRA new hire training and onboarding. Performs CRA mentoring. Collaborates with development and maintenance of Clinical Trial Management System (CTMS). Manages and resolves conflicting priorities to deliver on commitments. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS Quality focused; Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment Able to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy and disciplined Ability to problem-solve unstructured or ambiguous challenges Strong command of Local language, both written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture Self-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular
    $50k-79k yearly est. Auto-Apply 60d+ ago
  • Respiratory Care Research Coordinator (Intermittent)

    University of Washington 4.4company rating

    Remote research nurse 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 (********************************************************* . University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.
    $40k-55k yearly est. 2d ago
  • Senior Clinical Research Coordinator

    Topography Health

    Research nurse job in Washington, DC

    Job DescriptionOVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Train and mentor junior research staff Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Conduct Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience Ability to be on site 5 days a week in Chevy Chase, MD5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $59k-92k yearly est. 28d ago
  • Research Administrator, Post Award

    George Mason University 4.0company rating

    Research nurse job in Fairfax, VA

    Department: College of Science Classification: Financial Svcs Specialist 1 Job Category: Classified Staff Job Type: Full-Time Work Schedule: Full-time (1.0 FTE, 40 hrs/wk) Workplace Type: Hybrid Eligible Pay Band: 04 Salary: Salary commensurate with education and experience Criminal Background Check: Yes About the Department: The function of the Research Administration team, in the Office of the Dean, within the College of Science (COS), is to support faculty in proposal submission, financial management and compliance of their research grants and contracts in an efficient manner and with a customer-service focus. George Mason University College of Science (Mason Science) is committed to advancing inclusive excellence and fostering an environment free from discrimination, harassment, and retaliation throughout our STEM community. At Mason Science, our values include cultivating an organizational culture that promotes belonging, respect, and civility. We believe that varied opinions, cultures, and perspectives are what provides vibrancy, innovation, and growth to an academic community. By prioritizing cultural responsiveness in academics, teaching, research, and global engagement, we strive to attract faculty and staff who exemplify the Mason Science mission and vision. About the Position: The Post Award Research Administrator is responsible for managing post-award activities in support of an assigned portfolio of grants and contracts within one or more units (i.e., school, department, division, institute, or center) using knowledge of grant and contract management rules and regulations, technical expertise, and analytical skills. Post-award activities include regular review, reconciliation, and projection of award finances, preparing adjustments and corrections to award budgets, preparing financial reports, and at the end of the award, ensuring all financial requirements have been met and closing out the award. The Post Award Research Administrator interacts regularly with and provides high quality customer service to faculty members conducting sponsored research. This position ensures adherence to quality standards and all policies and award regulations. This position is expected to function with minimal oversight or supervision, be highly engaged with investigators, and collaborative with the Office of Sponsored Programs (OSP). This position is expected to demonstrate understanding, adoption, and adherence to Standard Operating Procedures (SOPs) and training. Responsibilities: * Reviews and reconciles award expenditures, budgets, and makes adjustments as necessary; * Projects and forecasts future award expenditures; * Reviews all expenditures to ensure they are allowable, allocable, and reasonable; * Manages budget, reporting and compliance timelines through the lifecycle of the grant or contract; * Communicates and meets with PIs on a regular basis regarding budget and expense adjustments and revisions; * Completes financial reports to be sent to sponsor, as required by the award terms and conditions; * Monitors compliance with agency and University regulations regarding reporting; * Completes invoices for sponsor (for certain award types only); * Assists PIs with non-financial report submissions, as necessary; * Coordinates and submits requests for no cost extensions, carryover, budgeting requests, changes in scope, and other changes to the award; * Ensures all requests are done in compliance with sponsor guidelines and University policies, and coordinates with pre-award counterparts as needed; * Facilitates the approval of invoices to pay subcontractors, as needed; * Reviews effort reports and manages quarterly effort certification process for assigned units; * Applies federal and University rules to management of effort allocation appropriately for individuals compensated whole or in part from federal awards; * Assists in transferring awards out of the university; * Prepares funded projects for closeout for all funded projects consistent with University processes and timelines, and follows and adheres to defined business practices related to post-award functions; * Works with Senior Post Award Research Administrators; * Follows and adheres to processes and activities related to post-award functions; * Performs post-award activities including assisting faculty/Pl in the financial, regulatory, and reporting of grant and contract awards; * Develops related knowledge and skills; * Upon award acceptance, defines account establishment parameters, including billing and reporting requirements, budget, and cost sharing obligations; * Sets-up awards in financial system; * Distributes award information to PIs, co-PIs, and relevant staff; and * Coordinates with relevant individuals to adjust payroll for all budgeted positions (including relative cost sharing positions). Required Qualifications: * High school diploma or equivalent; * Some experience related to grants and contracts management (generally 0-2 years); * An appropriate combination of relevant education and/or work experience may be considered; * Knowledge of federal rules, regulations, and University policies and procedures relating to research grant and/or contract activity; * Knowledge of University processes, systems, and offices related to and/or involved in grant and contract submission and management; * Knowledge of financial processes and controls including the reconciliation process; * Knowledge of principles and processes for providing customer service; * Skill in mathematics, financial management, and/or accounting, with the ability to analyze data and formulate conclusions; * Excellent oral and written communication with fundamental, professional interpersonal skills, including skill in creating high quality written documents; * Skill in the use of computers with solid working knowledge of MS Office Suite (Word, Excel, PowerPoint); * Demonstrated ability to learn complex electronic systems and changing technologies related to grants and contracts management; * Ability to proactively resolve problems and issues in a timely manner; * Understanding of and ability to apply costing rules and regulations to federally funded projects; * Understand and apply federal and University rules to management of effort allocation for individuals compensated whole or in part from federal awards; * Ability to manage and prioritize multiple projects/tasks simultaneously; * Work well under pressure and meet deadlines; * Work independently with minimal supervision managing a large volume of complex awards; * Ability to effectively manage research budgets, interpret allowable costs, and other specific financial issues; * Ability to work collaboratively with other levels of post-award specialists to solve problems, answer questions, and give guidance on post-award activities and other grants management topics on a daily basis; * interact and communicate with senior leadership and communicate effectively with colleagues and peers; * Work collaboratively with colleagues to solve questions and challenges in their daily work; and * Performs other related duties as assigned. Preferred Qualifications: * Bachelor's degree in related field; * Experience in Sponsored Programs Administration or related field preferred; and * Knowledge of the Banner Financial system, or demonstrated ability to learn complex electronic systems. Instructions to Applicants: For full consideration, applicants must apply for the Research Administrator, Post Award at ********************** Complete and submit the online application to include three professional references with contact information, and provide a cover letter and resumes for review. Posting Open Date: July 29, 2025 For Full Consideration, Apply by: August 12, 2025 Open Until Filled:
    $49k-61k yearly est. 60d+ ago
  • Research Scientist & Clinical Psychologist

    Maryland Treatment Centers, Inc. 3.5company rating

    Research nurse job in Rockville, MD

    Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).
    $35k-59k yearly est. 44d ago
  • Clinical Research Systems Coordinator - (Clinical Conductor experience required)

    Alcanza Clinical Research

    Remote research nurse job

    Department Clinical Systems Employment Type Full Time Location Alcanza Corporate Workplace type Fully remote Reporting To Tina White Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
    $39k-57k yearly est. 4d ago
  • Clinical Research Coordinator III - RN

    Invitrogen Holdings

    Remote research nurse 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 clinical research through our PPD clinical research 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 Clinical Research 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 clinical research 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 Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Desired Experience and Skills Advanced Cardiac Life Support (ACLS) certification encouraged. Certification in clinical research (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
  • Clinical Research Coordinator I

    St. Charles Health System 4.6company rating

    Remote research nurse job

    This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour. St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture. What We Offer: Competitive Salary Comprehensive benefits including Medical, Dental, Vision for you and your immediate family 403b with up to 6% match on Retirement Contributions Generous Earned Time Off Growth Opportunities within Healthcare ST. CHARLES HEALTH SYSTEM JOB DESCRIPTION TITLE: Clinical Research Coordinator I REPORTS TO POSITION: Research Manager DEPARTMENT: Research DATE LAST REVIEWED: November 15, 2024 OUR VISION: Creating America's healthiest community, together OUR MISSION: In the spirit of love and compassion, better health, better care, better value OUR VALUES: Accountability, Caring and Teamwork DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care. POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator. This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers. ESSENTIAL FUNCTIONS AND DUTIES: Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility. Obtains informed consent according to GCP and ICH guidelines. Performs study procedures and assessments following protocol specific guidelines. Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines. Adheres to St. Charles Health System's compliance plan. Attends IRB meetings as requested by the IRB. Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda. Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level Prepares for and participates in required sponsor and regulatory audits. Attend Investigator meetings as required to assure seamless study start-up. Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects. Educates patients regarding protocol diagnostic tests and assists with appointments. Process tissue/blood specimens and prepare it for shipment. Manages treatment and follow-up schedules to assure protocol compliance. Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence. Track study drug usage per protocol and oversee study drug supply. Maintains subject research records including long-term follow up and reporting. Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position. Keeps current with new developments in research methodologies. Participates in quality assurance program for St. Charles Health System and affiliated research partners. Supports the vision, mission and values of the organization in all respects. Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change. Provides and maintains a safe environment for caregivers, patients and guests. Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings. Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate May perform additional duties of similar complexity within the organization, as required or assigned. EDUCATION: Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties. Preferred: Bachelor of Science degree in related field. LICENSURE/CERTIFICATION/REGISTRATION Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification. Preferred: N/A EXPERIENCE: Required: None Required. Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge. ADDITIONAL POSITION INFORMATION: N/A Schedule Weekly Hours: 40 Caregiver Type: Regular Shift: First Shift (United States of America) Is Exempt Position? No Job Family: COORDINATOR CLERICAL Scheduled Days of the Week: Monday-Friday Shift Start & End Time: Variable
    $25.2-37.8 hourly Auto-Apply 9d ago
  • Clinical Research Regulatory Coordinator I

    Brigham and Women's Hospital 4.6company rating

    Remote research nurse job

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: * Careful attention to detail. * Good organizational skills. * Ability to follow directions. * Computer literacy. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: * Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly Auto-Apply 17d ago
  • Experienced Clinical Research Associate, CRA (Home-Based, anywhere in Denmark)

    Medpace 4.5company rating

    Remote research nurse job

    Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Operations team in Denmark (candidates can be based anywhere in Denmark). This position will work on a Nordic team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. If you are looking for a stable, consistently, rapidly, developing CRO, Medpace is a great place for you! We are currently seeking full-time, home or office-based Clinical Research Associates to join our energetic Clinical Monitoring team in the Denmark. We offer an exciting career where you can grow further, using your current and and previous expertise. Responsibilities * Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas; * Perform source document verification and case report form review; * Perform regulatory document review; * Conduct study drug inventory; * Perform adverse event and serious adverse event reporting and follow-up; and * Assess patient recruitment and retention. Qualifications * Bachelor of Science in health-related field; * Proven CRA experience of at least 1.5 years independent monitoring experience * Broad knowledge of medical terminology and clinical patient management; * Basic knowledge of drug therapy techniques and clinical research methodologies; * Fluency in local language and excellent English are required. 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 6,000 people across 50+ 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 compensation and benefits package * Competitive PTO packages * Structured career paths with opportunities for professional growth * Company-sponsored employee appreciation events * Employee health and wellness initiatives Awards * 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.
    $53k-85k yearly est. Auto-Apply 9d ago
  • Clinical Research Coordinator

    Cenexel 4.3company rating

    Research nurse job in Gaithersburg, MD

    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 clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research 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. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $26-30/h. Essential Responsibilities and Duties: Assists Director with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). 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: High school graduate or equivalent; Bachelor's Degree, preferred. 1-2 years of coordinating experience, high volume of clinical trials, preferably with psych/CNS trials Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research 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.
    $26-30 hourly 60d+ ago
  • Clinical Research Coordinator

    Uva Health

    Research nurse job in Manassas, VA

    Clinical Research Coordinator, UVA Health Affiliate Research Program This is a new position that will support the Affiliate Research Program within the Health Systems Strategy Office. This position is responsible for coordinating and overseeing clinical research activities across affiliated partners. The incumbent will facilitate study start-up, regulatory and compliance oversight, and support infrastructure development and on-site patient visits at affiliate locations to enable participation in clinical research studies. Candidate must have the ability to travel regularly to UVA Community Health hospitals, including Culpeper, Haymarket, and Prince William Medical Centers and Riverside Health Systems (Newport News). The final title and level (CRC level 3 or CRC level 4,) will be determined based on the qualifications of the selected candidate. JOB SUMMARY Clinical Research Coordinator- 4, Non-Licensed (CRC-4, NL), plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. A CRC 4 has the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective Department or Division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs. Manage multiple Principal Investigator relationships with internal and external research stakeholders. Provide guidance and assistance to Principle Investigators for grant submissions, budget management and research compliance oversight to ensure full compliance with local, state and federal policies and procedures. Serve as the primary liaison with the Sponsor for assigned studies. Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators n industry or government sponsor. Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity. Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval. Participate in planning and analysis of research portfolios, in conjunction with department management and Principal Investigators. Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts. Manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development, and performance management. Coordinate clinical research education, training and/or orientation for new Faculty, Fellows, Residents or medical students. Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review. Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions. Participate in at least 1 research-related working group at the institutional level, or lead a process improvement initiative at a department or division level. Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations Analysis: Analyzes processes and creates deliverables to provide information and recommendations for improvements. Breaks down problems and issues into sub-components and assesses the costs, benefits, and risks of various options. Is able to select and recommend the best solution based on a thorough examination of all considerations. Is able to explain and justify actions in a systematic and logical fashion. Communication: Shares and receives information using clear oral, written, and interpersonal communication skills. Demonstrates effective written and oral communication skills. Actively listens, provides constructive feedback, and demonstrates respect for differing views. Tailors communications to diverse audiences. Quality Improvement: Demonstrates involvement in the unit's annual and/or periodic assessment efforts, including efforts to improve the quality services. Understands the value of innovation and quality improvement. Improves processes and practices by identifying inefficiencies and redundancies. Demonstrates efficiency and quality in one's own work. Customer Service: Builds relationships and maintains strategic partnerships with key internal and external stakeholders. Understands the importance of quality service. Is able to adjust and adapt service delivery to diverse customer needs and sensitivities. Frequently suggests and implements changes to improve the quality of service. Financial Management: Manages tasks and resources within the department to achieve quality and meet budget requirements. Ensures that financial and material resources are used effectively and efficiently. Leverages resources to maximize utility and return on investment (ROI). Implements measures to minimize theft, damage, or equipment breakdown. The incumbent may be asked to perform additional duties as assigned. QUALIFICATIONS Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience. Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Additional Skills/Requirements Preferred: PHYSICAL DEMANDS Physical Demand Code: Work Function/Activity: OTHER May require the use of safety equipment, such as HEPA mask, for infection prevention: Yes On call responsibilities as directed: Yes Ability to travel between campus buildings, remote facilities, and out of town as needed: Yes
    $44k-65k yearly est. Auto-Apply 60d+ ago
  • Sr. Clinical Research Coordinator

    Cnhs 3.9company rating

    Research nurse job in Washington, DC

    Sr. Clinical Research Coordinator - (2500032W) Description The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned. Qualifications Minimum EducationB. A. /B. S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) OrMaster's degree with at least 2 years of relevant experience (Required) Minimum Work ExperienceAt least 3 years of experience with a bachelor's degree. (Required) OrAt least 2 years of experience with a master's degree. (Required) Required Skills/KnowledgeKnowledge of clinical research designs and needed infrastructure. Familiarity with databases, data collection tools and data analysis methods. Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission. Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment. Required Licenses and CertificationsInternal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required) External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies, and federal regulations (e. g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects' research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Identifies and resolves issues and challenges with appropriate input and oversight. Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs. Creates standard operating procedures (SOPs), and implements operational plans. Provides oversight and training to study team members for a variety of studies. Develops study documents, including consent forms and protocols. Participant Enrollment Adheres to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Study Management Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation. Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials. gov postings, Certificate of Confidentiality applications and scholarly presentations and publications. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks. Data Collection Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/CommunicationDemonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial ResponsibilityUse resources efficiently Search for less costly ways of doing things SafetySpeak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Cancer & Immunology RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 40Job Posting: Nov 25, 2025, 6:11:53 PMFull-Time Salary Range: 54516. 8 - 90854. 4
    $56k-66k yearly est. Auto-Apply 9h ago

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