Clinical Research Specialist remote jobs

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 12/12/2025. Applications for this job will be accepted for at least 30 days from the posting date.

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

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Position Overview This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team. This position is field based / remote based in the West Coast region (US). Essential Duties Include, but are not limited to, the following: Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies. Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships. Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates. Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams. Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements. Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies. Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team. Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate. Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management. Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members. Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study. Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members. Communicate project specific information to/from trial sites through teleconferences, newsletters, etc. Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis. Document monitoring activities in monitoring visit reports and follow-up letters. Communicate serious issues to appropriate parties, in a timely manner. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. Participate in Investigator Meetings, and other study trainings and meetings as required. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work designated schedule. Ability to work nights and/or weekends, as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 50% of working time away from work location may include overnight/weekend travel. Minimum Qualifications Bachelor's Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience. Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience. 4+ years clinical research monitoring experience or equivalent experience. No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability. Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems. Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively. Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices. Meticulousness with a focus on accuracy and precision in all tasks and activities. Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy. Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred Qualifications Experience or knowledge in In Vitro Diagnostics (IVD). Certifications related to clinical research. Working knowledge of the FDA submission process including IDE, PMA, and 510(k). Strong on-site monitoring experience in clinical trials, including: Site initiation. Routine monitoring visits. Site closeout. Knowledge of electronic trial master file (eTMF) systems and document management processes. #LI-JH1 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees. BIOTRONIK is looking to add a Regional Clinical Research Associate II to our Clinical Studies team. Responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures and IRB/EC policies and procedures) for assigned clinical studies in the field of cardiac rhythm management, vascular intervention or other therapeutic area. Your Responsibilities: Conduct assigned monitoring activities in accordance with BIOTRONIK procedures and applicable regulations to evaluate protocol compliance, data accuracy and subject safety by review of regulatory documents, medical records, reported data and device storage, if applicable. Responsible for all monitoring activities for assigned clinical studies including: Scheduling and conducting monitoring activities within specified timelines and according to the risk-based monitoring plan and BIOTRONIK procedures. Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining and resolve compliance concerns as appropriate. Works cooperatively with the BIOTRONIK Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits and pro-actively provides input on site performance. Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution. Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items and study visit preparation. Trains and mentors BIOTRONIK personnel on monitoring procedures and practices. Conducts site training and co-monitoring visits as requested by management. Completes monitoring visit reports, action items and monitoring visit follow-up letters per BIOTRONIK procedures. Assists the Manager, RCRA Group with team, department and study related projects as requested including audits, investigator meetings, training, etc. Interfaces with Clinical, Regulatory, Sales and clinical site staff as necessary to accomplish the above responsibilities. Your Profile Bachelor's degree or higher level degree in nursing, life sciences or related medical/scientific field. Must have a valid US driver's license. Minimum of 3 years on-site monitoring research experience for a CRO, Pharma, or Medical Device company. Experience supporting medical device IDE trials is preferred. Strong clinical trial monitoring experience in relevant BIOTRONIK product and/or relevant therapeutic areas (electrophysiology and vascular interventional cardiology) preferred. Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials. Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). Strong knowledge of medical terminology Ability to work independently in a regional area with minimal supervision Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently. Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management. Ability to interact constructively in communication of adherence to protocol and regulatory requirements. Responsible for adequate and reasonable home office set up including dedicated desk space to accommodate work responsibilities and BIOTRONIK supplied equipment Travel Approximately 60% travel required throughout the United States to investigational centers and BIOTRONIK, Inc. corporate office. The travel percentage may vary based on the study requirements. Travel may be conducted via air travel, driving or train. Location Remote opportunity based on the East Coast, United States Are you interested? Please apply online through our application management system! We are looking forward to welcoming you. Location: East Coast | Working hours: Full-time | Type of contract: Undefined Apply now under: ************************* Job ID: 61606 | BIOTRONIK Inc. | United States (US) We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.

🔗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

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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

Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value. Peachtree Bioresearch Solutions is a fast growing, full-service Clinical Research Organization with expertise in CNS and other therapeutic areas. We create strong, consultative relationships with sponsor clients and we're looking to add CRAs who are dedicated, want to make an impact, and enjoy having visibility across the entire project beyond their monitoring role. As a small/mid CRO, we focus on building great teams where all ops functions can provide a high level of service. You can see the impact you make, and get recognized for it. It's also fun working with others who are very good at what they do. Responsibilities: Work closely with the Site Management team and sponsor stakeholders so you can plan and manage your work most effectively Perform site selection, initiation, monitoring and close-out visits, plus maintain the appropriate documentation Establish relationships with sites while administering protocol and related study training Work with Peachtree's Data Management team and sites to ensure all queries are resolved Complete all reports and follow up items in a timely manner Work with project leadership to customize solutions that bring value to the sponsor Qualifications: Bachelor's degree 1-5 years of experience working on clinical trials (CRO or Sponsor) with at least a year of site monitoring Experience on CNS or neuro studies highly desirable Willing to travel 65%. Sometimes it's hectic. Sometimes it's not. We do a good job trying to manage it. Highly proficient with business software (MS365) Experience working in a CTMS and EDC system Excellent organizational and critical thinking skills Excellent written and verbal communication and presentation skills Be resourceful and curious - you figure out problems and think about the business beyond the task at hand. A team player who elevates others Leadership traits and attitude In addition to working with great people on high performing teams, full-time employees receive: Medical, Dental, Vision, Life, Disability coverage 20 days PTO + PTO rollover + 13 paid holidays 401(k)

Remote Clinical Research Associate III needs 2 years of site management and field monitoring experience Remote Clinical Research Associate III requires: Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm EST Qualifications: BS/BA Minimum of 2 years of site management and field monitoring experience Knowledge of applicable standards and regulations for clinical trials Proven oral and written communication skills Proven planning skills; ability to create and track detailed project plans Proven interpersonal, leadership, organizational and effective time management skills Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion Preferred: Experience in womens fertility VD Study Experience Medidata RAVE system Remote Clinical Research Associate III duties: Performs Site initiation, interim & close out monitoring visits Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete Manages site communication and escalates to leadership in a timely fashion when needed Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings

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.

About the Role Responsible for the successful execution of clinical trials, this role will proactively resolve study site issues and participate in process improvement initiatives as applicable. The CRA engages with study investigators, vendors, and internal/external stakeholders as a member of the Clinical Trial Development and Operations team. This role will accept projects as assigned per the changing needs of the Clinical Development Department. Let's talk about some of the key responsibilities of the role: Where appropriate, responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits and appropriate documentation (confirmation, follow-up letters, communication logs, as required). Reviews study specific monitoring procedures and guidelines. Involved in the development or review of protocols, Case Report Forms (CRFs), investigator brochures, informed consent forms and any other study-related documents as assigned. Assists in managing the identification, selection, and feasibility processes of study sites. Ensures the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study; helps to train the study staff in conducting the study per GCP and in performing procedures per protocol. Ensures the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Where appropriate, ensures the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitors for missing or implausible data. Prepares accurate and timely trip reports or site audit reports in accordance with Good Clinical Practice Guidance E6 R2. Organizes and makes presentations at Investigator Meetings. Acts as a contact for clinical trial supplies and other suppliers (vendors) as assigned. Reviews and assists in the preparation of Clinical Study Reports (CSRs). Provides support to Clinical Development and Operations for clinical planning, start-up, execution and close-out. Factors for Success: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology preferred. Minimum of 2 years of clinical research experience (including pre-study, initiation, routine monitoring and close-out visits) at a Pharmaceutical, Biotech or CRO company. Minimum of two (2) years of experience with Trial Master File (TMF) management/maintenance. Pharmaceutical experience preferred. Thorough knowledge of ICH/GCP R2 Guidelines. Site monitoring skills. The ability to thrive with minimal supervision. The drive to resolve project-related problems and can prioritize workload for self. Flexibility to adjust to changing needs in the Clinical Development Department and organization. Excellent knowledge of MS Office, Excel, PowerPoint as well as project management and clinical trials software (eDC systems). Ability to manage competing priorities in a fast-paced environment. Strict attention to detail. A Few Other Details Worth Mentioning: The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. [Remote work is an option.] We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact! This position reports directly to our Manager II, Clinical Research. Some travel may be required - up to 60% At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $84,000 - $117,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: ************************************************ #LI-Hybrid #LI-Remote Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better. - Your Human Resources Team About the Role Responsible for the successful execution of clinical trials, this role will proactively resolve study site issues and participate in process improvement initiatives as applicable. The CRA engages with study investigators, vendors, and internal/external stakeholders as a member of the Clinical Trial Development and Operations team. This role will accept projects as assigned per the changing needs of the Clinical Development Department. Let's talk about some of the key responsibilities of the role: Where appropriate, responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits and appropriate documentation (confirmation, follow-up letters, communication logs, as required). Reviews study specific monitoring procedures and guidelines. Involved in the development or review of protocols, Case Report Forms (CRFs), investigator brochures, informed consent forms and any other study-related documents as assigned. Assists in managing the identification, selection, and feasibility processes of study sites. Ensures the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study; helps to train the study staff in conducting the study per GCP and in performing procedures per protocol. Ensures the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Where appropriate, ensures the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitors for missing or implausible data. Prepares accurate and timely trip reports or site audit reports in accordance with Good Clinical Practice Guidance E6 R2. Organizes and makes presentations at Investigator Meetings. Acts as a contact for clinical trial supplies and other suppliers (vendors) as assigned. Reviews and assists in the preparation of Clinical Study Reports (CSRs). Provides support to Clinical Development and Operations for clinical planning, start-up, execution and close-out. Factors for Success: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology preferred. Minimum of 2 years of clinical research experience (including pre-study, initiation, routine monitoring and close-out visits) at a Pharmaceutical, Biotech or CRO company. Minimum of two (2) years of experience with Trial Master File (TMF) management/maintenance. Pharmaceutical experience preferred. Thorough knowledge of ICH/GCP R2 Guidelines. Site monitoring skills. The ability to thrive with minimal supervision. The drive to resolve project-related problems and can prioritize workload for self. Flexibility to adjust to changing needs in the Clinical Development Department and organization. Excellent knowledge of MS Office, Excel, PowerPoint as well as project management and clinical trials software (eDC systems). Ability to manage competing priorities in a fast-paced environment. Strict attention to detail. A Few Other Details Worth Mentioning: The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. [Remote work is an option.] We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact! This position reports directly to our Manager II, Clinical Research. Some travel may be required - up to 60% At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $84,000 - $117,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap. #LI-Hybrid #LI-Remote

How will you make an impact? The Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical Manager or Clinical Director. Study Master File Maintenance • Sets up Study Master File and Study Master File Tracker at the beginning of each study • Receives, QC's, scans and files documents in Study Master File • Provides status of documents to Clinical Management Collection of Site Start-Up Documents • Communicates directly with site staff to obtain site start-up documents • Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV) • Obtains site documents from Regional Clinical Research Associates during trial • Receives, QC's, scans and files site documents in Study Master File • Provides status of site documents in Study Master File to Regional Clinical Research Associates prior to Monitoring Visits Establishes and Maintains Tracking of Critical Trial Information • Team and site contact information • Site status information • Enrollment trackers • Adverse event trackers • Site payment trackers and site payments Team Support • Participates in clinical team meetings and may prepare minutes • May assist with meeting logistics, events and training, including Investigator Meetings • Scheduling meetings, set up of AV, teleconference or video conference equipment • Preparation of relevant materials • Support IP shipment and shipment of other materials to sites How will you get here? • 0-2 years' work experience with clinical data entry, and clinical research industry within ophthalmology • Familiarity with clinical trials study documentation • Accurate data entry experience • Excellent problem solving and analytical skills (ability to interpret and summarize data, perform statistics) • Excellent written and verbal communication and presentation skills • Motivated and able to work independently, as well as within a team • Excellent organizational skills • Medical terminology (and ophthalmology terminology) helpful • Exhibits personal integrity, credibility, and responsibility • Meets milestones and schedules • Collaborates with other team members and demonstrates good interpersonal skills • Demonstrates proficiency in study monitoring and auditing • Must be willing to travel up to 80% of the time (estimated) • Medical terminology (and ophthalmology terminology) helpful #GKOSUS

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

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

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.

This position has been deemed critical by the School of Humanities & Sciences Dean's Office and is exempt from the hiring freeze. Social Science Research Coordinator- Hybrid The School of Humanities and Sciences (H&S) is the foundation of a liberal arts education at Stanford. The school encompasses 23 departments and 25 interdisciplinary programs. H&S is home to fundamental and applied research, where free, open, and critical inquiry is pursued across disciplines. As the university's largest school, H&S serves as the foundation of a Stanford undergraduate education no matter which discipline students pursue as a major. Graduate students work alongside world-renowned faculty to pursue and shape foundational research that leads to breakthroughs and discoveries that shed new light on the past, influence the present, and shape the future. Together, faculty and students in H&S engage in inspirational teaching, learning, and research every day. Among the first departments established at Stanford University, the Department of Psychology has a long-standing tradition of ground-breaking theoretical research that also has powerful impact in the real world. The department is ranked as one of the top psychology programs in the nation and has been a leading psychology department among American universities for decades. This extraordinary achievement was honored by the Smithsonian Institution in Washington D.C. in 2003. This is a new full-time SSRC position in Prof. Jamil Zaki's lab. The SSRC will perform administrative and operational duties to support research and apply basic knowledge and understanding of scientific theory. The SSRC will be involved in recruiting people from the community and from Stanford University to participate in studies; run subjects in experimental protocols, organize and maintain data files, and assist with study related paperwork. Previous experience working with human subjects and data analysis skills are desired. Other responsibilities include organizing experimental protocols and materials, helping with data entry, and working with professors, graduate and undergraduate students and post-doctoral fellows. This is a 100% FTE, 1-year fixed term, non-exempt position. This position will be based on the Stanford campus and will be considered for an option of telecommuting (hybrid of working on-site and off-site), subject to operational need. If you believe that this opportunity is a match for your knowledge, skills and abilities, we encourage you to apply. Thank you for considering employment opportunities with the School of Humanities and Sciences. CORE DUTIES: * Prepare correspondence, documents and reports. * Maintain and file forms and documents, including consent forms and master subject logs. * Assist with the screening, recruiting, and obtaining consent of study participants. Perform telephone or in-person interviews to gather data, as needed. Schedule and/or call subjects for appointments. * Prepare, distribute, administer and process questionnaires and tests, score test measurements and questionnaires, and code data for computer entry. Perform quantitative review of forms, tests, and other measurements for completeness and accuracy. * Prepare data for input into statistical databases by typing, editing, and organizing data. * Apply formulas and calculations to research data using basic statistical programs. Review and verify accuracy of database information and assist in making necessary corrections according to specific guidelines. * Order and maintain equipment and supplies. * Process study compensation payments and thank you letters to subjects upon completion of trial activities. * Assist with post-study activities, as needed. Education & Experience: Two year college degree and one year of relevant experience or an equivalent combination of experience, education, and training. Knowledge, Skills and Abilities: * General understanding of scientific theory and methods. * General computer skills and ability to quickly learn and master computer programs. * Ability to work under deadlines with general guidance. * Excellent organizational skills and demonstrated ability to complete detailed work accurately. * Effective oral and written communication skills. * Ability to work with human study participants PHYSICAL REQUIREMENTS*: * Frequently perform desk-based computer tasks, grasp lightly/fine manipulation, lift/carry/push/pull objects that weigh up to 10 pounds. * Occasionally stand/walk, sit, use a telephone, writing by hand, and sort/file paperwork or parts. * Rarely twist/bend/stoop/squat, kneel/crawl, rarely reach/work above shoulders, and operates foot and/or hand controls. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job. WORKING CONDITIONS: * May be exposed to blood borne pathogens. * May be required to work non-standard, extended or weekend hours in support of research work. WORK STANDARDS: * Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. * Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. * Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************* The expected pay range for this position is $29.24 to $34.89 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (***************************************************** provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with: * Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak. * A caring culture. We provide superb retirement plans, generous time-off, and family care resources. * A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits. * Discovery and fun. Stroll through historic sculptures, trails, and museums. * Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more. The job duties listed are typical examples of work performed by positions in this job classifications and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at ************************. For all other inquiries, please submit a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Final offers of employment are contingent upon successful completion of national criminal background check, national sex offender registry search and, where applicable, driving record. Additional Information * Schedule: Full-time * Job Code: 4233 * Employee Status: Fixed-Term * Grade: D * Requisition ID: 107842 * Work Arrangement : Hybrid Eligible

**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.

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.