Registered Nurse-Clinical Trial-Alexandria, VA ProPharma Group Holdings LLCRegistered Nurse-Clinical Trial-Alexandria, VAAlexandria, VAWith 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. For the past 25 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.
Clinical Research Coordinator I - Hematology Washington University in St LouisClinical Research Coordinator I - HematologyWashingtonImplements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as to when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner.
Medical Lead - Acute Lymphoblastic Leukemia (ALL) AstraZeneca PlcMedical Lead - Acute Lymphoblastic Leukemia (ALL)Gaithersburg, MD$193,281.60–$289,922.40 / yearYou will also provide medical input into the safety profile of the product in collaboration with Patient Safety (PS) physicians and collaborate with the Medical Science Liaisons and work closely with National Clinical Account Managers to appropriately support key accounts. Accountabilities: As the Medical Lead, you will be responsible for leading Medical Affairs activities in Hematology Oncology Franchise and providing medical leadership to the Core Medical Team (CMT).
Clinical Research Coordinator I - Emergency Medicine Washington University in St LouisClinical Research Coordinator I - Emergency MedicineWashingtonImplements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as to when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner.
Clinical Research Coordinator I - Surgery Oncology Washington University in St LouisClinical Research Coordinator I - Surgery OncologyWashingtonImplements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as to when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner.
Manager Division Clinical Research - Medical Oncology Washington University in St LouisManager Division Clinical Research - Medical OncologyWashingtonAcademic Programs, Accounting, Business Administration, Clinical Research Coordination, Clinical Research Methods, Compliance Requirements, Employee Management, FDA Compliance, FDA Regulations, Financial Resources Management, Grant Funding, Health Care, Institutional Review Board (IRB), Leadership, Oral Communications, Problem Solving, Project Planning, Regulatory Compliance, State Regulations, Written Communication Grade . Responsible for overall clinical research study planning, coordinating, and execution of all study-related activities, including extensive interaction wth the Internal Review Board (IRB), study sponsors, and investigators.
Senior Specialist, Clinical Education, Clinical Development Edwards Lifesciences CorpSenior Specialist, Clinical Education, Clinical DevelopmentCalifornia, MD$134,000–$190,000 / yearRepresent TMTT during complex research cases (ESAPCU, clinical trial, commercial) with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during implants, including contingency planning to address unforeseen occurrences in support novel devices. This role partners cross-functionally with physicians, R&D, and commercial teams to support complex cases, develop procedural techniques, and translate real-world clinical insights into next-generation device and therapy improvements.
NewGlobal Clinical Program Lead, Late Respiratory and Immunology Clinical Development AstraZeneca PlcGlobal Clinical Program Lead, Late Respiratory and Immunology Clinical DevelopmentGaithersburg, MD$288,059–$432,088 / yearYou will set the vision and goals against therapeutic area leadership priorities and product strategy; ensure timely decision making; facilitate the balance of cost/time/quality against clinical development objectives; develop relevant risk mitigation strategies; enable quick and effective troubleshooting; represent the program at health authority interactions; review publications aligned to your program; and seek/share findings through your portfolio of studies. Scientific medical input to all relevant study documents (including and not limited to protocol, statistical analysis plan, amendments, informed consent, case report forms, safety, and risk-based monitoring plans) to ensure consistency within clinical program and alignment with scientific rationale.
Assistant Manager Clinical Research (Hybrid) - Radiology Washington University in St LouisAssistant Manager Clinical Research (Hybrid) - RadiologyWashingtonThe screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Clinical Research Coordinator III - Pediatrics Gastroenterology Washington University in St LouisClinical Research Coordinator III - Pediatrics GastroenterologyWashingtonYou will work closely with other team members and healthcare professionals to recruit and enroll study participants, explain the purpose of study and obtain informed consent from participants, conduct study visits in the hospital and the participant’s home, ensure compliance with protocol guidelines and requirements of the IRB and IACUC, enter data, assist with lab procedures, and perform data analyses. Serves as responsible for the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
Manager Clinical Trials (Hybrid) - Radiology Washington University in St LouisManager Clinical Trials (Hybrid) - RadiologyWashingtonCertified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Professional (CRP) - Association of Clinical Research Professionals (ACRP) . Clinical Project Management, Clinical Systems, Clinical Trials Administration, Deadline Management, Interpersonal Relationships, Leadership, Microsoft Excel, Microsoft Word, Oncology Research, Oral Communications, Prioritization, Radiopharmaceuticals, SQL Databases, Stress Management, Written Communication Grade .
Clinical Research Financial Coordinator II - Cardiology Washington University in St LouisClinical Research Financial Coordinator II - CardiologyWashingtonWhen necessary, works with other departments to set up services for clinical trial patients procedures performed in accordance with the protocol and is responsible for establishing a workflow to ensure study plans are in place to assist the study coordinators in completing study procedures and to ensure that supporting departments’ charges for study service are appropriately captured and billed to the study. Provides oversight, and training for clinical research financial billing coordinators who perform a review of new protocols, protocol amendments and Investigators initiated concept studies to establish and negotiate budgets for clinical trials.
Senior Program Manager - Medical & Clinical Affairs ConvaTec Group PlcSenior Program Manager - Medical & Clinical AffairsWashington DC, DCRemotePosition Overview: As part of the Project and Portfolio Management team for Medical and Clinical Affairs, the Sr Program Manager oversees the project management, planning, execution, tracking, and reporting of clinical studies and/or research projects in accordance with agreed upon resourcing, timing, and budget. Leader and team-worker who actively looks to develop themself and others; proactively networks across a complex organizational hierarchy and works cooperatively and effectively with others to set goals and resolve problems.
Clinical Research Coordinator I - Psychiatry Washington University in St LouisClinical Research Coordinator I - PsychiatryWashingtonEstablishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as to when to notify principal investigators with issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency and research sites. In your role as a Clinical Research Coordinator I, you will bring your clinical research expertise to assist the Principal Investigator in a longitudinal study examining STBs and non-suicidal self-injury (NSSI) among children and preteens, involving clinical interviews and behavioral assessments.
Clinical Research Coordinator III (Hybrid) - Orthopedic Surgery Washington University in St LouisClinical Research Coordinator III (Hybrid) - Orthopedic SurgeryWashingtonInvestigator Initiated Research Project Specific Tasks May act as primary liaison to Principal Investigator (PI) to assist in developing plans for investigator-initiated research projects; may assist in preparation of budgets and grant proposals to sponsoring agencies; may assist in writing initial study protocol and instructional manuals; may assist in preparation of amendments to protocols and/or modification to study design, as appropriate. Oversees and coordinates more complex clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; may supervise clinical research staff.
Executive Director, Research & Development Quality Assurance (RDQA) ModernaTXExecutive Director, Research & Development Quality Assurance (RDQA)Bethesda, Massachusetts10+ years’ experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Clinical Research Aide (PRN) - Pediatrics Emergency Medicine Washington University in St LouisClinical Research Aide (PRN) - Pediatrics Emergency MedicineWashingtonThe screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.
Senior Clinical Research Coordinator - Medical Oncology Washington University in St LouisSenior Clinical Research Coordinator - Medical OncologyWashingtonServes as responsible for the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. Designs, implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors participant’s progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
RN Clinical Nurse Coordinator - Pediatric Cardiology - Pulmonary Hypertension Washington University in St LouisRN Clinical Nurse Coordinator - Pediatric Cardiology - Pulmonary HypertensionWashingtonClinical Experience, Clinical Research Coordination, Clinical Research Management, Clinical Research Methods, Clinical Research Operations, Continuous Learning, Critical Thinking, Customer Empathy, Database Management, Effective Written Communication, Electronic Health Records (EHR), Epic EHR, Oral Communications, Patient Care, Patient Care Plans, Prioritization, Research Oriented, Spreadsheet Software, Statistical Analysis Software (SAS), Team Collaboration Grade . Additionally, this role oversees complex specialty therapies by managing prior authorizations, REMS program compliance, and lab monitoring (including therapies like Winrevair), while leveraging Epic EHR workflows to manage protocol orders and maintain communication.
Clinical Research Coordinator I - Neurology Washington University in St LouisClinical Research Coordinator I - NeurologyWashingtonImplements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as to when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner.