Clinical Research Compliance Director
2 days ago
We are seeking a highly motivated and detail-oriented individual to fill the position of IND/IDE Program Director at Johns Hopkins University. As a key member of our team, the IND/IDE Program Director will play a critical role in ensuring the successful implementation and management of our policy and program to support qualification and registration of JHU investigator-held INDs and IDEs.
The IND/IDE Program Director will be responsible for developing and maintaining all operational functions that support IND/IDE activities in the Office of Clinical Trials. This includes initial and ongoing qualification of JHU Investigators to serve as the role of sponsor-investigator, evaluation of the suitability of a proposed JHU investigator-sponsor for a specific IND/IDE application prior to submission to the FDA, issuance of letters of suitability or identification of potential areas of concern following an initial evaluation, and provision of administrative support to the IND/IDE review committee.
The ideal candidate will have a strong background in regulatory affairs, clinical research, and project management, with a minimum of 3 years of experience in a similar role. They will be well-versed in FDA regulations related to clinical research involving human participants and possess excellent communication and interpersonal skills.
The IND/IDE Program Director will serve as the liaison between the Office of Clinical Trials and internal partners, including the IRB, Office of Policy Coordination, Clinical Trials Contracting Unit, Office of Research Administration, Departmental/Divisional leadership, and JHU/JHHS compliance monitoring programs. They will also provide guidance to JHU faculty serving sponsor-investigators and their research teams in the development of their submissions to the FDA.
In addition to their technical expertise, the IND/IDE Program Director must have excellent time management skills, including the ability to manage multiple and competing priorities, and be able to work effectively in a team environment.
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Research Program Manager
2 days ago
Baltimore, Maryland, United States Johns Hopkins University Full timeAbout the RoleWe are seeking a highly skilled and experienced individual to fill the position of IND/IDE Program Director at Johns Hopkins University. This is an exciting opportunity for someone who is passionate about regulatory compliance and wants to make a significant contribution to the success of our research programs.The IND/IDE Program Director will...
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Clinical Operations Director
2 weeks ago
Baltimore, Maryland, United States MEDSTAR HEALTH Full timeJob TitleClinical Operations DirectorAbout the JobMEDSTAR HEALTH is seeking a highly skilled Clinical Operations Director to join our team. This role involves leading a team dedicated to clinical reviews and coordinating various care levels for members, while collaborating with interdisciplinary staff to improve health outcomes.ResponsibilitiesEvaluate the...
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Clinical Research Associate
4 days ago
Baltimore, Maryland, United States EVERSANA Company Full timeEvergreen Clinical JobsJob Title: Clinical Research AssociateThe EVERSANA Company is seeking an experienced Clinical Research Associate to join our team in the Pacific Northwest. This individual will work closely with our cross-functional teams to support the successful execution of clinical trials.Job Description:Conduct on-site monitoring visits at...
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Clinical Trials Compliance Specialist
1 week ago
Baltimore, Maryland, United States University of Maryland Medical System Full timeEstimated Salary: $43,849.80 - $45,100 annually.About the University of Maryland Medical SystemThe University of Maryland Medical System (UMMS) serves over one million patients and families every year. With more than 29,000 employees and 4,600 providers, we strive to deliver exceptional care while fostering a culture of empathy, inclusivity, and respect.Job...
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Regulatory Compliance Expert
4 weeks ago
Baltimore, Maryland, United States Johns Hopkins University Full timeAbout the Role:">The Johns Hopkins University is seeking a highly skilled and experienced IND/IDE Program Director to join our team. As a key member of our Office of Clinical Trials, you will be responsible for overseeing the implementation and management of policies and programs related to investigator-held INDs and IDEs.">Key Responsibilities:">">Develop...
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Regulatory Expert for Clinical Research
4 weeks ago
Baltimore, Maryland, United States The Johns Hopkins University Full timeOverview: We are seeking a highly skilled Regulatory Expert to lead our clinical research program and ensure compliance with regulatory requirements. This is a full-time position that offers a competitive salary and excellent benefits.
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Research Nurse Clinical Trials Coordinator
3 weeks ago
Baltimore, Maryland, United States Johns Hopkins University Full timeAbout the JobJohns Hopkins University is seeking a skilled Sr. Research Nurse to join our team. This role will be responsible for coordinating and implementing assigned clinical trials within the Developmental Therapeutics Program.ResponsibilitiesCoordinate and implement clinical trials, ensuring compliance with federal and local regulationsCollaborate with...
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Clinical Research Associate Director
4 days ago
Baltimore, Maryland, United States Apogee Therapeutics Full timeAbout the OpportunityWe are seeking a dynamic and experienced Medical Science Liaison to join our team at Apogee Therapeutics. As a key member of our clinical development program, you will be responsible for building strong relationships with investigators, KOLs, and other external stakeholders in the field of dermatology.ResponsibilitiesYour primary...
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Director of Strategic Research Partnerships
4 weeks ago
Baltimore, Maryland, United States InsideHigherEd Full timeAbout the PositionThe Office of the Vice Provost for Research at Johns Hopkins University is seeking a highly skilled Associate Director for Research Development to join our team.Company OverviewJohns Hopkins University is a world-renowned research institution committed to advancing knowledge and improving lives. Our Vice Provost for Research office plays a...
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Clinical Research Coordinator
2 days ago
Baltimore, Maryland, United States Johns Hopkins University Full timeClinical Research Experience:The Johns Hopkins University School of Medicine is seeking a CO Research Program Assistant II to join our team in the Department of Urology. This role will provide administrative support for clinical trials, including attending clinical trial biopsy procedures, collection, handling, and transport of patient specimens.The ideal...
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Director of Research Development Lead
4 weeks ago
Baltimore, Maryland, United States SRA International Full timeJob Summary: We are seeking a highly skilled and experienced professional to serve as the Director of Research Development Lead at SRA International. This role will play a pivotal part in shaping the learning and development landscape for our research administration community.About Us: At SRA International, we are dedicated to advancing knowledge and...
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Baltimore, Maryland, United States SRA International Full timeJob OverviewSRA International is seeking a highly skilled Training Director for Research Administration Development to join our team. In this role, you will play a pivotal part in shaping the learning and development landscape for our research administration community.About the RoleAs the Assistant Director of Research Administration Training, you will be...
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Clinical Research Assistant
4 weeks ago
Baltimore, Maryland, United States InsideHigherEd Full timeAbout InsideHigherEdInsideHigherEd is a leading source of news, opinion and data about the world of higher education.This role will provide support for clinical research activities in the Graduate School at InsideHigherEd.
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Clinical Research Liaison
5 days ago
Baltimore, Maryland, United States Sun Pharmaceutical Industries, Inc. Full timeAbout the RoleWe are seeking a highly skilled Medical Science Liaison to join our team at Sun Pharmaceutical Industries, Inc. in the Pacific Northwest region, focusing on medical dermatology and biologics. As a key member of our field force, you will play a vital role in representing our company's interests and advancing our scientific platform.Job...
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Clinical Program Director
3 weeks ago
Baltimore, Maryland, United States Change Health Systems I Full timeJob Opportunity: Clinical Program Director Change Health Systems I seeks a highly skilled and experienced Clinical Program Director to lead our behavioral health clinic in Baltimore, Maryland. About the Role:This is a full-time position with a competitive salary of $120,000 - $150,000 per year, based on experience.The successful candidate will...
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Clinical Research Nurse
4 days ago
Baltimore, Maryland, United States Marylandtreatmentcenters Full timeAbout UsAt Maryland Treatment Centers, we are dedicated to providing a comprehensive continuum of treatment for individuals with substance use disorder and co-occurring conditions. Our clinical programs include assessment, residential/inpatient, detoxification, day treatment, intensive outpatient, and outpatient substance abuse services. We also have a...
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Research Assistant Specialist
1 week ago
Baltimore, Maryland, United States Kennedy Krieger Institute Full timeOverviewAbout Kennedy Krieger InstituteKennedy Krieger Institute is a leading institution dedicated to the care and treatment of children with pediatric brain injury. As a Research Assistant II, you will play a critical role in conducting rehabilitation research, data collection, analysis, and interpretation for various research studies and grants.About the...
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Research Assistant
14 hours ago
Baltimore, Maryland, United States Maryland Treatment Centers, Inc. Full timeJoin our team at Maryland Treatment Centers, Inc. as a Research Assistant in the role of Clinical Trials Coordinator.**Location:** West Baltimore, MD**Estimated Salary:** $45,000 - $60,000 per yearWe are seeking an experienced Research Assistant to coordinate and manage clinical trials for innovative treatment approaches. The ideal candidate will have a...
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Data Scientist
4 weeks ago
Baltimore, Maryland, United States LifeBridge Health Full timeClinical Data Analyst OpportunityLifeBridge Health, a leading healthcare provider in Maryland, is seeking a highly skilled Clinical Data Analyst to join our team. This is an excellent opportunity for individuals with a passion for data analysis and clinical research.As a Clinical Data Analyst, you will play a critical role in supporting the LifeBridge Health...
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Senior Tax Director
1 week ago
Baltimore, Maryland, United States Jobot Full timeCompany OverviewA 30-year-old CPA firm is seeking a dynamic and highly motivated Tax Manager to join its finance team. This hybrid role offers the best of both worlds, allowing for remote and on-site work. The successful candidate will be responsible for managing all tax-related activities, including tax planning, compliance, and research.Job SummaryThe Tax...