Clinical Research Associate
2 weeks ago
Responsibilities:
Conduct single or multi-center medical device clinical studies.
Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items.
Participate in study start up activities.
Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.
Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.
Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
Participate in the interim and final reviews of study data in preparation of regulatory submissions.
May interact with RA/QA in responding to audits and FDA inquiries.
Requirements:
BS degree in life sciences or equivalent with minimum 3years of related experience, or MS degree in life sciences or equivalent with minimum 1 years of experience, or PhD with 1+ years of experience.
Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.
Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
Working knowledge of GCP, Clinical and Regulatory Affairs.
-
Research Associate I
2 weeks ago
San Diego, California, United States Adarx Pharmaceuticals Inc Full timeWe are seeking a highly motivated and qualified individual to join our Discovery Chemistry-Oligonucleotide Team as a Research Associate I-II and work as part of a team to drive success.We are looking for candidates as Research Associate I or II, Oligonucleotide Chemistry to join our discovery chemistry team to advance cutting-edge RNA editing drug discovery...
-
Research Associate
2 weeks ago
San Francisco, California, United States Gladstone Institutes Full timeCategory:ScienceLab/Area:Theodoris LabDescription:The laboratory of Christina Theodoris, MD, PhD, is seeking a talented and motivated research associate (I, II, III or Sr.) with background in experimental genomics to join her research program in the Gladstone Institute of Cardiovascular Disease and Gladstone Institute of Data Science and Biotechnology. Our...
-
San Diego, California, United States Takeda Full timeJoin Takeda as a Research Scientist II, Inflammation Discovery Research where you will be empowered to design, execute and analyze discovery immunology and in vitro preclinical pharmacology studies of inflammation and autoimmunity with a focus on TYK2 inhibition for multiple disease indications.You will also identify and implement new assay technologies that...
-
Clinical Trials Project Assistant
6 days ago
San Diego, California, United States Keck School of Medicine Full timeThe USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of an expert panel of scientific collaborators, committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials.The ATRI is seeking a dependable and...
-
San Rafael, California, United States BioMarin Pharmaceutical Full timeWho We Are From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Our Culture Our...
-
Staff Research Associate
3 weeks ago
South San Francisco, California, United States Aequor Full timeThe newly established Cell Therapy Department at Genentech is seeking a self-motivated and intellectually curious Research Associate to join our growing team.The ideal candidate is a skilled lab-based stem cell biologist who is driven to contribute to a rigorous scientific and collaborative environment.The successful candidate will be integral to setting up...
-
Associate Director, Clinical Science
2 weeks ago
South San Francisco, California, United States Maze Therapeutics Full timeThe Position:At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for an Associate Director, Clinical Science to join our Clinical Science team and take a central role in pioneering the future of...
-
Dermatologist
3 weeks ago
San Diego, California, United States MedDerm Dermatology Full timeJob Description:MedDerm Associates of San Diego, California has an opening available for a full-time or part-time, 2 to 5 days/week, BC/BE Dermatologist. Patient mix will include medical, surgical, and cosmetic. Clinical research and Mohs available for interested candidates. The combination of technology, procedures, and experienced support team make...
-
Associate Director/Director, DMPK
3 weeks ago
San Diego, California, United States Treeline Biosciences Full timeAssociate Director/Director, DMPK: About the roleThe Director, DMPK is responsible for overseeing drug metabolism and pharmacokinetic (DMPK) studies to advance small molecule drug candidates from preclinical through clinical development. The ability to plan, execute, monitor, and interpret DMPK studies for advancing therapeutic candidates through all stages...
-
Staff Research Associate II
2 weeks ago
San Francisco, California, United States University of California - San Francisco Full timeThe BCMM is focused on human microbiome research, with a particular interest in accelerating discovery and translation in the fields of early life microbiome and therapeutic development.The Center supports multiple collaborative technology hubs that facilitate microbiome research projects led by researchers across UCSF.Metabolomics: Sample preparation for...
-
Associate Director
3 weeks ago
San Diego, California, United States Escient Pharmaceuticals Full timeThe Senior Scientist, Translational Biology and Drug Discovery leads and contributes to the implementation and analysis of translational biology, in vitro and in vivo pharmacology for validation of multiple targets.Leads and supports the team to generate and test novel experimental hypotheses to advance discovery-based research and development in mast cell...
-
Associate Director Biostatistics
2 weeks ago
San Francisco, California, United States Proclinical Full timeAssociate Director Biostatistics - Permanent - RemoteProclinical Staffing is seeking an Associate Director Biostatistics to join a cutting-edge pharmaceutical company. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesThe Associate Director, Biostatistics is responsible for statistical activities in support of clinical...
-
Senior Clinical Trial Associate
2 weeks ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.As a Sr. CTA, you will work closely with the...
-
Chair of the Department of Otolaryngology
6 days ago
San Diego, California, United States University of California San Diego Full timeUniversity of California San Diego (UC San Diego) School of Medicine is committed to academic excellence, and to enhancing access, inclusion, and success of our diverse faculty, staff, and students and is seeking its founding Chair of the Department of Otolaryngology.The Chair will be an inspirational scholar, clinician, and leader with proven administrative...
-
Sr Research Analyst
2 weeks ago
San Francisco, California, United States CBRE Full timeCBRE is looking for a Sr Research Analyst in our San Francisco office to support our Northern California Region Offices. This is not a remote role but does require someone who can be in San Francisco a few days out of the week. What you'll doAs a Sr Research Analyst, you will be responsible for collecting, analyzing and creating content of actionable,...
-
Associate Producer
2 weeks ago
San Diego, California, United States Nexstar Media Group Full timeROLE: Daily production of a quality news product as defined by the KUSI/FOX 5 brand. Accuracy, excellence in production techniques and writing.RESPONSIBILITIES:Write and support line producers for assigned newscasts. Fill-in produce. Manage and write graphics for assigned stories and update them as need be.Research, confirm and update local, state, national...
-
Senior Scientist, Cell
3 weeks ago
San Diego, California, United States Pharmaron Full timeThe Senior Scientist will play a pivotal role by supporting in vivo studies to test cell and gene therapy treatments.The Senior Scientist serves as Study Director and is responsible for the oversight and conduct of in-vivo studies involving the testing of pharmaceutical compounds and cell and gene therapy.The Study Director functions as a key member of the...
-
Web Programmer
3 weeks ago
San Diego, California, United States UC San Diego Full timeDesign and develop research databases integrating data from government funded research institutions. Serve as a technical contact to the Metabolomics Workbench team and other programmers regarding application and database programming. Provide advanced technical expertise and analysis in the architecture design and programming of complex computer...
-
Associate or Senior Attorney
5 days ago
San Diego, California, United States gpac Full timeOne of our best clients is urgently interviewing candidates to join their established practice. This team has been well-established and offers a wonderful opportunity for growth, development and long-term stability. If you have an interest in specializing your skills and want to join a firm that will value you with limitless opportunity, reach out to me to...
-
Senior Counsel, Research
3 weeks ago
South San Francisco, California, United States Roche Full timeThe PositionThe Genentech R&D Law Group is seeking a highly experienced R&D attorney. As a partner and key business strategist, this individual will have deep experience in regulatory law and complex transactional legal support for global strategies and activities related to product research and development, digital health and personalized healthcare. As a...