Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver’s license information, etc) via email or messenger tools, or for a financial deposit of any kind. San Francisco, CA24 days ago
Train, supervise, and provide guidance to the CRC in reviewing medical history, performing study procedures, collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events, using medical charts and electronic records to extract medical information, and utilizing various data collection instruments including databases of sponsored studies, OnCore, iMEDris, and Apex EMR. The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
Huntington Beach, California30 days ago
As a Clinical Research Manager, you will own end-to-end US IDE study operations, leading a team of clinical research professionals, ensuring regulatory compliance across all active sites, and driving the clinical strategy that will help bring the world’s first Total Artificial Heart to patients who need it most. Collaborate on clinical strategy and author key clinical documents including clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, risk-benefit analyses, and clinical marketing materials.
Orange, California30+ days ago
p style="margin:0px">*Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer. Please utilize the links listed here to learn more about our compensation practices and benefits.
Essential Functions and Responsibilities Oversee the timely activation, execution, and management of Expanded Access Programs (EAPs) that support commercial launch activities at authorized treatment centers Leads the activities for the timely activation, execution, and management of Post Marketing study Oversee the timely activation, execution, and management of ISTs/non-clinical research projects Ensure Sunshine Act reporting data for lifileucel and Proleukin products across Research Alliances programs are collected Works closely with Legal to initiate CDAs, clinical trial and service agreements, amendments and change orders for EAPs, Phase 4, Investigator-Sponsored and non-clinical collaborations. In-depth knowledge of Microsoft Office, including MS Word, MS Excel, MS PowerPoint, and MS Outlook Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, and the regulations and laws governing the pharmaceutical industry (e.g., compliance, Sunshine Act) Preferred Education, Skills, and Knowledge Oncology/immunotherapy experience Phase 4, Expanded Access Program experience The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully.
Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. Preferred 8+ years clinical research administration experience including managing pre-award process of grant and protocol proposals for multiple projects in the solid tumor area.
City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. We are seeking an experienced and inspiring Clinical Research Nurse Manager to lead clinical research operations, elevate quality patient care, and support a high-performing team in a dynamic oncology research environment.
Beverly Hills, CA15 days ago
Provides leadership, guidance, and direction for day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance. Communicate regularly with DRG faculty and engage physicians, advanced practice providers, clinic nurses, and staff to address clinical research issues in a timely and compliant manner.
The Site Manager owns meeting or exceeding financial targets, KPIs, and patient enrollment, as well as champions screening, patient retention, and partnering with other Headlands centralized departments or sites. Partners with Human Resources and Management when hiring new employees for the site by reviewing candidate credentials, conducting interviews, and giving input about potential new hires.
Los Angeles, CA30+ days ago
p>Country Code+1+1242+1246+1264+1268+1284+1340+1441+1473+1649+1664+1670+1671+1684+1758+1767+1784+1849+1868+1869+1876+1939+20+211+212+213+216+218+220+221+222+223+224+225+226+227+228+229+230+231+232+233+234+235+236+237+238+239+240+241+242+243+244+245+248+249+250+251+252+253+254+255+256+257+258+261+262+264+265+266+267+268+269+27+290+291+297+298+299+30+31+32+33+34+345+350+351+352+353+354+355+356+357+358+359+36+370+371+372+373+374+375+376+377+378+379+380+381+382+385+386+387+389+39+40+41+420+421+423+43+44+45+46+47+48+49+500+501+502+503+504+505+506+507+508+509+51+52+53+54+55+56+57+58+590+591+593+594+595+596+597+598+599+60+61+62+63+64+65+66+670+672+673+674+675+676+677+678+679+680+681+682+683+685+686+687+688+689+690+692+7+77+81+82+84+850+852+853+855+856+86+872+880+886+90+91+92+93+94+95+960+961+962+963+964+965+966+967+968+970+971+972+973+974+975+976+977+98+992+993+994+995+996+998Phone Number. Req ID 15872 Working Title Clinical Research Program Manager, Multi-Site Operations (Onsite) Department Enterprise Research Admin Business Entity Cedars-Sinai Medical Center Job Category Academic / Research Job Specialty Research Studies/ Clin Trial Overtime Status EXEMPT Primary Shift Day Shift Duration 8 hour Base Pay $45.56 - $77.45.
Los Angeles, California30+ days ago
p>The Clinical Research Program Manager works closely with the Director, Principal Investigators (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to manage the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support. Ability to develop and maintain professional working relationships in complex program/organizational settings involving heterogeneous constituents such as academic and clinical faculty, staff, students, and community partners from diverse backgrounds.
Mountain View, CA19 days ago
Our teams are applying our expertise and technology to improve health outcomes globally - with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community. You are highly collaborative and will align with cross-functional, non-clinical teams, such as engineering, product management, legal, privacy, and regulatory affairs, and coordinate with external clinical trial sites, academic collaborators and agreement research vendors.
2025 University of California, Irvine, UCI Health, and UC Regents. Sign-up to be notified of hiring events, newly posted job opportunities, and much more.
p>2025 University of California, Irvine, UCI Health, and UC Regents. Sign-up to be notified of hiring events, newly posted job opportunities, and much more.
Riverside, California14 days ago
Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver’s license information, etc) via email or messenger tools, or for a financial deposit of any kind. Leveraging deep clinical, scientific, and engineering expertise, this role will partner with engineers, physicians, interaction designers, human factors specialists, training teams, technical publications, and other internal and external stakeholders to shape product and procedural innovation. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
Demonstrated success leading multi-center clinical trials across multiple geographies, including site management, IRB/EC submissions, and regulatory coordination. Develop and maintain clinical study plans, protocols, budgets, agreements, timelines; proactively identify and resolve threats to enrollment, data quality, and regulatory timelines.
Duties & Responsibilities: Lead the development and management of clinical study documentation, including protocols, case report forms (paper and electronic), informed consent forms, subject questionnaires, clinical study reports, statistical analysis plans, and regulatory submissions. Position Summary: The Manager, Clinical Research reports to the Director, Clinical Research and is responsible for leading and managing clinical research activities with participating study physicians and research sites.
San Francisco, CA24 days ago
Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository.
Verana Health, a digital health company that delivers quality drug lifecycle and medical practice insights from an exclusive real-world data network, recently secured a $150 million Series E led by Johnson & Johnson Innovation - JJDC, Inc. (JJDC) and Novo Growth, the growth-stage investment arm of Novo Holdings. Existing Verana Health investors GV (formerly Google Ventures), Casdin Capital, and Brook Byers also joined the round, as well as notable new investors, including the Merck Global Health Innovation Fund, THVC, and Breyer Capital.
Westlake Village, CA30+ days ago
Develop strong working relationships with internal Product Marketing/Management team members to provide voice-of-customer and market observations to help optimize and develop successful long-term portfolio strategies. Drive appropriate utilization of approved products with (but not limited to) Heart Failure (HF) specialists, cardiology, nephrology, emergency medicine, advanced practitioners, HF clinic staff, and all other health care professionals within assigned accounts.
San Francisco, CA24 days ago
Trains, supervises, and guide CRCs to prepare for monitoring and audit visits, including ensuring all study documents are complete, organized, and current, all data is submitted and queries answered, and all action items from prior visits are completed. Provides excellent judgment and initiative to ensure procedures are properly billed to optimize patient care and use of limited resources, may assist Clinical Research Manager in creating systems to ensure these operations are properly.
San Francisco, CA24 days ago
This involves coordinating study required procedures and treatments for study patients; managing and updating databases to insure data integrity; acting as intermediary between sponsors, research staff, and various UCSF departments; assuring compliance with all relevant regulatory agencies; assisting Clinical Research Manager, Associate Director of Clinical Research Program, and/or PI with research tasks; maintaining relevant regulatory documents in partnership with the Regulatory department; reporting study progress to investigators; participating in any internal and external audits or reviews of study protocols; and performing other duties as assigned. Must be a team player and participate in staff- wide assignments outside of protocol management, including: filing, cleaning and maintaining study supplies, maintaining common work spaces (office space and laboratory space); development of policies and procedures, and other duties as assigned by the Clinical Research Manager, Principal Investigator, and Associate Director.
The Clinical Trial Manager should have experience in managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings and CAPAs; ensures audit-ready condition of clinical trial documentation including the TMF; reviews monitoring visit reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate; participates in site monitoring visits, as appropriate. The Senior Clinical Trial Manager (Senior CTM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensures completion of study deliverables, typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.), proactively identifies and resolves clinical project issues, and participates in process improvement initiatives as required.
Redwood City, California3 days ago
For more information, please visit our website at https://www.adicetbio.com. Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. Contribute operational expertise to the development of study protocols, clinical study documents, and cross-functional clinical initiatives that support innovative neurovascular medical device programs.
El Segundo, CA30+ days ago
Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patients natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. Knowledge, Skills, & Abilities • Strong background in oncology clinical development • Demonstrated ability working directly with the highest levels of the company with ease • Excellent verbal and written communication skills in English • Knowledge of FDA guidelines as well as ICH/GCP Guidelines.