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. Fountain Valley, CA30+ days ago
ol>Under direct supervision of the Director of Clinical Operations, Manager(s) of Clinical Operations and Principal Investigator, the Research Assistant is responsible for helping enlist, maintain, and assure protocol compliance for all study participants in assigned clinical research protocol(s).
MemorialCare is a nonprofit integrated health system that includes four leading hospitals, award-winning medical groups consisting of over 200 sites of care, and more than 2,000 physicians throughout Orange and Los Angeles Counties.
SCORE''s physicians and scientists study the effects of traumatic injuries and sports activities to determine how well joint replacement and reconstruction techniques or the use of experimental prostheses can restore joint mechanics and range of motion. Responsibilities include: Assists with multiple aspects of clinical trials ensuring data integrity, positive interactions with potential study subjects, document management, administrative support and evaluation process.
li>Communicate with cross functional partners (e.g., Product, Marketing, Regulatory, Quality, and Legal) and site leaders (e.g., Principal Investigators and Key Opinion Leaders [KOLs]) to execute strategic initiatives. Manage a clinical study team that may include Clinical Research Associates, Senior Clinical Research Associates, and Clinical Study Assistants, supporting hiring, development, training, and motivation to meet departmental needs.
San Francisco, CA17 days ago
p>Incumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator's protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.
San Francisco, CA27 days ago
The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Clinical Research Support Office (CRSO) has experienced unprecedented growth in the recent years and is seeking a limited appointment Assistant Clinical Research Coordinator for the Cancer Immunotherapy Program to assist with the daily needs of our clinical trials. Under the supervision of a Clinical Research Supervisor, Clinical Research Manager, and/or Principal Investigator (PI), the incumbent will perform entry-level duties related to the support and coordination of clinical studies, and may receive training and development to prepare and advance for journey-level work at the next level within the series.
Collaborate with internal (e.g., Product, Marketing, Medical Affairs, Regulatory, Quality, and Legal) and external (e.g., Principal Investigators, Key Opinion Leaders) partners to execute strategic initiatives. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Huntington Beach, CA26 days ago
The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures.
p>Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; Verification that the investigator is enrolling only eligible subjects; Regulatory document review; Medical device and/or investigational product/drug accountability and inventory; Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Flexible work environment Competitive PTO packages - starting at 20+ days Company-sponsored employee appreciation events Employee health and wellness initiatives Competitive compensation and benefits package Structured career paths with opportunities for professional growth Discounts for local businesses Awards Named a Top Workplace in 2024 by The Cincinnati Enquirer Recognized by Forbes as one of Americas Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
p>Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; Verification that the investigator is enrolling only eligible subjects; Regulatory document review; Medical device and/or investigational product/drug accountability and inventory; Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Flexible work environment Competitive PTO packages - starting at 20+ days Company-sponsored employee appreciation events Employee health and wellness initiatives Competitive compensation and benefits package Structured career paths with opportunities for professional growth Discounts for local businesses Awards Named a Top Workplace in 2024 by The Cincinnati Enquirer Recognized by Forbes as one of Americas Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
Los Angeles, CA30 days ago
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Los Angeles, CA14 days ago
The Assistant Clinical Research Coordinator assists the Clinical Research Coordinator and/or Senior Clinical Research Coordinator in contributing to the overall operational management of clinical research/trial/study activities. Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.