Clinical Trial Associate
6 days ago
Design Therapeutics Inc. is seeking a highly motivated and detail-oriented Clinical Trial Associate to join our team. As a Clinical Trial Associate, you will play a critical role in the success of our clinical trials by providing administrative support and ensuring compliance with regulatory requirements.
Key Responsibilities- Study Operations Management
- Manage various aspects of day-to-day operations of clinical trials, including site activation, study guides, and informed consents.
- Provide general support to the Manager and field Clinical Research Associates (CRAs) to manage investigator sites and ensure compliance.
- Regulatory Compliance
- Manage the collection, review, and tracking of essential regulatory documents in support of new clinical study site activation.
- Ensure all clinical sites are provisioned with appropriate ancillary supplies, investigational product, and associated documentation.
- Vendor Management
- Manage and serve as a point of contact for contract research organization (CRO) and third-party vendors.
- Identify potential risks and proactively resolve issues that arise.
- Reporting and Communication
- Assist in the development of reports for communicating study progress and key metrics to the management team.
- Provide guidelines for assessing adequacy of potential clinical investigators and sites.
- Travel and Meetings
- As needed, travel to investigator sites to assist with site monitoring and reviewing source documents.
- Schedule and set up necessary tele- or videoconferencing meeting requirements for Clinical Development/Clinical Operations team.
- Education
- Bachelor's degree, life sciences preferred.
- Experience
- A minimum of 3 years of biotechnology or industry-related project management experience.
- Skills
- Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements.
- Strong verbal and written communication skills, including ability to organize and present concepts with written, oral, and technical media/approaches.
Design Therapeutics Inc. offers a competitive salary range of $70,000 USD to $120,000 USD, as well as eligibility to participate in the Company's 2021 Equity Incentive Plan and standard employee benefit programs, including medical, dental, vision, 401k, STD/LTD, life and accident insurance, and paid time off.
-
Clinical Trials Coordinator
2 days ago
Carlsbad, CA, US DCN Diagnostics Full timeJob SummaryThe Clinical Trials Assistant will provide critical support to the Clinical Research Services team in the management of clinical studies.This role involves a range of responsibilities, including:Managing inventory of investigational product and ensuring sites are properly suppliedOverseeing the management of documentation for clinical...
-
Clinical Trial Coordinator
4 days ago
Carlsbad, United States Bolt Medical Full timeJob SummaryBolt Medical is seeking a highly organized and detail-oriented Clinical Trial Assistant to join our team. As a Clinical Trial Assistant, you will play a critical role in the success of our clinical trials by assisting with the review, tracking, and monitoring of day-to-day aspects of clinical trials at investigative sites.Key...
-
Clinical Trials Coordinator
2 days ago
Carlsbad, United States DCN Diagnostics Full timeJob SummaryThe Clinical Trials Assistant will provide critical support to the Clinical Research Services team in the management of clinical studies.This role involves working closely with the Clinical Research team to ensure the smooth execution of clinical trials, from study setup to close-out.Key ResponsibilitiesStudy Management: Assist in the management...
-
Clinical Trial Assistant
5 days ago
Carlsbad, United States Bolt Medical Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Position Overview: The Clinical Trial Assistant will assist with the review, tracking and monitoring the day-to-day aspects of clinical trials at investigative sites and ensure clinical trial(s) documentation is collected, recorded, and filed. Ensure...
-
Clinical Trials Assistant
2 days ago
Carlsbad, United States DCN Dx Full timeCome Join the DCN Dx team! DCN Dx is seeking a Clinical Trials Assistant will support the Clinical Research Services team in the management of clinical studies. Responsibilities of the Clinical Trials Assistant include supporting filing of study documents, ensuring adequate supply to study sites, and maintaining inventories for study supplies. Some...
-
Clinical Trials Assistant
2 days ago
Carlsbad, United States DCN Dx Full timeCome Join the DCN Dx team! DCN Dx is seeking a Clinical Trials Assistant will support the Clinical Research Services team in the management of clinical studies. Responsibilities of the Clinical Trials Assistant include supporting filing of study documents, ensuring adequate supply to study sites, and maintaining inventories for study supplies. Some...
-
Clinical Trials Coordinator
2 weeks ago
Stanford, CA, United States Stanford University Full timePosition Overview:The Clinical Trials Coordinator is tasked with the comprehensive oversight and execution of designated research protocols, ensuring both efficiency and adherence to regulatory standards. This role involves collaboration with a clinical trials research team and requires reporting to various Principal Investigators engaged in clinical...
-
Sr. Clinical Trial Manager
3 months ago
Redwood City, CA, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: Act as the study lead delegate on cross-functional study teams, Vendor, and CRO operational meetings and ensure compliance with global operational standards and procedures.Support vendor selection, onboarding, management, and oversight of multiple vendors including but not limited to CRO (including RFPs and bid defense for CRO and...
-
Research Nurse
3 days ago
Miami, FL, USA, United States Syneos Health Full timeJob SummaryWe are seeking a highly skilled and experienced Research Nurse to join our team at Syneos Health. As a Research Nurse, you will play a critical role in ensuring the safety and well-being of study participants, while also contributing to the success of our clinical trials.Key ResponsibilitiesProvide high-quality medical support to study...
-
Research Nurse
4 days ago
Miami, FL, USA, United States Syneos Health Full timeJob SummaryWe are seeking a highly skilled and experienced Research Nurse to join our team at Syneos Health. As a Research Nurse, you will play a critical role in ensuring the safety and well-being of study participants, while also contributing to the success of our clinical trials.Key ResponsibilitiesProvide high-quality patient care and support to study...
-
Clinical Research Associate Coordinator
1 week ago
Stanford, CA, United States Stanford University Full timePosition Overview:The Clinical Research Associate Coordinator plays a crucial role in the comprehensive management and execution of various research protocols, ensuring both efficiency and adherence to regulatory standards. This position involves collaboration with a dedicated clinical trials research team and direct reporting to multiple Principal...
-
Clinical Laboratory Scientist, Generalist
1 week ago
Carlsbad, United States Novartis Group Companies Full timeJob SummaryWe are seeking a highly skilled Clinical Laboratory Scientist to join our team at Novartis Group Companies. As a key member of our laboratory team, you will be responsible for designing, creating, executing, and troubleshooting new procedures and assays.Key ResponsibilitiesWork in a GMP/GCP/GLP/CLIA regulated environment and follow all applicable...
-
Clinical Research Associate II
3 weeks ago
Los Angeles, CA, United States CEDARS-SINAI Full timeJob Description The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with...
-
St. Louis, MO, USA, United States Saint Louis University Full timeAbout the RoleAt Saint Louis University, we are seeking a highly skilled Associate Clinical Research Nurse to join our team. As a key member of our research team, you will play a vital role in the success of our clinical trials.Key ResponsibilitiesUnder the direction of the Principal Investigator or designee, you will be responsible for carrying out all...
-
St. Louis, MO, USA, United States Saint Louis University Full timeAbout the RoleAt Saint Louis University, we are seeking a highly skilled Associate Clinical Research Nurse to join our team. As a key member of our research team, you will play a vital role in the success of our clinical trials.Key ResponsibilitiesUnder the direction of the Principal Investigator or designee, you will be responsible for carrying out all...
-
Clinical Research Associate II
3 weeks ago
Los Angeles, CA, United States CEDARS-SINAI Full timeJob Description The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with...
-
Stanford, CA, United States Stanford University Full timeAbout the Role:The Division of Cardiovascular Medicine at Stanford University is a leading institution committed to advancing research, education, and patient care in the field of cardiovascular health. We are looking for a Clinical Research Associate to join our dynamic team. This role involves supporting multiple clinical trials under the guidance of the...
-
Clinical Research Associate I, PER DIEM
6 days ago
Sacramento, CA, United States CEDARS-SINAI Full timeJob Description Primary Duties and Responsibilities The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for...
-
Clinical Research Data Associate II
3 weeks ago
Los Angeles, CA, United States CEDARS-SINAI Full timeJob Description T he Clinical Research Data Associate II manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. In addition, may train clinical research staff, perform basic statistical...
-
Clinical Research Associate II
4 weeks ago
Los Angeles, CA, United States CEDARS-SINAI Full timeJob DescriptionThe Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol...
