S & P Specialist
Bethesda, MD · Hybrid
Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to ...
Bethesda, MD · Hybrid
Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to ...
Bethesda, MD · Hybrid
Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to ...
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
New
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
New
Bethesda, MD · Hybrid
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Bethesda, MD · Hybrid
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Bethesda, MD · Hybrid
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Bethesda, MD · Hybrid
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Bethesda, MD · Hybrid
Degree This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Bethesda, MD · Hybrid
Degree This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by TRI or Sponsor ...
Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by TRI or Sponsor ...
$36 - $49/hr
Triage incoming emails, either as HelpDesk or other centralized/group email box. Process/track/distribute/upload designated clinical trial documents/artifacts, e.g., protocol deviations, site ...
New
$36 - $49/hr
Triage incoming emails, either as HelpDesk or other centralized/group email box. Process/track/distribute/upload designated clinical trial documents/artifacts, e.g., protocol deviations, site ...
New
Bethesda, MD · Remote
$18.25 - $19.50/hr
Creation and ownership of risk-based quality management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials. Review protocols to ensure the set ...
Bethesda, MD · Remote
$18.25 - $19.50/hr
Creation and ownership of risk-based quality management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials. Review protocols to ensure the set ...
Prepare standard documentation supporting regulatory filings and distribution to stakeholders. Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
New
Prepare standard documentation supporting regulatory filings and distribution to stakeholders. Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
New
Serve as the point of contact for inquiries directed to the Chief Operating Officer (COO) from other departments/projects; gather information and provide key points to the COO. Anticipate COO needs ...
New
Serve as the point of contact for inquiries directed to the Chief Operating Officer (COO) from other departments/projects; gather information and provide key points to the COO. Anticipate COO needs ...
New
Supports the maintenance and upkeep of the Quality Management System. Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program. Supports ...
Supports the maintenance and upkeep of the Quality Management System. Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program. Supports ...
Bethesda, MD · On-site
Verifies GCP compliance to applicable Standard Operating Procedures (SOPs) and regulations Conducts audits of clinical sites and vendors/suppliers Provides full support to the Quality Management ...
New
Bethesda, MD · On-site
Verifies GCP compliance to applicable Standard Operating Procedures (SOPs) and regulations Conducts audits of clinical sites and vendors/suppliers Provides full support to the Quality Management ...
New
Bethesda, MD · On-site
$39 - $52.25/hr
Supports clinical quality management plan review process and updates. Provide consultative services to clinical sites upon request. Supports the maintenance and upkeep of the site performance ...
New
Bethesda, MD · On-site
$39 - $52.25/hr
Supports clinical quality management plan review process and updates. Provide consultative services to clinical sites upon request. Supports the maintenance and upkeep of the site performance ...
New
Oversight of clinical operations activities, including one or more of the following: clinical project management, clinical site management (essential regulatory documents, study start up, site ...
Oversight of clinical operations activities, including one or more of the following: clinical project management, clinical site management (essential regulatory documents, study start up, site ...
Port Jervis, NY · On-site
$90 - $130/hr
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$90 - $130/hr
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$90 - $120/hr
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$90 - $120/hr
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$250/day
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$250/day
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$250/day
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Quick apply
Port Jervis, NY · On-site
$250/day
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$250/day
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Port Jervis, NY · On-site
$250/day
About Tri-State Veterinary Hospital At Tri-State Veterinary Hospital, we are more than just a ... We lift each other up and are not afraid to challenge convention and create a unique space in the ...
Richland, WA · Remote
$33.65 - $38/hr
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention ... If you thrive in a fast-paced environment, enjoy the challenge of identifying solutions, excel in ...
Richland, WA · Remote
$33.65 - $38/hr
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention ... If you thrive in a fast-paced environment, enjoy the challenge of identifying solutions, excel in ...

Full-time
Re-posted yesterday
Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies Develops and ensures the uniform and timely processing of adverse event reports Provides medical evaluation of adverse event reports Performs various tasks in support of clinical research including the reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents Performs literature searches Performs various tasks in support of clinical research including adverse event analysis and processing, serious adverse event reconciliation. Preparation of IND safety reports for submission to the FDA; safety document or data analysis. Clinical trial site support; reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development.
Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary. May review experimental protocols and informed consent documents; and prepare, review, and edit presentations regarding safety issues.Knowledge of GCP and ICH guidelines preferred; drug development/clinical trial experience essential. Knowledge of safety databases and/or MedDRA coding preferred
Experience leading clinical and cross functional teams is a plus. Must have excellent oral, written, presentation and computer skills. 2+ years of academic, pharmaceutical or biotech industry or academic experience.
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.Knowledge of GCP and ICH guidelines preferred; drug development/clinical trial experience essential. Knowledge of safety databases and/or MedDRA coding preferred. Experience leading clinical and cross functional teams is a plus
Must have excellent oral, written, presentation and computer skills. 2+ years of academic, pharmaceutical or biotech industry or academic experience. This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.