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 ...
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 ...
Clinical Trials Associate
Bethesda, MD · On-site
$36 - $49/hr
Demonstrated understanding of medical and clinical trials terminology, including general understanding of Clinical Site Monitoring, Essential Regulatory Documents, and Trial Master Files. Able to ...
Clinical Trials Associate
Bethesda, MD · On-site
$36 - $49/hr
Demonstrated understanding of medical and clinical trials terminology, including general understanding of Clinical Site Monitoring, Essential Regulatory Documents, and Trial Master Files. Able to ...
Sr. TMF Manager
Rockville, MD · On-site
$34.25 - $46.75/hr
Summary of Position This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities ...
Sr. TMF Manager
Rockville, MD · On-site
$34.25 - $46.75/hr
Summary of Position This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities ...
Draft, review, and maintain clinical trial forms (e.g., eligibility forms, FAQs/Medical Monitoring Logs, Medical Review Summary Forms) and file them in appropriate folders (e.g., Trial Master File ...
Draft, review, and maintain clinical trial forms (e.g., eligibility forms, FAQs/Medical Monitoring Logs, Medical Review Summary Forms) and file them in appropriate folders (e.g., Trial Master File ...
MedTech Site Manager 1
$74K - $124K/yr
Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist with site training for assigned clinical trials. * Assist with site audits and site quality ...
MedTech Site Manager 1
$74K - $124K/yr
Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist with site training for assigned clinical trials. * Assist with site audits and site quality ...
MedTech Site Manager 1
$74K - $124K/yr
Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist with site training for assigned clinical trials. * Assist with site audits and site quality ...
MedTech Site Manager 1
$74K - $124K/yr
Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist with site training for assigned clinical trials. * Assist with site audits and site quality ...
Sr. In-House CRA
Rockville, MD · On-site +1
Performs upload of essential documents into the trial master file. * Independently communicates and coordinates effectively with internal project staff members and site staff. * Independently ...
Sr. In-House CRA
Rockville, MD · On-site +1
Performs upload of essential documents into the trial master file. * Independently communicates and coordinates effectively with internal project staff members and site staff. * Independently ...
Collaborate with Document Management team to archive DM-related documents in Trial Master File (TMF). * Write DM-related SOPs and/or Job aids and contribute to improving DM processes. Non-Essential ...
Collaborate with Document Management team to archive DM-related documents in Trial Master File (TMF). * Write DM-related SOPs and/or Job aids and contribute to improving DM processes. Non-Essential ...
Senior Clinical Research Associate / Clinical Research Associate II - Oncology - West Coast US - FSP
Washington, DC · On-site +1
Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters ...
Senior Clinical Research Associate / Clinical Research Associate II - Oncology - West Coast US - FSP
Washington, DC · On-site +1
Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters ...
CRA 1, IQVIA Biotech
Fairfax, VA · On-site
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
Fairfax, VA · On-site
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
Rockville, MD · On-site
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
Rockville, MD · On-site
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
Clinical Protocol Coordinator
Bethesda, MD · Remote
$130K - $216K/yr
Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust ... Maintain data files across multiple software systems and communication platforms. * Perform data ...
Clinical Protocol Coordinator
Bethesda, MD · Remote
$130K - $216K/yr
Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust ... Maintain data files across multiple software systems and communication platforms. * Perform data ...
... filing and study close-out. This is a fractional, deliverable-driven role with workload ... Master's degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent ...
... filing and study close-out. This is a fractional, deliverable-driven role with workload ... Master's degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent ...
Clinical Trials Program Monitor and Auditor
Bethesda, MD · On-site
$130K - $216K/yr
Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust ... Master's degree in biology, life sciences or related discipline. * Minimum EIGHT (8) years of ...
Clinical Trials Program Monitor and Auditor
Bethesda, MD · On-site
$130K - $216K/yr
Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust ... Master's degree in biology, life sciences or related discipline. * Minimum EIGHT (8) years of ...
Clinical Trials Program Monitor and Auditor
Bethesda, MD · On-site
$130K - $216K/yr
Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust ... Master's degree in biology, life sciences or related discipline. * Minimum EIGHT (8) years of ...
Clinical Trials Program Monitor and Auditor
Bethesda, MD · On-site
$130K - $216K/yr
Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust ... Master's degree in biology, life sciences or related discipline. * Minimum EIGHT (8) years of ...
... files. * Assisting, under general supervision, with witness interviews, trial preparation ... Two (2) full years of progressively higher-level graduate education leading to a master's degree or ...
... files. * Assisting, under general supervision, with witness interviews, trial preparation ... Two (2) full years of progressively higher-level graduate education leading to a master's degree or ...
... files. * Assisting, under general supervision, with witness interviews, trial preparation ... Two (2) full years of progressively higher-level graduate education leading to a master's degree or ...
... files. * Assisting, under general supervision, with witness interviews, trial preparation ... Two (2) full years of progressively higher-level graduate education leading to a master's degree or ...
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In-House Clinical Research Associate
Bethesda, MD • Hybrid
TRI Challenge Convention
Full-time
Re-posted 27 days ago
Job description
The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to: 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/Client. Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.
Track essential regulatory documents in a centralized web-based system and/or other database. Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems. Coordinate or assist in distribution of trial-related materials to study sites.
May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation. NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.Understanding of medical and clinical trials terminology
Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution. Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity.
Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum). Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation.
Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right. Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus.
Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.Understanding of medical and clinical trials terminology. Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution
Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity. Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum).
Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation. Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.
Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus. Experience with using a Trial Master File, a plus.
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.