Clinical Documentation Specialist
$39 - $52.50/hr
Title: Clinical Documentation Specialist Location: Lexington, MA Duration: 6 months (possible ... Manages the Trial Master Files (all of the documents that support the clinical trials-everything ...
$39 - $52.50/hr
Title: Clinical Documentation Specialist Location: Lexington, MA Duration: 6 months (possible ... Manages the Trial Master Files (all of the documents that support the clinical trials-everything ...
$39 - $52.50/hr
Title: Clinical Documentation Specialist Location: Lexington, MA Duration: 6 months (possible ... Manages the Trial Master Files (all of the documents that support the clinical trials-everything ...
Uploads/files/performs quality control on documents to be submitted to the Trial Master File. Includes identification of missing documentation and follow-up with authors or other stakeholders to ...
Uploads/files/performs quality control on documents to be submitted to the Trial Master File. Includes identification of missing documentation and follow-up with authors or other stakeholders to ...
... Specialists, and contributes to process improvements that enhance operational efficiency while ... Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the ...
... Specialists, and contributes to process improvements that enhance operational efficiency while ... Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the ...
... Specialists, and contributes to process improvements that enhance operational efficiency while ... Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the ...
... Specialists, and contributes to process improvements that enhance operational efficiency while ... Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the ...
$36.75 - $50.25/hr
This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...
$36.75 - $50.25/hr
This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...
Manhattan, NY · On-site
$36.75 - $50.25/hr
This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...
Manhattan, NY · On-site
$36.75 - $50.25/hr
This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...
Cambridge, MA · On-site
The primary purpose of this job is to provide support for document approval/finalization and preparation for publishing; submission of documents to clinical study Trial Master File and QC of Trial ...
Cambridge, MA · On-site
The primary purpose of this job is to provide support for document approval/finalization and preparation for publishing; submission of documents to clinical study Trial Master File and QC of Trial ...
Wilmington, DE · On-site
Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area ... Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of ...
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Wilmington, DE · On-site
Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area ... Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of ...
Fort Detrick, MD · On-site
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
Fort Detrick, MD · On-site
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
$33.75 - $45.25/hr
Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form ...
$33.75 - $45.25/hr
Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form ...
Irvine, CA · On-site
... Specialist supports all phases of clinical studies, including study start-up, conduct, and closeout, with a primary focus on maintaining an audit- and inspection-ready Trial Master File (TMF). This ...
Irvine, CA · On-site
... Specialist supports all phases of clinical studies, including study start-up, conduct, and closeout, with a primary focus on maintaining an audit- and inspection-ready Trial Master File (TMF). This ...
Frederick, MD · On-site
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
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Frederick, MD · On-site
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Lawrenceville, NJ · On-site
$122K - $122K/yr
Scientific - eTrial Master File Senior Analyst Research and Development/Global Clinical Compliance ... Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF ...
Lawrenceville, NJ · On-site
$122K - $122K/yr
Scientific - eTrial Master File Senior Analyst Research and Development/Global Clinical Compliance ... Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF ...
$110K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
$110K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
$100K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
$100K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
Acton, MA · On-site
$37 - $50.25/hr
Trial Master File (TMF) & Documentation Own the ongoing oversite, maintenance, quality, and completeness of the electronic Trial Master File (eTMF) in accordance with regulatory and internal ...
Acton, MA · On-site
$37 - $50.25/hr
Trial Master File (TMF) & Documentation Own the ongoing oversite, maintenance, quality, and completeness of the electronic Trial Master File (eTMF) in accordance with regulatory and internal ...
San Carlos, CA · On-site
$40.50 - $55.25/hr
Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master Files (eTMFs). * Review documents for completeness, accuracy, and TMF filing readiness. * Support ...
San Carlos, CA · On-site
$40.50 - $55.25/hr
Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master Files (eTMFs). * Review documents for completeness, accuracy, and TMF filing readiness. * Support ...
$25.75 - $35.25/hr
You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and archived according to established procedures and regulatory expectations. The position combines document ...
$25.75 - $35.25/hr
You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and archived according to established procedures and regulatory expectations. The position combines document ...
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$39 - $52.50/hr
Full-time
Re-posted 5 days ago
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Title: Clinical Documentation SpecialistÂ
Location: Lexington, MA
Duration: 6 months (possible extension)
JOB SUMMARY:
Manages the Trial Master Files (all of the documents that support the clinical trials-everything that the FDA and regulatory agencies review)Â
Support group for clinical, data managing, medical writing, safety, clinical supplies (Global Clinical Development Operations)Â
JOB REQUIREMENTS:
Processing, filing and tracking of Trial Master File (TMF) documents (paper and/or electronic) in accordance with study-specific TMF RoadmapsÂ
Performing quality checks of TMF documents as neededÂ
Providing oversight of TMF quality checks performed by functional areas and/or CRO'sÂ
Assisting with audit and inspection preparation as applicable
MUST HAVE:
2 years minimum experience doing anything associated with TMF (Trial Master Files) or Clinical Documentation
GCP Experience preferred
clinical experience
CTA/CRA experience OK
Experience with using an electronic document management system and proficient in excel necessary
Feel free to forward my email to your friends/colleagues who might be available
2 years minimum experience doing anything associated with TMF (Trial Master Files) or Clinical Documentation
GCP Experience preferred
clinical experience
CTA/CRA experience OK
Experience with using an electronic document management system and proficient in excel necessary
Ron Sharma
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 &- 2013 (7th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Direct No. :- 732-429-1649
Tel: (732) 549 2030 Ext. - 230
Fax: (732) 549 5549
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Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Recruiting and staffing services
51 - 200 Employees
Edison, NJ, US
1996