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Clinical Research Tmf Documentation Associate Jobs

Consulting Associate - Healthcare, Clinical Documentation
By Huron Consulting Group Inc. At , Chicago, 60631, Il
Direct supervisory experience including coaching, mentorship, and performance management
3 to 5 years relevant project implementation or process improvement experience in a team-based environment, preferably within healthcare or consulting
Willingness and ability to travel every week (Monday-Thursday with occasional onsite Fridays) and work extended hours as needed
Proficient in Microsoft office (Word, PowerPoint, Excel)
Clinical Documentation Associate Jobs
By Planet Pharma At Deerfield, IL, United States
Efficient and effective time management skills with ability to successfully manage competing priorities.
Train/mentor departmental and vendor staff on file management systems and processes.
Assist in management of internal and external assessments and corrective/preventive actions .
AA or BA/BS degree and 5 years clinical experience including organizing and coordinating Trial Master Files for clinical trials
High level of competency with Veeva eTMF and knowledge of the TMF Reference Model, supported by DIA.
Accountable for delivery of assigned TMF activities in accordance with project requirements/timelines and as outlined in the TMF Plan.
Tmf Support Analyst Jobs
By LMK Clinical Research Consulting At United States
Provide project teams with outstanding trial and data management
To continuously improve performance and productivity (ensure high skill level), and provide operational excellence through best practices and lesson learned.
Continuously improve performance and productivity (ensure high skill level and
2 years of Clinical Research experience or professional equivalent.
2 years of Document QC experience or professional equivalent.
To develop strong values and foster innovations in TMF process.
Clinical Document Management Associate (Tmf /Oncology) - 1 Year Contract – Hybrid- Nc Pharma
By Frankel Staffing Partners At Raleigh-Durham-Chapel Hill Area, United States
Support the management of eTMF documentation issues throughout the lifecycle of a study
Proactive management of clinical documentation and trackers
Experience working with documents at study start-up, during study conduct and close-out will be required
Experience in handling TMF documents during a regulatory inspection will be a plus.
Proactive and smart organizational skills
Excellent documentation skills and detail-orientation
Remote - Part-Time - Clinical Tmf Documentation Operations Manager
By Beacon Hill Staffing Group At United States
Maintain expert level knowledge of regulations, guidelines, policies, and practices for TMFManagement (global/international)
5+ years TMF management experience in the pharmaceutical/clinical research environment, specifically using electronic records management systems
1+ year of personnel management experience
Previous clinical trials records management experience is preferred
Previous experience using computerized clinical trials records management technologies is preferred
Provide study management operations expertise as needed
Clinical Documentation Associate Jobs
By The Steely Group At United States
Efficient and effective time management skills with ability to successfully manage competing priorities.
Train/mentor departmental and vendor staff on TMF management systems and processes.
Assist in management of internal and external assessments and corrective/preventive actions.
Manage Expected Document Lists and Milestones in Veeva eTMF
Perform/volunteer for other duties and special projects as assigned or appropriate for skill set.
Good organizational and problem-solving skills, able to work independently.
Clinical Research Associate Jobs
By Bionical Emas At Paulsboro, NJ, United States
Previous experience that provides the knowledge, skills, and abilities to perform the job
The CRA will complete all role specific required training and documents needed in the applicable learning management system
Previous independent monitoring experience is essential
They will comply all applicable Bionical Emas SOPs and policies
Completes and submits timesheet and expenses in a timely manner, as per company guidelines
When necessary, they will be a mentor to other CRAs
Clinical Research Associate Jobs
By Barrington James At New York, United States
MUST have 5+ years experience as a CRA monitoring experience.
MUST have therapeutic experience in Medical Devices or Neurology.
Excellent verbal and written communications skills.
Identify patients eligible for studies
You will ensure monitoring visits are being conducted as needed and tasks are being completed in an appropriate and timely manner
Analyze and prepare data, writing reports and assisting in drafting manuscripts and papers
Sr. Clinical Research Qc Associate
By Clinilabs At , Eatontown, 07724, Nj
Provide support (e.g. data entry, filing, QC, etc…) to CRU personnel and other Clinilabs personnel ad requested and needed.
Manage and track project timelines and quality issues.
Must have related experience for at least five years.
Must possess excellent clerical, strong computer and good interpersonal skills.
Reading and understanding study protocols.
Communicate with all operational departments regarding project status/issues.
Clinical Research Associate Jobs
By Laborie Medical Technologies At , Minnetonka, 55343, Mn $100,000 - $125,000 a year
Create and maintain PMS documents to ensure compliance with applicable regulatory requirements and guidance’s (i.e., MDCG).
3-5 years of relevant CRA work experience with medical device
Experience with or exposure to Good Clinical Practices.
Good written and verbal communication, problem-solving, and critical thinking skills.
Support cross-functional teams in responding to requests from competent authorities, registries and notified body.
Supports post-market clinical plan activities, including physician surveys, retrospective and/or prospective studies etc.
Clinical Research Associate Jobs
By Castle Biosciences, Inc. At Elk Grove Village, IL, United States
M-F; working remotely from home, Midwest USA-based location, near a major airport; travel routinely 50-60% and up to 80% at times.
Bachelor's degree in a science or healthcare-related field or a registered nursing certification or equivalent certification/licensure from an appropriately accredited institution.
3 years of CRC experience or previous 1-year experience as a CRA.
Direct patient care or clinical research experience required.
Familiarity with clinical research and study development processes.
Valid Driver's License where applicable.
Documentation Associate-Utility Mapping Jobs
By Walt Disney World At Lake Buena Vista, FL, United States
Records Information Management (RIM) experience
1+ years of experience working in an office environment
Effective verbal and written communication skills
Demonstrated computer skills using Microsoft Suite
2+ years of applicable experience in Engineering, Construction, or utility operations
Proven project document control experience
Clinical Research Associate Jobs
By Digital Prospectors At Cambridge, MA, United States
Good conflict management and negotiation skills.
Attend qualification and site initiation visits.
Assist the Clinical Trial Manager in the review of ICFs and essential documents.
Track clinical supply shipments and manage shipment logistics.
Strong communication skills both verbally and written in English.
Minimum of 2-3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical, and/or CRO company.
Tmf Specialist / Clinical Trial Associate
By EPM Scientific At Chicago, IL, United States

3-5+ years of industry experience

In-depth knowledge of TMF process

Clinical Research Associate Jobs
By FibroGen, Inc. At , San Francisco, 94158, Ca $98,000 - $113,100 a year
Manages submission of documents and maintenance of the Trial Master File (TMF); reviews TMF to ensure inspection-readiness
At least 2 years of relevant experience in the pharmaceutical industry, Biotech or equivalent
Knowledge of GCP and ICH guidelines required
Excellent communication and interpersonal skills
Strong computer skills in MS Word, Excel, Outlook, and PowerPoint
Responsible for ensuring external service providers execute activities in a quality manner and per the established contract

Are you looking for an exciting opportunity to join a dynamic team of Clinical Research TMF Documentation Associates? We are looking for a highly motivated individual to join our team and help us ensure the accuracy and completeness of our clinical trial documentation. You will be responsible for reviewing and maintaining clinical trial documents in accordance with regulatory requirements and company standards. If you have a keen eye for detail and a passion for clinical research, this could be the perfect job for you!

Overview Clinical Research Tmf Documentation Associate is responsible for managing and maintaining the Trial Master File (TMF) for clinical studies. This includes ensuring that all documents are properly filed, indexed, and tracked in accordance with applicable regulations and guidelines. The Clinical Research Tmf Documentation Associate is also responsible for providing support to the clinical team in the preparation and submission of documents to regulatory authorities. Detailed Job Description The Clinical Research Tmf Documentation Associate is responsible for managing and maintaining the Trial Master File (TMF) for clinical studies. This includes ensuring that all documents are properly filed, indexed, and tracked in accordance with applicable regulations and guidelines. The Clinical Research Tmf Documentation Associate is also responsible for providing support to the clinical team in the preparation and submission of documents to regulatory authorities.

The Clinical Research Tmf Documentation Associate will be responsible for:

• Ensuring that all documents are properly filed, indexed, and tracked in accordance with applicable regulations and guidelines.
• Assisting with the preparation and submission of documents to regulatory authorities.
• Maintaining the TMF in accordance with applicable regulations and guidelines.
• Ensuring that all documents are properly stored and archived.
• Providing support to the clinical team in the preparation and submission of documents to regulatory authorities.
• Assisting with the development and implementation of TMF processes and procedures.
• Assisting with the development and implementation of quality assurance processes and procedures.
• Assisting with the development and implementation of audit processes and procedures.
• Assisting with the development and implementation of training processes and procedures.
• Assisting with the development and implementation of document control processes and procedures.
• Assisting with the development and implementation of document management systems.
• Assisting with the development and implementation of document retention policies.
• Assisting with the development and implementation of document archiving processes and procedures.
• Assisting with the development and implementation of document security processes and procedures.
• Assisting with the development and implementation of document destruction processes and procedures.
• Assisting with the development and implementation of document tracking processes and procedures.
• Assisting with the development and implementation of document review processes and procedures.
• Assisting with the development and implementation of document version control processes and procedures.
• Assisting with the development and implementation