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Trial Master File Jobs in Spring, TX (NOW HIRING)

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

CRA 2, IQVIA Biotech

Houston, TX · On-site

$71K - $145K/yr

Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site ...

Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site ...

Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site ...

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 ...

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 ...

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Trial Master File information

What are the key skills and qualifications needed to thrive in the Trial Master File position, and why are they important?

To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.

What is a Trial Master File job?

A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.

What are the typical responsibilities and daily tasks of a Trial Master File (TMF) Specialist?

As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.

What is the salary of trial master file?

The Trial Master File (TMF) role typically offers a salary range between $60,000 and $100,000 annually, depending on experience, location, and the size of the organization. Professionals in this field often have skills in document management, regulatory compliance, and clinical trial processes, which can influence compensation.

What jobs pay 2000 a day?

High-paying jobs that can pay around $2,000 a day often include specialized roles such as trial master file managers in clinical research, senior consultants, or freelance professionals like consultants, surgeons, or legal experts. These roles typically require advanced skills, certifications, or extensive experience and may involve project-based or contract work with high hourly or daily rates.

Can you be a CRA with no experience?

A Clinical Research Associate (CRA) typically requires some prior knowledge of clinical trial processes, regulations, and monitoring techniques. While entry-level positions may be available, most employers prefer candidates with relevant education or experience in healthcare, life sciences, or related fields, along with familiarity with electronic data capture tools and Good Clinical Practice (GCP) guidelines.

What jobs pay $500,000 a year in the US?

High-level roles related to managing clinical trials, such as Trial Master File managers or directors, typically do not reach $500,000 annually. Executive positions in pharmaceutical companies, biotech firms, or clinical research organizations, such as Chief Medical Officers or Vice Presidents, are more likely to earn this level of compensation, often including bonuses and stock options. These roles require extensive experience, advanced degrees, and leadership skills in the industry.
What are popular job titles related to Trial Master File jobs in Spring, TX? For Trial Master File jobs in Spring, TX, the most frequently searched job titles are:
What job categories do people searching Trial Master File jobs in Spring, TX look for? The top searched job categories for Trial Master File jobs in Spring, TX are:
What cities near Spring, TX are hiring for Trial Master File jobs? Cities near Spring, TX with the most Trial Master File job openings:
CRA 2, Oncology, IQVIA

CRA 2, Oncology, IQVIA

IQVIA

Houston, TX

$87K - $145K/yr

Full-time

Posted 7 days ago


IQVIA rating

8.2

Company rating: 8.2 out of 10

Based on 52 frontline employees who took The Breakroom Quiz

46th of 204 rated it services


Job description

IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:

Essential Functions

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Collaborate and liaise with study team members for project execution support as appropriate.

If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.

If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Education: Bachelor's Degree (Degree in scientific discipline or health care preferred)

Experience: 1.5 to 2 years of relevant CRA experience including on-site monitoring.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $87,200.00 - $145,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

What IQVIA employees say

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Benefits

Hours and flexibility

Workplace

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About IQVIA

Sourced by ZipRecruiter

At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Durham, NC, US