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Trial Master File Associate Jobs in Georgia (NOW HIRING)

IQVIA

Sr. Clinical Research Associate, IQVIA

Marietta, GA · On-site

$101K - $169K/yr

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

CRA 1, IQVIA Biotech

Marietta, GA · On-site

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

Syneos Health

CRC II (Onsite) - Marietta, GA

Marietta, GA · On-site

$23 - $30.50/hr

Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study. * Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV ...

Dal-Tile

CSR Warehouse Associate II

Atlanta, GA · On-site

$13.75 - $19/hr

As the Customer Service/Warehouse Associate II will need someone responsible for providing a ... master file, and creates vendor orders. * Performs various product order duties such as entering ...

Rafus Law

Associate Attorney

Lawrenceville, GA · On-site

... client files. If you've recently graduated from law school, have excellent fact-finding and ... trial presentation Qualifications • Licensed attorney in Georgia • Strong work ethic and ...

Rafus Law

Associate Attorney

Lawrenceville, GA

$105K/yr

Maintain client files in an organized fashion to ensure up-to-date information is handy for other ... Prepare witnesses and assist in trial presentation Qualifications: * Completion of a Juris Doctor ...

Dal-Tile

CSR Warehouse Associate II

Atlanta, GA · On-site

$14 - $19.25/hr

As the Customer Service/Warehouse Associate II will need someone responsible for providing a ... master file, and creates vendor orders. * Performs various product order duties such as entering ...

Portman

Hospitality Associate

Atlanta, GA · On-site

$14.50 - $19.75/hr

Hospitality Associate Business Vertical: Hospitality Location: Work from Office: Downtown Atlanta ... master file data are properly established in the system and that correct reports are generated and ...

Portman

Hospitality Associate

Atlanta, GA · On-site

$14.50 - $19.75/hr

Hospitality Associate Business Vertical: Hospitality Location: Work from Office: Downtown Atlanta ... master file data are properly established in the system and that correct reports are generated and ...

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All JobsTrial Master File Associate JobsTrial Master File Associate Jobs in Georgia

Trial Master File Associate information

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate, and why are they important?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
What are the most commonly searched types of Trial Master File jobs in Georgia? The most popular types of Trial Master File jobs in Georgia are:
What are popular job titles related to Trial Master File Associate jobs in Georgia? For Trial Master File Associate jobs in Georgia, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Georgia look for? The top searched job categories for Trial Master File Associate jobs in Georgia are:
What cities in Georgia are hiring for Trial Master File Associate jobs? Cities in Georgia with the most Trial Master File Associate job openings:
Trial Master File Associate jobs near you
Clinical Research Associate (CRA) -Cardiovascular Medical Device

Clinical Research Associate (CRA) -Cardiovascular Medical Device

Mirus LLC

Marietta, GA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 15 days ago

Job description


Role: Clinical Research Associate (CRA) - Cardiovascular Medical Device

Location: Remote

Position Summary:

Assist with the management of cardiovascular clinical studies for MiRus products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization.

Essential Duties and Responsibilities:

  • Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
  • Assist with the management of investigational studies from start through study closure.
  • Engage in new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
  • Contribute to the development of CRFs
  • Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials, as applicable.
  • Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
  • Serve as a point of contact between clinical site investigators and the MiRus team.
  • Work with investigators and site personnel to quickly and effectively resolve discrepancies.
  • May be responsible for patient accruals and tracking payments to sites for clinical study programs
  • Serve as a point of contact between CRO personnel and MiRus.
  • Oversee/support CRO and field study monitors, with monitoring related items and follow-up on study tasks.
  • Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
  • Provide continuous data review of source documents, case report forms, data reports as appropriate.
  • Assist in review of monitoring reports and tracking of action items.
  • Review source documentation to confirm subject eligibility for clinical trials.
  • Track and upload study imaging
  • Manage clinical study documentation (trial master file and study related tracking).
  • Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager
  • Interact with data management, as applicable
  • Support applications and technical files as needed.
  • Assist with preparation for investigators meetings.

Minimum Education and/or Experience:

  • Bachelor’s or Master’s degree in nursing with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role. CRA certification desired.
  • At least 2 years of experience in clinical research role, with at least 2 years in CRA role, preferably in cardiovascular medical device.
  • Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
  • Current knowledge of medical device clinical trials design and best practices.
  • Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
  • General application of medical terminology (cardiovascular specific preferred).

Benefits:
MiRus offers competitive compensation, options, full benefits, and relocation assistance.

  • 401(k)
  • Dental insurance
  • Vision insurance
  • Disability insurance
  • Employee assistance program
  • Flexible spending account or Health Savings Account
  • Health insurance
  • Life insurance
  • Paid time off

Schedule:

  • Monday to Friday (8am – 5pm)

Work Location:

  • Remote
  • Position may require domestic travel at least 20-40%