Remote Trial Master File Jobs (NOW HIRING)

Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA, USA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.

We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a "white glove service" approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients' needs as they evolve.

Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.

Position Overview:

This is an exciting entry-level opportunity to join a fast-paced and dynamic
learning environment to learn the clinical trial and drug development industry
on several levels. This position is responsible for supporting the daily workflow of study activities across Clinical Operations, Study Start-Up (SSU), Trial Master File (TMF), and Data Management at Vanguard Clinical. The COA will be responsible for general administrative activities in support of clinical trial execution and may also participate in Vanguard infrastructure activities in a cross-functional capacity.

Essential Duties & Responsibilities:

Clinical Operations Support

• Provide administrative and operational support across the clinical trial
  lifecycle.
• Track study metrics (enrollment, screening, recruitment, site updates).
• Assist in preparing and documenting meeting materials.
• Schedule and coordinate meetings.
• Prepare, ship, and track investigational products and study supplies.

Study Start-Up (SSU) Support

• Support collection, tracking, and review of essential documents.
• Assist with feasibility, qualification, and regulatory document
  management.
• Support IRB/EC submissions and ICF preparation.
• Track study start-up timelines and follow up with sites and vendors.
  

TMF Management

• Perform QC review of TMF documents.
• File documents per TMF Reference Model.
• Identify gaps, inconsistencies, and missing documentation.
• Support audit and inspection readiness.
  

Data Management Support

• Review and enter clinical data into EDC systems.
• Manage data queries, reconciliation, and quality control checks.
• Support documentation review and source verification activities.
  

Cross-Functional Study Support

• Provide customer service to clients, vendors, and sites.
• Draft or update trackers, presentations, and study reference
  materials.
• Support cross-functional initiatives and process improvements.
• Participate in study meetings and assist with follow-up actions.
• Other duties as assigned per client or company needs
  

Experience & Skills:

• Strong self-motivation, ability to work independently, and quickly
  learn new information and skills
• Demonstrated strengths in planning, organization, time management,
  problem solving, and attention to detail
• Strong organizational skills, the ability to manage multiple priorities,
  and produce accurate and timely work
• Excellent oral and written communications and presentation skills;
  ability to communicate effectively with vendors and clients
• Basic understanding of US clinical research process, FDA, regulations,
  and ethical guidelines preferred
• Detailed knowledge of Microsoft Office suite of software programs:
  o Microsoft Outlook including shared calendars & invitations
  o Microsoft One Drive and Share Point
  o Microsoft Power Point
  o Microsoft Excel
  o Document change tracking & version control
  

Preferred:

• Familiarity with GCP/GDP/ICH guidelines
• Experience with eTMF, EDC, CTMS, or document management
  systems
• Prior exposure to clinical research
  

Education:

Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees
with relevant industry experience will be considered.

Compensation Range:

Clinical Operations Associate: $70,304 - 80,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)

Senior Clinical Operations Associate: $75,000 - 90,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)

COVID-19 Vaccination: To protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the client site requirements. Proof of vaccination may be required, in accordance with applicable laws.

Vanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.