Clinical Operations Associate (Pool)

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, 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:
  • Microsoft Outlook including shared calendars & invitations
  • Microsoft One Drive and Share Point
  • Microsoft Power Point
  • Microsoft Excel
  • 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.

Equal Opportunity

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.