eTMF Coordinator
Alliance for Clinical Trial in Oncology Foundation, United States

Purpose/Scope:

The Electronic trial master file (eTMF) Coordinator is responsible for coordinating and supporting activities of the AFT operations, quality management and compliance (QMC) teams with a primary assignment to support the electronic Trial Master File (eTMF).

Role and Responsibilities:

• Under the immediate supervision of the eTMF Administrator, serves as coordinator of the AFT electronic Trial Master File (eTMF)

• Participates in the configuration and maintenance of the eTMF system
• Assists study teams with eTMF quality control and reconciliation of study documents to address documentation gaps
• Addresses eTMF related support tickets submitted by eTMF users through AFT’s helpdesk system including eTMF troubleshooting
• Supports periodic reviews of the study eTMF per AFT standard operating procedures (SOPs) and study specific plans
• Assists the eTMF Administrator in retrieving reports necessary for assessment of eTMF metrics (i.e., monthly and quarterly metrics)
• Assists with preparation of eTMF audits of the Sponsor and site files
• Provides ad-hoc eTMF system training to internal and external eTMF users

Requirements

Qualifications and Education Requirements:

• Bachelor’s degree and relevant work experience (pharma, biotech, CRO preferred)

• 1-2 years’ experience in clinical trials, eTMF document management experience preferred; however, other suitable experience will be considered (e.g., study coordinator, regulatory operations, etc.)
• High proficient in MS Office suite (MS Office products, word processing, Excel spreadsheets, e-mail management and good etiquette)

Candidates must demonstrate the following competencies:

• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations, preferred
• Understanding of GCP and regulatory requirements as well as a working knowledge of clinical research documents that are maintained in the eTMF preferred
• Familiarity with the eTMF Reference model and a demonstrated understanding of records management best practices preferred
• Highly motivated with strong attention to detail and quality of work
• Capacity to understand and analyze data/metrics
• Comfortable with technology and ability to learn new systems quickly
• Ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
• Demonstrated ability to work independently and in a team environment
• Communicate effectively, both orally and in writing
• Strong organizational abilities and effective time management
• 100% COVID Vaccincated

Benefits

• 100% Medical Option, Dental amp; Vision for employee, with 50% spouse and children - begins on the 1st day of employment
• 20 Days PTO, 5 Sick Days amp; 10 Holidays Off (Already Designated)
• Tuition Reimbursement
• Match 3% of a Simple IRA.
• 50% Transit or Parking paid
• Annual Employee Bonus Program
• Annual Cost of Living Increase

Job Rewards and Benefits