Clinical Trial Assistant

Overview

Provides technical and administrative support to Clinical Operations and Clinical Technology study team members for the execution of clinical trials. As a skilled specialist, completes tasks in resourceful and effective ways. This position is responsible for the appropriate collection, scan, index, quality check, file, archival, and retrieval of records for the Clinical Operations section of the electronic Trial Master File (eTMF) for assigned studies. May also be assigned other tasks to support study teams.

Responsibilities

• Set up Trial Master File
• Provide eTMF and study-level training metrics and reporting
• Provide eTMF access to study team members (including Sponsors) upon request from Project Manager; provide ongoing support and serve as an eTMF resource to study team members and sponsors
• Provide Site Reconciliation Reports
• Support final EDC subject data to sites (as directed by the COS)
• Complete final eTMF study export request and export
• Perform eTMF document QC
• Perform second review of site regulatory documents
• Assign study-level training to designated team members in QMS
• Perform debarment checks on potential Study PIs and record findings in CTMS
• Build CTMS templates: FQ, MVR and checklists
• Open and close file reviews in eTMF

Requirements

Education:

BA/BS in a science/health care field, nursing degree, or equivalent combination of education and experience.

Experience:

• Experience in a contract research organization (CRO), or pharmaceutical or biotechnology company is preferred.
• Competent computer skills including MS Office Suite.
• Basic working knowledge of Good Clinical Practice guidelines and clinical trial operations.
• Experience working with eTMF and EDC systems is preferred.

Skills:

• Demonstrates good communication skills (written and verbal).
• Attention to detail.
• Able to resolve routine problems and elevate issues appropriately using independent judgement.
• Able to work in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities.
• Ability to work in a team environment

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.