WORK THAT MATTERS.

Position Summary:

The Senior Clinical Trial Associate will support all phases of clinical trial activities (feasibility, start-up, conduct and close-out) under the direction and supervision of Clinical Operations Lead(s). Plans, supports, and communicates clinical trial timelines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of processes across clinical trials. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations (e.g., site and vendor selection). Monitors progress and follows up with team members when issues develop. May assist in the development and implementation of recruitment strategies for the trial.

Characteristics sought for a good cultural fit to the company include the ability to work collaboratively, nimble problem-solving skills, an innate sense of urgency, creative thinking about what is possible in execution, and general positivity.

Specific Responsibilities

• Conduct clinical trial support activities related to assigned trials (including coordination and documentation, eTMF management and review, etc.) in accordance with regulatory requirements, independently
• Proactively provide ongoing support to trials in terms of logistics management, support for sponsor oversight by the study team, and coordination with vendor teams & CROs
• Run reports and review metrics on data entry (EDC), related coordination with other cross-functional team members and trial progress tracking by updating the Clinical Trial Management systems (CTMS)
• Review, track and coordinate regulatory and other essential documents, eTMF metrics, investigator database, clinical supplies, internal/external correspondence, translations, other study materials, and assimilate information to present to the internal study team and/or Vendor / CRO.
• Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals
• Competency with ICH/GCP and appropriate regulations
• Proactively process essential documents (i.e., logging, tracking, and quality control) as appropriate for the trial
• Lead quality control review of clinical study documentation (e.g. Main Study Files, eTMF, CRF Files, Investigator Site Files, Monitoring Files, etc.)
• Assist in co-ordination of payments to investigators and consultants, if applicable
• Correspond with clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, day-to-day operational activities, etc.)
• Assist in the tracking and distribution of safety reports, as appropriate
• Attend project team meetings and generate meeting minutes, as required
• Assist study lead(s) with Investigator Meeting coordination, activities preparation and generate meeting minutes
• Assist in the production of slides, as needed for project presentations
• Support the needs of field CRAs in preparation, execution and follow-up for monitoring visits (eTMF, CTMS, site communications, etc.).
• Other duties as assigned

Education & Qualifications

• Bachelor’s degree in science, nursing, pharmacy or equivalent area
• A minimum of 2 years of relevant experience working with multi-site, clinical trials
• eTMF set-up and management; experience with Veeva eTMF preferred
• Experience working with vendors / CROs and their systems, preferred
• Experience managing cross functional communication, especially liaison between site and study teams.
• Competent in navigating Electronic Data Capture systems
• Experience working with regulatory & compliance standards/guidelines including ICH-GCP
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail
• Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
• Excellent written and verbal communication skills
• Computer literacy (e.g. Microsoft Word, Excel, PowerPoint, Outlook)
• Willingness to travel for job related activities if required (expected travel for this position is < 10%)

Department

Clinical Operations

Updated

February 2026

Location

Fulltime, office-based position, in Blue Bell, PA

EEO

iECURE is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.