Sr. Clinical Trial Assistant
Provides support to the clinical study teams in the execution of clinical trials. Primary responsibilities include maintaining Trial Master File (TMF) in an inspection-ready state, initiating collection, reviewing and tracking of essential documents throughout the life of the trial, initially the 140 triple-negative breast cancer(TNBC) study. Contributes to the production and distribution of study materials and site/study communications.
This position would be located in Pennington, NJ or San Diego, CA.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES:
- Establishes and maintains essential documents within the TMF.
- Reviews the TMF for compliance, addressing finds as needed and supporting the study team with study activities.
- Assists in the development, handling, distribution, review, filing and archiving of essential documents in the TMF.
- Assists projects team with the maintenance and quality review of study specific documentation.
- Initiates orders for outgoing clinical trial-related materials shipments to site, study team, CRAs, and vendors as needed.
- Communicates with CROs, and CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities.
- Participates in clinical team meetings, including attending required meetings and generating meeting agenda, minutes, and action items.
- Identifies and escalates issues appropriately.
- Other duties as assigned.
- Bachelor’s degree in life sciences or other field related to human study. An equivalent combination of education and applicable job experience may be considered.
- Five (5) years’ experience in a combination of the following:
- Experience maintaining Trial Master File (TMF)
- Experience with clinical operations duties
- Experience with initiating and tracking orders of clinical trial and study related materials shipments
- Experience with providing superior customer service and communicating appropriately with a wide range of people, esp. CRO and CRA staff.
- Experience organizing and maintaining electronic and hard copy files
- Experience resolving discrepancies in computer systems and applications
- Knowledge of clinical research procedures and regulatory requirements including following SOPs, FDA regulations and ICH GCP guidelines
- Understanding relevant clinical operations activities
- Ability to multi-task under limited direction and on own initiative
- Ability to build and maintain positive relationships both internally and externally
- Strong organizational, attention to detail and communication skills (written and verbal) in English
- Computer proficiency in Microsoft Word, Excel, Project and Outlook.
- Ability to learn and adapt new systems and processes
- Ability to recognize potential obstacles and work to resolve them within set timelines
- Conscientious and precise delivery of work even when under pressure
Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks. Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations. Normally receives little instruction on daily work, general instructions on newly introduced assignments.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment. In a lab setting, occasionally use hands to finger, handle objects, tools, or controls. Employee must occasionally lift and/or move up to 20 pounds.
To apply, email your resume and cover letter to [email protected]. In the subject line of your email, please enter the exact name of the position for which you’re applying.