Clinical Trial Assistant, San Antonio, TX
Provide administrative support to the Clinical Affairs team to ensure the successful completion of the clinical trial milestones and deliverables. May assist with general administrative functions as required.
Duties and responsibilities
- Sets up and maintains clinical trial files and documentation (TMF) to be audit and archive ready. Route, track and receive all essential clinical documents from CROs, other departments, sites and vendors. Perform a periodic review of the TMF including all GCP-related documents.
- Prepare study site files, review for accuracy and completeness, and send to sites prior to study initiation visits.
- Supports Clinical Affairs processes and tracking systems at the direction of the project team(s).
- Coordinates information and communications for designated projects, including internal and external correspondence.
- Assists Clinical Affairs team with preparation for internal and external meetings. This may include the set-up and coordination of team meetings; assess meeting requirements in advance and plan appropriately (including arranging meeting rooms, scheduling teleconferences, preparing and distributing meeting agendas / minutes).
- Generate/Track check requests for Investigator, Vendor and Pass Through payments.
- Coordinates project logistics, scheduling and other duties as assigned. This includes maintenance of study documents, binders, manuals and supplies to ensure adequate inventory for Clinical Affairs and sites.
- May join CRAs at sites for support activities such as documentation review and IP accountability.
- Works with Supervisor and Clinical Affairs team to achieve corporate goals and departmental goals within the expected time frames.
- All other duties as assigned
- HS diploma or equivalent acceptable with prior Industry experience.
- Minimum of 1 year of clinical research experience working at a clinical trial site, CRO, or Sponsor company.
- Strong communication skills (verbal and written) and high degree of professionalism.
- Highly organized and flexible team player who is able to assess priorities and meet deadlines.
- Good working knowledge of FDA regulatory requirements (i.e. GCPs, HIPPA)
- Knowledge and understanding of working on global clinical trials.
- Takes direction well and is able to understand and complete tasks under minimal supervision and with a high degree of accuracy and quality.
- Due to the nature of this position, it may be required to travel domestically & internationally if needed approximately 10% for study-related meetings or site visits.
- Proficiency with Microsoft Office (particularly Word, Excel, Outlook and PowerPoint).
- Ability to manage the clinical operations of multiple studies.
- Undergraduate degree preferred.
- Experience with regulatory document collection, review and tracking.
- Experience with maintaining a clinical study budget.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.
While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects. The employee is regularly required to stand; walk; sit; use hands and fingers, handle or feel: and reach with hands and arms.
Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus.
The employee must occasionally lift and/or move office products and supplies, up to 20 pounds.
The noise level in the work environment is usually low to moderate.