Job: Clinical TMF Associate, Istari Oncology, Morrisville, NC
Clinical TMF Associate
Morrisville, NC 27560 United States
Istari Oncology, Inc. offers full-time employees the opportunity to participate in an excellent compensation and benefits package including a 401(K) and medical, dental, vision, STD, LTD and life insurance.
Istari Oncology seeks a Clinical Trial Master File (TMF) Associate to provide administrative and project tracking support and assistance to the clinical research team, helping to ensure effective and efficient conduct of clinical research studies.
-Provide general administrative support to Clinical Research, Medical Affairs and Project Management.
-Assist Clinical Operations in completing required tasks to meet department and project goals.
-Support Clinical Operations with ongoing conduct of studies.
-Assist project teams with study specific documentation and guidelines.
-Set up, organize and maintain clinical study documentation (i.e. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archiving.
-Process Data Collection Forms including log in, tracking and quality control.
-Assist with quality control audits of clinical study documentation (i.e. Main Study Files, CRF Files, Monitoring Files, etc.).
-Coordinate ordering, dispatch and tracking of trial materials (i.e. CRFs, diary cards, lab supplies, drug supplies).
-Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
-Copy and route incoming correspondence, internal documentation, CRFs, etc.
-Assist in coordination of Investigator payments.
-Contact clinical sites for specific requests (i.e., enrollment updates, missing documentation, meeting arrangements).
-Assist in tracking and distributing safety reports.
-Coordinate document translation.
-Attend project team meetings and draft meeting minutes.
-Assist project management and project teams in coordinating Investigator Meetings, preparing activities and drafting meeting minutes.
-Assist in preparing and producing slides, overheads, and other materials.
-Assist with the coordination of team member tracking.
-High School Diploma (or equivalent) with related research or health care academic or work experience. Bachelor's degree in a scientific discipline and/or clinical trials experience preferred.
-Basic understanding of clinical trial regulations and processes.
-Familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.
-Understanding of Clinical Research Associates (CRA) work, including site visits.
-Good organizational, project management, and time management skills.
-Ability to easily learn and understand complex scientific and clinical concepts.
-Ability to manage multiple tasks.
-Meticulous attention to detail.
-Ability to work independently, with little oversight and lots of initiative.
-Strong written and oral communication skills.
-Exceptional computer skills including Microsoft Word, Excel, PowerPoint and Outlook. Microsoft Project skills a plus.
-Willingness to travel for job related activities if required.
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