Clinical Research Associate Morphotek
THIS JOB HAS EXPIRED -- Provides sponsor oversight of clinical monitoring activities including document management, study training, support of field CRAs, safety reporting, and monitoring report review.
-- Manages site selection and activation, essential document collection, clinical supply tracking, and investigator site budgets.
-- Provides oversight to CROs, central imaging and labs, supply vendors, and other study vendors.
-- Develops and reviews clinical study documents including informed consent forms, source document worksheets, study manuals, and operational plans.
-- Coordinates meetings with study teams, vendors, and site staff.
Job Qualifications -- Bachelors preferred, or Associate degree in allied health with appropriate experience (e.g. RN, MT)
-- Minimum 2 years of clinical research experience with at least 1 year of monitoring experience. Experience with EDC/eCRFs is a plus.
-- Working knowledge of GCP/ICH regulatory guidelines and data management practices.
-- Proficient with document management practices relative to assuring quality of essential documents and other study-related documents.
-- Solid oral and written communication skills with ability to communicate effectively and professionally with various clinical trial and site personnel.
-- Strong attention to detail and good organizational skills.
||210 Welsh Pool Rd |
Exton, PA 19341
|Employment Type:||Full Time|
THIS JOB HAS EXPIRED